Life Science News Briefs Vol. 6 no.28 - October 11, 2006

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

Pharmaceuticals & Biotherapeutics Update

Biophage signs an M.O.U. to access exclusive nanomaterials

Biophage Pharma Inc. (Montreal) announced that it has signed an M.O.U. with QuarTek Corporation, Greensboro, NC in order to access QuarTek Nanomaterials (QNMs) for its own development and for distribution purposes. QuarTek Nanomaterials (QNMs) have exclusive properties and are protected by several issued and pending patents. QNMs show uniform size, morphologies, modulated magnetic moments and high binding efficiency to proteins (antibodies, peptides, or oligonucleotides). Coated with albumin, polyethylene, polypropylene, or polystyrene some super paramagnetic particles can be used for the separation of different biological components from complex samples (such as blood and food samples) eliminating the process of sample centrifugation. http://www.biophage.com

YM BioSciences receives clearance to import nimotuzumab

YM BioSciences Inc. (Mississauga), a company engaged in the acquisition, development and commercialization of oncology and acute care products, announced that the Office of Foreign Assets Control (OFAC) of the US Treasury Department has approved a license that allows YM BioSciences' wholly-owned U.S. subsidiary to import nimotuzumab into the United States for the purpose of clinical trials in pediatric patients with pontine glioma. Nimotuzumab is a monoclonal antibody that targets the Epidermal Growth Factor Receptor (known as EGFR) and was developed at the Center for Molecular Immunology affiliated with the University of Havana. As a result of the OFAC license, YM BioSciences plans to submit an IND to the FDA to allow the investigation of nimotuzumab for the treatment of children with intrinsic diffuse pontine glioma. Upon FDA granting permission for the IND to proceed nimotuzumab, to the knowledge of the company, would be the first anti-cancer drug from Cuba to be used in clinical trials in the US. www.ymbiosciences.com

Elan and Transition Therapeutics Inc. Announce Global Collaboration

Elan Corporation, plc (Dublin) and Transition Therapeutics Inc. (Toronto), announced an exclusive, worldwide collaboration agreement for the joint development and commercialization of a novel therapeutic agent, AZD-103, for the treatment of Alzheimer's disease. AZD-103 is a small molecule compound in Phase I clinical development that acts by breaking down and preventing the assembly of beta amlyoid fibrils, a hallmark pathology of Alzheimer's disease. Under the terms of the agreement, Transition will receive upfront payments of US$15 million: US$7.5 million in 2006 and the remaining US$7.5 million in 2007. In addition, dependant upon the successful development, regulatory approval and commercialization of AZD-103, Transition will be eligible to receive milestone payments of up to US$185 million. Elan and Transition will share the costs and operating profits of AZD-103 if successfully developed and commercialized. Each party's cost share and ownership interest may vary throughout the term of the Agreement dependant on certain elections that may be made during the development of AZD-103. http://www.transitiontherapeutics.com

Clinical Trials

Isotechnika reports safety and efficacy data from Psoriasis Extension trial

Isotechnika Inc. (Edmonton) reports final safety and efficacy data subsequent to 60 weeks of continuous treatment with ISA247. All safety and efficacy endpoints were met. Patients completing the 24 week Canadian Phase III SPIRIT trial were given the opportunity to continue ISA247 therapy at a 0.3 mg/kg twice daily oral dose for an additional 36 weeks. The goal of the extension trial was to gather long term safety data while demonstrating continued therapeutic benefit. Patients have now received continuous treatment with ISA247 for a total of 60 weeks. Over the course of the 24-week Phase III trial, patients exhibited a 60% mean improvement in Psoriasis Area and Severity Index (PASI) scores. After an additional 36 weeks of treatment, there was a 54% mean improvement in PASI scores indicating continued therapeutic benefit. This beneficial effect was still observed twelve weeks after discontinuing ISA247 treatment; mean PASI scores remained at 35% below pre-treatment scores. Subsequent to 60 weeks of continuous treatment, there were no clinically significant changes in kidney function, cholesterol, triglycerides, new onset diabetes, infectious complications, or other laboratory parameters. This supports the long term safety of SA247. http://www.isotechnika.com.

LAB reports positive results from its LAB-CGRP Phase IIA study

LAB International Inc. (Laval), a drug development company focused n developing therapies for the inhalation market, announced positive results from the first Phase II clinical trial of its LAB CGRP product. LAB CGRP showed statistically significant broncho-protective effects compared to placebo and a similar safety profile to placebo except for transient and mild headaches and flushing in some of the patients. The objectives of this randomized, double blind, cross-over Phase II study were to investigate the protective efficacy of LAB CGRP on metacholine induced bronchial hyper-responsiveness in adult patients with mild to moderate asthma, to compare this efficacy to salbutamol and placebo and to evaluate the safety and tolerability of LAB CGRP in asthma patients. The trial enrolled a total of 12 patients and reached statistical difference. Each patient received one dose of LAB CGRP (5mg), one dose of Salbutamol sulphate (500(micro)g) and one dose of placebo. The doses were given in a randomized order and study agents were compared in terms of absolute provocative concentration (PC20) of methacholine causing at least 20% fall in forced expiratory ventilation volume. LAB CGRP increased PC20 in a majority of patients (7 out of 12) while Salbutamol and placebo respectively achieved 11 and 2 out of 12. On average, the PC20 with LAB CGRP was approximately two-fold as compared to placebo (geometric mean 1.97 mg/ml, and 0.95 mg/ml, respectively p(less than)0.05). http://www.labinc.ca

AEterna Zentaris Announces Positive Phase 2 Results for Ozarelix

AEterna Zentaris Inc. (Quebec City) disclosed highly statistically significant positive data from its Phase 2 trial with ozarelix for patients suffering from benign prostatic hyperplasia (BPH). The study achieved its primary efficacy end-point of improving clinical symptoms of BPH, at week 12, as measured by significant changes in the International Prostate Symptom Score (I-PSS), the standard method of assessing BPH symptoms. This multi-center double-blind, randomized, placebo-controlled, dose-ranging Phase 2 trial included a total of 144 patients who received either different intramuscular dosage regimens of the luteinizing hormone-releasing hormone (LHRH) antagonist, ozarelix, or a placebo, to assess its safety and efficacy. The trial was conducted in Europe in collaboration with AEterna Zentaris' partner, Spectrum Pharmaceuticals Inc. The results of the trial demonstrated an excellent safety profile with ozarelix where patients had no serious side effects. In particular, the erectile function, as measured by the International Index of Erectile Function, was not affected at any dose regimen. Full details on the trial results will be presented at an international conference in 2007. http://www.aeternazentaris.com

Ondine Biopharma Announces Results from Clinical Trial

Ondine Biopharma Corporation (Vancouver) announced results from a prospective, randomized, controlled, blinded clinical trial of its Periowave(TM) Photodynamic Disinfection (PDD) System for the treatment of periodontal diseases. Results showed significant improvement in pocket depth, clinical attachment level and bleeding on probing when compared to the gold standard of scaling and root planing (SRP). This study focused on a maintenance protocol, in which patients received Periowave(TM) during initial therapy and then again at recall 6 weeks later. Statistically significant improvements were found on all endpoints. The primary goal of periodontal therapy is to return a pocket from a diseased state (greater than 5 millimeters) to recovery (less than or equal to 3 millimeters). The Periowave(TM) arm had 56% of the 698 diseased sites recover ((less than or equal to) 3 millimeters) at 12 weeks as compared to 37% of the 588 diseased sites in the SRP arm. Over 50% more sites treated under this Periowave(TM) arm fully recovered at 12 weeks compared to those treated with SRP alone (p(less than)0.0001). http://www.ondinebiopharma.com

Medical Devices and Diagnostics Update

MDS to Sell Diagnostics Business to Borealis Infrastructure Management

MDS Inc. (Toronto), a global life sciences company, announced a new chapter in the Company's history as it signed an agreement to sell its Canadian laboratory services business, MDS Diagnostic Services, to Borealis Infrastructure Management Inc. in a CAD $1.325 billion transaction. This strategic sale is designed to shift the company's business focus to the life sciences market. Under this agreement, Borealis Infrastructure Management, an investment entity of Ontario Municipal Employees Retirement System (OMERS), one of Canada's largest pension plans, will acquire MDS Diagnostic Services, Canada's largest provider of laboratory services, with annualized revenues of CAD$335 million and over 2,900 employees. This sale is pivotal to the strategy that MDS has been executing since last September. This strategy also included streamlining its cost structure to be more competitive and selling non strategic assets. http://www.mdsinc.com

Industry Briefs

AnorMED Inc. (Vancouver) announced that its Board of Directors has recommended that AnorMED shareholders accept and tender their shares to the offer by Millennium Pharmaceuticals, Inc., filed with applicable securities regulators and being mailed to shareholders, to purchase all of the outstanding common shares of AnorMED including all common shares issuable on the exercise of outstanding stock options, for US$12.00 per share in cash. The Millennium offer expires on November 10, 006. http://www.anormed.com

Sanofi pasteur, the world’s leading vaccine company, announced that a $30 million capital expansion project is underway at its Canadian global manufacturing site in north Toronto. The investment is focused on expanding the company’s global leadership in acellular pertussis and polio vaccine manufacturing by significantly increasing the manufacturing capability for these products. On site to celebrate the capital expansion was Ontario Premier and Minister of Research and Innovation Dalton McGuinty and Mark Lievonen, President, Sanofi Pasteur Limited. They recognized sanofi pasteur employees in Canada for putting Ontario research and innovation on a global stage.

Stem Cell Therapeutics Corp. announced the formation of its Clinical Advisory Board (CAB) with three internationally renowned clinicians. Drs. Steven Cramer, Hannelore Ehrenreich, and Michael Hill have agreed to provide input and guidance on SCT's current stroke program with NTx(TM)-265, as well as potential future programs in Schizophrenia, Multiple Sclerosis, Traumatic Brain Injury, and Huntington 's disease. http://www.stemcellthera.com

Xenon Pharmaceuticals Inc. (Vancouver) and Takeda Pharmaceutical Company Limited announced that the companies have entered into an exclusive agreement to develop and commercialize oral formulations of Xenon's lead product for pain, XEN401, in Japan and certain Asian countries. XEN401 is currently in preclinical development. http://www.xenon-pharma.com

Ceapro Inc. (Edmonton) announced the appointment of Mr. Branko Jankovic as Controller, effective . For the past nine years, Mr. Jankovic has been a business consultant providing consulting services to public, private, and government clients. He currently serves as a director of ProMetic Life Sciences Inc. http://www.ceapro.com

Lorus Therapeutics Inc. (Toronto), a biopharmaceutical company specializing in the research and development of pharmaceutical products and technologies for the management of cancer, announced the appointment of Georg Ludwig and Dr. Michael Moore as directors of the company. http://www.lorusthera.com

BC Biotech announced the appointment of two new board members who represent leading life sciences companies in British Columbia. Peter O'Callaghan, Senior Vice President, Corporate Development and Senior Counsel at QLT Inc., and Dr. Simon Pimstone, Director, and President & Chief Executive Officer at Xenon Pharmaceuticals Inc., were elected to BC Biotech's Board of Directors at last week's Annual General Meeting. http://www.bcbiotech.ca