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Life Science News Briefs Vol. 6 no.19 - June 28, 2006
Pharmaceuticals & Biotherapeutics UpdateConjuChem's PC-DAC(TM):Exendin-4 data presentedConjuChem Biotechnologies Inc. (Montreal) announced that data relating to its proprietary PC-DAC(TM):Exendin-4 compound for the treatment of Type 2 diabetes. The study demonstrated that PC-DAC(TM):Exendin-4 (CJC-1134) lowered glycemic excursion in a dose-dependent manner in mice and significantly reduced food intake over a 24-hour time period. Chronic administration of PC-DAC(TM):Exendin-4 significantly reduced body weight, reduced total fat mass, increased total pancreas weight and produced significant reductions in HbA1c levels. Authors concluded that these studies indicate that PC-DAC(TM):Exendin-4 "is capable of activating both peripheral and central pathways that modify feeding behaviour, body weight and glucose hemostasis." http://www.conjuchem.com Stem cells found in adult skin can be transplanted, function in mouse modelsRearchers at The Hospital for Sick Children (SickKids) and the University of Calgary have found that stem cells derived from adult skin can create neural cell types that can be transplanted into and function in mouse models of disease. SickKids researchers previously discovered what type of cells can be made from these stem cells (called skin-derived precursors, or SKPs) based on the role played by neural-crest stem cells during embryogenesis. In addition to generating the peripheral nervous system, neural crest stem cells generate other tissues such as bone, cartilage, some types of muscle, and even part of the heart. The research team found that SKPs can efficiently generate a type of glial cell, called Schwann cells, that can myelinate demyelinated axons (part of a neuron), and that have been shown to provide a good growth environment for injured central nervous system axons. These types of axons normally do not regenerate. The research showed that these SKP-derived Schwann cells can myelinate axons in culture, in the injured peripheral nerve, and even in the central nervous systems of mice that don't have myelin in their brains. While the research occurred in mouse models, some of their data indicate that human SKPs can do the same thing. Genetic Discovery Unlocks Cause of a Common Form of Heart DiseaseResearch at the University of Ottawa Heart Institute has revealed that one of the most common forms of heart disease - atrial fibrillation (AF) - is caused by a genetic mutation that occurs during in-utero development. The landmark discovery provides a fresh view of how common diseases may develop and is expected to fuel targeted therapies that help eliminate or prevent AF, which affects millions of North Americans and is responsible for more than a third of all strokes. The work has been led by the Heart Institute's Dr. Michael Gollob. Dr. Gollob and colleagues focused on a gene (GJA5) which makes a protein known as Connexin 40. The protein is specific to the atrial tissue of the heart and plays a crucial role in how electrical impulses are conducted. They discovered genetic mutations in the Connexin 40 gene in AF patients. Researchers proved the disease was tissue-specific and not present in all body cells by detecting the mutation only in the heart tissue and not in the blood cells of affected patients. Clinical TrialsMIGENIX Completes Enrollment of Celgosivir (MX-3253) Phase IIbMIGENIX Inc. (Vancouver), a clinical-stage developer of drugs for infectious and degenerative diseases, has completed enrollment in a Phase IIb study of celgosivir (MX-3253) in combination with PEG-INTRON(R) (peginterferon alfa-2b), and PEGETRON(TM) (peginterferon alfa-2b plus ribavirin) for the treatment of hepatitis C virus (HCV) infection in genotype 1 patients who were non-responders or partial responders to previous treatment with pegylated interferon-based therapy. A total of 57 subjects have been enrolled. The subjects will be treated for 12 weeks and results are expected to be available in October 2006. This study is being supported in part through an agreement with Schering-Plough. http://www.migenix.com European Journal publishes MBP8298 Phase II and follow-up dataBioMS Medical Corp (Edmonton), a leading developer in the treatment of multiple sclerosis (MS), announced that results of the phase II and long-term follow-up treatment of MS patients with MBP8298 have been published in the European Journal of Neurology (EJN). The publication highlights long-term efficacy, safety and mechanism of action data in respect of MBP8298. The results show that MBP8298 safely delayed disease progression for five years in progressive MS patients with HLA-DR2 or HLA-DR4 immune response genes. Treatment and follow-up of patients demonstrated that patients in this DR2 and DR4 responder group, who comprise up to 75% of MS patients, had a median time to disease progression of 78 months as compared to 18 months for patients who received placebo. http://www.biomsmedical.com LAB International enrollment in phase IIb Fentanyl TAIFUN(R) trialLAB 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 enrollment of the first patients in its Fentanyl TAIFUN(R) Phase IIb clinical trial. Fentanyl TAIFUN(R) is a fast-acting Fentanyl formulation delivered using the Company's TAIFUN(R) dry powder inhaler platform. The multi-centered, multinational, dose titration, single arm and open-label trial is evaluating the time to significant pain relief with Fentanyl TAIFUN(R) with successful titration in the treatment of breakthrough cancer pain. The trial is enrolling 32 cancer patients on maintenance opioid therapy for persistent pain. The first two patients treated with Fentanyl TAIFUN(R) have both achieved successful titration, one with 400 (micro) g dose and the other with 100 (micro) g fentanyl per dose. For both patients the selected dose was effective in all 5 pain episodes treated under the protocol, with the first observed effects within 5 minutes from administration. http://www.labinc.ca BioMS Medical expands pivotal multiple sclerosis trial into The NetherlandsBioMS Medical Corp (Edmonton), a leading developer in the treatment of multiple sclerosis (MS), announced it has received approval to start patient enrolment in The Netherlands for its pivotal phase II/III clinical trial of MBP8298, a proprietary synthetic peptide for the treatment of secondary progressive multiple sclerosis (SPMS). Approval was received from the Competent Authority in The Netherlands, CCMO (Central Committee on Research Involving Human Subjects). http://www.biomsmedical.com AEterna Zentaris Receives Green Light from FDA to Move ForwardAEterna Zentaris Inc. (Quebec City) announced that during a recent end of Phase 2 meeting, the U.S. Food & Drug Administration (FDA) reviewed the safety and efficacy data from an extensive Phase 2 program with cetrorelix, its lead luteinizing hormone-releasing hormone (LHRH) antagonist product candidate, for the treatment of benign prostatic hyperplasia (BPH). Accordingly, the Company plans to submit an Investigational New Drug (IND) application to the FDA within the next few months for the initiation of a Phase 3 program for cetrorelix in BPH. http://www.aeternazentaris.com ConjuChem Successfully Completes Patient Enrollment of its Phase II TrialConjuChem Biotechnologies Inc. (Montreal) announced it has completed the enrollment of its phase II trial with DAC(TM):GRF in patients having lipodystrophy associated with HIV. DAC(TM):GRF, a growth hormone therapeutic, is a compound employing the Growth hormone Releasing Factor (GRF) peptide and is being evaluated in a once-weekly dosing regimen. Study design: The study is a multicenter, randomized, double-blind, placebo-controlled trial in HIV-associated Lipodystrophy patients. The primary endpoint is the change in IGF-1 levels from baseline to week 12. Secondary endpoints include changes in Visceral Adipose Tissue (VAT) and Subcutaneous Adopise Tissue (SAT) (as measured by CT scan), lean body mass, body composition (as measured by DEXA scan), weight and body image assessment. http://www.conjuchem.com Lorus Therapeutics announces new clinical program with GTI-2040Lorus Therapeutics Inc. (Toronto), a biopharmaceutical company specializing in the research, development and commercialization of pharmaceutical products and technologies for the management of cancer, announced a plan for a new clinical investigation of GTI-2040 as a single-agent in patients with high grade myelodysplastic syndrome (MDS) and acute myeloid leukemia (AML). These two disease conditions may represent a continuum in malignant progression of the abnormal production of blood cells in the bone marrow that results in a rapidly progressing form of leukemia. Patients that have MDS which progresses to AML have been identified as an especially high-risk group for poor survival. http://www.lorusthera.com Medical Devices and Diagnostics UpdateAmorfix leading sensitivity for prion detection in spiked human bloodAmorfix Life Sciences Ltd. (Toronto) announced it had completed the analysis of the international reference blinded panels of human blood samples spiked with prions from variant Creutzfeldt-Jakob Disease (vCJD) patients which were provided by the UK government. "Our excellent results from the blinded panels match our previous internal tests using spiked blood samples. Based on data presented at industry conferences on 4 other laboratories and companies that have completed the blinded panels, we are confident that the company's EP-CJD(TM) assay is significantly more sensitive in detecting prions," said Dr. George Adams, Chief Executive Officer, Amorfix. http://www.amorfix.com Industry BriefsAmorfix Life Sciences Ltd. (Toronto) announced the appointment of William Lambert to the Board of Directors and the resignation of Dr. Donald Rix as Director. http://www.amorfix.com iCo Therapeutics Inc. (Vancouver) announced that Dr. Philip Rosenfeld has joined iCo's strategic advisory team. Dr. Rosenfeld is Professor of Ophthalmology at the world-renowned Bascom Palmer Eye Institute at the University of Miami, Miller School of Medicine. http;//www.icotherapeutics.com Chromos Molecular Systems Inc. (Burnaby) announced the appointment of Mr. Jeff Charpentier, CA as the Company's Vice President, Finance and Chief Financial Officer. http://www.chromos.com Cardiome Pharma Corp. (Vancouver) announced the appointment of Curtis Sikorsky, CA to the position of Chief Financial Officer. http://www.cardiome.com 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 that William Hunter, MD, MSc has been appointed to the Company's Board of Directors. http://www.aspreva.com QLT Inc. (Vancouver) announced that it has appointed Dr. Ian John Massey, to its board of directors. http://www.qltinc.com Cipher Pharmaceuticals Inc. (Mississauga) announced the appointment of Dr. Jason A. Gross as Vice President, Scientific Affairs. http://www.cipherpharma.com Nuvo Research Inc. (Mississauga) announced that it has closed its previously announced bought deal public offering of 37,500,000 Units (the "Units") at a price of $0.40 per Unit for total gross proceeds of C$15,000,000. http;//www.nuvoresearch.com NIR Diagnostics Inc. (Campbellville) a leading-edge developer of handheld spectroscopy based medical instruments, announced that it has entered into a definitive license and royalty agreement with Shaklee Corporation, a nutrition, skin care, and household products company, to develop, manufacture, distribute and market NIR Diagnostics' in-vivo light-based technology and the HemoNIR(TM) CO-oximeter device. http://www.nirdiagnostics.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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