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Life Science News Briefs Vol. 6 no.22 - August 9, 2006
Pharmaceuticals & Biotherapeutics UpdateAmorfix Life Sciences and Biogen Idec to collaborate on research for ALSAmorfix Life Sciences Ltd. (Toronto), an emerging Canadian theranostics company, announced that it has entered into a research and investment agreement with Biogen Idec of Cambridge, Massachusetts, which includes an option to license the exclusive worldwide rights to Amorfix's technology to develop and commercialize therapeutic products directed against the neurodegenerative disease Amyotrophic Lateral Sclerosis (ALS). Amorfix will conduct a planned research program with operational support and investment from Biogen Idec. http://www.amorfix.com AEterna Zentaris Enters a License and Collaboration AgreementAEterna Zentaris Inc. (Quebec City) announced that it has entered into a licensing and collaboration agreement with Nippon Kayaku for its fourth generation luteinizing hormone-releasing hormone (LHRH) antagonist, ozarelix. Under the terms of the agreement, AEterna Zentaris granted Nippon Kayaku an exclusive license to develop and market ozarelix for all potential oncological indications in Japan. In return, AEterna Zentaris is to receive an upfront payment upon signature, and is eligible to receive payments upon achievement of certain development and regulatory milestones, in addition to low double-digit royalties on potential net sales. Further financial details were not disclosed. http://www.aeternazentaris.com YM Biosciences Licenses Monoclonal AntibodyYM BioSciences Inc. (Mississauga), a company engaged in the acquisition, development and commercialization of oncology and acute care products, announced that its majority owned subsidiary, CIMYM BioSciences Inc. (CIMYM), has licensed development and marketing rights in Japan for its anti-EGFR humanized antibody, nimotuzumab, to Daiichi Pharmaceutical Co., Ltd. (a wholly owned subsidiary of DAIICHI SANKYO COMPANY, LIMITED, one of Japan's largest pharmaceutical companies). Under the agreement, CIMYM will receive an up-front payment of US$14.5 million and significant milestone payments at certain stages of development for each of a number of indications as well as payments based on supply of nimotuzumab and sales performance in the territory. Daiichi will develop nimotuzumab for the Japanese market in several cancer indications. http://www.ymbiosciences.com Clinical TrialsCardiome Announces Interim Phase 2a Results for Oral RSD1235Cardiome Pharma Corp. (Vancouver) announced interim clinical results from the 300mg dosing group for its Phase 2a pilot study of RSD1235 (oral). The safety data for this first of two dosing groups suggests that RSD1235 (oral) appears well-tolerated within the target population. The interim analysis further demonstrated a clear positive trend toward efficacy, with 61% (33 of 54) of patients receiving RSD1235 (oral) completing the study in normal heart rhythm, as compared to 37% (10 of 27) of patients receiving placebo.http://www.cardiome.com LAB International announces positive Fentanyl phase IIA resultsLAB 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 positive results for the first phase II trial of its lead product, Fentanyl TAIFUN(R), in breakthrough cancer pain. The results support clinical efficacy already at the lowest dose of 100 micrograms, and a trend of dose response relationship. The safety of Fentanyl TAIFUN(R) was similar to that of placebo, with the exception of an increase in mild to moderate somnolence. http://www.labinc.ca AnorMED completes enrollment in Phase III trial for MOZOBILAnorMED Inc. (Vancouver) announced that enrollment has been completed for one of two pivotal Phase III trials being conducted with MOZOBIL for stem cell transplant. The multiple myeloma (MM) trial reached its target enrollment having enrolled 300 patients. Recruitment continues for the second Phase III trial in non-Hodgkin's lymphoma (NHL), having enrolled 241 of the targeted 300 patients. The two Phase III trials are evaluating MOZOBIL in a standard stem cell mobilization regimen. http://www.anormed.com Transition Therapeutics Inc. Announces 12-Week Data from HCV-I.E.T.Transition Therapeutics Inc. (Toronto), announces 12-week data from an open label, multi-centre Phase I/II clinical trial evaluating the interferon enhancing product, HCV-I.E.T., in hepatitis C non-responders. The clinical trial was designed to evaluate safety and HCV-I.E.T.'s ability to produce a positive therapeutic response in patients who have failed to respond to previous treatment with the current "gold standard" hepatitis C therapies consisting of pegylated interferon and ribavirin. HCV-I.E.T. combines Transition's interferon enhancer, EMZ702, with the current standard of care for hepatitis C, a combination therapy of pegylated interferon alpha and ribavirin. The study data demonstrated that 6 of 21 (28%) of the hepatitis C non-responder patients that were treated for 12-weeks had a greater than 99% reduction of virus levels (2 log10 decrease). http://www.transitiontherapeutics.com AEterna Zentaris Announces Positive Phase 2 Results for OzarelixAEterna Zentaris Inc. (Quebec City) disclosed positive headline data from its Phase 2 trial with ozarelix for patients suffering from hormone-dependent inoperable prostate cancer. This open-label, randomized-controlled Phase 2 dose-finding trial originally designed for 48 patients was extended to 64 patients where 4 groups of 16 patients received different intramuscular dosage regimens of the luteinizing hormone releasing hormone (LHRH) antagonist, ozarelix, to assess its safety and efficacy. The study achieved its primary end-point of defining a tolerable dosage regimen of ozarelix that would ensure continuous suppression of testosterone at castration level ((less than) 0.5 ng/ml) for a three-month test period. An important secondary efficacy end-point of the study aimed at assessing tumour response as determined by a 50% or greater reduction of serum PSA levels, compared to baseline, was also achieved. The trial was conducted in Europe in collaboration with AEterna Zentaris' partner Spectrum Pharmaceuticals Inc. (NASDAQ: SPPI). http://www.aeternazentaris.com FDA Provides Clearance to Initiate Phase I Clinical TrialTransition Therapeutics Inc. (Toronto), announced that they have received clearance from the United States Food and Drug Administration ("FDA") to initiate a Phase I clinical trial for its lead Alzheimer's drug product, AZD-103. The AZD-103 compound is a possible disease-modifying therapeutic drug candidate for the treatment of Alzheimer's disease. This unique class of drug candidates may provide significant advantages over the current therapies on the market. The Phase I trial is a single blind, randomized, placebo controlled study in which healthy volunteers will receive placebo or an escalating acute dose of AZD-103. The primary objectives of the trial are to evaluate the safety, tolerability and pharmacokinetics of AZD-103. Enrolment for this trial is expected to begin September 2006. http://www.transitiontherapeutics.com BioAxone Therapeutic completes patient enrollment for Phase I/IIa trialBioAxone Therapeutic (Montreal) announced that it has completed its targeted patient enrollment of the Phase I/IIa North American clinical trial of Cethrin(R) for the treatment of acute spinal cord injury (SCI). Cethrin(R), a recombinant protein-based inhibitor of Rho signaling, is co-delivered with a fibrin sealant and administered once directly onto the surface of the spinal cord during spinal decompression surgery. Results of the trial are expected in the fall of 2006. http://www.bioaxone.com Medical Devices and Diagnostics UpdateResponse Biomedical Initiates US Clinical Trials of RAMP NT-proBNPResponse Biomedical Corporation (Vancouver) announced it has begun patient enrollment at four leading sites in the United States for the purpose of demonstrating substantial equivalence of the RAMP NT-proBNP Test to a predicate device. The results of this multi-center clinical trial will form the basis for a US FDA 510(k) submission and European CE Certification. The four sites conducting the trials are the Mayo Clinic, Minneapolis Medical Research Foundation at Hennepin County Medical Center, Massachusetts General Hospital and San Francisco General Hospital. http://www.responsebio.com Adaltis receives favourable report for "state-of-the-art" diagnostic HIV testAdaltis Inc. (Montreal), an international in vitro diagnostic company, announced that a product evaluation report published by the Microbiological Diagnostics Assessment Service, has ranked Adaltis' fourth generation test for HIV screening - the Detect-HIV(TM) (v.4) - as the second most sensitive microplate product among the diagnostic kits tested by the Service. http://www.adaltis.com PreMD Receives CE Mark for New Handheld PREVU* ReaderPredictive medicine company PreMD Inc. (Toronto) announced that its second-generation spectrometer, or color reader, for the PREVU(*) Point of Care (POC) Skin Sterol Test now has the Conformité Européene (CE) Mark. The CE Mark designation signifies that the new reader conforms to the essential requirements of the European Union Medical Devices Directive and validates the viability of the product. http://www.premdinc.com Industry BriefsNIR Diagnostics Inc. (Campbellville), a leading-edge developer of handheld spectroscopy based medical instruments, announced that it is proceeding towards successfully closing the previously announced strategic alliance transaction with Shaklee Corporation, having received shareholder approval at a special meeting of shareholders on July 28, 2006. The strategic alliance is expected to close on August 9, 2006, at which time the first milestone payment of $2 million will be advanced by Shaklee to NIR Diagnostics. http://www.nirdiagnostics.com CANTEST Ltd. (Burnaby) announced the acquisition of Vizon SciTec Inc., a Vancouver-based contract science company with a focus on chemical and biological technology development. The transaction follows in the footsteps of CANTEST's acquisition of Elemental Research, Inc. (ERI), a specialty analytical laboratory, in April and the announcement of a $9.5 Million expansion plan for the company's Burnaby facilities in June. http://www.cantest.com LAB Research Inc. (Laval), a rapidly growing non-clinical contract research organization, announced the successful completion of its initial public offering of 10,000,000 common shares including 6,250,000 common shares sold by LAB International and 3,750,000 shares issued by LAB Research from treasury, at a price of $4.00 per share for gross proceeds to LAB International of $25,000,000 and gross proceeds of $15,000,000 to LAB Research. http://www.labinc.ca Biovail Corporation (Toronto) announced that on August 1, 2006, in the United States District Court for the Central District of California, Judge James V. Selna issued an order granting Anchen Pharmaceutical Inc.'s (Anchen) Motion for Summary Judgment on the Wellbutrin XL(R) patent-infringement case, and denied it on the invalidity issue. This ruling becomes final only after the Court has formally issued and entered a Final Order. Judge Selna's order also denied Biovail's Motion for Partial Summary Judgment. http://www.biovail.com DiagnoCure, (Quebec City) has appointed a leading U.S. executive, with extensive experience in the field of gene-based diagnostics, to realize the company's substantial potential, Chairman Paul Gobeil announced.www.diagnocure.com Cangene (Toronto) announces that the U.S. Department of Health and Human Services has exercised its option to purchase 10,000 doses of anthrax immune globulin ("AIG") under a modification to an earlier development and supply contract. The AIG is to be made available for treating or preventing inhalational anthrax, which is an acute infectious disease that is caused by inhaling spores of the bacterium Bacillus anthracis. The value of this modification to the Project BioShield contract is approximately US$143 million and comes as a result of successful preliminary efficacy testing done earlier under the contract, which was originally signed in September 2005. http://www.cangene.com Caprion Pharmaceuticals Inc. (Montreal) announced that it has withdrawn its initial public offering due to adverse market conditions. http://www.caprion.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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