Life Sciences News Brief
Vol. 5 no.31 - October 12, 2005
　

Protox receives IRB approval to conduct clinical testing of PRX302

Protox Therapeutics Inc. (Vancouver) announced that it has received approval from the Institutional Review Board (IRB) at the Scott and White Memorial Hospital and Clinic in Temple, Texas (Scott and White) to conduct a Phase 1 clinical study of PRX302 for the treatment of localized, recurrent prostate cancer. The clinical study may begin once Protox has submitted an Investigational New Drug Application (IND) to the United States Food and Drug Administration (US FDA) and is informed by the US FDA that Protox may proceed with the Phase 1 study.

Cardiome And Astellas Initiate ACT 4 Study

Cardiome Pharma Corp. (Vancouver) and its co-development partner Astellas Pharma US, Inc. announced the initiation of an open-label safety study of intravenous RSD1235 for the acute treatment of atrial fibrillation. The study, called ACT 4 (Atrial arrhythmia Conversion Trial 4) will evaluate the safety of intravenous RSD1235 in approximately 120 atrial fibrillation patients. There is no placebo or active control group in the study, which is being conducted by Astellas and carried out across approximately 30 centers in the U.S., Canada, and Europe. ACT 4 is primarily a safety study and it is anticipated that the added safety data will supplement the pivotal ACT 1 and ACT 3 trial results.

Lorus announces results of Virulizin(R) Phase III Clinical Trial

Lorus Therapeutics Inc. (Toronto), a biopharmaceutical company specializing in the development and commercialization of pharmaceutical products and technologies for the management of cancer, announced the top-line results of their randomized Phase III clinical trial of Virulizin(R) in the first-line treatment of pancreatic cancer. The trial compared Virulizin(R) plus gemcitabine to placebo plus gemcitabine for treatment of chemonaive patients with locally advanced or metastatic pancreatic cancer. For the efficacy evaluable population, the study showed that the addition of Virulizin(R) to gemcitabine resulted in a median overall survival of 6.8 months and a one-year survival rate of 27.2%, compared to 6.0 months and 16.8% for placebo plus gemcitabine. In the intent to treat population the median overall survivals were 6.3 months for Virulizin(R) plus gemcitabine (one year survival rate of 25.9%) compared to 6.0 months for placebo plus gemcitabine (one year survival rate of 17.6%). While comparison of the median overall survival times did not reach statistical significance, exploratory analysis did show promising trends in specific patient populations. Several examples are provided below.

Clinical Development Commences for Alzheimer's Disease Lead Product

Hemosol Provides Corporate Update

Hemosol Corp. (Toronto) provided investors with an update on the status of its financing and strategic initiatives. Hemosol has held several discussions with potential investors in connection with its proposed private placement financing but no commitments have been obtained to date. Hemosol has also held discussions with several parties in connection with potential strategic transactions but no commitments have been obtained to date. No assurance can be given that Hemosol will be able to complete any such transactions given its current financial resources. Hemosol requires additional capital shortly to continue as a going concern and is in discussions with its secured creditors with respect to its current financial position.

PreMD Provides Progress Report on PREVU, LungAlert(TM)

Predictive medicine company PreMD Inc. (Toronto) provided a progress report on PREVU Skin Sterol Test, the company's non-invasive cardiovascular risk assessment technology, and LungAlert(TM), its test for the early detection of lung cancer. McNeil Consumer Healthcare is developing its marketing strategy for PREVU Point of Care (POC) Skin Sterol Test at the retail level, and plans to activate a pilot program in Quebec targeting customers of a major North American retail chain. If successful, it is currently anticipated that the program, which will be conducted in an on-site pharmacy or clinic, may be extended to additional locations. "Supermarkets and mass retailers represent an increasing percentage of overall pharmacy sales, so it's logical for McNeil to target this growing market segment," said Dr. Brent Norton, President and Chief Executive Officer. McNeil is continuing to develop the professional market and is actively promoting PREVU POC through medical conferences, including the annual meeting for the European Society of Cardiology and the upcoming Canadian Cardiovascular Congress.

Bioniche and AngioDynamics Sign Exclusive Distribution Agreement

Bioniche Life Sciences Inc. (Belleville), a research-based, technology-driven Canadian biopharmaceutical company, announced that its Pharma Division has signed an exclusive distribution agreement with AngioDynamics, Inc. for Sotradecol(R) Injection (Sodium Tetradecyl Sulfate Injection) in the United States for the treatment of small, uncomplicated varicose veins. Under the agreement, AngioDynamics has exclusive rights to distribute and sell the product to vascular surgeons, interventional radiologists, and general surgeons in the U.S. Promotions of the product in these market segments will be shared between Bioniche and AngioDynamics. Bioniche Pharma manufactures the product at its GMP facility in Galway, Ireland.

TOPIGEN Initiates Phase II Clinical Trial of Lead Drug Candidate

TOPIGEN Pharmaceuticals Inc. (Montreal), an emerging biopharmaceutical company specializing in respiratory disorders, announced the completion of Phase I and the initiation of a Phase II clinical trial of ASM8 in patients with allergic asthma. The randomized, placebo-controlled, multicenter, crossover, Phase II trial will assess the efficacy and overall safety and tolerability of TOPIGEN's investigational drug. The study in mild allergic asthmatics will evaluate repeated administration of ASM8 in patients for the treatment of allergen-induced asthma, a validated model of drug efficacy in patients. The principal investigator of the study is Dr. Paul O'Byrne, Chairman of Medicine, McMaster University, Canada.

Oncolytics Ends Patient Treatment in Canadian Phase I Clinical Trial

OLYMPIA registry supports positive safety profile of TAXUS(R)

Angiotech Pharmaceuticals, Inc. (Vancouver) corporate partner, Boston Scientific, announced 30-day safety data from the transitional phase of its OLYMPIA registry. The OLYMPIA registry is designed to collect and analyze "real-world" clinical outcomes data using BSC's next-generation TAXUS(R) Liberté(TM) paclitaxel-eluting stent system in the treatment of patients with coronary artery disease. Enrollment has begun in the next two phases of the study, which will include up to 30,000 patients at 500 sites in more than 70 countries where the product is commercially available. BSC made the announcement at the annual Transcatheter Cardiovascular Therapeutics symposium, in Washington, D.C.

TAXUS(R) stent system shows significant reduction of restenosis

Angiotech Pharmaceuticals, Inc. (Vancouver) corporate partner, Boston Scientific, announced nine-month sub-population data from its TAXUS V clinical trial that further supports the performance of the TAXUS(R) Express(2)(TM) paclitaxel-eluting coronary stent system for the treatment of coronary artery disease in diabetic patients, particularly higher-risk insulin-requiring diabetics. TAXUS V expands on the TAXUS IV pivotal trial by studying the most challenging lesions and highest-risk patients ever studied in a randomized, controlled clinical trial in the United States. BSC made the announcement at the annual Transcatheter Cardiovascular Therapeutics symposium in Washington, D.C.

VSM MedTech and Simon Fraser University win Synergy Award

VSM MedTech Ltd. (Vancouver), world leader in the emerging clinical market for magnetoencephalography (MEG) functional brain imaging, will receive jointly with Simon Fraser University a Synergy Award for Innovation from Canada's Natural Sciences and Engineering Research Council (NSERC). Because it uses a non-invasive approach in an environment that is comfortable for the patient, MEG is gaining medical acceptance worldwide for real-time, high-resolution measurement of the brain's electromagnetic signatures. MEG, long-recognized as a leading-edge research tool, is increasingly in demand in the much larger clinical market for the diagnosis and treatment of neurological disorders.

• BCY LifeSciences Inc. (Toronto) announced that it has entered into a letter of intent to negotiate a business combination with Pipex Therapeutics, Inc. ("Pipex"), a privately-held biopharmaceutical company located in Ann Arbor, Michigan……
• LAB International Inc. (Laval), an integrated drug development company with subsidiaries focused on developing therapies for the inhalation market and on providing contract research services, announced that LAB Pharma, it's drug development subsidiary headquartered in Finland, has secured approximately $2.22 million (1.55 million euros) to support product development……
• Stressgen Biotechnologies (Victoria) announced that it has received a favorable decision in its patent challenge by Antigenics from an Opposition Division of the European Patent Office that maintained the Company's European Patent EP-B1 1,002,110 in amended form. The Opposition by Antigenics was therefore dismissed, although they have the right to appeal this decision…… SAFC Biosciences, a member of the Sigma-Aldrich Group and
• Chromos Molecular Systems Inc. (Burnaby), have entered into a non-exclusive co-marketing arrangement whereby SAFC Biosciences and Chromos will jointly market and offer Chromos' proprietary ACE System for cell line engineering for protein production applications…….
• Transition Therapeutics Inc. (Toronto) announced the receipt of the first anniversary payment of $475,000 from the sale of its subsidiary, Stem Cell Therapeutics Inc……
• Stressgen Biotechnologies (Victoria) announced that it has engaged Canaccord Capital Corporation for a private placement offering of up to 7,500,000 Units at a price of $0.35 per Unit for aggregate gross proceeds of up to $2,625,000. Stressgen Biotechnologies also announced that it has reduced its workforce by thirty-three percent to twenty-seven permanent staff in a continuing effort to lower its operating costs and realign its resources to permit the development of HspE7, the Company's lead compound……
• AnorMED Inc. (Vancouver) announced that it will seek a Conditional Marketing Authorization (CMA) for MOZOBIL (AMD3100, Plerixafor) in Europe in early 2007. The Company also plans to file a Marketing Authorization Application (MAA) with the European Medicines Agency (EMEA) based on the Phase III program currently ongoing in the U.S…….
• VSM MedTech Ltd. (Vancouver) won a contract for the sale of a magnetoencephalography (MEG) functional brain imaging system to the Center for Neuromagnetism at NYU Medical Center and the New York University School of Medicine. The 275-channel CTF MEG(TM) device is scheduled for installation in the first half of 2006. It replaces a Magnes(R) 2500 WH MEG system from VSM's competitor 4-D Neuroimaging……
• Angiotech Pharmaceuticals, Inc. (Vancouver), announced that Greg Peet, a former CEO and Chairman of A.L.I. Technologies Inc, has been appointed to Angiotech's board of directors……..
• Welichem Biotech Inc. (Burnaby), a biotechnology company developing therapeutic drugs in the fields of autoimmune/anti-inflammatory diseases and cancer, announced that Dr. Moulay Alaoui-Jamali, an international expert in cancer pharmacology and therapeutics from the Departments of Medicine and Oncology at McGill University, Montreal, has joined the Company's Scientific/Clinical Advisory Boards…….
• Oncolytics Biotech Inc. (Calgary) has been granted Canadian Patent 2,283,280 entitled "Reovirus for the treatment of neoplasia." The claims describe the use of a reovirus for the manufacture of a medicament to treat Ras-mediated neoplasia as well as methods of treating various cancers by the administration of the reovirus……..
• MedMira Inc., (Halifax) a global market leader in flow-through rapid diagnostic tests, announced that Nova Scotia business woman, Maureen Millier has been appointed to the MedMira Board of Directors.

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