Wednesday, January 29, 2014

CytRx Corp.’s (CYTR) Aldoxorubicin Shows Potential for Extended Application in Field of Cancer Treatment

There are more than 100 different cancer diseases. Cancer is the leading cause of death in the United States, and according to National Cancer Institute (NCI) estimates, half of all U.S. males and one-third of all U.S. females will develop cancer in their lifetime. While soft tissue sarcoma is a very rare form of cancer, the NCI reports that in 2011 nearly 11,000 new cases of soft tissue sarcomas were diagnosed in the U.S. and that approximately 3,900 deaths were caused by these cancers.

CytRx is a biopharmaceutical R&D company focused on the development of its cancer-centered clinical pipeline, which includes aldoxorubicin, the company’s improved version of the widely used chemotherapeutic agent doxorubicin. In a recent phase 2b study head-to-head between the drugs, aldoxorubicin met primary endpoints and demonstrated its superiority over doxorubicin. Furthermore, aldoxorubicin was found to be safe and well-tolerated with no treatment-related deaths.

The results were huge. The outcome of the trial triggered a triple-digit rally in CytRx stock as the investment community picked-up on the statistically significant results and aldoxorubicin’s potential to open the door for additional therapeutic applications.

Aldoxorubicin will soon undergo a phase 3 pivotal trial under a special protocol assessment (SPA) as a therapy for patients with soft tissue sarcomas whose tumors have progressed following treatment with chemotherapy.

The U.S. Food and Drug Administration granted the drug candidate orphan drug designation for the treatment of patients with soft tissue sarcomas and pancreatic cancer. This designation is granted to therapeutics being developed for the treatment of rare diseases that affect fewer than 200,000 people in the United States. With this position, CytRx has a seven-year marketing exclusivity period, clinical protocol assistance with the FDA, and access to federal grants and tax credits.

With high expectations for 2014, CytRx appears to be well-positioned to revolutionize the unmet medical needs in cancer, starting with soft tissue sarcoma.

For more information visit www.cytrx.com

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Tuesday, January 28, 2014

Exact Sciences (EXAS) Breakthrough Colorectal Cancer Screening Test

The world of colorectal cancer screening may not be the most “extravagant” place to invest; nevertheless, the industry does offer some opportunities. Exact Sciences is one of those opportunities. This small-cap biotech company has developed a screening test for colorectal cancer which is expected to face the FDA “panel” in March. This $100 million dollar industry could find favor with EXAS as it introduces the first screening that is able to detect both cancerous and pre-cancerous cells. There are no other tests out there with this claim.

Screening in the Key
Colorectal cancer is supposed to be the most preventable type of cancer yet it is the least prevented. 50,000 people died from this type of cancer last year and another 140,000 in the United States were diagnosed with it.

Unfortunately, more than half the time the cancer isn’t detected until it is in its later stages which makes it difficult and often expensive to treat. Early detection is the key to fighting this type of cancer and it begins with simple cancer screening.

All colon cancers start as polyps and those polyps shed cells into the stool stream and some of these cells contain altered DNA. Exact Sciences stool DNA test analyzes for molecular alterations associated with cancerous or precancerous conditions in the colon and rectum. If an abnormal DNA test is identified, patients are then referred for a colonoscopy. It’s a very simple and patient friendly procedure with no dietary restrictions. The test is available in the United States currently under regulatory review by the FDA.

There are a few types of stool-based colorectal cancer screening tests presently. They are non-invasive, but they do not detect pre-cancer cells like the Exact Sciences stool DNA test does.

The Product
Exact Sciences’ screening test to detect clorectal cancer is called “Cologuard.” In its preliminary analysis, it met or exceeded all primary and secondary endpoints of its DeeP-C pivotal clinical trial. The purpose of the trial was to evaluate the test’s use for detection of the cancer and pre-cancerous polyps.

The screen demonstrated 92% sensitivity to the detection of cancer and 42% for the detection of pre-cancerous polyps. Polyps that were 2 cm or greater in size had a 66% sensitivity. The trial was quite large including 10,000 patients between the age of 50 and 84 who are considered average risk for colorectal cancer.

Thomas F. Imperiale, M.D., professor of medicine, a member of IU Simon Cancer Center, had this to say about the results of Cologuard’s trial results: “There is significant unmet clinical need for an accurate, convenient and non-evasive colorectal screening test. The data from the DeeP-C trial are very promising. Cologuard may well be a future solution for identifying slow growing polyps much before they develop into cancer.”

Exact Sciences will submit data from the DeeP-C study to the U.S. Food and Drug Administration as part of its pre-market approval (PMA) submission. It is considered an investigative device, not available for sale in the United States. This testing information is strictly preliminary, pending any additional analysis by the company or review by the FDA.

Market Potential
Roughly 5% of men and women in the United States will be diagnosed with colorectal cancer in their lifetime. More than 80% of the cancer arises from polyps which are amiable to screening. Diagnosing the case through screening usually occurs 2 to 3 years before a case with symptoms and has the potential to reduce deaths from colorectal cancer by 60%. This being said, there is a huge drive to continue to encourage colorectal screening.

The adult population in the United States is roughly around 224 million people. This means about 11 million of these people will be diagnosed with colorectal cancer in their lifetime. Although there are currently three types of screening available, patients would likely opt for Cologuard given the simplicity of the screen as well as its unique ability to detect pre-cancerous cells.

EXAS testing is far superior to the present fecal tests (FOBT & FIT) which in themselves are considerably less accurate and nowhere near as good as a colonoscopy. While a colonoscopy can cost well over $1,000, the standard stool tests are just under $50. Cologuard is roughly in the middle at a cost of between $300-$500. Since it is so effective and cost-efficient, it has a potential to take the place of a colonoscopy recommendation to start with. A test once every three years would not be as expensive or evasive as a colonoscopy.

In a market with good residual potential, don’t be surprised if 2014 sees the stock price rising as the FDA meets about licensing the test.

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Cisco (CSCO) and Alcatel-Lucent (ALU): 2 Solid Long-Term Investments That You Shouldn’t Miss

2013 was a good year for the telecommunications equipment industry, especially Alcatel-Lucent (ALU), which almost tripled last year. Another closely watched company was Cisco (CSCO), a bellwether in telecommunication equipment. Both of these companies performed decently in 2013, but Cisco saw some weakness toward the end of the year. The question remains if they will remain good investments in 2014? The answer appears to be yes.

Alcatel’s Moves

Alcatel is focusing on the mobile network market and is selling off non-core assets. In 2013, Alcatel took various measures to re-build its business on the new path. The company now plans to be much more focused in mobile networks for ultra-broadband access and Internet-protocol networking.

Alcatel’s focus on this market is not surprising as the mobile network market is growing quite fast due to an increase in mobile subscriptions globally. It is predicted that by the end of 2014, the number of mobile subscribers worldwide will reach 7.5 billion. By 2016, this number is expected to hit 8.5 billion. Alcatel plans to focus on such high-growth areas like LTE and high-speed broadband for revenue growth. At the same time, it is looking to lower fixed costs by more than 15%, saving a total of $1.37 billion. This looks like a good strategy as the company will be able to grow its business in fast-growing areas and also control costs.

Alcatel is shedding non-core assets and recently sold off its U.S. subsidiary LGS Innovations for $200 million. Now, Alcatel has further plans to sell off its enterprise business. The potential buyers are Unify GmbH & Co. KG, a Gores Group LLC and Siemens AG venture. The enterprise business was mainly involved in selling telecommunication equipment and services and was incurring a loss. By selling this business, Alcatel enjoys a dual benefit by generating extra cash to strengthen its balance sheet and disposing of an under-performing asset.

A Big Win

Given these gradual and on-going improvements, Alcatel-Lucent is all set to witness its first year of overall profitability since 2011. So, it looks like the company is all set to enjoy better times in 2014 as well.

Alcatel-Lucent has also established a stronger footprint in the Chinese mobile market where it has won tenders for selling LTE equipment to China Mobile. In December 2013, Alcatel-Lucent was granted the tender for rolling out TD-LTE in China. China Mobile will be installing Alcatel-Lucent’s metro cells in public areas for its TD-LTE network. Alcatel-Lucent is now one of the three companies picked by the Chinese telco to supply equipment for the FDD-LTE and TD-LTE networks.

Cisco and Juniper

One of Alcatel-Lucent’s biggest rivals is Cisco. The two compete mainly in the router business. The router market has been dominated by companies such as Cisco and Juniper (JNPR), but Cisco is facing strong challenges from software defined networking (SDN) solutions. Also, Juniper is posing a major threat to Cisco with its software-defined network solutions.

Network up-time in the era of cloud computing is an important factor to provide quality and zero downtime. Juniper’s development of “High IQ” networks claims to provide 100% up-time and it also claims that it can never go down.

With this technology, Juniper is looking to increase its customer base and bag new clients in various cloud-centric data centers. Network security is also an important factor and the “High IQ” based networks are hack proof, enhancing Juniper’s credibility. But, Cisco’s diversification is what sets it apart from Juniper.

Cisco’s Move Into The Internet Of Everything

Cisco is also eyeing the Internet of Everything (IOE). IOE has been revolutionizing our life with smart homes, cars, drones, and various entertainment devices. According to Cisco’s research team, 37 billion new things will be hooked on to the Internet in the next eight years. It is also projected that 2.5 billion people will be new users of the Internet by that time and Cisco is looking to tap this market.

For example, Cisco collaborated with New York City to launch an interactive platform to provide valuable information to the public. This information can be accessed from any device connected to the internet. This is just the beginning of a new era where IOE will be transforming the lives of city dwellers.

IOE, as defined by Cisco, will integrate process, data, and things with networked connections, bringing a richer experience and relevancy. This will further create a better economic opportunity for individuals, corporations, and even countries.

Thus, Cisco’s focus on IOE should help it reap the benefits in the future due to its wide application.

Fundamentals and Conclusion

Both Alcatel-Lucent and Cisco are looking to maintain their momentum in 2014 while employing different strategies to do so. As far as an investment in either is concerned, both companies could prove to be good picks. Alcatel is currently generating a net loss, so there is no P/E metric available for valuation. However, the company’s cheap PEG ratio of 0.27 indicates that analysts expect the company to grow at a fast pace in the future. Analysts expect Alcatel’s earnings to grow 97% next year, which means that another good year lies ahead.

Cisco, on the other hand, is a more conservative pick with a P/E ratio of just 12.45. Its PEG ratio is higher at 1.37, but it also has a juicy dividend yield of 3%, making it a solid investment. Also, its five-year earnings growth forecast is pegged at 8.4% annually, but given Cisco’s solid dividend and cheap valuation, it could be a decent investment. All in all, both Alcatel and Cisco look like good picks depending on investors’ taste and both could outperform the broad market in 2014.

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Skkynet Cloud Systems, Inc. (SKKY) Inks Collaboration Deal with BellChild Ltd. of Japan

Skkynet Cloud Systems, a developer of real-time cloud information systems, has formed a partnership with BellChild Ltd. of Osaka, Japan, in which the companies will leverage specific expertise to provide cloud systems and services to the industrial sector.

Per the agreement, BellChild will develop and maintain secure servers used to support high-speed financial transactions, while Skkynet will furnish the software to support real-time data integration via the cloud.

“We are keen to combine Skkynet’s real-time data-handling capabilities for industrial systems with our BEAM™ (BellChild Express ASP Maker) platform for financial applications,” Yoshikuni Fujita, president of BellChild stated in the news release. “The resulting system should be secure, robust and flexible enough to support industrial cloud-based systems.”

In addition to providing infrastructure technology for industrial systems, BellChild said it is considering the pursuit of potential markets for real-time cloud services in the financial services arena as well.

“BellChild’s expertise in secure hardware and software solutions is exactly what we need to begin offering real-time cloud solutions in Japan and worldwide,” said Paul Thomas, president of Skkynet Cloud Systems. “This agreement is the first step toward building a strong cooperative relationship and a new global business model.”

For more information, visit www.skyynet.com

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DS Healthcare Group (DSKX) Moves Forward with IND Application for Prescription Hair Loss Treatment, Appoints Aptiv Solutions as CRO

Leading developer of personal care products DS Healthcare Group announced it has appointed Aptiv Solutions as its clinical research organization (CRO) for a proprietary topical prescription treatment. The drug, if approved, will be positioned as a frontline therapy against hair loss.

DS Healthcare’s Investigational New Drug Application (IND) for this proprietary topical hair loss treatment will be prepared by Aptiv Solutions for submission to the FDA. Only one other topical hair loss treatment has been approved by the FDA to date. Additionally, Aptiv Solutions will conduct a Gap analysis to ensure that DS Healthcare’s operations are in line with regulatory requirements for drug approval.

A leading global CRO with extensive global drug development and trial management expertise, Aptiv Solutions has conducted more than 2,600 clinical trials and has assisted with more than 140 FDA and European Union drug and biologic approvals and more than 700 medical device approvals and clearances.

Recently, DS Healthcare announced its intention to submit an IND to the FDA – a move that follows the company’s patent application filing with the U.S. Patent and Trademark Office for its invention of the prescription hair loss treatment.

For more information, visit www.dslaboratories.com

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Save the World Air, Inc. (ZERO) Video Chart for Tuesday, January 28, 2014

ZERO is holding a base at 88 cents as part of a multi-month downtrend after striking new highs in August. This video discusses the importance of the price per share breaking above the 50-day moving average in conjunction with a bullish cross of the MACD.

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

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Laidlaw & Company Initiates Coverage on Actinium Pharmaceuticals, Inc. (ATNM)

Actinium Pharmaceuticals is a public biopharmaceutical company specializing in the development of cancer drugs. The company’s product candidates are based on its patented technology, co-developed with Memorial Sloan Kettering Cancer Center (MSKCC), for combining the cancer targeting precision of monoclonal antibodies (mAb) for targeting specific types of cells with the power of alpha emitting radioisotopes, the most potent cancer killing agents in existence.

Currently, Laidlaw & Company is initiating coverage on ATNM, with a buy rating and a price target of $18.00. It is believed that ATNM’s technology platform using the cancer-cell killing ability of alpha and beta-emitting isotopes will produce novel drugs that will ultimately become viable oncology treatments. Among its current projects:

* Iomab-B, a combination of a monoclonal antibody and a beta-emitting radioisotope, is being developed for patients in need of a hematopoietic stem cell transplantation (HSCT) and is potentially entering Phase III in 2014, after showing impressive Phase I/II data.

* Actimab-A is an innovative treatment for acute myeloid leukemia (AML), and is a radioimmunoconjugate consisting of a monoclonal antibody and the isotope actinium-225. Phase I data showed elimination of leukemia calls from blood in 67% of all evaluable patients who received a full dose. The Phase II portion of this trial to complete in mid-2014 and Actimab-A could possibly be launched by the end of 2019, potentially addressing a global AML market of $1 billion.

* Broad Applications Possible for Several Cancer Types. Actinium has technology to attach radioisotopes to monoclonal antibodies. The company aims to use this platform to develop in-licensed monoclonal antibodies to target several cancer types and it has a strategy to improve on marketed oncology products by adding alpha-emitting isotopes.

ATNM has an expert team of professionals, possessing the vision and desire to enhance shareholder value and position the company to benefit from increased market recognition of targeted payload therapies and an initial high-value, niche product model. For more information about the company and what it can offer investors, visit www.actiniumpharmaceuticals.com.

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