Ottawa, ON November 28, 2003 The following life sciences news briefs were published by Industry Canada this week:
1) Pharmaceuticals Update
MethylGene MG98 preclinical synergy data with interferon disclosed
MethylGene (Montreal) announced results of preclinical synergy studies of MG98 in combination with interferon in human renal cancer cells at the 2003 AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics in Boston, MA, November 17-21, 2003. MethylGene demonstrates in collaboration with the Cleveland Clinic that MG98 pretreatment followed by administration of type 1 interferons result in synergistic induction of apoptosis in renal cancer cells which are either interferon sensitive or highly interferon resistant. The treatment with MG98 alone led to the reactivation of RASSF1A, a gene silenced by methylation in approximately 50% of all human tumors and almost 90% of human renal cancers. The abstract # A167 is entitled: “Selective depletion of DNA methyltransferase-1 (DNMT1) by MG98 sensitizes renal cancer cells to interferon induced apoptosis.”
AnorMED initiates third Phase II trial in cancer patients for new drug
AnorMED (Vancouver) announced the initiation of its third Phase II clinical trial to evaluate AMD3100 as a new stem cell transplantation drug candidate for cancer patients. Clinical data to date in cancer patients shows AMD3100 effectively increases the number of stem cells available for transplantation. The strongest predictor of success in stem cell transplant is the number of stem cells available for transplantation. This new Phase II trial will be conducted at two centers in the US and will enroll up to 10 non-Hodgkin’s lymphoma (NHL) patients. The objective of this study is to determine if NHL patients who are given AMD3100 plus the standard agent, granulocyte-colony stimulating factor (G-CSF), have more stem cells available for transplantation compared to patients given G-CSF alone. AMD3100 is a novel drug candidate, developed by AnorMED, that blocks a specific cellular receptor triggering the movement of stem cells out of the bone marrow and into the circulating blood. AnorMED’s clinical program on AMD3100 is being conducted at multiple transplant centers in the US. Data from 140 participants, from all clinical studies conducted by AnorMED on AMD3100 to date, show the drug candidate has a good safety profile.
2) Diagnostics and Therapeutics Update
Health Canada and US FDA sign memorandum of understanding
US and Canadian officials met for the signing of a memorandum of understanding (MOU) that will further enhance cooperation between Health Canada and the US Food and Drug Administration. Dr Mark McClellan, commissioner of food and drugs (US Food and Drug Administration, department of health and human services) and Diane Gorman (assistant deputy minister, health products and food branch, Health Canada) signed the MOU. This MOU builds on existing collaborative efforts between Health Canada and the US FDA. In general, it will better enable the two regulatory authorities to share information on the post-market safety of therapeutic products, information related to the review and evaluation of new product submissions and information on product investigations and enforcement activities.
MedMira makes rapid in-roads in Chinese market
MedMira (Halifax) announced that it has finalized arrangements with Long Hao Healthcare Technology Company, of Guangzhou, China, which will act as distributors for MedMira MiraWell Rapid HIV tests. MedMira also announced an increase in the annual purchase commitment by the distributors to 1,000,000 units, with 100,000 of these units to be delivered by mid December. This is an increase of 600,000 units in the 12-month order for MiraWell Rapid HIV tests and follows the People’s Republic of China State Food and Drug Administration (SFDA) regulatory approval earlier this year.
Micrologix Biotech reports efficacy from Phase IIb acne study
Micrologix Biotech (Vancouver), a developer of anti-infective drugs, achieved statistically and clinically significant efficacy results from its Phase IIb study of MBI 594AN, a topical drug candidate under development as a first-in-class prescription treatment for acne. The Phase II study was designed to evaluate acne lesion count reductions at various time points (3, 6, 9, and 12 weeks), comparing MBI 594AN (1.25% and 2.5%) with the alcohol vehicle. MBI 594AN 2.5% achieved statistically significant superiority at 6 weeks in reducing all three lesion parameters measured: inflammatory lesions (p equals 0.004), non-inflammatory lesions (p equals 0.037), and total lesions (p less than 0.001). A physician’s global severity assessment, the fourth parameter measured, also resulted in clear superiority of the product as compared to the vehicle. The drug was extremely well tolerated, with no serious drug-related adverse events encountered in the study.
Axcan completes acquisition of gastrointestinal products from Aventis
Axcan Pharma (Mont St Hilaire) announced the closing of its agreement for the acquisition of rights to a group of gastrointestinal products from Aventis. The US$145 million purchase price was paid out of Axcan’s cash on hand. Axcan also announced that it will immediately start marketing Carafate/Sulcrate, Bentyl/Bentylol and Proctosedyl.
ARC and the University of British Columbia sign license agreement
The University of British Columbia (UBC) and ARC Pharmaceuticals announced that they have entered into an exclusive worldwide license agreement for the development and commercial sale of a novel class of anti-inflammatory compounds. The license agreement will provide key intellectual property in the development of ARC’s anti-inflammatory program. In exchange, ARC will provide UBC with milestone and royalty payments in addition to further equity in the company.
Network launched to conduct trials of new drugs for rheumatoid arthritis
Dr Ed Keystone, chairman of the board of directors announced the launch of the Canadian Rheumatology Research Consortium (CRRC), a national network of academic and community rheumatologists, which will conduct clinical trials in new therapies for rheumatoid arthritis. Already, 46 clinicians in eight provinces are involved with the federally incorporated non-profit corporation. Their mission, to increase the volume and scope of trials performed in Canada, will ensure that Canadians with arthritis will have earlier access to novel and effective treatments.
BCY results from Phase II cystic fibrosis clinical trial for DCF 987
BCY LifeSciences (Toronto) announced that its clinical advisory board (CAB), management and advisors have completed the analysis of the Phase II clinical trial designed to assess the efficacy and safety of DCF 987 in the treatment of cystic fibrosis (CF). The results indicated that DCF 987 was well tolerated and may have shown positive trends in the improvement of FEV (1) (forced expiratory volume in one second), a measure of lung function, and the reduction of Pseudomonas aeruginosa bacterial load in patient sputum.
4) Medical Devices
CryoCath initiates patient enrolment in atrial fibrillation study
CryoCath Technologies (Montreal) announced that it has enrolled and treated its first patient in its investigational device exemption (IDE) study for atrial fibrillation (AF). The study involves a unique “tool box” approach to treat AF using up to three different CryoCath catheters: Arctic Circler, Freezor Xtra and Freezor MAX. The study is designed to take place in two stages. In the first stage, the company will enroll up to 30 patients at three US centers. Dr Vivek Reddy of Massachusetts General Hospital in Boston, Dr Jim Irwin of St Joseph’s Hospital in Tampa and Dr John Seger of St Luke’s Episcopal Hospital at the Texas Heart Institute will participate as clinical investigators in the first stage, with Dr Reddy acting as the principle investigator.
FDA panel recommends a
pproval for Taxus Express2
Angiotech Pharmaceuticals (Vancouver), the original developer of the paclitaxel-coated stent technology, was notified by its corporate partner, Boston Scientific, that the circulatory system devices panel has unanimously recommended US Food and Drug Administration (FDA) approval for the company’s Taxus Express2 paclitaxel-eluting coronary stent system. The panel provides the FDA independent, professional expertise and technical assistance on the development, safety and efficacy, and regulation of medical devices. A final decision on approval will be made by the FDA.
Angiotech announces to acquire STS Biopolymers for $23 million
Angiotech Pharmaceuticals (Vancouver) announced that it has entered into an agreement and plan of merger to acquire all of the outstanding shares of STS Biopolymers, (Henrietta, NY) for cash consideration of approximately US$23 million. STS is a privately owned company located in Henrietta, NY, specializing in the development and manufacture of state-of-the-art biocompatible coatings for medical devices. The transaction is expected to close by the end of December 2003 and is subject to the approval of STS’s shareholders as well as other customary closing conditions. The acquisition will be accounted for using the purchase method of accounting.
5) Industry Update
Celmed BioSciences, a subsidiary of Theratechnologies (Montreal), which targets niche applications in oncology and neurology, today announced four appointments that it says will reinforce its scientific management team and accelerate its clinical efforts. Mr Mark Kaufmann, MBA, presently vice president, corporate development, will also assume the responsibilities of chief operating officer (COO) of Celmed. Reporting to him will be three new vice president positions: Dr Pierre A Caudrelier will assume the position of vice president, clinical affairs. Dr Pascal Puchois, PharmD, DSc, will assume the position of vice president, preclinical research and technologies. Ms Raphaela (Ela) Borenstein, MSc, MBA, will assume the position of vice president, regulatory affairs and product strategy.
Axcan Pharma (Mont St Hilaire) announced that its stock will be added to the Nasdaq Biotechnology Index effective as of the market’s opening on Monday, November 24.
Duft Biotech Capital (Vancouver) is pleased to announce the company has closed its short form offering document financing for gross proceeds of $1.2 million (six million units at $0.20 a unit, each unit consisting of one share of the company and one warrant for the purchase of an additional share of the company for a price of $0.30 until May 13, 2005).
Oncolytics Biotech (Calgary) announced that it has been granted US Patent 6,649,157 entitled “Viruses for the treatment of cellular proliferative disorders.” The claims in this patent cover the treatment of Ras mediated tumours using modified herpes viruses.
BioMS Medical Corp (Edmonton) announced it has submitted its pre-CTA (clinical trial application) information package for its lead product, MBP8298, a novel proprietary peptide therapeutic for the treatment of secondary progressive multiple sclerosis (MS), to the Therapeutic Products Directorate of Health Canada for discussion.
CEDARA SOFTWARE (Toronto) announced it has received approximately $0.9 million in full and final settlement of loans outstanding by its former chairman and chief executive officer.
The clinical laboratory division of Adaltis, an international diagnostic company based in Montreal, announced that it has acquired the Prenatest exclusive license agreement and laboratory assets from its new partner, Procrea Cliniques.
Tm Bioscience (Toronto) announced that Mayo Foundation has signed a five-year master purchase agreement for the company’s line of genetic tests. Under the terms of this agreement, Mayo Foundation has agreed to purchase the Tag-It Mutation Detection Kit for CFTR (cystic fibrosis gene). The master purchase agreement will also enable Mayo to easily purchase additional tests from Tm as they are commercialized.
LAB International (Laval), a drug development company supported by a profitable research services arm, announced the appointment of Mr Luc Mainville as chief financial officer.
Robert Rieveley, the president of Biotech Holdings (Vancouver), reported that the company will expand its partnership with its packager in Mexico to include tableting for the Mexico market and some export markets, including potentially supply of Sucanon for a part of the diabetes market in the US
Medical Services International (Edmonton) announced that it had agreed to begin live testing in medical clinics in Florida. On November 7, 2003 the company announced that it had received approval to begin live testing from the independent investigational review board (IRB).
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).