Ottawa, ON — July 7, 20003 — The following life sciences news briefs were recently published by Industry Canada:
1) Pharmaceuticals Update
Neurochem reports promising findings from Alzhemed study
Neurochem (Montreal) announced a preliminary analysis of the data from its recently completed Phase II clinical trial for the investigational drug candidate, Alzhemed, in patients with mild-to-moderate Alzheimer’s disease (AD). The study revealed promising results for both the primary and secondary objectives of the trial. There were no safety findings of concern in patients treated with Alzhemed. The pharmacokinetic profile of Alzhemed has been well characterized and it was detected in the cerebrospinal fluid (CSF) of the patients, suggesting an ability to cross the blood brain barrier. Patients with the greatest decrease in amyloid protein in the CSF were all on Alzhemed. Furthermore, the majority of patients on the highest dose of Alzhemed showed, at the six-month time point of the ongoing open-label extension study, stable results on cognitive function test (as measured by the ADAS-Cog.
MDS Pharma introduces monoclonal antibody development program
MDS Pharma Services (Montreal), a provider of drug discovery and development solutions, announced the introduction of its new drug development program for therapeutic monoclonal antibodies, offered through the company’s drug development programs service. The integrated program is designed to minimize the risk and maximize the efficiency of guiding a monoclonal antibody (mAb) compound through molecular design, mAb pharmacology, manufacturing process design, product quality control and non-clinical and clinical development. Key decision gates addressing viability, developability, safety and efficacy are also addressed.
MethylGene signs worldwide agreement with Merck-Frosst
MethylGene (Montreal), a private Canadian drug discovery and development company announced that it has entered into a worldwide license, research, development, and commercialization agreement with Merck-Frosst Canada on a small molecule inhibitor program against bacterial beta-lactamases to fight antibiotic resistance. Under the terms of the agreement, MethylGene contributes a synthetic chemistry effort to optimize its small molecule lead compound into clinical candidates. The progression of clinical candidates through preclinical and clinical development will be undertaken by Merck-Frosst who will also be responsible for worldwide commercialization and marketing. Merck-Frosst will pay MethylGene initial fees of US$4 million.
Biovail announces receipt of an approvable letter for Wellbutrin
Biovail Corporation (Toronto) announced that the US Food and Drug Administration has issued an approvable letter for the once-daily antidepressant Wellbutrin XL (bupropion hydrochloride extended-release tablets) developed for the treatment of major depressive disorder in patients aged 18 and older. The approvable letter involves resolution of routine matters and consequently, approval of Wellbutrin XL is still expected during the second half of 2003. Responses to these routine matters are being prepared expeditiously and are expected to be submitted to the FDA promptly.
Positive clinical results for INEX application for Onco TCS
Inex Pharmaceuticals (Vancouver) said that data from all 119 patients treated in the pivotal phase II/III clinical trial evaluating its lead anticancer product Onco TCS as a single-agent therapy for relapsed aggressive non-Hodgkin’s lymphoma (NHL) confirms the positive results of the first 102 patients released in December 2002. David Main, INEX president and CEO, said the complete pivotal trial results will form the basis of a new drug application (NDA) that will be filed late in the third quarter or early in the fourth quarter of this year to seek regulatory marketing approval from the US Food and Drug Administration (FDA). Prior to enrollment in this study, the 119 patients had received on average four other therapies and 72% had disease that was “resistant” to their last treatment. After treatment with Onco TCS, the overall response rate was 25%, including seven patients (6% of patients) whose tumors were completely eliminated and 23 patients (19% of patients) whose tumor volume was reduced by more than 50%. An additional 31 patients (26% of patients) had their disease stabilized while being treated with Onco TCS.
2) Diagnostics and Therapeutics Update
Stem cells trigger regeneration of damaged organs
Canadian scientists have discovered that stem cells can trigger regeneration of severely damaged organs in animals, a feat that suggests it might be possible to trick the human body into healing itself. Scientists at the Robarts Research Institute in London, Ontario, injected bone marrow stem cells into diabetic mice, which were cured or back to normal within seven to 14 days. Further, the stem cells triggered the rodents’ damaged pancreases to regenerate on their own. It is not clear how the stem cells triggered the regeneration in mice, but the scientists suspect the stem cells might produce potent molecules.
MRSA clinical studies start on new screening test
Infectio Diagnostic (Quebec City) has completed development of a new ultra-rapid screening test for the extremely virulent methicillin-resistant Staphylococcus aureus (MRSA). Clinical studies are just underway and may be completed by the fall. Results will then be submitted to the Food and Drug Administration (FDA) in the US and to Health Canada for approval. IDI is looking to market its product by the end of the year. This test will enable detection of MRSA in under one hour, whereas the existing method, involving a bacterial culture, can take up to two or three days. “There is a potential here of enormous savings for the health system,” predicts Mr Jacques Milette, Vice president, sales and business development for IDI.
Cangene enters partnership to develop hyperimmunes related to SARS
Cangene (Toronto) announced that it has signed a memorandum of understanding with Health Canada’s National Microbiology Laboratory to further public health research into Severe Acute Respiratory Syndrome. The agreement will facilitate the development of a hyperimmune globulin from plasma obtained from recovered SARS patients. This hyperimmune may result in diagnostic and therapeutic agents for use in the treatment of SARS. Toronto-based physicians with the support of patient donors first proposed this initiative.
Study identifies stem cells responsible for regenerating damaged muscle
A research team from the Ottawa Health Research Institute, led by Dr Michael Rudnicki, has published a groundbreaking study that demonstrates how a novel population of adult stem cells resident in muscle tissue plays an important role in muscle regeneration. For the first time, the research also identifies details of the molecular signals that direct these adult stem cells to form new muscle, offering hope for millions of people with neuromuscular disorders. The Rudnicki team’s findings are published in the June 27 issue of the prestigious scientific journal Cell. This landmark research shows that a class of adult muscle stem cells, called CD45+ cells, plays a natural role in regeneration when they receive signals in the form of a secreted protein known as Wnt. Wnt proteins are secreted in response to tissue damage and act to trigger the stem cells to divide and then develop into highly specialized muscle cells. A focus of future research will be to develop drugs that target the Wnt signaling pathway as new treatments for neuromuscular diseases and muscle injury.
3) Medical Devices
Medical Ventures submits 510k premarket notification to FDA
Medical Ventures (Richmond), announced that a 510(k) premarket notification has been submitted to the US Food and Drug Administration for MEV’s PeriPatch Sheet and the StepSaver Cylinder. The 510k marketing clearance is required for Medical Ventures to begin selli
ng these products in the US. The PeriPatch Sheet is intended for the internal tissue repair as part of a general surgical or cardiovascular repair procedure. The StepSaver Cylinder is intended for suture line and staple line reinforcement and is commonly used in lung and stomach surgical procedures.
ART announces interim results of clinical study with McGill
ART Advanced Research Technologies (Montreal), a developer of optical molecular imaging technologies and the McGill University Health Centre (MUHC), one of the largest university teaching hospitals in Canada, are pleased to announce interim results of the ongoing SoftScan clinical study. ART has obtained promising preliminary results from the engineering optimization study of SoftScan, currently undergoing at the MUHC Cedars Breast Clinic. “The preliminary analysis of the clinical study indicates that the SoftScan technology is promising in discriminating between malignant and benign breast lesions,” comments Dr David Fleiszer, co-director of the MUHC Cedars Breast Clinic and principal investigator of the clinical study.
4) Genomic Update
$65 Million for applied genomics, and proteomics research projects
Allan Rock, Canadian Industry Minister announced up to $65 million will be made available for a special competition on Applied Genomics and Proteomics Research in Human Health. The Minister made the announcement at the official opening of the Canada Cafe (Canadian Pavilion) at BIO 2003, the world’s largest and most prestigious biotechnology meeting. BIO is celebrating its 10th anniversary. More than 16,000 biotech leaders from around the world attended this year’s event.
5) Industry Update
Viventia Biotech (Toronto) and Affitech AS of Oslo, Norway, announced at BIO 2003 that they have entered into a research collaboration to identify novel antigens on various cancer cells and to select antibodies targeting those antigens for subsequent development as potential therapeutics.
ChondroGene (Toronto) reported that the proposed acquisition of GeneNews, previously announced on May 16, 2003, was approved by its shareholders at the company’s annual and special meeting held on June 16, 2003, in Toronto.
AI Software (Vancouver) announced that it has acquired all of the issued and outstanding shares of Pluristem, an Israeli biotechnology company that has the facilities and personnel to provide research and development services in the biotechnology field, particularly in stem cell research.
Transition Therapeutics (Toronto) announced the closing of a previously announced private placement raising gross proceeds of approximately $5.4 million.
Lorus Therapeutics (Toronto) reported that it has received notice from the European Patent Office of the allowance of a patent, which protects the company’s intellectual property for its lead immunotherapeutic anticancer drug, Virulizin.
Corixa Corporation (Seattle), a developer of immunotherapeutics, and MDS Nordion (Ottawa) announced that the companies have signed a new seven-year manufacturing agreement in which MDS Nordion will continue to radiolabel the antibody in BEXXAR (tositumomab and iodine I-131 tositumomab) therapy.
PanGeo Pharma (Toronto) said there were doubts the company could continue as a going concern beyond early next year. The drugmaker said that as of January it has been in default on the terms of its financing agreement with its prime lender.
Applitox Bio Pharma (Montreal) announced that it has acquired 70% of the controlling interest of FPL Pharma, a company developed from university research at the University of Quebec at Chicoutimi. FPL now becomes a subsidiary of Applitox. The total cost of the transaction was settled by cash payment.
Inex Pharmaceuticals (Vancouver) announced that it has entered into an agreement with a syndicate of underwriters led by BMO Nesbitt Burns and including Raymond James, Desjardins Securities and Orion Securities under which the underwriters have agreed to buy 4,600,000 common shares from the company and sell to the public at a price of $5.45 per common share, representing an aggregate amount of the issue of $25,070,000.
Tm Bioscience (Toronto) announced it has acquired a non-exclusive license from the Hospital for Sick Children (Toronto, Ontario) and the University of Michigan (Ann Arbor, Michigan) for the use of their cystic fibrosis (CF) gene mutation patents in the company’s Tag-It Mutation Detection Kit for Cystic Fibrosis.
VSM MedTech (Vancouver) announced that its CTF subsidiary has signed an agreement with a Nevada-based physician/investor consortium for three 275-channel magnetoencephalography systems. The first system is scheduled for delivery in 2003, with the remaining two systems to be delivered late in 2004. The deal marks a significant milestone for VSM as it is the first multiple-unit order in the US.
Life Sciences News Brief is prepared by Armar International for the Life Sciences Branch of Industry Canada (contact: Paul Vaillancourt; Telephone: (613) 952-7700; E-mail: firstname.lastname@example.org).