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Life Science News Briefs Vol. 6 no.37 - December 12 2006
Pharmaceuticals & Biotherapeutics UpdateBioniche Clears Path for Priority Review of its E. coli O157:H7 VaccineBioniche Life Sciences Inc. (Belleville), a research-based, technology-driven Canadian biopharmaceutical company, announced that the Canadian regulator of its E. coli O157:H7 cattle vaccine has accepted the Company's submission regarding the safety of an administrator in the event of an accidental needlestick while administering the vaccine to cattle. Health Canada advised CFIA that it was their conclusion that there is no significant risk of toxicity associated with accidental self-injection by the vaccine administrator. Health Canada had raised concerns about potential health risks associated with accidental injection of the vaccine into the administrator. In order to provide the requested data to the CFIA, Bioniche agreed to conduct an additional animal safety study. The Company found published information about a piglet model, with which it conducted a small study. The data from this study were submitted to the CFIA and Health Canada for review. http://www.Bioniche.com Université de Montréal Launches Drug Safety CollaborationIn a move that will further extend its international reach, the Faculty of Pharmacy of the Université de Montreal announces a collaboration with the European Medicines Agency (EMEA) in the field of drug risk management. The European Union's drug regulatory agency will access Canada's leading expertise in balancing the risks and benefits of marketed drugs. Under the Direction of acting Dean of the Faculty, Dr. Pierre Moreau, Université de Montréal Professor Yola Moride, PhD, FISPE, will serve as a National Expert at the EMEA's London offices through a secondment exchange program. A risk management program spells out a strategy that aims to maximize health benefits while minimizing known risks. For example, drug utilization studies may be planned to monitor patterns of medication use in a real-life setting and, if concerns are raised, patients who may be more susceptible to an adverse drug reaction could be required to undergo, for example, monthly blood tests prior to getting their next prescription refilled. Risks cannot only be identified in pre-market clinical trials but also when a treatment is commercially available. The types of patients and treatment patterns that offer the least favorable risk/benefit profile are identified and this knowledge is formalized and implemented in a risk management program. http://www.umontreal.ca Xenon Enters Into Anemia Collaboration With RocheXenon (Vancouver) announced a partnership with Roche to discover and develop protein therapeutics targeting hemojuvelin (HJV) as a novel approach for the treatment of anemia of inflammation. Xenon discovered HJV as the defective protein underlying Juvenile Hemochromatosis and this protein appears to play an important role in the regulation and availability of iron for red blood cell production. Xenon and Roche have entered into an exclusive worldwide research and license agreement to jointly research protein-based inhibitors of HJV. In addition to the research and license agreement, the Roche Venture Fund has purchased $7 Million of Xenon stock. http://www.xenon-pharma.com Clinical TrialsBioMS pivotal multiple sclerosis trial receives sixth positive reviewBioMS Medical Corp. (edmonton), a leading developer in the treatment of multiple sclerosis (MS), announced that following the sixth meeting of the independent Data Safety Monitoring Board (DSMB), the Company has received a recommendation to continue its pivotal phase II/III clinical trial for MBP8298 for the treatment of secondary progressive multiple sclerosis. This was the sixth 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. The pivotal phase II/III study is now ongoing at trial sites across Canada and Europe. http://www.biomsmedical.com Cannasat Announces Successful pre-CTA Meeting with Health CanadaCannasat Therapeutics Inc. (Toronto) announced a successful pre-CTA ("Clinical Trial Application") meeting with Health Canada for Phase 1 testing of its lead product, CAT 310, a cannabinoid based pharmaceutical product. The purpose of this pre-CTA meeting was to discuss Cannasat's proposal for a Phase 1 clinical trial in humans for CAT 310 in order to evaluate the product's safety and pharmacokinetics. This meeting was held in Ottawa, Canada, on October 4th, 2006. Prior to this meeting, Cannasat submitted a pre-CTA package that included the intended clinical uses, product rationale, pre-clinical pharmacokinetic data, toxicology data, and the proposed Phase 1 protocol for review by the regulator. Health Canada provided feedback on Cannasat's plans and provided Cannasat with additional guidance on the information required for submitting the CTA to Health Canada for final review. Cannasat is finalizing the formulation of CAT 310 prototypes to be tested in Phase 1. If final formulation data for CAT 310 also satisfies regulatory requirements, Health Canada indicated that it saw no major obstacles for Cannasat the product to move forward in human testing. http://www.cannasat.com Isotechnika enrols first patient in European/Canadian psoriasis clinical trialIsotechnika Inc. (Edmonton) announced that the Company has enrolled its first patient in a pivotal Phase III European/Canadian clinical trial for the treatment of moderate to severe psoriasis with its lead immunosuppressive drug, ISA247. The Phase III European/Canadian psoriasis trial (ESSENCE trial) will be performed at thirty-six clinical centers in Canada, Germany, and Poland involving a total of 500 patients with moderate to severe psoriasis. The 24-week trial will be conducted as a randomized, orally administered placebo and cyclosporine controlled study with 300 patients receiving ISA247 (0.4 mg/kg twice daily), 100 patients receiving cyclosporine (1.5 mg/kg twice daily), and 100 patients receiving placebo. In an effort to maximize the benefit to patients randomized to the placebo group, those patients will be administered the ISA247 0.4 mg/kg twice daily dose subsequent to the first 12 weeks of the trial. To determine successful completion of the trial, the following parameters will be measured; Static Physician's Global Assessment (SPGA) scores, Psoriasis Area and Severity Index (PASI) scores and kidney function. http://www.isotechnika.com Medical Devices and Diagnostics UpdateResponse Announces Strategic Alliance with 3MResponse Biomedical Corporation (Vancouver) announced that it has entered into a worldwide, exclusive agreement with 3M Company (NYSE: MMM) through its medical division to pursue the development and commercialization of diagnostic products targeting hospital and community acquired infectious diseases using Response Biomedical's RAMP(R) testing platform. As part of this collaboration, 3M is making a US $8 million equity investment in Response Biomedical, representing approximately a 13 percent ownership position. Under the terms of the strategic alliance, Response Biomedical will be responsible for development and manufacturing of the RAMP-based products, while 3M will be responsible for clinical and regulatory matters, and all sales, marketing and distribution of the infectious disease tests. 3M will pay Response Biomedical a transfer price for the components of the RAMP technology produced by Response Biomedical (principally Readers and individual test cartridges) and will fund the development of future RAMP-based products in the infectious disease area. Initially, 3M will market rapid tests for Staphylococcus aureus (S. aureus) and Flu A/B that have been developed on Response Biomedical's RAMP platform and are expected to enter clinical testing in the near future. The parties expect to begin marketing initial products in 2007. http://www.responsebio.com Biophage initiates performance and validation testing of BiosensorBiophage Pharma Inc. (Montreal) announced that it has reached an important milestone in the development of a compact PDS96(R) Biosensor. The company is now conducting extensive in-house performance testing and validation of the alpha prototype, and expects to file US and PCT patents in the first quarter of 2007. The Biosensor's compact size, performance and functionality promise to be a quantum leap over existing technologies. Moreover, it uses specially designed sample arrays in a standard 96 well plate configuration, making it amenable to high throughput automation. Data acquisition and analysis are handled with user-friendly software. "The increased capacity, functions and lower selling price of the PDS96(R) Biosensor will result in substantial savings of time, money and human resources for our customers. These features give us an important edge over our competitors and responds to true concerns of consumers in the health care industry," commented Dr Rosemonde Mandeville, President and CEO of Biophage Pharma Inc. http://www.biophagepharma.net Amorfix technology lauded by World Economic ForumAmorfix Life Sciences Ltd. (Toronto) will be the only Canadian recipient of 47 organizations from around the world to be named as a "Technology Pioneer" by the World Economic Forum at its prestigious annual meeting in Davos, Switzerland in January 2007. Amorfix is also one of only a few World Economic Forum Technology Pioneers chosen to be featured in a bonus section of the December 11, 2007 issue of Time Magazine. Amorfix was selected because of its development of a technology with the potential to permit diagnosis of several brain-wasting diseases, including Alzheimer's and Parkinson's diseases, Amyotrophic Lateral Sclerosis (ALS or Lou Gehrig's Disease) and variant Creutzfeldt-Jacob Disease (vCJD), also known as the human form of mad cow disease (Bovine Spongiform Encephalopathy or BSE). The development of effective treatments for these diseases has been slow because scientists have not been able to directly measure the abnormal molecules that cause them and have only been able to accurately diagnose patients after death. http://www.amorfix.com Industry BriefsBioniche Life Sciences Inc. (Belleville), a research-based, technology-driven Canadian biopharmaceutical company, announced that it has completed the sale of two of its remaining assets associated with Bioniche Pharma Holdings Limited, the entity which now holds the shares of Bioniche Pharma Group Limited. http://www.Bioniche.com LAB Research Inc. (Laval), a rapidly growing non-clinical contract research organization (CRO), is pleased to announce that it has completed the expansion of its Canadian site. This $12 million investment is consistent with the Company's goal of enhancing its global capacity by some 30% before the fall of 2007. With its greater capacity and large order backlog, the Company will be able to better meet increasing demand for its services and facilitate organic growth. http://www.labresearch.com MIGENIX Inc. (Vancouver) has closed its previously announced offering, on a bought deal basis, of units at a price of $0.60 per unit. The 15% underwriter over-allotment option was exercised in full resulting in the issuance of a total of 19,262,500 units for gross proceeds of approximately $11.6 million. http://www.migenix.com Biovail Corporation (Toronto) announced that it will no longer maintain a U.S.-based sales organization, and that it intends to enter into supply-and-distribution agreements with strategic partners to target physicians groups in the United States. As a result of this decision, the Company has enhanced the operational efficiency of its business model. In addition, the Company announced that it would drive business growth through a targeted focus on a number of core research-and-development programs. http://www.biovail.com Biovail Corporation (Toronto) announced that, effective immediately, Kenneth G. Howling has been promoted to Senior Vice-President, Chief Financial Officer. Charles Rowland, Biovail's former Senior Vice-President, Chief Financial Officer has left the firm to assume a senior position with another pharmaceutical company. http://www.biovail.com LAB Research Inc. (Laval) is pleased to announce, that Mr. Stephen R. Farrell President and CEO of Uniboard Canada has been elected to its board of directors. http://www.labresearch.com Opsens Inc. (Quebec City) has announced that it closed a private placement for an aggregate amount of $1,100,000. The subscribers, a premier US financial institution and a private investor, subscribed for respective amounts of $1,000,000 and $100,000. http://www.opsens.com BioMS Medical Corp (Edmonton), a leading developer in the treatment of multiple sclerosis (MS), announced that it has completed the second and final tranche of a private placement, issuing an additional 1,832,300 million units at a price of CDN $3.41 per unit for gross proceeds of approximately CDN $6.2 million. Combined with the previously announced closing of an initial $20.9 million, total gross proceeds of CDN $27.1 million have been raised in this two-tranche private placement. http://www.biomsmedical.com (Life Sciences News Briefs © 2005 is prepared by Armar International for the Life Sciences Branch of Industry Canada (contact: Louise Leduc Tel: (613) 954-4715; E-mail: Leduc.Louise@ic.gc.ca).
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