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Life Science News Briefs Vol. 6 no.25 - September 20, 2006Pharmaceuticals & Biotherapeutics UpdateBiophage accelerates its phage therapy programsBiophage Pharma Inc. (Montreal) announced that it has accelerated its phage therapy program in response to a groundbreaking announcement made last Friday by the US Food and Drug Administration (FDA) on the safety of phages in the treatment of meat. "A mixture of phages can be safely sprayed on meat to combat common microbes that kill hundreds of people a year" federal health officials said on Friday in granting the first ever approval of viruses as a food additive. Over the past 6 years, Biophage has built an extensive library of lytic phages against a large number of these deadly human bacterial pathogens. These "natural" phages have been isolated from environmental samples (e.g. water treatment plants, farms in the US and Canada) and a number of these phages have been fully characterized. In its phage therapy program Biophage performed several in vivo studies in experimental animal models (i.e. piglets and chickens) and generated very encouraging results. Biophage also obtained Health Canada (VDD) approval to perform clinical studies in farm animals. http://www.biophagepharma.com Stem Cell Therapeutics Options Clinical ProgramsStem Cell Therapeutics Corp. (Calgary), a biotechnology company engaged in treating central nervous system (CNS) disorders by stimulating endogenous neural stem cells, announced that it has entered into an Option to Acquire agreement for up to two additional clinical stage programs, one in schizophrenia and the other in multiple sclerosis. The agreement between SCT and two researchers from the Max Planck Institute of Experimental Medicine in Germany provides SCT with the right, but not the obligation, to acquire one or both of the clinical stage programs under option. The two clinical programs described in the agreement are each based on therapeutic approaches to treating CNS disorders with erythropoietin (EPO) and are protected by pending patent applications. http://www.stemcellthera.com Clinical TrialsBioMS Medical expands pivotal multiple sclerosis trial into Spain, GermanyBioMS Medical Corp (Edmonton), a leading developer in the treatment of multiple sclerosis (MS), announced it has received approval from the Spanish Agency for Medicines and Healthcare Products (SAMHP) in Spain and from the Federal Institute for Medicines and Medical Products in Germany to start patient enrolment for its pivotal phase II/III clinical trial of MBP8298, a proprietary synthetic peptide for the treatment of secondary progressive multiple sclerosis (SPMS). http://www.biomsmedical.com CryoCath receives FDA approval to start AF trialCryoCath Technologies Inc. (Montreal), the global leader in cryotherapy products to treat cardiovascular disease, announced conditional approval by the U.S. Food and Drug Administration for its STOP AF trial, allowing the Company to proceed to the pivotal stage of its Investigational Device Exemption ("IDE") trial for the Company's proprietary Arctic Front(TM) catheter to treat Atrial Fibrillation (AF). http://www.cryocath.com Isotechnika Inc. announces promising results from Phase I TAFA93 trialsIsotechnika Inc. (Edmonton) announced promising results from its Phase I TAFA93 trials. TAFA93, a pro-drug of rapamycin, is a novel small molecule mTOR inhibitor, which is a class of drugs currently used in the prevention of organ rejection in transplantation. mTOR inhibitors are typically used in combination with calcineurin inhibitors after organ transplant. mTOR inhibitors also have potential use in oncology and in cardiac stent technology. A TAFA93 Phase Ia single center, randomized, placebo-controlled, Single Ascending Dose (SAD) trial commenced in July, 2004. The results indicated that doses of 0.04, 0.08 and 0.16 mg/kg TAFA93 taken once daily were safe and well tolerated in healthy volunteers. No serious adverse events were reported. The data obtained from the Phase Ia trial was used to ascertain the most appropriate dose levels for the Phase Ib clinical trial. http://www.isotechnika.com Celacade(TM) Shown to Reduce Time in HospitalVasogen Inc. (Mississauga), a leader in the research and commercial development of technologies targeting the chronic inflammation underlying cardiovascular and neurological disease, announced that new data from the 2,400-patient ACCLAIM trial of Celacade in chronic heart failure, showed that the average days spent in hospital for cardiovascular cause was reduced by 32% in a prime heart failure target population, consisting of New York Heart Association (NYHA) Class II-IV non-ischemic cardiomyopathy patients, characterized as having no prior history of heart attack, and Class II patients with ischemic heart failure (n=1,305 patients, p=0.013). The results were presented today by Guillermo Torre-Amione MD, PhD, at the 10th Annual Scientific Meeting of the Heart Failure Society of America in Seattle, Washington. Chronic heart failure is estimated to cost the healthcare system $25 billion annually in the U.S., and recurring hospitalizations are the major cost driver. http://www.vasogen.com Cardiome Announces Positive Phase 2a Results For Oral RSD1235Cardiome Pharma Corp. (Vancouver) announced top-line results from both the 300mg and 600mg dosing groups for its recently-completed Phase 2a pilot study of RSD1235 (oral). The study was initiated in December 2005, and an interim analysis of the 300mg dosing group relative to the initial placebo group was announced on July 24, 2006. For the 300mg dosing group, 61% (33 of 54) of patients receiving RSD1235 (oral) completed the study in normal heart rhythm, as compared to 43% (24 of 56) of all patients receiving placebo. For the 600mg dosing group, 61% (30 of 49) of patients receiving RSD1235 (oral) completed the study in normal heart rhythm, as compared to 43% of all patients receiving placebo. A Kaplan-Meier analysis of the results demonstrated a statistically significant efficacy difference between the 300mg dosing group and the placebo group (p=0.048). The difference between the 600mg dosing group and the placebo group trended toward but did not reach statistical significance (p=0.060). A combined analysis of all drug group patients relative to the placebo group also demonstrated a statistically significant difference (p=0.028). For the entire study, a total of 171 patients were successfully cardioverted after the initial 3 days of dosing and continued in the study, of which 159 reached an endpoint of the study (completion of dosing or relapse to atrial fibrillation). The remainder of the patients were discontinued from the study for reasons unrelated to atrial fibrillation. http://www.cardiome.com Final Results of PC-DAC(TM):Exendin-4 Phase I/II TrialConjuChem Biotechnologies Inc. (Montreal) announced that final data from its Phase I/II single escalating dose clinical study for the treatment of Type 2 diabetes using the Company's proprietary PC-DAC(TM):Exendin-4 compound confirmed the excellent tolerability profile, positive efficacy on glucose reduction and extended duration of activity reported as preliminary data on April 26th, 2006. There were no safety or tolerability issues reported in the first four cohorts (310, 620, 1250 and 2500 microgram doses); specifically, no nausea, no vomiting and no injection site reactions. In each of the 3750 and 5000 microgram cohorts, there was one case of vomiting observed post-lunch on day one; no anti-emetic medications were needed for either of these cases nor were any anti-emetics needed throughout the trial. Low titer antibodies directed towards the peptide portion of drug were detected in 3 of 36 subjects. The pharmacokinetic profile exhibited slow absorption and prolonged exposure with plasma drug levels peaking at around 7 days and then declining thereafter with a half-life of approximately one week. Plasma concentrations were dose linear for both Cmax (maximum drug concentration) and AUC (area under the curve).ConjuChem will be conducting a multi-dose Phase I/II trial in which the product will be administered once-a-week at three different dosages for one month. The study is expected to commence in the fourth quarter. http://www.conjuchem.com Cipher reports results from Phase III trial for CIP-TRAMADOL ERCipher Pharmaceuticals Inc. (Mississauga) announced preliminary results from the 02.05 Phase III study of CIP-TRAMADOL ER, an extended-release capsule formulation of the pain medication tramadol. While all three active treatment groups in the study demonstrated a reduction in pain from baseline, the 02.05 efficacy results did not achieve a statistically significant effect relative to placebo with respect to the primary endpoint. A higher than anticipated placebo effect was observed in the control arm. Cipher's New Drug Application (NDA) for CIP-TRAMADOL ER has been accepted for review by the U.S. Food and Drug Administration (FDA) as disclosed by the Company on September 5, 2006. In January 2006, Cipher announced that it had been advised by the FDA that its existing clinical data package met the requirements to file a NDA. The NDA contains data from six completed pharmacokinetic studies and five Phase III studies (three of these providing pivotal efficacy data and two providing long-term safety data). Data analysis on the 02.05 trial is continuing and Cipher will provide the final report on the 02.05 trial to the FDA once it is available. http://www.cipherpharma.com MethylGene Initiates Phase II Clinical Trial With HDAC InhibitorMethylGene Inc. (Montreal), a biopharmaceutical company focused on developing products for the treatment of cancer, along with its partner Pharmion Corporation announced the initiation of a Phase II clinical trial with its lead histone deacetylase (HDAC) inhibitor product candidate, MGCD0103, in patients with relapsed or refractory B-cell lymphomas. Specific patient populations include patients with diffuse large B-cell lymphoma (DLBCL) and follicular lymphoma, two tumor types that are classified as non-Hodgkin's lymphomas (NHL). The first patient was enrolled at MD Anderson Cancer Center, where Dr. Anas Younes is the principal investigator. http://www.methylgene.com Industry BriefsEastMed Inc. (Halifax), a medical device company, has secured $1.5 million in initial financing from InNOVAcorp and BDC Venture Capital's Technology Seed Investments fund, a division of the Business Development Bank of Canada. The investment will fund clinical improvements and marketing initiatives to support the launch of the company's new product that will be marketed under the brand name Uresta(TM). The product is designed to help women control stress urinary incontinence (SUI). http://www.eastmed.com Labopharm Inc. (Laval) announced the appointment of Mark D'Souza to the position of Chief Financial Officer. Labopharm also announced that Warren Whitehead is leaving the Company to pursue other opportunities. http://www.labopharm.com Transition Therapeutics Inc. (Toronto) announced that it has established a partnership with the Juvenile Diabetes Research Foundation (JDRF) to support a clinical development plan for Transition's diabetes regenerative product, GLP1-I.N.T.(TM) JDRF, the world's leading charitable funder of type 1 diabetes research, will provide milestone-driven payments of up to U.S. $4 million to the project over two years, facilitating the rapid advancement of the GLP1-I.N.T.(TM) diabetes regenerative product into Phase II clinical trials in type 1 diabetes patients. http://www.transitiontherapeutics.com LAB International Inc. (Laval), an integrated drug development company focused on developing therapies for the inhalation market, announced the closing of the over-allotment option exercised by the syndicate of underwriters for the recently completed initial public offering of its former subsidiary LAB Research Inc. ("LRI"). The over-allotment option provided for the purchase of an additional 1,500,000 common shares of LRI at a price of $4.00 per share for aggregate gross proceeds to LAB of $6.0 million. http://www.labinc.ca LAB Research Inc. (Laval), announced the completion of the exercise in full of the over-allotment option granted to the underwriters of its initial public offering for gross proceeds of $6 million in respect of its previously announced initial public offering of $40 million which was completed on August 3rd, 2006. This amount adds to the $40 million IPO financing and constitute an additional financing for LAB International Inc. http://www.labinc.ca Amorfix Life Sciences Inc. (Toronto) announced the issue of 47,619 common shares and 23,810 warrants to Genomics Ontario Inc, the investment arm of the Ontario Genomics Institute (OGI), for gross proceeds of $50,000. This is the second investment by OGI in support of Amorfix's development of a blood diagnostic test for Alzheimer's disease. Each warrant entitles the holder to purchase one common share of Amorfix at an exercise price of $1.05 for a term of two years. The common shares and warrants are subject to a four month hold period. http://www.OntarioGenomics.ca http://www.amorfix.com Transition Therapeutics Inc. (Toronto) announced the appointment of Dr. Andre Uddin as Vice-President of Strategic Development. http://www.transitiontherapeutics.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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