Life Science News Briefs Vol. 7 no.30 - November 15 2007

• Pharmaceuticals & Biotherapeutics Update
• Clinical Trials Update
• Medical Devices and Diagnostics Update
• Industry Briefs
  

Pharmaceuticals & Biotherapeutics Update

Neurochem announces important initiatives

Neurochem Inc. (Laval) announced important initiatives including the expansion of its productcandidate portfolio, the refocusing of its proprietary R&D; assets and the expected reduction of its burn rate compared to fiscal 2007. As part of these initiatives, Neurochem is: Moving its next generation lead candidate NRM-8499 into preclinical development for the treatment of Alzheimer's disease (AD) and is also announcing the early termination of its European Phase III clinical trial for tramiprosate (ALZHEMED(TM)); taking steps, in light of promising results from preliminary post-hoc analysis of the data from the North American Phase III trial for tramiprosate, to commercialize this product as a branded nutraceutical, starting as early as 2008; continuing to advance its programs for Amyloid A (AA) amyloidosis as well as for Diabetes Type II/features of metabolic syndrome. www.neurochem.com

Transition Therapeutics Provides Update on Diabetes Program

Transition Therapeutics Inc. (Toronto) announced an update on the clinical development and partnership activities for the Company's diabetes programs. Following good faith negotiations, Novo Nordisk A/S and Transition were not able to come to agreement for an exclusive license to the Company's diabetes programs. Accordingly, Transition has sent notice to Novo Nordisk A/S terminating the agreement between the companies, which will return to Transition all rights held by Novo Nordisk A/S, relating to E1-I.N.T. Transition will continue on-going discussions with other interested parties to partner the diabetes programs. In the interim, the Company is fully committed to support and advance the clinical development of the diabetes programs, leveraging its expertise in disease-modifying therapies for diabetes, world-class scientific advisory board and solid financial position. www.transitiontherapeutics.com

ProMetic Announces an Agreement With Kedrion

Kedrion S.p.A. (Lucca, IT) and ProMetic BioTherapeutics, Inc., (Montreal) a subsidiary of ProMetic Life Sciences Inc. announced that they have reached a preliminary agreement for multiple hyperimmunes. Under the terms of this agreement, Kedrion will in-license technologies from ProMetic to enable the manufacturing of hyperimmune products in Europe. The agreement, based on license fees, service fees, and royalties to be paid by Kedrion to ProMetic for the sales in Europe, will be closed shortly. Kedrion will fund the product development program initiated this year, which also includes a clinical trial to demonstrate bioequivalence to their existing products. The clinical trial will be performed to meet European and U.S. regulatory requirements. Full scale commercial manufacturing will take place within Kedrion's facility in Italy. ProMetic retains the commercial rights for the fully developed hyperimmune products for the North American market. ProMetic will in turn pay Kedrion royalties on its sales of the hyperimmune products in North America. www.kedrion.com www.prometic.com

Biovail Enters into Development Agreement

Biovail Corporation (Toronto) announced that through its subsidiary, Biovail Laboratories International SRL, the Company has entered into an agreement with Pharma Pass II, LLC (PPII) of Irvine, California, for two early-stage development products - BVF-068, a product for the treatment of a central nervous system (CNS) disorder and BVF-247, a novel formulation of a cardiovascular agent. Pursuant to the terms of the agreement, Biovail has acquired the worldwide rights to develop, manufacture and market BVF-068 and BVF-247. In return, Biovail will pay an upfront fee to PPII, and is contingently obligated to make additional milestone payments for each product, including upon the filing of a New Drug Application (NDA) with the U.S. Food and Drug Administration (FDA), and upon FDA approval. The agreement also stipulates the payment of tiered, single-digit royalties on net commercial sales of the product. www.biovail.com

Caffeine use to regulate breathing of very preterm babies, long-term benefits

Very premature babies who were given caffeine to regulate their breathing have a significantly lower incidence of disabilities at the age of two years, according to an international study led by researchers at McMaster University. Researchers studied more than 2000 premature babies who were either treated with caffeine or given a placebo. The latest results of this large clinical trial will appear in the Nov. 8 issue of the New England Journal of Medicine (NEJM). Babies receiving the caffeine were less likely to develop cerebral palsy and cognitive delay. Caffeine and similar drugs have been used for more than 30 years to make the breathing of very preterm babies more regular, but without sufficient knowledge of the possible benefits and risks. The study involved infants who weighed between 500 and 1250 grams at birth, and who were at risk of apnea – interrupted or irregular breathing due to immaturity. The ongoing study, with colleagues in Canada, Australia, the US, Europe and Israel, will continue to follow the children until they reach the age of five. The project is funded by the Canadian Institutes of Health Research and the National Health and Medical Research Council of Australia. According to Dr. Barbara Schmidt, the principal investigator of the research project, the latest results of the study showed that 46 percent of the infants receiving the placebo died or survived with a neurodevelopmental disability. Among the babies receiving caffeine therapy, only 40 percent had an unfavourable outcome by the time they reached the end of their second year of life. www.mcmaster.ca

AlphaRx Inc. Vansolin(TM) On Track To Enter Human Trials in '08

AlphaRx (Markham) announced pre-clinical data on Vansolin(TM), a Vancomycin compound encapsulated in the company's Nano Drug Delivery Platform intended for the treatment of nosocomial pneumonia. In the recent clinical trial, mice treated with Vansolin(TM) in a Murine Model of Pneumonia showed better efficacy than Vancomycin, achieving 100% survival rate vs. 30% in the Vancomycin treatment group. With these results, Vansolin(TM) is now on track to enter into human trials in 2008. These results support The Company's belief that encapsulating Vancomycin into AlphaRx's nano-particle formulation may increase its efficacy. According to published research papers, in vitro uptake of Vancomycin nanoparticles by white blood cells is 20 times greater than free drug. The Company anticipates that in vivo, after IV infusion, white blood cells will readily absorb Vansolin nanoparticles and transport them to the site of inflammation and infection, thereby increasing the local concentration of Vancomycin and ultimately increasing its bactericidal effect. www.alpharx.com

Clinical Trials

BioMS Medical's relapsing-remitting multiple sclerosis trial

BioMS Medical Corp. (Edmonton), a leading developer in the treatment of multiple sclerosis (MS), announced that the independent Data Safety Monitoring Board (DSMB) for the Company's phase II MINDSET-01 trial of MBP8298 in patients with relapsing-remitting MS has completed a safety analysis and recommended that the trial continue as per the protocol. This was the second of several regularly scheduled reviews by the DSMB that will occur over the duration of the trial. The purpose of the DSMB is to provide objective, independent safety monitoring of the trial. MINDSET-01 Trial: The MINDSET-01 phase II, double-blind, placebo-controlled trial is designed to evaluate the safety and efficacy of MBP8298 in patients with relapsing-remitting MS. The fifteen month trial is fully enrolled with 218 patients at 24 sites in 6 countries. The objectives of the study are to demonstrate safety and efficacy of MBP8298 versus placebo as measured by relapse rate, MRI activity and disease progression. www.biomsmedical.com

Medical Devices and Diagnostics Update

DiagnoCure Furthers Development of Diagnostic Pipeline

DiagnoCure Inc. (Quebec City), a life sciences company commercializing high-value cancer diagnostic tests and specialty laboratory services, announced the publication of new data regarding one of its proprietary prognostic tests for breast, colon and potentially other cancers. The October 1st issue of Clinical Cancer Research states that measuring p66 Shc tumor levels provides a unique and simple tool for stratifying stage IIA colon cancer patients by risk of recurrence and disease-specific death and may assist in determining treatment strategies for these patients. The study included 240 chemotherapy patients with stage IIA colon cancer. An analysis of p66 Shc scores was found to be a significant prognostic indicator of relapse-free survival. DiagnoCure intends to conduct additional validating clinical studies. www.diagnocure.com

Skin Cholesterol Linked To Cardiovascular Disease Risk

PreMD Inc. (Toronto) announced that the company's novel non-invasive skin cholesterol test has demonstrated the ability to detect risk of cardiovascular disease in asymptomatic subjects, according to new data being presented this morning at the Annual Scientific Sessions of the American Heart Association in Orlando, Florida. This study marks the largest clinical trial to date to evaluate levels of skin cholesterol in asymptomatic individuals. Entitled -"Increased Skin Cholesterol Identifies Individuals at Increased Cardiovascular Risk: The Predictor of Advanced Subclinical Atherosclerosis (PASA) Study," the study supports the usefulness of non-invasive skin cholesterol measurements for cardiovascular disease risk assessment. Results of the PASA Study showed that skin cholesterol content, measured by PreMD’s skin cholesterol test, were associated with carotid intima-media thickness (CIMT) and the presence of carotid plaque. This association was observed in subjects across all ranges of cardiovascular risk, particularly in those at low and intermediate risk, based on traditional cardiovascular risk factors. CIMT and carotid plaque are both well-established markers for risk of future heart attack and stroke. www.premdinc.com

Industry Briefs

MonoGen, Inc. (Montreal) announced the addition of James R. Boyle to its senior management team. James R. Boyle will join the company as Chief Financial Officer and Vice President of Finance and Administration effective November 12, 2007. Mr. Boyle, a Certified Public Accountant, has 19 years of accounting and finance experience. Mr. Boyle comes to MonoGen from Midway Games Inc. where for the last five years he has held various positions including Vice President of Finance, Chief Accounting Officer and Corporate Controller. For the seven years prior to that Mr. Boyle was with PricewaterhouseCoopers LLP where he held several management positions involving the delivery of financial reporting services and consulting projects for venture-backed, start-up and other high growth companies. Mr. Boyle earned his BA at the University of Pennsylvania and his MBA at the University of Chicago. www.monogen.com

Cannasat Therapeutics (Toronto), the developer of novel cannabinoid-based pharmaceutical products, today announced that George Nomikos, former Scientific Director at Amgen, Inc. has been appointed as Senior Director, Scientific Affairs. Dr. Nomikos has published more than 140 papers in the field of Neuroscience, Neuropsychopharmacology and Cannabinoid Therapeutics, and brings invaluable knowledge and experience to the Cannasat drug development team. www.cannasat.com

Genizon BioSciences Inc. (Montreal) and Neuropsychiatrie, Decouverte & Innovation Inc. (NDEI) announced an agreement under which the groups will collaborate to enhance and potentially add to discoveries made by Genizon early this year in a genome-wide association study of schizophrenia. Genizon's study identified multiple genes associated with the disease using DNA samples from patients from the Quebec Founder Population. www.genizon.com

Response Biomedical Corporation (Vancouver) announced that the Toronto Stock Exchange (TSX) has conditionally approved the Company's application for listing its common shares on the TSX. Listing on the TSX will be subject to the Company filing satisfactory final documentation with the TSX. The Company will issue a news release when final listing approval has been granted by the TSX. www.responsebio.com

AIM Therapeutics Inc. (Toronto) announced that it has successfully completed a round of private equity financing of $4 million CDN. AIM Therapeutics is an early stage pharmaceutical company focused on developing breakthrough medical treatments for inflammatory and immune disorders including asthma, COPD, spinal cord injury, restenosis and diabetes. AIM has established two proprietary technology platforms: Neutropel and Ep1B. The company will use the capital to advance its lead compound, AIM-002, for the treatment of asthma through GMP manufacturing, pre-clinical toxicology and safety pharmacology studies and formulation development by the end of 2008. www.aimtherapeutics.com

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