VolitionRx’s Ltd. (VNRX) Diagnostic Platform Confirmed to Show High Sensitivity and Specificity for Colon, Breast, and Lung Cancers

VolitionRx, a life sciences company focused on making easy-to-use blood tests, earlier today reported tremendous preliminary findings from its ongoing internal clinical trials of the NuQ® diagnostic platform. The company was able to detect 76% of the patients with colon cancer, 96% of those with breast cancer, and 100% of patients with lung cancer.

Dr. Jake Micallef, Chief Scientific Officer for Belgian Volition, stated, “Our internal results are extremely promising, and are consistent with independent data from external studies. Although these are early figures and the results will need to be validated over larger numbers of patient samples, it provides further validation that our Nucleosomics tests are effective at detecting certain types of cancers. We are reaching out to several universities to collaborate on further trials of larger numbers of several single cancers, in order to have enough data to apply for European regulatory approval.”

Of the 105 patients tested, 74 had cancer (25 colon cancer, 25 breast cancer, and 24 lung cancer), and 31 were without cancer. Volition tested all the patient samples for elevated nucleosome structures using one of its NuQ kits.

The following results were included in today’s press release:

• Colon: 76% of cancers detected (19 of 25 patients) and 90% specificity (3 false positives from 31 healthy samples)
• Breast: 96% of cancers detected (24 of 25 patients) and 90% specificity (3 false positives from 31 healthy samples)
• Lung: 100% of cancers detected (24 of 24 patients) and 79% specificity (6 false positives from 28 healthy samples).

The company told investors that further clinical results will be announced as they become available.

As previously announced, VolitionRx is currently moving through an independent 800-patient (twice the original number of patients) retrospective study on multiple cancer types, which is being carried out at Rheinische Friedrich-Wilhelms-Universitat Bonn. This study is expected to be completed sometime in the next 8 weeks. Preliminary results from this study are consistent with VolitionRx internal results and indicate that Nucleosomics tests appear to distinguish cancer patients from patients with benign colon tumors as well as healthy patients.

Priv.-Doz. Dr Stefan Holdenrieder of Rheinische Friedrich-Wilhelms-Universitat Bonn, coordinator of the external trials, commented, “I am encouraged by the data coming out of Volition’s internal trial and our study here in Bonn. Given the results we have thus far, we will begin collecting patient blood samples for the 2,000 patient prospective trial focusing on twenty prevalent cancers.”

According to Volition, full data from both studies will be published in a peer-reviewed journal when the studies are complete.

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BioMimetic Therapeutics Inc. (BMTI) Video Chart for Monday, November 5, 2012

BMTI broke a steady uptrend about one month ago, but wrapped last week with three green closes. The indicators are starting to turn as the chart holds support at $3.60, putting this low-volume play on watch for upward pressure to flow back in again.

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

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Anslow + Jaclin, LLP Fully Operational after Hurricane Sandy

Anslow + Jaclin today announced that power and communications services have been completely restored. The firm’s attorneys, paralegals, and administrators are currently contacting clients to ensure all matters are handled in an efficient, expeditious, and professional manner.

An email broadcast to clients emphasized that management is discussing all available options to continue to provide timely service if a natural disaster or similar event should cause challenges in the future. Cell phone numbers of the attorneys were provided as well as a guarantee of 24/7 availability.

Hurricane Sandy had (and continues to have) a tremendous impact on the New York tri-state area, including New Jersey, where most of the Anslow + Jaclin employees live. Everyone at the firm lost power to their homes at some point and some are still without power. Thankfully, all employees and their families are safe.

To learn more about Anslow + Jaclin, visit www.anslowlaw.com

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Galena Biopharma, Inc. (GALE) Presents Promising NeuVax™ Data at the 27th Annual Meeting of the Society of Immunotherapy and Cancer

Galena Biopharma, a biotechnology company focused on developing innovative, targeted oncology treatments that address major unmet medical needs to advance cancer care, recently finished presenting data from its Phase 1/2 clinical trial of NeuVax™ (nelipepimut-S or E75) at the 27th Annual Meeting of the Society of Immunotherapy and Cancer. Galena presented data from its research at the event, which was held on October 26-28, 2012, at the Bethesda North Marriott Hotel & Conference Center in North Bethesda, Maryland.

The poster presentation entitled: “Trends in Circulating Tumor Cells (CTCs) in Multiple Adjuvant Trials of HER2-Directed Peptide Vaccines (PVs)” measured CTC’s from blood samples from NeuVax™ (nelipepimut-S or E75) patients using the CellSearch® system (Veridex). Progress in this area is vital to ongoing cancer research so that CTC’s — cells that have detached from the primary breast tumor and then circulate in the bloodstream, which may then cause the growth of additional tumors (metastases) in different tissue — can be better understood and controlled, reducing the chance of further metastasization. The recurrence of CTC’s may occur soon after the original cancer or many years after initial treatment. Those individuals with higher levels of CTC’s are, therefore, at an increased risk of cancer recurrence, resulting in poor disease-free survival (DFS) and overall survival (OS), suggesting a dormancy of isolated micrometastases.

“Even with the major advances in earlier diagnoses and better treatment options, approximately 25% of resectable node-positive breast cancer patients will still relapse within three years, despite having no evidence of disease following surgery and chemotherapy/radiation treatment,” said Mark J. Ahn, Ph.D., Galena’s President and Chief Executive Officer. “The data presented today shows that treatment with NeuVax reduces CTCs and therefore may prevent growth of future micrometastasis, lending support to the idea of using the woman’s immune system to prevent relapse of her breast cancer.”

Additionally, Galena has kept busy with several presentations over the past month. Mark J Ahn, Ph.D., President and Chief Executive Officer, presented a corporate update at BioX: Noble Financial Capital Markets’ Life Sciences Exposition held at the University of Connecticut, Stamford Campus, on September 24, 2012. Immediately following, Mr. Ahn presented a corporate overview at the 2012 Aegis Capital Healthcare Conference, held at The Wynn in Las Vegas, NV, on September 28.

Galena Biopharma is focused on discovering, developing and commercializing innovative therapies addressing major unmet medical needs using targeted biotherapeutics.

For more information on Galena Biopharma, visit www.galenabiopharma.com

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Pulse

IntelGenx Technologies Corp. (IGXT) Launches Forfivo XL™

IntelGenx Technologies is a Montreal based company devoted to developing its novel and innovative proprietary technologies for enhanced drug delivery. The company makes use of its proprietary drug delivery technologies to improve existing drug compounds with proven efficacy and safety and, in conjunction with strategic development and distribution partners, reintroduce these drug compounds to the market as branded products with improved deliverability and efficacy.

On October 9, 2012, IntelGenx made a significant stride when its Forfivo XL™ product was made available by prescription in the USA. IntelGenx’s product Forfivo XL™ is indicated for treatment of Major Depressive Disorder (MDD) and is currently the only extended-release bupropion HCI product to provide once-daily, 450mg dose in a single tablet. The company’s Forfivo XL™ utilizes buproprin as the active ingredient, similar to another well-known antidepressant, Wellbutrin XL®. Previously, patients in the US requiring a 450mg dose of bupropion were required to take multiple tablets to achieve the dose requirement. However, with Forfivo XL™ now available in the US, these patients can simplify their dosing regimen to a single Forfivo XL tablet, once-daily.

Dr. Horst G. Zerbe, President and CEO of IntelGenx, stated, “Until today, physicians in the US treating their MDD patients with high-dose bupropion have had to use multiples of the lower strength, 150mg and 300mg, products. With the US commercial launch of Forfivo XL, physicians can now prescribe a simpler and more convenient single-pill 450mg dose of bupropion to better meet the needs of their MDD patients. We feel that the combination of market need and the targeted marketing approach applied by our commercial partner Edgemont Pharmaceuticals will make Forfivo XL a successful product.”

On August, 7, 2012, IntelGenx recently announced financial results for the three and six month periods ended June 30, 2012. In addition to IntelGenx’s financials, the announcement also highlighted recent business developments, primarily pertaining to its anti-migraine product VersaFilm (rizatriptan) and Forfivo XL™.

IntelGenx reported cash of $3.1 million as of June 30, 2012, a decrease of approximately $0.1 million when compared to its cash position at June 2011. Revenue of $0.1 million and total expenses of $1.3 million for the first half of 2012 remained relatively unchanged when compared to revenue of $0.1 and total expenses of $1.3 for the first half of 2011.

For more information on IntelGenx Technologies, visit www.intelgenx.com

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Vical, Inc. (VICL) Announces Appointment of Mammen P. Mammen, Jr., M.D., to Vice President of Clinical Vaccines

Vical Inc. announced today that Mammen P. “Anza” Mammen, Jr., M.D., has been appointed to the position of Vice President of Clincal Vaccines. Dr. Mammen is coming off of a 21-year career in the Army’s Medical Corps, retiring as a colonel and recipient of the Legion of Merit. Throughout his career, Dr. Mammen has gained experience in the areas of clinical medicine, infectious disease research, medical diplomacy, clinical trials, vaccine program management, and public health.

“Anza brings a wealth of infectious disease vaccine knowledge to Vical’s management team, including extensive experience in infectious disease research and vaccine trials,” said Vijay B. Samant, Vical’s President and Chief Executive Officer. “His demonstrated expertise in clinical program management supplements Vical’s existing strengths and provides focused support for our pipeline of vaccine development programs.”

In his most recent position, he worked as Infectious Disease Consultant and Chief, Pandemic Warning Team, U.S. Department of Defense, Fort Detrick, Maryland. From 2006 to 2010, he worked on vaccines in Advanced Development against dengue, hepatitis E, and HIV viruses as a Product Manager for the U.S. Army Medical Research and Material Command (USAMRMC), Fort Detrick, Maryland. While serving as Chief, Department of Virology, the Armed Forces Research Institute of Medical Sciences (AFRIMS), Thailand, from 2001 to 2006, Dr. Mammen contributed to a great array of the Army’s U.S. Food and Drug Administration regulated vaccine studies. He also worked as the Principal Investigator of an infant trial to determine the safety and immunogenicity of the Army’s live-attenuated dengue vaccine in Thailand, in collaboration with GlaxoSmithKline Biologicals (GSK). This particular study was published in the American Journal of Tropical Medicine and Hygiene. Another position Dr. Mammen previously held was Project Director for an efficacy trial in Nepal of a recombinant hepatitis E vaccine, conducted in collaboration with GSK, published in The New England Journal of Medicine. Other previous assignments he has held include Infectious Disease Officer, Department of Virus Diseases, the Walter Reed Army Institute of Research (WRAIR), and Chief, Internal Medicine Clinic, 121st General Hospital, Seoul, South Korea.

Dr. Mammen received his M.D. degree from the Pennsylvania State University College of Medicine and is Board-certified in Infectious Diseases. He has been elected as Fellow by the Infectious Disease Society of America (IDSA) and the American College of Physicians (ACP). He received his Internal Medicine and Infectious Disease clinical training from the Walter Reed Army Medical Center and audited the Medical Research Fellowship at WRAIR. He earned a B.A. degree in mathematics from Williams College. Dr. Mammen has authored or co-authored nearly 50 scientific publications spanning multiple emerging and re-emerging infectious diseases.

For further information, please visit www.vical.com

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Keryx Biopharmaceuticals, Inc. (KERX) Begins Phase II Study of Zerenex for Treatment of Patients with Kidney Disease

Keryx Biopharmaceuticals is focused on medically important pharmaceutical products for the treatment of renal disease. The company is currently developing Zerenex (ferric citrate), an oral, ferric iron-based compound that has the capacity to bind phosphate and form non-absorbable complexes.

The company today announced the initiation of a Phase 2 study of Zerenex in managing serum phosphorus and iron deficiency in anemic patients with Stage 3 to 5 non-dialysis dependent chronic kidney disease (NDD-CKD). In the U.S. alone, over 1.5 million people suffering from Stages 3-5 NDD-CKD have iron deficiency anemia. However, there are currently no oral iron supplements with an FDA label nor are there any FDA-approved phosphate binders.

The Phase 2 study started today is a multi-center, randomized, safety and efficacy clinical trial designed to compare the ability of Zerenex to manage serum phosphorus and iron deficiency versus placebo in anemic patients with Stages 3 to 5 NDD-CKD. The study plans to randomize about 150 patients in approximately 15 sites in the U.S.

Eligible patients will be randomized 1:1 to receive either Zerenex or placebo for a 12-week treatment period. The primary endpoints of the study are to demonstrate changes in ferritin, TSAT, and serum phosphorus levels over the 12-week treatment period. Secondary endpoints of the study include changes in hemoglobin and FGF-23. Study completion is expected sometime in mid-2013.

Zerenex is also in a long-term Phase 3 study, under Special Protocol Assessment, as a treatment for end-stage renal disease patients with hyperphosphatemia on dialysis. Top-line data from this study is expected to be announced around year-end. The NDA filing is expected to occur in the first quarter of 2013 for this indication.

For further information about Keryx Biopharmaceuticals and its Zerenex product, please visit www.keryx.com

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