Life Science News Briefs Vol. 6 no.36 - December 7 2006

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

Pharmaceuticals & Biotherapeutics Update

ARIUS Receives Six Key US Patents

ARIUS Research Inc. (Toronto) announced that it has received Notices of Allowance from the United States Patent and Trademark Office for patents on their lead antibody, ARH460-16-2, targeting the CD44 antigen implicated as markers of cancer stem cells in breast and prostate cancer plus separate patents covering antibodies to the CD63, CD59 and MCSP antigens. These patents are important additions to the ARIUS Intellectual Property portfolio that underlie the value of existing partnerships and ongoing business development and licensing activities. ARIUS has licensing and collaboration agreements with leading biotechnology and pharmaceutical companies such as Genentech, Takeda and PDL Biopharma with a global potential value to ARIUS of approximately $400 million plus royalties on sales. ARIUS will be eligible for these milestone fees based on research activities, clinical milestones, regulatory approvals and 1st commercial sales. The terms include $10.7 million in upfront payments, equity investment and research support funding. These new patents cover the antibody molecules and various uses of each antibody and other similar antibodies to treat cancers such as ovarian, prostate and breast cancer. In addition, ARIUS has patent claims covering epitopes or specific parts of a cancer antigen target. This patent approach represents a large step up in value over more general target coverage because it is the epitope that determines what a cell will do when an antibody binds to it. In ARIUS' case, functional antibodies bind to epitopes that signal a cancer cell to die. http://www.ariusresearch.com

Kiadis and Celmed Merge to Create New Force in Oncology

Kiadis B.V, a Dutch early product development company, and Celmed BioSciences Inc., (Montreal) a Canadian clinical product development company, announce their plans to merge both oncology-focused companies. The combined company will be named Kiadis Pharma B.V. and headquartered in the Netherlands with supporting facilities in the Netherlands and Canada. Kiadis Pharma is fully dedicated to in-house pharmaceutical product development and has extensive experience in oncology. Kiadis Pharma currently has an impressive small molecule pipeline with four products in various phases of clinical development allowing fast track potential and significant market opportunities. Its lead product, ATIR, has successfully allowed blood cancer patients, without access to a fully matched donor, to receive a life-saving transplantation of bone-marrow. ATIR is currently in phase I/II clinical development and could open treatment opportunities for a significant group of patients. The product pipeline of Kiadis Pharma relies on three proprietary technology platforms that form a strong foundation for the development of existing and future innovative drugs. The combination of Kiadis and Celmed BioSciences creates a leading international biotechnology company with proven strengths in oncology, both in products and development platforms. The companies complement each other well when it comes to pipeline, network, regulatory experience and management teams. The merger marks a key milestone in the development of new treatment options for difficult to treat diseases. http://www.celmedbio.com http://www.kiadis.com

Clinical Trials

AEterna Zentaris to Initiate Phase 3 Program with Cetrorelix in BPH

AEterna Zentaris Inc. (Quebec City) announced the Company's plan to initiate its Phase 3 program in benign prostatic hyperplasia (BPH) before year-end with its luteinizing hormone-releasing hormone (LHRH) antagonist compound, cetrorelix, after the Company's Investigational New Drug Application (IND) was accepted by the U.S. Food and Drug Administration (FDA). The first study of this Phase 3 program titled, "Cetrorelix pamoate intermittent IM dosage regimens in patients with symptomatic BPH: a 1 year placebo-controlled efficacy study and long-term safety assessment", will assess an intermittent dosage regimen of cetrorelix as a potential safe and tolerable treatment providing prolonged improvement in BPH-related signs and symptoms, under the supervision of lead investigator, Herbert Lepor, M.D., Professor at NY University School of Medicine, New York. This first study, involving approximately 600 patients, is part of an extensive Phase 3 program enrolling a total of about 1,500 patients, which will include other large safety and efficacy studies conducted in North America and Europe. "Cetrorelix has shown promising and compelling results in our prior extensive Phase 2 program, and we are now very excited about the possibility of bringing to market a safe and novel treatment for the millions of men suffering from BPH," said Dr. Jurgen Engel, Executive Vice President, Global R&D; and Chief Operating Officer at AEterna Zentaris. http://www.aeternazentaris.com

Bradmer Contracts With Prologue Research to Manage Pivotal Trial

Bradmer Pharmaceuticals Inc., (Toronto) a biopharmaceutical company dedicated to the development and commercialization of cancer therapies, announced that it has reached an agreement with Prologue Research, Inc. for the management of Bradmer's upcoming multi-center pivotal trial of its lead product candidate, Neuradiab, for the treatment of primary glioblastoma multiforme (GBM). Under the terms of the multi-year agreement, Prologue will provide comprehensive project management in support of the trial including clinical monitoring, data management, biostatistics, medical affairs, reporting, pharmacovigilance, quality assurance, and regulatory support. "Prologue's project team supporting Bradmer has a wealth of experience managing multidiscipline oncology trials involving radiolabeled monoclonal antibodies. Their experience will compliment our existing scientific and clinical expertise to ensure that the Neuradiab pivotal trial is conducted in a professional and timely manner," commented Dr. Alan M. Ezrin, Chief Operating Officer of Bradmer. http://www.bradmerpharma.com

Isotechnika's ISA247 positioned to enter Phase II/III clinical trials

Isotechnika Inc. (Edmonton) announced that its lead immunosuppressive drug, ISA247 is positioned to enter Phase II/ III human clinical trials in uveitis by its partner Lux Biosciences, following interactions with the Food and Drug Administration and clearance of its Investigational New Drug Application (IND). On May 25 of this year, Isotechnika signed an agreement with Lux Biosciences, Inc. of Jersey City, New Jersey granting Lux Biosciences exclusive, worldwide rights to develop and commercialize Isotechnika's lead drug, ISA247 for the treatment and prophylaxis of all ophthalmic diseases. ISA247, which is referred to as LX211 by Lux, will be investigated in the oral capsule formulation for the treatment of active and control of quiescent non-infectious uveitis in three separate pivotal protocols. http://www.isotechnika.com

CryoCath receives FDA approval to expand AF trial

CryoCath Technologies (Montreal), the global leader in cryotherapy products to treat cardiovascular disease, announced it has received notification from the U.S. Food and Drug Administration (FDA), allowing the Company to expand its pivotal Investigational Device (IDE) STOP AF trial. Effective immediately, the Company can now enroll up to 150 patients in up to 20 centers. To date, five centers have received Internal Review Board (IRB) approval and have begun screening patients, including 16 that have already been enrolled and randomized. The Company expects four additional centers to come online in December with the remainder to be actively recruiting patients early in the new calendar year. http://www.cryocath.com

BioAxone Study Demonstrates Positive Interim Results

BioAxone Therapeutic (Montreal) announced positive interim results on its Phase I/IIa North American dose escalation clinical trial on Cethrin(R) for the treatment of acute spinal cord injury (SCI). The Company reported that data on safety, tolerability and neurological outcome from the six-week follow-up of the trial of Cethrin(R) at four dose levels (0.3, 1, 3 and 6 mg) indicates that this treatment is safe and well tolerated and that the functional benefit may be dose dependent. The twelve-month study is evaluating 37 patients from 9 centers in the U.S. and Canada who suffered a complete thoracic or cervical injury (i.e. ASIA Grade A, having no sensory or motor function below the level of the spinal cord injury). The trial is not placebo controlled but has an efficacy component based on the American Spinal Injury Association's (ASIA) scale which is designed to assess sensory and motor function in patients. In this trial, 31% of patients, after six weeks, recovered some sensory and/or motor function below the level of their injury and converted from a complete injury to an incomplete injury. http://www.bioaxone.com

AEterna Zentaris Reports Positive Top Line Phase 1 Results for AN-152

AEterna Zentaris Inc. (Quebec City) disclosed additional positive top line Phase 1 results for its cytotoxic conjugate AN-152 in patients with gynaecological and breast cancers. Further data showed the compound's good safety profile and established the maximum tolerated dose (MTD) at 267 mg/m(2) which will be the recommended dose for a Phase 2 trial. In addition to good safety data, the trial provided a hint of efficacy as disease stabilization and regression of lesions were observed at the 160 mg/m(2) and 267 mg/m(2) dose levels. Dr. Jurgen Engel, Executive Vice President, Global R&D; and Chief Operating Officer at AEterna Zentaris, stated, "This additional data provides further proof of concept that the chemical linkage of doxorubicin and the luteinizing hormone-releasing hormone part of the drug molecule is stable in human blood. Most importantly, we witnessed a good safety profile and a hint of efficacy enabling us to establish a suitable dose for further development of AN-152 in the treatment of various cancers." http://www.aeternazentaris.com

Medical Devices and Diagnostics Update

Biophage announces the capability of its PDS(R) Biosensor

Biophage Pharma Inc. (Montreal) announced that its PDS(R) Biosensor has the ability to rapidly detect the harmful properties of metals on living cells (cytotoxicity). A recent article published in the Washington Post (Nov 23, 2006) announced that the EPA will begin regulating a large class of Nanoproducts sold as germ-killing mainly because they may pose unanticipated environmental risks. "Measuring cytotoxic effects enables quantitative measurements of such risks. We believe our PDS(R) Biosensor responds to this need and will help EPA and manufacturers assess the potential harmful effects of certain classes of metals on living cells of human, animal or plant origin," stated Dr. Rosemonde Mandeville, President and CEO of Biophage Pharma Inc. "Conventional materials, such as carbon, silver or gold, exhibit unconventional properties when manufactured on a nanoscale. This is largely because the nanoparticles have relatively large surface areas for their small mass, and the exposed atoms have increased chemical reactivity that could induce potential adverse effects measurable by cytotoxicity test." Dr. Mandeville explained." http://www.biophage.com

Industry Briefs

Protox(TM) Therapeutics Inc. (Vancouver) announced that it has successfully completed its previously announced unit offering with the issue of 18,349,500 units at a price of $0.50 per unit for total gross proceeds of $9,174,750. Each unit comprises one common share and one-half of one common share purchase warrant. Each whole warrant entitles the holder to purchase one common share of Protox at a price of $0.65 on or before 29 November 2008. http://www.protoxtherapeutics.com

Chromos Molecular Systems Inc. (Burnaby) announced that Mr. David Barr has been appointed to its Board of Directors. Mr. Barr is currently the CFO and Investment Manager of PenderFund Capital Management Ltd. PenderFund is a shareholder of Chromos and a participant in the recent bridge loan financing. http://www.chromos.com

QLT Inc. (Vancouver) announced that Dr. Bruce Carter has been appointed to its board of directors. Concurrent with the addition of Dr. Carter to the board of directors, Dr. Julia Levy is retiring from the board and becoming Director Emerita. Dr. Levy will continue to be actively involved in QLT's Scientific Advisory Board. http://www.qltinc.com

Nventa Biopharmaceuticals Corporation (Victoria) announced that it has received a receipt for a preliminary prospectus filed with the securities regulators in British Columbia, Alberta and Ontario for a proposed "best efforts" unit offering. Each unit will be comprised of one common share in the capital of the Company and one half of one common share purchase warrant. Each whole warrant will entitle the holder to purchase one common share in the capital of the Company. The agents of the proposed offering are Jennings Capital Inc. and HPC Capital Management Corporation. http://www.nventacorp.com

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