Life Sciences News Brief
Vol. 5 no.39 - December 7, 2005
　

AEterna Zentaris Announces Completion of Patient Enrollment for Ozarelix

AEterna Zentaris Inc. (Quebec City) announced it has completed enrollment of 144 patients for a Phase II trial with ozarelix (D-63153) in benign prostatic hyperplasia (BPH), more than four months ahead of schedule. The randomized, placebo-controlled multi-center clinical trial is designed to evaluate both objective parameters, such as improvement in urine flow and shrinkage of the prostate volume, as well as various symptoms of BPH over a period of several months. The trial is being conducted in Europe with the collaboration of Spectrum Pharmaceuticals Inc. (NASDAQ: SPPI) and results are expected to be disclosed during the second half of 2006.

Inflazyme Pharmaceuticals Announces Results from Helicon Phase Ib

Inflazyme Pharmaceuticals Ltd. (Vancouver) announced preliminary results of the oral, multiple dose Phase I study conducted in healthy volunteers by their partner Helicon Therapeutics, Inc. of New York. The oral, multiple dose, double-blinded, placebo controlled Phase Ib study in healthy young and elderly subjects has been completed. Helicon has reported the data indicates that IPL455,903 (also known as HT-0712) was safe and well tolerated in all volunteers and at all doses tested. The doses evaluated ranged up to 135mg per subject per day for 14 days. The Company will report further on the results of the study when they become available. According to Helicon, IPL455,903 is currently being prepared for Phase IIa clinical testing indicating the compound is on track to enter that study early next year. The compound is to be evaluated as a potential treatment for memory disorders.

Labopharm Submits NDA for Once-Daily Tramadol

Labopharm Inc. (Laval) announced that it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for its once-daily formulation of the analgesic tramadol. Labopharm is seeking regulatory approval to market its once-daily tramadol for the management of moderate to moderately severe pain. The action date under the Prescription Drug User Fee Act (PDUFA) for Labopharm's NDA is September 28, 2006.

Stem Cell Therapeutics Corp. and Medicon A/S initiate dosing of patients

Study shows Procyon's PSP94 diagnostic marker is better

Procyon Biopharma Inc. (Montreal), a biotechnology company developing innovative therapeutics in the fields of cancer and HIV/AIDS, announced that the findings of an extensive study, conducted by Dr. Robert K. Nam, MD, FRCSC, Assistant Professor of Surgery, Division of Urology at the Sunnybrook and Women's College Health Sciences Centre, University of Toronto, with its Prostate Secretory Protein of 94 amino acids (PSP94) immunoassays for the diagnosis and prognosis of prostate cancer, will be published in the Journal of Urology. The study conducted with 1212 patients who underwent biopsy confirmation of prostate cancer due to either an abnormal digital rectal examination (DRE) or high Prostate Specific Antigen (PSA) showed that PSP94 serum levels were a better predictor of the aggressivity of the cancer than PSA or FTPSA (Free to Total PSA ratio).

AnorMED announces enrollment of HIV patients into XACT study

AnorMED Inc. (Vancouver) announced the enrollment of HIV patients into its new clinical trial to evaluate the potential of AMD070 as a new anti-HIV drug. The XACT (X4 Antagonist Concept Trial) trial is fully funded by AnorMED and is being conducted at two leading HIV research centers, one in the U.S. and one in the U.K. XACT is an open label dose finding study which may include up to 4 study cohorts of 12 patients each. Patients in the first cohort will receive 200 mg of AMD070, twice daily, for 10 consecutive days. The objective of the study is to determine the safety and antiviral activity of AMD070 in HIV-infected patients who harbor the CXCR4 using virus. Anti-viral activity is measured by a 1 log reduction in the CXCR4 using virus. Initial data from this study is expected in early 2006.

Aspreva Announces Completion of Patient Enrolment

Aspreva Pharmaceuticals Corporation (Victoria), an emerging pharmaceutical company focused on increasing the pool of evidence-based medicines available for patients living with less common diseases, announced completion of enrolment of 176 patients in the phase III clinical study to assess the safety and efficacy of mycophenolate mofetil (MMF or CellCept(R)) to maintain or improve symptom control with reduced corticosteroids in patients with myasthenia gravis (MG). The randomized, double-blind, placebo-controlled clinical trial is designed to evaluate the efficacy and safety of MMF to maintain or improve symptom control with reduced corticosteroids in patients with myasthenia gravis over a treatment period of 36 weeks. The primary endpoint of responder status in the trial encompasses both minimal disease activity and low steroid dose. The company expects to complete the trial in late 2006.

Response Biomedical Achieves Superior Performance Targets

Response Biomedical Corp. (Vancouver) announced the Company has successfully achieved its analytical sensitivity targets for its Flu A Test. It is intended that the test be commercialized for both human and animal applications. Using a variety of Flu A strains, the performance results to date indicate that the RAMP Flu A Test produces results that are in excess of 100 times more sensitive than commercially available rapid influenza A tests. This superior level of performance is particularly important as leading public health agencies continue to express caution about the lack of sensitivity and related performance limitations of currently available rapid Flu A tests.

Forbes Medi-Tech Initiates Dosing Phase in Clinical Trial

Millenium Biologix Announces FDA 510(k) Clearance for First Device

Millenium Biologix Corporation (Kingston) announced that it has received a Class II 510(k) clearance from the U.S. Food and Drug Administration to market and sell its Microporous Skelite(TM) Resorbable Cement Restrictor product in the United States. "This clearance allows us to bring our first product to market based on our Microporous Skelite Technology," said Dr. Timothy Smith, President and COO of Millenium. "This Microporous Skelite Technology enables the development of specialized synthetic bone graft implants with greater compressive strength and impact resistance. With these enhanced properties, the range of orthopedic applications for our Skelite technology has been broadened to include those where higher stresses are involved." The Microporous Skelite Resorbable Cement Restrictor is a hollow, rounded rectangular device with textured surfaces on two opposing sides and is available in various sizes. It is packaged as a sterile, single use implantable device that is intended to be used as a cement restrictor in orthopedic surgeries such as those involving the femoral and tibial canals in hip stem and total knee replacements.

Angiotech completes acquisition of Lifespan(R) vascular graft product line

Angiotech Pharmaceuticals, Inc. (Vancouver) announced that it has completed its acquisition of the Lifespan(R) ePTFE vascular graft business, located in Laguna Hills, California, from Edwards Lifesciences Corporation (NYSE:EW) for $14 million in cash. The transaction includes a distribution agreement with Edwards, whereby Edwards will continue to market and sell the existing Lifespan product line for a period of up to five years, and will be the exclusive distributor of Angiotech's Vascular Wrap(TM) paclitaxel-eluting mesh product, packaged in combination with Lifespan(R) vascular grafts, in the European Union for a period of up to two years from the receipt of European regulatory approval of the Vascular Wrap(TM) product. Per the agreement, Angiotech retains all marketing and distribution rights with respect to any and all Vascular Wrap(TM) paclitaxel-eluting mesh related products in the United States, and has co-exclusive marketing and distribution rights with respect to the standalone Lifespan(R) product line in the United States.

Biophage announces capability of its PDS(R) Biosensor

MUHC/McGill Scientists Identify Gene for Vitamin B12 Disease

Scientists at the MUHC and McGill University have identified a gene responsible for a disease that impairs the body's ability to handle vitamin B12 and that may contribute to heart disease, stroke and dementia. The details of the CIHR and March of Dimes funded research are published in this week's issue of Nature Genetics. The research, which began more than 20 years ago, will allow doctors to perform earlier diagnosis, assess 'carriers' of the disease-Combined Methylmalonic aciduria (MMA) and Homocystinuria-and open the door to new and improved treatments for this debilitating disease. "Although this disease sometimes starts in adolescence or adulthood, we usually diagnose this rare inability to process vitamin B12 in the first few months of life," says Dr. David Rosenblatt, Chairman of Human Genetics at McGill, Director of Medical Genetics in Medicine at the MUHC, Chief of Medical Genetics at the Jewish General Hospital and lead researcher of the new study. "Babies may have breathing, feeding, visual and developmental difficulties, older patients may develop sudden neurological disease." Vitamin B12, which is found in all animal products -- including dairy, eggs, meat, poultry, and fish -- but not in plants, is vital for synthesis of red blood cells and maintenance of the nervous system. Vitamin B12 also helps control homocysteine levels in the human body. Homocysteine control is important because in excess this compound can increase the risk of heart disease, stroke, and dementia.

• Hemosol Corp. (Toronto) announced that PricewaterhouseCoopers Inc., in its capacity as trustee under the Notices of Intention to Make a Proposal of Hemosol Corp. and Hemosol LP dated November 24, 2005, is filing an application with the Ontario Superior Court of Justice returnable December 5, 2005 seeking, among other things, an order appointing PricewaterhouseCoopers Inc. as the interim receiver over the property, assets and undertaking of Hemosol Corp. and Hemosol LP and approving interim financing by Hemosol's secured creditors in the amount of $2.0 million. Hemosol Corp. also announced that all of its directors have tendered their resignations from the board of directors……..
• AnorMED Inc. (Vancouver) announced that it has obtained receipts for a final short form prospectus relating to the recently announced agreement with an underwriting syndicate co-led by Raymond James Ltd. and BMO Nesbitt Burns Inc., and including CIBC World Markets Inc. and Canaccord Capital Corporation under which the underwriters have agreed to purchase 6,250,000 Common Shares from AnorMED and sell to the public at a price of $4.00 per Common Share (the "issue price"), representing an aggregate issue amount of $25,000,000……..
• Isotechnika Inc. (Edmonton), a biopharmaceutical company focused on the discovery and development of novel immunosuppressive therapeutics, announced that effective December 1, 2005, Mr. Lawrence G. Meyer, a board member since 2001 has resigned from its Board of Directors…….
• Response Biomedical Corp. (Vancouver), announced that it has appointed LXU Healthcare, Inc., a leading provider of premier medical equipment and specialty devices, as its exclusive distributor for the RAMP Cardiovascular Tests in a number of key markets in the USA……..
• ChondroGene Limited (Toronto) announced that Dr. Daniel H. Farkas has joined the Company as VP, Clinical Diagnostics. Dr. Farkas will work to identify applications for the Company's Sentinel Principle, develop clinical and commercial opportunities for the Company's products and assist in the Company's regulatory strategy development and implementation…….

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