Updates from Galena Biopharma, Inc. (GALE)

Biopharmaceutical company Galena Biopharma has moved forward with its Phase IIb trial of NeuVax (nelipepimut-S or E75) combined with Herceptin as an adjuvant treatment in HER2 1+/2+ breast cancer patients. An investigator is conducting the trial in collaboration with the company.

Roche Holding subsidiary Genentech is responsible for providing Herceptin for the trial at no charge. Galena began enrolling patients in the trial in March 2013. The trial has been designed to randomize 300 breast cancer patients (1:1) – node positive or negative – who are disease-free following standard of care, comparing NeuVax plus Herceptin vs. Herceptin alone with a primary endpoint of disease-free survival (DFS) at 24 months.

Galena also recently reported data from its ongoing Phase I/IIa trial of FPB (folate binding protein or E-39) in ovarian cancer (OC) and endometrial cancer (EC). FBP is overexpressed in more than 90% of OC and EC, compared with limited expression in nonmalignant tissues, which is a feature that makes the drug a good immunotherapy target. Galena uses FBP (plus GM-CSF) as an adjuvant treatment for preventing cancer recurrence in high-risk OC and EC. Enrollment in the study begun in February 2012, and 20 patients have been enrolled to date. FBP-treated patients had an 11.1% recurrence, while untreated patients had a 27.3% occurrence – representing a 59% reduction.

Galena’s Abstral (fentanyl) sublingual tablets, which are indicated for managing breakthrough pain in cancer patients 18 years and older who are already receiving and are tolerant to opioid therapy, is projected to contribute $1.5 million in revenue in 2013 and $8.2 million in 2014. This is contrasted with management’s guided revenues of $1.5 million to $3 million in 2013 and $8 million to $12 million in 2014. The company’s 10-year DCF values NeuVax at $4/share and Abstral at $1/share. At this stage, Galena is not assigning a market value to FBP. The company believes its long-term risk-reward profile is favorable.

A biopharmaceutical company based in Portland, Ore., Galena Biopharma is engaged in the development of innovative, targeted oncology treatments to address major unmet medical needs in the advancement of cancer care. For more information about Galena Biopharma, visit www.galenabiopharma.com.

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Plug Power Inc. (PLUG) Video Chart for Wednesday, July 31, 2013

PLUG has been trekking upward since February. Tuesday the stock made a move to hold above the 50-dma and break through the 200-dma on increased volume. The chart is in a nice position to challenge resistance at 53 cents as the indicators hold bullish readings. Support is at the previous resistance of 41 cents.

To view the video chart, visit the following link:
http://www.missionir.com/videos.html

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Calpian, Inc. (CLPI) Offers Latest Payment Transaction Processing Technology and Industry Connections

Calpian’s U.S. operations center around the company’s wholly owned subsidiary, Calpian Commerce, which provides a variety of merchant payment transaction services and software, including credit and debit card processing, for both physical and online businesses. Their products come from well-established companies that represent the latest in transaction processing technology, including VIMAS virtual merchant application for transaction monitoring and control.

• Northern Merchant Services (NMSI) has become a top producer for Elavon (formerly NOVA), a credit card transactioning subsidiary of U.S. Bancorp supporting millions of merchants, and is the premier servicing agent for Elavon’s community bank program. NMSI has also developed their own programs for community banks and their business deposit customers.

• AIRCHARGE is a well-known developer of software and hardware for commercial payment applications, covering multiple hardware and software platforms. The company offers leading-edge payment processing systems and payment solutions, allowing merchants to accept card and check payments from mobile devices, PDAs, and laptop computers.

• SecurePay provides continually upgraded payment gateway offerings for every aspect of ecommerce and physical merchant payment processing. SecurePay, a subsidiary of Pipeline Data Corp., supports thousands of merchants nationwide, offering both off-the-shelf and custom payment solutions.

In addition to Calpian’s operating partners, the company works with a number of strategic partners to ensure superior processing options and industry communication.

• Elavon
• CHASE Paymentech
• First Data
• Transaction World
• Electronic Transactions Association

For additional information, visit www.Calpian.com

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ZBB Energy Corp. (ZBB) Energy Storage and Power Control Solutions Continue to Gain Traction in China

ZBB Energy continues to win favor in the global market for exceptionally well engineered and integrated energy storage and intelligent power control platform technologies, designed to make using renewable sources a cinch, with multiple AC and DC inputs able to be dovetailed together seamlessly.

We are talking demand-driven power flow and optimized source usage here, with the capacity to operate as a modular, expandable power plant that can even function as an emergency power system during grid outages. The ZBB EnerSystem™ storage and control platform makes it extremely easy to manage a complex array of AC and DC sources, with inputs ranging anywhere from solar and fuel cells, to diesel generator sets. This robust, factory-tested power conversion system is ideal for off-grid solutions like remote communications towers, forward military bases, disaster relief scenarios, and even electric vehicle (EV) charging hubs, but the ZBB EnerSystem also features single point of power connection, making it suitable for a variety of on-grid solutions as well, like in commercial buildings.

At the core of the ZBB EnerSystem is the ZBB EnerSection™ power and energy control center (a patented hybrid conversion system), which meshes disparate AC and DC sources as well as multiple types of storage units easily. The company even offers an optional Grid Isolation Device that lets the customer isolate the entire system (to or from the grid) when connecting customer loads during outages, allowing for a seamless subsequent reconnect when service comes back up.

The backbone of storage is the company’s ZBB EnerStore® flow battery modules, representing a superb bulk energy storage solution that provides the lowest cost of ownership over a 20-year target lifecycle (per module) and handles advanced tasks like continuous output, load management, and time shifting, all without sacrificing one iota of performance, scalability, or modularity. These ZBB EnerStore units are completely self-contained, front-accessible cabinets that require no additional ventilation, no external power input to fire up, and a completely integrated DC bus that removes the need for onsite wiring of power connections. These incredibly powerful zinc/bromide battery-based systems are perfect for distributed energy applications and offer a whopping seven times expected service life over traditional lead/acid (with five times the energy density of redox flow designs) in typical 100% capacity usage scenarios. Better yet, the ZBB EnerStore units are expandable up to 500kWH in a single enclosure, with up to 6000kWH available if you daisy-chain several enclosures together.

A recent show of strength by the company as they continue to make inroads in global markets with their renewable-friendly grid modernization hardware can be seen in the recent (July 23) third-party certification of the ZBB EnerStore by the PRC’s equivalent of OSHA, NIOSH (National Institute for Occupational Safety and Health), a major coup that paves the way for more sales of ZBB hardware throughout Chinese markets. Extensive ion chromatography done by NIOSH on the ZBB EnerStore advanced flow battery confirms the safety standards inherent in their design and these batteries have some of the best chemical and vapor containment ratings in the entire product class.

This important certification actually comes in via Meineng Energy (Anhui Meineng Store Energy System Co., Ltd.), a leading provider of energy storage systems and solutions in the PRC with whom ZBB is currently in a joint venture. Meineng Energy GM and CEO, Brad Hansen, commented on the mounting acceptance by customers in China of the ZBB EnerStore, saying that the continued growth in adoptance was tied directly to an outstanding reputation for safety earned by the product.

Also in increasing demand among the company’s growing customer footprint are their designs for innovative hybrid vehicle power controls, made available through a supply agreement with Cummins Crosspoint, LLC subsidiary, Crosspoint Kinetics. Targeted at the domestic Class 4, 5, and 6, small to medium bus market, this ingenious controller technology is designed from the start to be easily adopted and is fully government compliant, perfect for integration or retrofitting in new or existing fleet vehicle). These systems are a real performance and mileage upgrade that also reduces emissions, while simultaneously doing away with any need for batteries, thanks to the use of onboard super capacitors.

For more info visit www.ZBBenergy.com

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Chanticleer Holdings, Inc. (HOTR) Rides Franchising Wave

America is no stranger to controversy when it comes to international relations. The U.S. has never been isolationist, and its growing influence in the world has continually come under scrutiny and fire. Nevertheless, while American political influence may be contested, American cultural influence remains strong. In spite of periodic calls for resistance, American culture, in one form or another, continues to spread. Industrial and economic globalization, together with the fall of communism, has accelerated the process, until now there are few places on the planet that don’t embrace at least some aspects of American popular life.

Although American influence crosses virtually every industry, perhaps the most visible aspect of American culture reach is seen in the spread of American based franchises. The concept of franchising goes back a long way in the U.S., which helps explain the ubiquitous nature of Coca-Cola, one of the first franchisers, which started in the 1800s. Today there are American food, hotel, and real estate operations in almost every country, and it continues to grow.

Chanticleer Holdings is riding the American franchising wave as part owner of Hooters of America (HOA). The iconic restaurant with its casual sports-themed atmosphere and popular orange-clad Hooters girls, has found a welcome home in a range of international markets. HOA is now operator and franchisor of over 400 Hooters restaurants in 28 countries. In the meantime, Chanticleer Holdings itself has been opening Hooters restaurants, with rights covering Hungary, South Africa, Australia, and parts of Brazil.

Chanticleer has partnered with Alex Hemingway and his team to form Hungary-based Crown Restaurants, with the goal of exclusively developing Hooters in Hungary. The first locations are in Budapest, but Hungary will also serve as a base for future expansion in Europe. In South Africa, Chanticleer already has four operating Hooters restaurants, and anticipates many more. The company has three locations in Australia, and is currently working to open two more. And they are now also working to open their first restaurant in Brazil, in Rio de Janeiro.

For additional information on Chanticleer Holdings, visit www.ChanticleerHoldings.com

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Dynamics Research Corp. (DRCO) Wins High Performance Computing NOAA Contract with a Ceiling Value of $10 Million

Dynamics Research, a prominent technology and management consulting company directed towards driving performance, process, and results for government clients, announced today that it has received a Blanket Purchasing Agreement for high performance computing software development and technical services at the National Oceanic and Atmospheric Administration (NOAA) Geophysical Fluid Dynamic Laboratory (GFDL). The 3-year contract has a maximum value of $9.7 million.

The contract stipulates that DRC will deliver a wide array of technical, scientific, and management support services including application development, high-performance computing tools development, network engineering, visualization, data engineering, software optimization, analysis of climate models, and strategic planning.

NOAA’s GFLD specializes in comprehensive, long lead-time research to expand the scientific knowledge of the foundational physical processes underlying the complex fluid systems of the atmosphere, oceans, and their interactions with Earth’s biogeochemical cycles. NOAA’s cutting-edge computing systems, featuring large scalable computers, coupled with archiving systems, analytics, visualization, networking and telecommunications capabilities, are absolutely critical to the GFDL mission and the success of NOAA’s research.

“Through this contract, DRC will have the opportunity to leverage our core capability of architecting complex predictive modeling, data visualization and high performance computing software to help drive government results,” Paul Strasser, senior vice president of DRC’s High Performance Technologies Group. “High performance computing is critical to NOAA’s scientific research and discovery mission.”

For further information, visit www.drc.com

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Edward Carney Appointed as Executive Vice President of Product and Customer Success at Extreme Networks, Inc. (EXTR)

Extreme Networks recently announced that Edward T. Carney has been appointed as Executive Vice President of Product and Customer Success. Carney will oversee the development of the company’s network platforms while also shaping customer experiences through Extreme Networks’ global service and support organizations. Carney will be based at Extreme Networks’ facility in Morrisville, NC.

“I look forward to helping Extreme Networks extend our R&D leadership that accelerates innovation, difference making services and provides an excellent customer experience across the board,” remarked Carney.

Carney is a recognized industry leader with over 30 years of experience leading R&D and customer support teams. His resume includes 15 years in general management at Cisco in Research Triangle Park (RTP), where he was vice president of the Networked Solutions Integration Test Engineering (NSITE) laboratory and was the senior executive for its RTP site.

Carney also spent 14 years at IBM where he directed engineering for the IBM Global Network. He currently serves on the Board and is past Chairman for the Food Bank of Central and Eastern North Carolina. Carney holds a B.S. in General Engineering from the United States Military Academy at West Point, NY.

“We have always been known for extreme product innovation. Ed has an impressive history of consistently delivering great networking products, leading successful teams and delivering a superior customer experience,” said Chuck Berger, CEO of Extreme Networks. “Our ability to attract an executive of Ed’s caliber is another testament to Extreme Networks potential going forward. We all look forward to working with Ed in the coming years.”

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Netlist, Inc. (NLST) Receives Notice of Allowance for Patent

Netlist, a leading provider of high performance memory solutions for the cloud computing and storage markets, yesterday announced that the United States Patent and Trademark Office has issued the company a notice of allowance for a patent application claiming key functions in non-volatile DIMMs. The patent application used by Netlist focuses primarily on the controlled transfer of critical information from volatile memory to non-volatile memory in response to events such as power disruption or failure.

Hybrid DIMM products have been part of Netlist’s shipments for over five years, included as part of its NVvault® and ExpressVault® product lines. According to the company, over 300,000 Netlist hybrid DIMM products have been used within mission critical servers and storage products. Additionally, Netlist’s technologies applied within PCIe form factor are now used by leading SSD and hybrid storage vendors. Hybrid DIMMs are quickly being adopted as the standard DDR4 memory for all servers.

“We are proud of our achievement in creating the hybrid DIMM,” said Netlist President and CEO, C.K. Hong. “This recent PTO allowance of another hybrid DIMM related patent application validates our technology leadership position in memory products for the storage market that protect and provide the highest bandwidth available for critical data in enterprise systems.”

Having steadily invested in and grown its IP portfolio, Netlist now boasts 36 issued patents and 38 US and foreign pending patent applications in the areas of high performance and high density memory subsystems and hybrid memory technologies.

For more information on Netlist, please visit www.netlist.com

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PITOOEY! Inc. (PTOO) Introduces a Better Way to Link Consumers and Businesses

PITOOEY! Inc. is all about breaking through the clutter of consumer search, to help people simplify and customize their interface with the vendor community, so that they are dealing one-on-one with businesses, and only the businesses, that they have chosen.

With PITOOEY! the user builds a list, reflecting the places and things that they like. Taken together it generates a composite picture of who they, as a consumer, really are. A picture that filters out all of the advertising noise, while maintaining the communications and opportunities they want to know about. For once, it puts the consumer in control of the messages they get, while creating an efficient, organized, and rewarding preference-based search experience.

The iPhone app process is simple and effective to use:

• Search and add your favorite places to a list
• Find new places near you and add them to your list
• ‘Auto-magically’ build your list based on those preferences
• Receive notifications only from companies on your list
• Find, save, and redeem offers for places near you

Through its rapidly developing app., PITOOEY! is pioneering a new approach to electronic marketing, while giving consumers a break. Not only does it provide consumers with a new and more personalized way to get the information they want, it also helps businesses enhance communication with target customers, consumers that are far more likely to actually purchase their product or service. By so doing, PITOOEY! addresses the single biggest problem facing online marketing, the problem of irrelevance.

Electronic advertising, versus print advertising, has made it far too easy for businesses to simply broadcast their marketing, hitting thousands or even millions of consumers, regardless of interest. As more and more businesses have jumped on the wagon, the result has become an irritating and off-putting barrage of unwanted solicitations, turning away the very consumers that vendors want to attract.

For more information, visit www.PITOOEY.com

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Progress in Galena Biopharma’s (GALE) Phase 1/2 Study with FBP Cancer Vaccine

Biopharmaceutical company Galena Biopharma, Inc. continues its ongoing Phase 1/2 dosing and safety study with the Folate binding protein (FBP) cancer vaccine.

Twenty patients have been enrolled in the first portion of the 1/2a FBP (E39) clinical trial, which is being initially performed as a 3×3, dose-escalation safety trial enrolling endometrial (EC) and ovarian (OC) cancer patients with tumors expressing any level of FBP. E39 + GM-CSF is being administered in the adjuvant setting with the aim of preventing recurrences in high-risk EC and OC patients who have been rendered disease-free with standard-of-care therapy. HLA-A2+ patients are enrolled into the vaccine group (VG), while HLA-A2- patients are being prospectively followed as the untreated control group (CG). During the primary vaccine series (PVS), six monthly intradermal inoculations (R1-R6) of 100/500/1,000 mcg of E39 + 250 mcg GMCSF (immunoadjuvant) are administered to the VG. After each inoculation, local reactions (LR) are measured as the orthogonal mean (OM). IR in the VG is assessed in vivo by delayed type hypersensitivity (DTH) test, measured as the OM. DTH is measured pre-vaccination (R0) and after the PVS (R6).

The arms of the study are well-balanced without any differences in age, grade, stage III, or node positivity status between the groups. E39 was well-tolerated overall, and the study, to date, has shown an 11.1% recurrence rate with E39 versus a 27.3% recurrence rate in the control group, which is a recurrence reduction of 59.3%.

E39 is an immunogenic peptide derived from FBP/FOLR-alpha and is emerging as a potential target for cancer immunotherapy, due to its high expression in various malignancies and its low expression in normal human cells. Early results from Galena’s Phase 1/2a trial indicate the E39 vaccine is well-tolerated and elicits a strong in vivo immunologic response that could provide clinical benefit.

A biopharmaceutical company based in Portland, Ore., Galena Biopharma is engaged in the development of innovative, targeted oncology treatments to address major unmet medical needs in the advancement of cancer care. For more information about Galena Biopharma, visit www.galenabiopharma.com.

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Verenium Corp. (VRNM) and Novus Unveil New Phytase Enzyme Product, Unlocking the Hidden Value of Phytate

Industrial biotechnology company Verenium and global animal health and nutrition solutions leader Novus International have announced the name of their new phytase enyme product.

Known as CIBENZA PHYTAVERSE, this new, innovative phytase is designed specifically to unlock more of the hidden nutritional value in phytate to improve animal growth and wellbeing.

Vernium and Novus, who entered into a strategic partnership in 2011, have designed CIBENZA PHYTAVERSE to have specific performance characteristics, offering significant advantages over current phytase products. The product’s performance characteristics include: high in vivo activity under gastric conditions for sustained performance; improved activity at low substrate concentrations to maximize phytate hydrolysis; high gastric stability for activity throughout the upper gastrointestinal tract; high intrinsic thermotolerance and pelleting stability; and improved bioavailability due to eliminating the need for thermo protective coatings.

CIBENZA PHYTAVERSE has demonstrated these superior performance characteristics in animal trials, based on standard metrics like weight gain, feed conversion ratios, and phosphorous mineralization (tibia ash) as compared with other phytase products. The results have indicated that including CIBENZA PHYTAVERSE in monogastric diets can offer improved nutrition and economics to the animal feed industry.

The two companies plan to launch CIBENZA PHYTAVERSE in certain geographical regions beginning this year.

For more information, visit www.verenium.com or www.novusint.com

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VistaGen Therapeutics, Inc. (VSTA) Uses Proprietary Stem Cell Technology to Address Two Separate Medical Needs

VistaGen Therapeutics is applying its innovative stem cell technologies in two separate but related fields. On the one hand, the company has developed one of the most important new approaches to the field of drug testing in decades, the use of stem cells to create their proprietary Human Clinical Trials in a Test Tube bioassay platform, which is designed to avoid the extensive time and expense involved in animal or other traditional tests. But VistaGen is also exploring a number of opportunities in the field of regenerative cell therapy, focused on blood, cartilage, heart, liver, and pancreas cells, each based on the proprietary stem cell differentiation and production capabilities of the company’s testing platform.

VistaGen’s stem cell based drug testing technology has resulted in CardioSafe 3D, a three-dimensional in vitro bioassay system for accurately assessing toxic (as well as non-toxic) effects of small-molecule drug candidates on human heart tissue. They are also finalizing the development of LiverSafe 3D, offering early and cost effective drug effect testing for the liver. VistaGen’s primary near-term goal for their testing technology is to use CardioSafe 3D, and eventually LiverSafe 3D, for drug rescue, to recapture substantial potential value associated with the pharmaceutical industry’s prior investment in drug discovery and development, involving once-promising small molecule drug candidates that were discontinued due to safety issues related to unexpected heart or liver toxicity or drug metabolism issues.

On the regenerative cell therapy side of things, VistaGen has developed AV-101, an orally available small molecule prodrug candidate, aimed at the needs of the multi-billion dollar neurological disease and disorders market. AV-101 has successfully completed Phase I development in the U.S. for treatment of neuropathic pain, a serious and chronic condition causing pain after an injury or disease of the peripheral or central nervous system. Neuropathic pain affects approximately 1.8 million people in the U.S. alone. The company has already been awarded over $8.3 million of grant funding by the National Institutes of Health to support preclinical and Phase I clinical development of AV-101. The company believes that AV-101 may also be a candidate for development as a therapeutic alternative for depression, epilepsy, and Parkinson’s disease.

For additional information, visit www.VistaGen.com

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Aehr Test Systems (AEHR) Receives Orders Totaling Over $2.5 Million from Leading IC Manufacturer

Aehr Test Systems, a global vendor of semiconductor test and burn-in equipment, announced today that it has received orders from a leading manufacturer of advanced logic integrated circuits (ICs) totaling over $2.5 million for its burn-in and test systems. This particular customer makes its products for automotive, embedded processing, digital signal processing, and analog applications. This batch of orders includes down payments to ensure delivery slots and volume pricing discounts.

Specifically, the orders are for multiple Advanced Burn-in and Test Systems (ABTS™), as well as a follow-on MAX™ system. The ABTS systems were designed with an innovative low-cost high volume configuration directed at production test and burn-in of lower-power devices. This new ABTS delivers the flexibility of high voltage Device Power Supplies configurable with 60V, 80V, 150V, or 230V programmable voltage ranges, all of which are required for automotive and power-line applications. This new ABTS will begin to ship in the fourth quarter of 2013.

“We are pleased to receive these orders for production test and burn-in systems,” said Carl Buck, vice president of marketing at Aehr Test Systems. “The new ABTS system configuration offers over 50% more device test capacity than our previous MAX family of production test and burn-in systems. Importantly, this new ABTS is designed to allow the customer to continue to use their extensive inventory of MAX-style burn-in boards on the ABTS while also offering the increased capacity for new devices. This ABTS configuration extends the capabilities of our MAX systems by providing an increase to 128 I/O channels and 8 unique device power supplies per burn-in board, in addition to the new high-voltage supplies.

“The new configuration extends our already successful ABTS-Pi system, which features Individual Temperature Control of each device for high power applications, to provide a lower cost and higher parallel solution for automotive, standard logic and high voltage applications,” Buck concluded.

The ABTS family of products is founded upon a new hardware and software platform that was purposely designed for compatibility with currently available devices, as well as devices that will be introduced in the coming years. It can test and burn-in both logic and memory devices, including resources for high pin-count devices and configurations for high-power and low-power applications. The ABTS system can be configured with up to 72 burn-in boards with up to 320 I/O channels each and 32M of test vector memory per channel. The ABTS system is optimized for use with the Sensata iSocket* Thermal Management Technology, which provides a scalable cost-effective solution using individual device temperature control for ICs up to 75 watts or more. Individual temperature control enables high-power devices with a broad range of power dissipation to be burned-in simultaneously in a single burn-in chamber while maintaining a precise device temperature. The ABTS system also uses N+1 redundancy technology for many key components in the system to maximize system uptime.

For further information, please visit www.aehr.com

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Snap Interactive’s (STVI) AYI.com Reports Increased Message Activity Following Friends and Interests Integration

AYI.com announced today that its seeing increased messaging between users on its social dating site, now that users can discover what they have in common via the new friends and interests integration. The site, owned by Snap Interactive, now makes it easier for users to see how they’re connected to each other.

AYI.com’s friends and interests integration is a move towards differentiating itself from other dating sites. Historically, there has been a large disconnect between the way singles meet in the real world versus online. Offline, singles commonly meet through friends and interests, but very few dating sites offer functionality around the social and interest graph. AYI.com aims to change that. Through its improved browsing experience, the site offers targeted and increased activity, making online dating a better experience for all.

AYI.com’s interest-based matching feature can also extend to other areas of their social media identity; over 25 million AYI.com users have Facebook-connected profiles, making it possible to import interests with just one click. This seamless integration has allowed AYI.com to build up significant scale of interest data, which is updated in real time as users add interests through Facebook. This keeps AYI.com profiles fresh and updated, compared to typical dating sites where data is often infrequently updated or can grow stale.

Clifford Lerner, SNAP’s CEO, remarked, “With over 25 million Facebook connected profiles, SNAP is in the unique position of being able to integrate friends and interests into online dating in a meaningful way. Friends and interest-based functionality also provides singles with an online dating experience that more closely mirrors the way singles traditionally meet in the real world.”

According to current database statistics, AYI.com users have amassed over 1 billion interests in the aggregate. Profiles have an average of about 68 interests per user. Music-related messages seem to generate the most activity on the site, with Adele, Pink Floyd, and Celine Dion being the top interests leading to messaging.

For more information, visit www.snap-interactive.com

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ORBCOMM, Inc. (ORBC) GlobalTrak Finalizes Shipment of Fuel Monitoring Solution in Afghanistan

ORBCOMM, a global provider of Machine-to-Machine (M2M) solutions, today announced that Globaltrack, a division of ORBCOMM, has completed the shipment of its state-of-the-art fuel monitoring system, which is designed to prevent theft of mission-critical fuel used by U.S. and NATO forces in Afghanistan. The company has also deployed a team to manage on-site installation and launch of the new system.

The Defense Logistics Agency (DLA), following comprehensive review of several major companies, selected GlobalTrak for this project and determined that it was the only solution provider that could demonstrate both fuel level monitoring as well as security of the fuel ports and valves. The primary customers who will benefit from this are those that have been contracted by DLA to deliver fuel to critical points around Afghanistan.

This fuel monitoring system utilizes an integrated tracking device that delivers near-real-time location, fuel level, and security status of fuel tankers via the use of cellular and satellite communication networks to a central data fusion monitoring center. This data can in turn be accessed by the customer through the Internet or by mobile devices. To meet a customer’s specific requirements, the system enables the generation of customized reports.

Fuel sensors have been installed in chambers of a fuel tanker and wireless security seals that can be connected to valves or other fuel access points enabling the system to communicate effectively with these tankers. Through continuous monitoring of fuel levels and security status, this high-performance solution will send an alarm in the event of a sudden breach or change in fuel level. The solution also delivers valuable metrics on driver and company performance for transportation contractors, creating a powerful forensics tool for the investigation of theft events.

“The shipment of our fuel monitoring solution to Afghanistan is an exciting milestone for this project, and we are already seeing a growing market need for fuel security in areas outside the region, such as in Africa, Latin America and other parts of the Middle East, where fuel theft is also prevalent,” said Marc Eisenberg, ORBCOMM’s Chief Executive Officer.

“We believe this solution will become a major deterrent to fuel theft in both military and commercial zones throughout the globe and will significantly improve operational efficiency for fuel transporters and other key stakeholders.”

For more information on ORBCOMM, please visit www.orbcomm.com

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Cardium Therapeutics, Inc. (CXM) Wraps Up a Busy Month

The financial front has been especially active for Cardium Therapeutics over the past few weeks. The San Diego based health sciences and regenerative medicine company finalized and executed a reverse stock split, a condition of an earlier securities purchase agreement, and also completed the second tranche of a major stock offering, bringing the total gross proceeds of the offering to approximately $4.0 million. Cardium focuses on the acquisition and strategic development of products and businesses with the potential to address significant unmet medical needs, and they’ve been careful in structuring their finances to fit the company’s short-term and long-term strategic plans.

Cardium’s clearly laid out strategy is to build a portfolio of medical product candidates at various stages of development, commercializing them in a timely manner. So far, this is exactly what they’ve managed to do as they move forward with products at different levels of development and commercialization.

Their major product candidate Generx has been undergoing clinical study at key medical centers in Russia, all in connection with commercialization plans covering the marketing and sale of Generx in the Russian Federation (and CIS). Generx, a DNA-based angiogenic growth factor therapeutic, offers a uniquely easy to use and cost effective treatment for people with advanced coronary artery disease. Unlike other non-invasive heart disease treatments, Generx actually stimulates the growth of blood vessels around the heart, rather than simply masking the pain. They are also seeking clinical development and commercialization partners for Generx in other countries, such as India, China, and Brazil, where the need for simpler but cost effective treatments is greatest.

At the same time, Cardium has been securing commercialization partners for the marketing and sale of their already FDA-cleared advanced wound care product, Excellagen. The company recently announced a distribution agreement with Academy Medical, LLC to market, sell, and distribute Excellagen to U.S. government medical providers, a big step considering that Academy is a key supplier to the government’s massive Veterans Administration healthcare system and military hospitals. Cardium is also developing additional related tissue regeneration product extensions, to include small molecule drugs, peptides, stem cells, conditioned cell media, DNA-based biologic products, and Excellagen-based antimicrobials.

As far as products already holding a well-established place in the market, Cardium’s subsidiary To Go Brands has a wide portfolio of healthy-lifestyle products, already proven in the marketplace and generating dependable revenue. To Go Brands sells 100%-natural nutraceutical powder mixes, supplements, and chews, designed for convenient use by a growing market of health-conscious consumers.

For additional information, visit www.CardiumTHX.com

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Joe’s Jeans, Inc. (JOEZ) Debuts Retail Boutique in Northern California at the Westfield Valley Fair Mall

Casual chic lifestyle brand Joe’s Jeans announced earlier today the exciting opening of its thirty-second retail boutique. The trendy boutique will be located at the Westfield Valley Fair shopping center in the city of Santa Clara, California. Joe’s® 1,500 square-foot boutique will feature the brand’s signature all-white interior juxtaposed, crystal chandeliers, and vintage furniture pieces, all handpicked by Joe Dahan, Founder & Creative Director.

With over a decade in fashion, Joe’s has remained true to their DNA throughout their expansion. The Santa Clara location, Joe’s eleventh retail store in the state of California is set to feature the complete denim and lifestyle line for men, women, and children. Joe’s currently has boutiques across the United States that include major metropolitan cities such as New York City, Los Angeles, Chicago, Miami, Atlanta, and San Francisco. In addition Joe’s Jeans is available internationally in Europe, Asia, Canada, and Latin America. Expansion efforts will continue throughout 2013.

President and CEO, Marc Crossman commented, “With California being home to our brand, we’re excited to expand our presence in upscale, fashion-forward markets. Joe’s is dedicated to offering its customers the best in premium denim and apparel, and our newest location in one of Northern California’s largest shopping destinations will only help us to further serve new and existing fans of our brand.”

To learn more about Joe’s Jeans, please visit www.joesjeans.com

Joe’s Jeans, Inc. (JOEZ) Debuts Retail Boutique in Northern California at the Westfield Valley Fair Mall

Casual chic lifestyle brand Joe’s Jeans announced earlier today the exciting opening of its thirty-second retail boutique. The trendy boutique will be located at the Westfield Valley Fair shopping center in the city of Santa Clara, California. Joe’s® 1,500 square-foot boutique will feature the brand’s signature all-white interior juxtaposed, crystal chandeliers, and vintage furniture pieces, all handpicked by Joe Dahan, Founder & Creative Director.

With over a decade in fashion, Joe’s has remained true to their DNA throughout their expansion. The Santa Clara location, Joe’s eleventh retail store in the state of California is set to feature the complete denim and lifestyle line for men, women, and children. Joe’s currently has boutiques across the United States that include major metropolitan cities such as New York City, Los Angeles, Chicago, Miami, Atlanta, and San Francisco. In addition Joe’s Jeans is available internationally in Europe, Asia, Canada, and Latin America. Expansion efforts will continue throughout 2013.

President and CEO, Marc Crossman commented, “With California being home to our brand, we’re excited to expand our presence in upscale, fashion-forward markets. Joe’s is dedicated to offering its customers the best in premium denim and apparel, and our newest location in one of Northern California’s largest shopping destinations will only help us to further serve new and existing fans of our brand.”

To learn more about Joe’s Jeans, please visit www.joesjeans.com

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Corcept Therapeutics, Inc. (CORT) Partners with Idis to Provide Worldwide Access to Korlym

Pharmaceutical company Corcept Therapeutics has announced that its Korlym (mifepristone) 300 mg tablets are available to patients outside the U.S. through an Idis Access Program.

Through a regulatory-compliant and ethical channel on a named-patient basis, Idis Access Programs enable patients worldwide to be prescribed investigational or approved drugs prior to their commercial launch in the patient’s country.

Since April 2012, Corcept has been offering Korlym in the U.S. as a once-daily oral treatment for hyperglycemia secondary to endogenous Cushing’s syndrome in adult patients with type 2 diabetes or glucose intolerance who have failed surgery or are not candidates for surgery.

“We are pleased to partner with Idis so that physicians outside the United States can prescribe Korlym,” said Corcept Vice President of Commercial Operations Steven Lo. “We are dedicated to meeting the needs of patients worldwide. Our partnership with Idis will help us make sure that every Cushing’s syndrome patient who could benefit from Korlym will have access to the medicine.”

Interested licensed healthcare professionals outside the U.S. who have patients that might benefit from Korlym can contact Idis directly for more information.

For more information, visit www.corcept.com

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Advaxis, Inc. (ADXS) Provides Corporate Update, Program Development, Outlook for 2013

Advaxis, a clinical-stage biotech company developing the next generation of immunotherapies for cancer and infectious diseases, today issued an updated business outlook for 2013, highlighting its clinical initiatives to advance lead product candidate ADXS-HPV to registrational trials. The company also provided additional development and financial data.

“Earlier in the year, Advaxis stated that it would provide periodic updates to its business outlook and announced two overarching objectives for 2013: one, to advance our lead product candidate, ADXS-HPV, toward a registration development program and, two, to continue to significantly strengthen our financial position,” Thomas A. Moore, chairman and CEO of Advaxis, stated in the press release. “We have outlined the progress the Company has made on these two goals, as well as anticipated 2013 milestone events.”

Corporate Goals for 2013

A determination for three applications for Orphan Drug      Designations with the FDA for ADXS-HPV in three human papillomavirus      (HPV)-associated indications: invasive cervical cancer, anal cancer, and      head and neck cancer;
Initiate dialogue with the FDA to discuss ADXS-HPV      clinical development plans for the treatment of cervical cancer;
Complete the elements required to file an      Investigational New Drug (IND) application with the FDA for ADXS-PSA for      the treatment of prostate cancer in the first half of 2014;
Advance the canine osteosarcoma study into Phase 2 and      expand to additional collaborative academic centers; and
File an initial listing application for the NASDAQ      Capital Market or NYSE AMEX.
ADXS also provided the following 2013 clinical program update:

GOG 0265 safety run-in completed and study opened to the GOG group-wide
Cervical Cancer Program – Final 12-month survival data from the Phase 2 cervical cancer trial announced at the 2013 ASCO Annual Meeting in Chicago in June.  Preliminary efficacy data continue to show apparent prolonged survival, durable complete and partial tumor reductions, as well as stable disease with ADXS-HPV alone or in combination with cisplatin.  ADXS has made substantial progress in analyzing the Phase 2 data and is planning a study to determine the best dose and dosing regimen to enhance efficacy without compromising the encouraging preliminary safety profile already observed. As of July 2013, 10 patients have been enrolled in the safety run-in portion of the study.
Head and Neck Cancer Program – Cancer Research UK (CRUK) is funding a Phase 1/2 to evaluate the use of ADXS-HPV for the treatment of 27 patients with HPV positive head and neck cancer. As of July 2013, 16 patients have been enrolled in the study.
Anal Cancer Program – The Brown University Oncology Group (BrUOG) is funding and coordinating a Phase 1/2 study of ADXS-HPV in 25 patients with HPV-associated anal cancer. As of July 2013, 3 patients have been enrolled in the study.
Canine Osteosarcoma Study – Third dose cohort underway in the canine osteosarcoma study. In this trial, dogs that have undergone SOC for osteosarcoma, and over-express HER-2/neu in their tumors, are treated with ADXS-cHER2. Updated preliminary data show a significant survival advantage for 9 dogs that received SOC plus ADXS-cHER2 compared to 11 dogs, whose owners elected not to participate in the trial, but who were followed for survival. At this point in the study, 8 of 9 dogs treated with ADXS-cHER2 are alive (mean survival undefined), compared with 5 of 11 dogs in the control group (mean survival 265 days).
Prostate Cancer Program – ADXS plans to file an IND with the FDA for ADXS-PSA in the treatment of prostate cancer in the first half of 2014. In June 2011, the company conducted a pre-IND meeting with the FDA to discuss the CMC, pharmacology, toxicology, and clinical plans for ADXS-PSA. The required toxicology studies have been completed and data analyses are ongoing.
Pertaining to business development, ADXS reports it has established several confidentiality agreements with biopharmaceutical companies for the license of ADXS-HPV in the U.S., Asia, and India. ADXS plans to pursue these negotiations to closure in the coming months.

The company has also entered into a confidentiality agreement with the animal health division of a major pharmaceutical company, among other potential licensing agreements with other companies, for the license of ADXS-cHER2.

ADXS stockholders in June approved the effect of a 1-for-25 reverse stock split and a decrease in authorized shares of the company to 25 million from 1 billion shares. The company intends to seek an uplisting to a national exchange in the near term, and said it believes that the combination of completing the reverse stock split and the contemplated uplisting could heighten the interest of the financial community in Advaxis, potentially increase investor interest in the company, and strengthen its financial health.

For more information visit: www.advaxis.com

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Galena Biopharma, Inc. (GALE) is “One to Watch”

Galena Biopharma is focused on developing and commercializing targeted oncology treatments to address major unmet medical needs and advance cancer care. The company’s peptide vaccine immunotherapies harness the patient’s own immune system to identify and destroy cancer cells. Utilizing peptide immunogens has many clinical advantages, including an excellent safety profile and long-lasting protection through immune system activation and convenient delivery.

Abstral® is Galena’s FDA-approved therapy for breakthrough cancer pain in opioid-tolerant cancer patients. It is estimated that at least 40% of cancer patients experience breakthrough pain episodes multiple times per day, each with a median duration of 30 minutes. The innovative Abstral formulation rapidly dissolves under the tongue in seconds, provides rapid relief of breakthrough pain in minutes, and matches the duration of the entire pain episode.

NeuVax™, currently in a Phase III trial, has been developed to bolster the immune response in breast cancer patients. The trial, entitled PRESENT (Prevention of Recurrence in Early-Stage, Node-Positive Breast Cancer with Low to Intermediate HER2 Expression with NeuVax Treatment), is being conducted under an FDA-approved Special Protocol Assessment (SPA). The therapy targets the 50% to 60% of patients with tumors that express HER2 in low-to-intermediate amounts and achieve remission with current standard of care, but who have no available HER2 targeted adjuvant treatment options to maintain their disease-free status. NeuVax can be used to help the body target and kill undetected cancer cells before they grow into metastatic tumors.

The company’s second product candidate, Folate Binding Protein (FBP), is a highly immunogenic peptide that can stimulate the immune system to recognize and destroy preclinical FBP-expressing cancer cells. FBP is over-expressed in more than 90% of ovarian and endometrial cancers, as well as 20%-50% of breast, lung, colorectal, and renal cell carcinomas. This vaccine is currently in a Phase 1/2 trial in two gynecological cancers: ovarian and endometrial adenocarcinomas.

Galena’s experienced management team has an excellent track record in clinical development, commercial operations, and successful partnership execution. Enhanced by multiple development and commercial collaborations, the company’s suite of immunotherapeutic solutions is poised to capitalize on the vast opportunities in today’s healthcare industry.

Note: Abstral carries a Black Box warning. Please refer to the full Prescribing Information for further information.

Key Investment Highlights
FDA-Approved Product to Treat Breakthrough Cancer Pain
Phase III PRESENT trial ongoing under FDA-approved SPA
Pipeline of Targeted Immunotherapies Addressing Major Markets
Strong Analyst Support with Median Price Target of $5.50
The Therapeutic Cancer Vaccine Market is Doubling in Size Each Year

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NeoGenomics, Inc. (NEO) Launches Tests for Profiling of Myelodysplastic Syndrome

NeoGenomics is a leading clinical laboratory that specializes in cancer genetics testing, the fastest growing segment of the laboratory industry. The company’s testing services include: cytogenetics, morphology studies, anatomic pathology, flow cytometry, immunohistochemistry, fluorescence in-situ hybridization, and molecular genetic testing.

The company announced today it had validated and introduced a number of clinical molecular tests for the comprehensive profiling of myelodysplastic syndrome (MDS). MDS is a complex and hard-to-diagnose disease because of its wide range of clinical behaviors. It is myeloid malignancy characterized by peripheral blood cytopenias. The disease can arise de novo or after therapies for other cancers such as chemo or radiation therapies. It is diagnosed in more than 10,000 people annually in the U.S.

NeoGenomics’ comprehensive MDS testing covers all of the known relevant molecular mutations associated with the disease. The company now provides mutation analysis of the following genes: SF3B1, U2AF1, SRSF2, ZRSR2, RUNX1, EZH2, ASXL1, TET2, TP53, NRAS, CBL, PTPN11, IDH1/2, and ETV6. The genes can be analyzed individually or as a group. NeoGenomics’ tests can provide profound insights into the disease and guide physicians in designing the proper personalized therapeutic strategies for each individual patient.

The new MDS tests mean the company now offers the most extensive menu of molecular testing services focused on cancer in the U.S. The tests are part of NeoGenomics’ strategy to become the leading laboratory in the quickly evolving field of molecular pathology. For additional information about NeoGenomics, its new MDS tests, and its entire range of testing services, please visit www.neogenomics.com.

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Digital Cinema Destinations Corp. (DCIN) Strategy to Expand Theatrical Footprint, Screen Count

Digital Cinema Destinations, operating 18 cinemas and 178 digital screens under the name Digiplex Destinations, is a rapidly growing U.S. motion picture exhibitor featuring major motion pictures, coverage of live sports events, concerts, conferences, operas, ballet, Broadway plays, independent films, and more.

To continue its historical growth, the company has established a consolidation strategy it believes will maximize the digital cinema circuit and drive financial benefits for the company.

DCIN sees its opportunity in acquiring solid performing theaters in accretive transactions at reasonable cash flow multiples. The company’s long-term goal is to create a national circuit of cinemas consisting of 100 theaters/1,000 screens in 75/100 top designated marketing areas.

Thus far, this business model has fared well. Since its IPO in April 2012, DCIN has grown its screen count to 18 theatres/178 screens (as of February 2, 2013) from 3 theaters/19 screens. This has resulted in increased total revenue per screen over last four quarters versus prior-year periods by 18%, 30%, 15%, and 48% respectively.

DCIN has secured a Start Media Joint Venture and Term Loan to assist in support of its theater circuit expansion goals. The company says that most recent acquisitions via joint venture will produce a return on investment to DCIN of approximately 30%.

For more information, visit www.digiplexdest.com

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Chanticleer Holdings, Inc. (HOTR) Well Received in Hungary, Says CEO of European Ops

Chanticleer Holdings owns and operates Hooters branded restaurants in emerging international markets. HOTR holds exclusive franchise rights to these restaurants in parts of Brazil, all of South Africa, and Hungary, and has joint ventured with the owner of exclusive Hooters franchise rights in Australia.

Currently the company owns in whole or part six Hooters restaurants, double from three restaurants in 2011. The company’s goal is to grow its number of operational restaurants by 67 percent to 10 total restaurants in the near future. As part of this strategy, HOTR currently is working to open a restaurant in Rio de Janeiro, Brazil; Townsville and Broadbeach, Australia; and most recently opened a new store in Budapest, Hungary.

“The European reception to U.S.-based restaurants is quite good … one of the big benefits of Hooters as brand is that there’s really no other brand like it. For that reason, and frankly our ability to execute well, I think we’re going to do very well in Europe,” Alex Hemingway, CEO of Chanticleer Holdings European Operations, states in a company video. “The reception to Hooters in Hungary has been very strong.”

HOTR has partnered with management group Crown Restaurants, an agreement under which HOTR owns an 80 percent interest in the Hungary restaurant while Crown owns the remaining 20 percent. HOTR later intends to also expand in other European markets.

For more information visit www.chanticleerholdings.com

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Calpian, Inc. (CLPI) Rolling Out New Services in India

Texas-based Calpian is a payment processing leader, providing a full range of payment processing services and software to physical and online merchants in the U.S. market. But there’s another side of the company. In April 2012, Calpian acquired significant ownership of India-based My Mobile Payments Limited (“MMPL”) through a newly-formed company, Digital Payments Processing Limited (“DPPL”). Working with MMPL, DPPL is the customer face of Money-on-Mobile (MOM), a stored-value mobile payments service that gives consumers the ability to use their mobile phones to pay for goods and services or transfer funds from one cell phone to another using simple SMS text functionality. Money-on-Mobile has been accessed by approximately 53 million unique telephone number customers at over 138,711 Indian retail locations.

Now, Money-On-Mobile has announced plans to introduce person to person (P2P) money transfer service in India sometime later this year. In an article by Danish Khan at Light Reading India (http://dtg.fm/Zn4q), MOM Managing Director Shashank M. Joshi says that the new P2P service should roll out in the next six months. He also says that the company will be introducing a new mobile service that essentially converts a smartphone into a payment device for retailers. The article points to MOM’s claim that it has the largest market share in B2C mobile payments in terms of distribution network in India, with Joshi saying the company works on a zero capex and operator agnostic model, which helps the company to achieve better efficiency.

According to a 2012 study by MasterCard Worldwide, less than 50% of India’s population has a bank account and yet mobile penetration is over 50%. It’s a market that is rapidly growing and is significantly higher than Internet penetration which MasterCard counts at 15-25%. As such, Money-on-Mobile’s pre-paid mobile payment solution provides a vital service to Indian consumers. According to the Telecom Regulatory Authority of India, there are over 900 million cell phone subscribers in India, with nearly 10 million new subscribers being added each month. In India, Money-on-Mobile has approximately 35 million unique phone number customers and over 118,000 retail partners currently offering the service.

For additional information, visit www.Calpian.com

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Virtual Piggy, Inc. (VPIG) Partners with FlipGive in Give-Marketing Initiative

Financial management platform for teens Virtual Piggy announced yesterday that it will be providing its youth-friendly payment system to FlipGive, a digital give-marketing platform.

Give-marketing programs help brands create positive social impact in their communities while also driving sales. FlipGive connects brands to the $200+ billion fundraising market, essentially converting customers into a money-raising sales force. FlipGive is currently partnered with Johnson & Johnson, Lowes, Schwan’s, Aldo, Indigo, and more.

“Community giving is a key value for Virtual Piggy’s consumers, and FlipGive provides our user base with an excellent fundraising option that we’re really excited about,” said Dr. Jo Webber, Virtual Piggy’s Founder and CEO. “It’s important for all ages to be able to support causes they care about on a local, regional and global level.”

FlipGive’s Brand Director, Mark Marovich, added, “Virtual Piggy’s technology makes it much easier for kids and teens to directly support the fundraising efforts of their friends and people in their communities.”

Virtual Piggy empowers youth under 18 to make purchasing, saving, and other money management decisions for themselves within boundaries established by parents. Always 100% free to use, the technology serves as a family wallet that is available online or via mobile.

For information about Virtual Piggy visit www.VirtualPiggy.com

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Ford and GM See Surge in Above-Average Transaction Prices

Ford and General Motors announced this week that the vast majority of all their global profits are again coming from North America, in part due to low interest rates, affluent baby boomers, and Americans’ rekindled passion for pickup trucks, pushing the average price of a new vehicle above $31,000.

Coupled with Americans willingness to pay higher prices, automakers are also spending much less on rebates, cut-rate financing, and other sales lures.

“People complain cars are expensive, but they also buy the most expensive ones,” commented analyst Jesse Toprak of TrueCar, which tracks pricing data. “People are happy to pay more if they get more.”

A cause for concern is that loans are getting longer. In the fourth quarter of 2012, loans lasted for 65month on average which, according to Experian, is the longest ever. Longer-term loans allow buyers to reduce monthly payments.

Accounting for 30% of new-vehicle retail transactions in the first half of 2013 are loans of 75 months or longer, up from 29% in the first half of 2012, according to J.D. Power and LMC Automotive.

Compared with 21% in the same period of 2012, leasing has increased to 24% of all sales in the first half of 2013. But John Humphrey, senior vice president of the global automotive practice at J.D. Power, stated the rise in new-vehicle leasing “is providing a counterbalance” to the increase on long-term loans.

Consistent with long-term loans, leasing tends to make a $30,000 vehicle more affordable than buying it with three-year to four-year financing. Additionally, dealers embrace leasing because it assures those customers return in three to four years.

For the Detroit Three, this can be likened to a surfer’s perfect wave. Trucks have had one of the largest impacts on Ford and GM, increasing average transaction price by $2,000, higher than the industry average – $33,272 for Ford and $33,218 for GM in June.

According to Kelley Blue Blook, the average pickup sold for $40,361 in June, up 2% from a year earlier, even with GM selling down inventories of their outgoing 2013 models.

Industry-wide new vehicle prices are up 2% from a year earlier, only slightly more than the 1.8% increase in the consumer price index (the inflation rate) from June 2012 to June 2013, TrueCar reports.

The Federal Reserve potentially retreating from its stimulative policy of buying about $85 million of government bonds every month also creates a potential risk. However, Thomson Reuters and the University of Michigan report that consumer confidence in May and June was as strong as at any point in the last six years. According to Bankrate.com, the average interest rate on a four-year new car loan is 2.7%.

“The stage is set for stronger growth for the rest of the year,” added Robert Dye, chief economist at Comerica Bank.

Jessica Caldwell, economist with Edmunds.com, stated that the average age of vehicles on the road remains at 11-12 years, underscoring that there is still plenty of pent-up demand that will push more people into showrooms.

The fact that the majority of buyers are older, wealthier baby boomers – while young millennials don’t have the income or interest to buy a car – is another aspect to monitor. The Consumer Financial Protection Bureau projects that Americans now owe the federal government more than $1 trillion in student loan debt.

A report released in May by the University of Michigan Transportation Research Institute found that people between the ages of 55 and 64 are 15 times more likely to buy a new vehicle than those born after 1980.

However, Dye said a robust economic cycle “starts with wealthy baby boomers buying cars, and then we put more autoworkers to work and income growth and confidence and more jobs for millennials. That’s the way it works. It is not necessarily a bad and unsustainable thing if a certain segment of the market is buying cars.”

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VistaGen Therapeutics, Inc. (VSTA) Offers Innovative Technological Solution to Ongoing Drug Discovery and Development Crisis

California based VistaGen Therapeutics, a biotech company focused on using their proprietary pluripotent stem cell technology for superior predictive toxicology and drug metabolism screening, is aggressively pursuing an innovative drug development path with unusually high profit potential. The company intends to identify once-promising small molecule drug candidates on which large amounts of research and development money has already been spent, but which have been discontinued and “shelved” due to unexpected safety concerns relating to heart or liver toxicity. The company’s one-of-a-kind bioassay platform, called Human Clinical Trials in a Test Tube, allows highly cost effective toxicity testing for heart and liver cells right in the laboratory, offering a unique way to quickly test and modify drug candidates, maintaining drug efficacy while eliminating toxicity.

VistaGen’s strategy leverages their developing stem cell technology based bioassay systems, CardioSafe 3D™ and LiverSafe 3D™, as well as their network of strategic relationships, and substantial prior third-party investment in drug discovery and development

The company’s approach is buoyed by the ongoing drug discovery and development crisis being experienced by the U.S. pharmaceutical industry. Last year, in spite of a $49 billion R&D investment by the pharmaceutical industry, the FDA’s Center for Drug Evaluation and Research approved only 39 novel NME (New Molecular Entity) drugs. Since 2003, the FDA has approved an average of only 26 NME’s annually. The high cost of drug development, coupled with this very low approval rate, means that such drug failures are a serious economic drain on the industry, and a potential economic catastrophe for the developing company.

A big part of the problem comes from known limitations of the industry’s current toxicological testing methodology, which relies primarily on animal models, transformed cell lines, or human cadaver cells. It’s an approach that can only approximate live human biology, and can lead to unpleasant surprises after millions or billions of dollars have already been spent on drug development.

VistaGen’s system offers mature human cells for more accurate and timely testing. It’s a technology of huge potential value to the industry, but also of value to VistaGen as a base for developing their own line of drug rescue variants.

For additional information, visit www.VistaGen.com

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ShoreTel (SHOR) Joins the HP AllianceOne Program

ShoreTel, the preeminent supplier of exquisitely simple unified communications platforms including business phone systems, applications, and mobile UC solutions, announced yesterdaythat it has joined the global HP AllianceOne partner program.

The HP AllianceOne program supplies the tools and resources necessary for hardware and software vendors, original equipment manufacturers, and systems integrators to address HP client needs much more effectively. Through this program, ShoreTel will continue to deliver brilliantly simple unified communication (UC) solutions that operate smoothly in conjunction with the HP Networking infrastructure.

The combination of ShoreTel and HP business communication hardware, software, and infrastructure works to lower costs and eradicate complexities for businesses of all sizes and allows IT administrators to manage their entire network, including data and voice, wired and wireless, core to edge, from an individual management application.

“ShoreTel has one goal in mind, and that is to delight our SMB and enterprise customers worldwide with robust, easy-to-use and manage solutions,” said Chris Burgy, vice president of GTM strategy/planning, business development & alliances at ShoreTel. “Best-of-breed vendors streamline the sales and implementation process, enabling companies to get up and running in record time, and we are extremely pleased to be able to jointly achieve this objective with our HP AllianceOne partnership.”

With the inclusion of the ShoreTel UC platform, HP Networking can deliver an established end-to-end solution for boosting productivity, increases flexibility for employees, and provides an unparalleled option for decreasing expenses, while significantly improving how communications are managed and delivered within any business. The new partnership will give companies the flexibility to perform a multitude of actions including designing, employing, and managing a solid-state network and VoIP infrastructure, as well as providing a consistent user experience with video, voice, and IM presence across the entire HP FlexNetwork architecture.

“Organizations’ networks need to be simple, scalable and automated to accommodate multimedia applications like voice and videoconferencing across an increasingly distributed workforce,” said Mike Banic, vice president of marketing, Networking, HP. “As a member of the HP AllianceOne program, ShoreTel will be able to deliver an end-to-end unified communications infrastructure – creating a highly collaborative and productive anytime, anywhere environment for their customers.”

“The AllianceOne relationship between ShoreTel and HP Networking is ideal for us to migrate our legacy 3Com voice and data customers to future-proof solutions,” said Matt Ferro, vice president, sales and marketing for InPath Devices. “By focusing on these two best of breed vendors, InPath Devices can provide businesses of all sizes with wired and wireless IP networks, unified communications, contact center, and mobility solutions that are easy to deploy and manage while keeping operational costs low.”

For further information, please visit www.shoretel.com or www.shoretelsky.com

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Three Industry Professionals Join ARCA biopharma, Inc. (ABIO) GENETIC-AF Leadership Team

Biopharmaceutical company ARCA biopharma announced it has expanded its clinical trial leadership team with the addition of three new hires in the areas of clinical development and quality assurance.

The new employees are being hired for the positions of vice president, clinical development; senior director, quality; and senior clinical program manager. These three industry professionals, who have more than 45 collective years of clinical development and QA experience, will join current ARCA employees in overseeing the carrying out of GENETIC-AF, ARCA’s Phase 2B/3 clinical trial evaluating Gencaro as a potential treatment for atrial fibrillation.

Joining ARCA as its new vice president, clinical development is Christopher Dufton, Ph.D. Dufton who previously served as director of clinical research at Gilead Sciences. Prior to that, he was the associate director of clinical development of Myogen, Inc., where he served as a member of the development team responsible for the clinical program leading to the approval of Letairis (ambrisentan) for treating pulmonary arterial hypertension (PAH). Letairis has been approved for the treatment of PAH in the United States and Europe.

ARCA’s new senior director, quality, Sharon Perry, served previously as director of quality assurance (QA) at Accera Pharma. She also brings additional relevant QA experience from her previous work at Gilead Sciences, PR Pharmaceuticals, and Pfizer.

Finally, Jennifer Merriweather joins ARCA as the company’s new senior clinical program manager. Merriweather served previously as the clinical program manager at Gilead Sciences and also brings relevant clinical development experience from her work with Myogen, Inc.

ARCA biopharma is a biopharmaceutical company focused on developing genetically targeted therapies for cardiovascular diseases. Gencaro (bucindolol hydrochloride), the company’s lead product candidate, is an investigational, pharmacologically unique beta-blocker and mild vasodilator that is being developed for atrial fibrillation. The company has identified common genetic variations it believes can predict individual patient response to Gencaro, which gives it the potential to be the first genetically targeted atrial fibrillation prevention treatment. ARCA has partnered with Medtronic, Inc. for the Phase 2B portion of the GENETIC-AF trial.

For more information, visit www.arcabiopharma.com

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XenoPort, Inc. (XNPT) Reports Active Ingredient in Horizant Guidelines for Treatment of Restless Legs Syndrome

XenoPort is a biopharmaceutical company focused on developing and commercializing a portfolio of internally discovered and developed drug candidates for the potential treatment of neurological disorders. The company is currently commercializing its first FDA-approved product, Horizant.

The company announced today the inclusion of gabapentin enacarbil, the active ingredient in Horizant® (gabapentin enacarbil) Extended-Release Tablets, as a first-line therapy in new treatment guidelines created by the Task Force of the International Restless Legs Syndrome Study Group (IRLSSG). This disease is a neurological condition that causes those afflicted to have an irresistible urge to move the legs. The urge is usually accompanied by unpleasant sensations of burning, creeping, tugging, or tingling inside the legs.

Horizant is the only non-dopamine agent and the only alpha-2-delta ligand currently approved by the FDA for the treatment of moderate-to-severe primary restless legs syndrome in adults. The newly-released guidelines indicate that alpha-2-delta ligands be considered for initial treatment in patients with severe sleep disturbance, insomnia or anxiety, RLS/WED-related pain, or a history of an impulse control disorder or anxiety. The guidelines also recommend a long-acting agent for patients with clinically significant daytime symptoms.

The release of these guidelines is an important breakthrough for Xenoport. There is growing recognition that dopamine agonists are not a sufficient answer for long-term treatment of patients with the disease. Most importantly, Horizant product is being recognized as an key treatment option for patients with RLS/WED.

For further information about XenoPort Inc., its Horizant product, and its whole portfolio of drug candidates, please visit www.xenoport.com

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BioCryst Pharmaceuticals, Inc. (BCRX) Adds Dr. Fred Cohen to Board of Directors

Optimizer and developer of small molecule drugs that target inflammatory diseases BioCryst Pharmaceuticals announced earlier today that Fred E. Cohen, M.D., D.Phil., has been recruited to the company’s Board of Directors.

“The Board of Directors and Leadership Team of BioCryst are very pleased to have Fred join the Company’s Board,” stated Chairman of the Board of BioCryst, George B. Abercrombie, “Fred brings a wealth of scientific knowledge and business acumen to BioCryst and has been a valuable resource to the organization for several years as both an advisor and as an investor. We look forward to his guidance and insights toward the further success of BioCryst.”

Dr. Cohen joined TPG in 2001 to facilitate TPG’s venture initiatives into life sciences and biotechnology. He currently serves as a Partner and Managing Director at TPG Biotech. In addition, Dr. Cohen has been a faculty member since 1986 of the University of California, San Francisco (UCSF). At UCSF, Dr. Cohen has served as an Internist for hospitalized patients, a consulting Endocrinologist and most impressively as the Chief of the Division of Endocrinology and Metabolism. Most known for his research in the fields of protein structure and the conformational basis of prion disease, Dr. Cohen’s research interests include prion diseases, structure based drug design, computational biology, and heteropolymer chemistry.

Dr. Cohen received his B.S. degree in Molecular Biophysics and Biochemistry from Yale University, a D.Phil. in Molecular Biophysics from Oxford on a Rhodes Scholarship, and an M.D. from Stanford. He completed postdoctoral training and postgraduate medical training in Internal Medicine and Endocrinology at UCSF. Also a Fellow of the American College of Physicians and the American College of Medical Informatics, as well as a member of the American Society for Clinical Investigation and Association of American Physicians, Dr. Cohen was elected to the Institute of Medicine of the National Academy of Sciences in 2004 and the American Academy of Arts and Sciences in 2008.

Dr. Cohen currently serves on the Board of Directors of Genomic Health, Quintiles Transnational, and on the Boards of several privately held companies.

“Both peramivir and BCX4161 were discovered using structure based drug design, a proven approach to developing potent and selective inhibitors of enzymes involved in disease. With the recent progress in BioCryst’s hereditary angioedema and peramivir influenza development programs, it is an exciting time to join its Board of Directors,” commented Dr. Cohen.

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Odyssey Marine Exploration, Inc. (OMEX) Hauls Up Record Recovery of 1.8M Ounces of Silver from WWII Cargo Vessel Wreckage

Odyssey Marine Exploration, a world-class team of archaeological researchers, experienced recovery personnel, management, and technical people, made a huge splash today with their announcement of having pulled a whopping 61 tons of silver bullion out of the sea this month, recovering the impressive cache from a wreck some three miles below the surface of the Atlantic Ocean.

This incredible haul of some 1,574 ingots (1.8M ounces) from the remains of the WWII-era SS Gairsoppa, a British cargo vessel sunk by a German U-boat back in 1941, is a new record for deep-ocean precious metal salvage and spells a real endorsement for the deep-ocean salvage industry’s future, as well as OMEX’s pioneering activities in the sector. Today’s announcement by the Tampa-based recovery experts brings their tally up to nearly all of the insured silver that went down with the Gairsoppa, a total of 2,792 ingots counting what was pulled up back in 2012.

At today’s clearly suppressed silver price of around $20 an ounce, this haul also gives one pause over the considerable appreciation of the largely industry-consumed metal, only worth around $1.1M in total when it went down. The cache of ingots is today worth roughly $63.8M. Indeed, this effort starts one thinking about the vast wealth of unrecovered insured and uninsured assets like precious metals in the world’s oceans, thinking which could easily stray to other commodities like rare earths and even base metals.

CEO of OMEX, Greg Stemm, underscored the complexity of the extremely deep water operation, complicated further by the sheer size of the massive vessel and tiny, secured compartment which held the insured silver. Stemm personally named Senior Project Managers, Andrew Craig and Ernie Tapanes, as being key to the success of this operation and with 99% of the insured silver recovered by OMEX’s highly-skilled and ingenious offshore team, it now seems possible that with such an assemblage of experts, more highly successful deep-ocean recovery operations like this are in the near future.

Stemm even hinted at how this latest effort by the company opens up the parameters for broader deep-ocean mineral exploration and the recovery of important cultural heritage materials, the latter of which leans heavily on precisely the kind of best-in-class archaeological work that can be done by the company’s team, who knows how to read the deep-ocean targets properly, and also has the tools/experience to get the job done. The company ran this effort from their Seabed Worker, a 291-foot recovery vessel specially equipped by OMEX with deep-ocean hardware and ROVs (remotely operated vehicles) rated down to 5k meters. With the metal now safely stored at a secure UK facility, the Seabed Worker has returned to work investigating the 2011 discovery by OMEX of the 450-foot SS Mantola, as part of the company’s 2013 North Atlantic Expedition.

The Mantola reportedly went down with some 600k UK War Risk program-insured troy ounces of silver onboard and with the exceptional profitability on the Gairsoppa awarded via the company’s contract with the UK Department for Transport, a standard commercial 80% of net cargo value to look forward to, you can bet all hands on the Seabed Worker are eager to get back in the water.

President and COO of OMEX, Mark Gordon, hailed the exceptional performance by the company’s team and assured investors that they have the unique tools and talent required to continue pioneering new horizons in the deep-ocean exploration and recovery game.
For more info on Odyssey Marine Exploration, visit www.Shipwreck.net

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Gelena Biopharma (GALE) Introduces New Ways of Thinking about Cancer Therapy

Imagine you’re at the doctor’s office facing one of the scariest diagnoses out there: cancer. In that moment, nothing is more important than knowing there is hope for treatment and recovery. With so much time and money spent looking for a way to fight this disease, companies must set themselves apart not just with their products but with a high level of commitment and care to truly making a difference. Galena Biopharma is one of these companies.

Galena Biopharma is a developer of innovative, targeted oncology treatments. The treatments address major unmet medical needs designed to advance cancer care. Though the company has several projects targeted at various forms of cancer, Galena’s primary focus is on treating breast cancer. More specifically, the company is looking to prevent breast cancer from recurring in patients who have been diagnosed and treated previously.

Breast cancer is becoming increasingly more common in the United States. With over 230,000 women diagnosed every year, about 25% of node-positive patients relapse within three years of being treated. For these women, Gelena has developed NeuVax™, a novel cancer immunotherapy. NeuVax™ is an innovative and helpful therapy, but its major selling point is that it’s the only one of its kind. As the proprietor of the only late-stage breast cancer vaccine currently in development, Gelena has the market cornered on this type of therapy, making it an exciting time for patients and shareholders alike.

NeuVax™ has been in the company’s pipeline for a while, but reached an important milestone in the first quarter of 2012: phase 3 clinical trials. The pivotal trials are currently enrolling in over 100 sites around North America, Europe, and Israel; if the trials show positive results, NeuVax™ will be on the fast track to gaining FDA approval. The vaccine will be a huge breakthrough in cancer treatments, and will help Galena and breast cancer survivors realize their vision of living free from fear of the cancer metastasizing.

Though Galena could focus only on NeuVax™ and still make waves in cancer therapy, the company has a whole host of over innovative products to support its reputation as an aggressive, go-getting force to be reckoned with. In March 2013, Galena acquired Abstral® Sublingual Tablets, a product that is believed to significantly improve care for cancer patients who experience breakthrough pain during treatment. The innovative, FDA-approved Abstra® l formulation rapidly dissolves under the tongue with predictable dosing, is easy to use and convenient to carry, but most importantly, provides rapid relief of patients’ breakthrough pain.

Galena, always a forward-thinking company, acquired Abstral® to produce near-term revenues while they wait for NeuVax™’s launch. The company expects the revenue from Abstral® to reduce its overall cash burn in that waiting period, but the product also provides an avenue for the company to build relationships with future NeuVax™ prescribers. Galena reps say that these clients include oncologists, who could be treating patients with advanced breast cancer or patients experiencing breakthrough pain.

The company’s current financial status serves as an appropriate compliment to its product suite. The company is well positioned thanks to Galena’s strong leadership team of individuals with experience in developing and commercializing cancer treatment drug candidates. What’s more, the company has recently expanded its Scientific Advisory Board with distinguished leaders in the field of oncology whose expertise is crucial to advancing the product pipeline.

All of these factors contribute to Galena’s presence as not only an innovative solutions provider, but as a company truly dedicated to improving the lives of the people whom it’s trying to help. Bolstered by its ever-expanding pipeline and multiple development and commercial partnerships, Galena’s suite of immunotherapeutic solutions is bound to take the industry by storm.

For more information, visit www.galenabiopharma.com

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