Ottawa, ON December 19, 2003 The following life sciences news briefs were published this week by Industry Canada:
1) Pharmaceuticals Update
Inex releases Onco TCS data from three clinical trials
Inex Pharmaceuticals (Vancouver) announced that it released results from three separate clinical trials that indicate the company’s lead anticancer product, Onco TCS, is able to reduce the size of tumours in lymphoma patients with advanced disease. Inex released the final results from its pivotal phase II/III trial evaluating Onco TCS as a single agent treatment for relapsed aggressive non-Hodgkin’s lymphoma (NHL). This data was previously released by Inex in June 2003. Inex also released interim results from a phase II trial evaluating Onco TCS as a single agent treatment for relapsed Hodgkin’s disease and interim results from a phase II trial evaluating Onco TCS in combination with Rituxan as a treatment for relapsed large B-cell lymphoma.
Neurochem announces continued positive results for Alzhemed
At its annual general and special meeting of shareholders, Neurochem (Montreal) announced additional positive interim results on cognitive function as measured by the ADAS-cog(1) test in mild(2)-to-moderate(3) Alzheimer’s Disease patients participating in its ongoing open-label Phase II extension study. Neurochem is reporting on patients who have completed nine and also 12 months of treatment on the highest dose (300 mg daily) of the investigational product candidate Alzhemed.
Theratechnologies reports results for phase II trial
Theratechnologies (Montreal) announced that its drug candidate, ThGRF, did not demonstrate improvement in functional recovery following hip fracture surgery among elderly patients in a Phase II clinical trial. This conclusion follows examination of preliminary data from the two clinically important parameters in the study, the lower extremity measure and the functional autonomy measurement system (SMAF). As was the case in previous studies, ThGRF continued to exhibit a very good safety profile.
Axcan Pharma reports positive Itax phase II results
Axcan Pharma (Mont Saint Hilaire) disclosed efficacy and safety results of a phase II study related to Itax (Itopride hydrochloride or Itopride), a patented oral gastroprokinetic drug with antiemetic properties recently acquired from Abbott Laboratories. Itax is indicated for the treatment of gastrointestinal symptoms caused by reduced gastrointestinal motility. Axcan also plans to hold a pre-investigational new drug (IND) meeting on Itax with the US Food and Drug Administration (FDA) on January 20, 2004 and intends to submit an IND for Itax in the treatment of non ulcer dyspepsia shortly thereafter.
Health Canada requests additional information on Circadin
Paladin Labs (Montreal), a Canadian specialty pharmaceutical company, announced that its licensor, Neurim Pharmaceuticals, has been advised by the Therapeutic Products Directorate (TPD) of Health Canada that its new drug submission, for Circadin (controlled release melatonin tablets) will not be approved at this time. Neurim Pharmaceuticals has received a notice of non-compliance and has 90 calendar days to submit a complete response to Health Canada’s issues.
2) Diagnostics and Therapeutics Update
Response Biomedical files for US FDA market clearance
Response Biomedical (Vancouver) announced it has filed a regulatory submission with the US FDA seeking market clearance to commercially introduce its lead medical application in the US. The regulatory submission follows positive results from the recently completed multi-centre clinical trial of Ramp tests for troponin I and CK-MB, two cardiac marker tests used with the Ramp Reader in the early diagnosis of heart attacks. Last year, the company announced receipt of FDA 510(k) market clearance of the Ramp Reader for general clinical use, as well as its cardiac test for myoglobin. Subsequently, the company also received CE Mark for the Ramp Reader and all three cardiac tests.
Medicago’s approach may be ideal for more efficient biopharmaceuticals
Dr Louis P Vzina of Medicago, (Quebec) and Dr Loic Faye (CNRS University of Rouen, France), with their respective groups, have discovered that a monoclonal antibody (IgG1) expressed in alfalfa plants shows a remarkable homogeneity in its N-glycan structures. This is a molecular decoration (sugar chain) attached to the antibody that is key in determining time efficacy in the blood stream. The details of their research were published last month in the Plant Biotechnology Journal where they present the many advantages of such findings. This discovery is of major importance in the field of biopharmaceuticals as it may save an important problem on which regulating authorities are vigilant. There is indeed a real need to improve the homogeneity of N-glycan structures of proteins since they are known to influence safety and efficiency of biopharmaceuticals.
Chronogen secures exclusive license and extends research contract
Chronogen, (Montreal) a drug discovery company developing human therapeutics to treat highly prevalent age-dependent diseases, announced that it has secured an exclusive worldwide license from McGill University for screening assays for targets and drugs useful in the treatment and prevention of lipid disorder linked to atherosclerosis. The licensed technology is based on discoveries made by Dr Siegfried Hekimi, PhD, founder and chief scientific officer of Chronogen and professor of biology at McGill. Professor Hekimi’s recent discoveries, partly described in an article published in the December 5th, 2003 edition of Science, indicate that mutations in clk-1, a longevity gene, reduce the oxidation of LDL, which is the main factor in the development of atherosclerosis in people. This is shown through the exploration of an interaction of clk-1 with the worm homologue of the microsomal triglyceride transfer protein (MTP), which is known to be required for LDL production in humans.
ID Biomedical reports positive data against variant influenza strains
ID Biomedical (Vancouver) reported that it has data demonstrating protection against variant strains of influenza. Results from pre-clinical experiments performed by ID Biomedical scientists and recently published in the September 2003 issue of the peer reviewed journal, Vaccine, provides evidence that nasal Proteosome-influenza subunit vaccines can protect against infection by variant strains of influenza virus that have ‘drifted’ from the strain present in the vaccine.
3) Medical Devices
Draxis radiopharmaceutical facility receives ISO 9001
Draximage (Mississauga), the radiopharmaceutical subsidiary of Draxis Health has been certified under ISO 9001: 1994, including ISO 13485: 1996, an international standard for medical device manufacturers. The standard provides a common approach to quality management systems and addresses the requirements of European regulators as well as the US FDA. Draximage has also been certified under the Canadian medical devices conformity assessment system (CMDCAS) as required by the Therapeutic Products Directorate of Health Canada.
Celmed BioSciences to collaborate with Institutes
Celmed BioSciences, (Monreal) a subsidiary of Theratechnologies, announced that it has signed a collaboration agreement with the National Heart, Lung and Blood Institute (NHLBI) and the National Institutes of Health (NIH) Clinical Center in Bethesda, MD. The agreement involves preclinical research in human cells using Celmed’s photodynamic (PDT) Theralux device, for the treatment of graft-versus-host disease (GvHD), a major life-threatening side effect associated with allogeneic transplants (from a donor). Celmed’s PDT-based approach is aimed at specifically eliminating the T lymphocytes that cause GvHD following an allogeneic transplant while keeping the antileukemic effect of the graft.
Canada Health Infoway invests $11.4 million in diagnostic imaging system
Canada Health Infoway (Montreal) announced that it will invest $11.4 million in one of Canada’s largest diagnostic imaging system implementations. The project will link 12 British Columbia hospitals operated by the Fraser Health Authority. These hospitals will share a digital picture archiving and communication system (Pacs), which will enable patients to have an X-ray or MRI scan performed at one hospital with the results accessible at other Fraser Health hospitals and online to physicians. Fraser Health’s Pacs system will be launched today at the Royal Columbian Hospital in New Westminster, BC.
US Army validates Response Biomedical’s Ramp anthrax test
Response Biomedical (Vancouver) released positive results from an independent and comprehensive evaluation performed by the US Military’s leading biological research facility confirming the company’s Ramp anthrax test consistently produces accurate results with sufficient sensitivity to detect even trace amounts of non-visible anthrax spores. Furthermore, Ramp did not produce a single false positive result and was not affected by potentially interferingsubstances during the evaluation.
4) Industry Update
Stressgen Biotechnologies (Victoria) announced that it has entered into a bought deal agreement with a syndicate of underwriters co-led by Canaccord Capital and Raymond James and including Desjardins Securities, Orion Securities and Dlouhy Merchant under which the underwriters have agreed to buy 10,638,298 units at a price of Canadian $1.88 per unit for total gross proceeds of C$20 million.
AnorMED (Vanvouver) announced that it has entered into an agreement with a syndicate of underwriters led by BMO Nesbitt Burns, including RBC Capital Markets, Raymond James, and Desjardins Securities, under which the underwriters have agreed to buy 5,200,000 common shares from AnorMED and sell to the public at a price of $4.90 per common share, representing an aggregate issue amount of $25,480,000.
ART Advanced Research Technologies (Montreal) announced the most recent appointments to its scientific advisory board: Dr Samuel Achilefu, Dr Amir H Gandjbakhche and Dr Joseph R Lakowicz.
Cyberpresse.ca, a Montreal-based news website, has named Dr Francesco Bellini, chairman and CEO of Neurochem (Montreal) personality of the year for 2003, in the business category.
Theratechnologies (Montreal) announced that it has completed enrolment for its phase II clinical study in HIV?related lipodystrophy using ThGRF.
VSM MedTech (Vancouver) announced that its CTF Systems subsidiary has finalized an agreement to provide a 275-channel magnetoencephalography (MEG) system to Westfalische Wilhelms-Universitat Munster.
Adherex Technologies (Ottawa) announced it has signed a memorandum of agreement to acquire non-cancer related cadherin-based intellectual property from Cadherin Biomedical. The World Economic Forum announced the 30 companies selected worldwide as “Technology Pioneers” for 2004. Among the companies is Angiotech Pharmaceuticals. “The companies we have selected as technology pioneers exemplify the ingenuity and drive that underpin life-changing innovation and, just as important, their discoveries are now reaching market readiness,” said Jos Mara Figures, co-chief executive officer of the World Economic Forum.
BioMS Medical (Edmonton) announced it intends to file its clinical trial application in Canada for approval to commence a Phase III clinical trial in respect of its lead product, MBP8298 for the treatment of secondary progressive multiple sclerosis.
Tm Bioscience (Toronto) announced that it has entered into an agreement to issue approximately 31.3 million units at a price of $0.32 per unit for total gross proceeds to the company of approximately $10 million.
Depomed (Menlo Park) and Biovail (Toronto) announced positive top line results from the second pivotal phase III clinical trial of Metformin GR, a once daily, extended release formulation of the leading diabetes drug metformin based on Depomed’s proprietary gastric retention drug delivery system.
ART Advanced Research Technologies (Montreal) announced the continued success of the commercialization efforts with the recent sale of additional pre-clinical optical molecular imagers, now named eXplore Optix, to the pharmaceutical and academic research sectors. GE Medical Systems is the exclusive distributor of explore Optix.
Stressgen Biotechnologies (Victoria) announced that Donald Tartre, Stressgen’s vice president and chief financial officer, will resign his position at Stressgen.
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: email@example.com).