Life Sciences News Brief
Vol. 5 no. 12 - May 05, 2005
　

Vasogen Reaches Full Enrollment In Pivotal Phase III ACCLAIM Trial

Vasogen Inc. (Toronto), a leader in the development of immune modulation therapies for the treatment of cardiovascular disease, announced it has reached full enrollment in the 2,000-patient pivotal phase III ACCLAIM trial in advanced chronic heart failure. The ACCLAIM trial is a double-blind, placebo- controlled, multinational clinical study designed to definitively assess the impact of Vasogen's Celacade(TM) technology on the risk of death and cardiovascular hospitalization in patients with advanced chronic heart failure. Heart failure, which affects over ten million people in North America and Europe, is associated with more than 600,000 deaths each year and is the leading cause of hospitalizations in people over the age of 65.

Pharmagap Announces Excellent Results of Tests for Lead Cancer Drug

PharmaGap Inc. (Ottawa) announced excellent results from acute tests in mice for toxicity of its lead cancer drug PhG-alpha-1. The drug was non toxic in mice at dosage levels several orders of magnitude greater than the levels used in bench tests which have demonstrated effectiveness in killing lung, breast and certain other cancer cells. These results are preliminary. The drug was delivered to test groups of mice by intravenous, oral and topical delivery. Full results of these acute toxicity tests will be announced when completed over the course of the next few weeks.

Adherex Initiates Phase II Trial Of Adh-1

Adherex Technologies Inc. (Ottawa), a biopharmaceutical company with a broad portfolio of oncology products under development, announced that it has initiated a Phase II clinical trial of ADH-1 (Exherin(TM)) at the Ottawa Regional Cancer Centre in Ottawa, Ontario, Canada. The study is designed to evaluate the anti-tumor activity and tolerability of repeated doses of ADH-1 on an every three-week schedule in patients whose tumors express the molecular target, N-cadherin. In addition to the Ottawa location, this open-label trial is expected to include up to two additional sites in Canada. This trial, the first in the Company's Phase II ADH-1 program, is expected to enroll up to 60 patients and will include eight different tumor types, including some more common cancers such as breast and lung as well as some rare cancers such as adrenocortical and esophageal.

Inflazyme Announces Preliminary Phase I Results With PDE4 Inhibitor,

Theratechnologies reports on a positive meeting with Health Canada

Theratechnologies (Montreal) reports on a positive meeting with the Therapeutic Products Directorate (TPD) of Health Canada held on May 3, 2005, in Ottawa for its Phase III program for ThGRF (TH9507) in HIV-associated lipodystrophy. Following this meeting, the Company is now preparing a Phase III Clinical Trial Application (CTA), which will be submitted to the Canadian regulatory body in the coming weeks. The response from the TPD is expected within 30 days of receipt of this application. "We received the go ahead for our Phase III program from the Food and Drug Administration (FDA) in the United States in late March. Following this positive meeting with Health Canada, we foresee no major hurdles that would prevent us from proceeding with our program also in Canada," said Yves Rosconi, President and Chief Executive Officer of the Company. "All elements of our Phase III program are coming together as planned and we are on track to enroll the first patient by mid-year," Mr. Rosconi concluded.

IMI announces pivotal breast cancer test study

Predictive medicine company IMI International Medical Innovations Inc. (Toronto) is launching a pivotal clinical study for its non-invasive breast cancer detection test, in collaboration with the University of Louisville, in Louisville, Kentucky, the company announced. IMI's test identifies a cancer-associated sugar in a sample of nipple-aspirate fluid, which is painlessly derived from the mammary ducts and expressed through the nipple.

Medicure Inc. (MCU) Announces Positive Preclinical Results For MC-1

Medicure Inc. (Winnipeg), a cardiovascular drug discovery and development company, announced that results from a preclinical in vivo study have shown potential for MC-1 in the treatment of hypertriglyceridemia. Hypertriglyceridemia is commonly associated with metabolic disorders such as type II diabetes, metabolic syndrome, insulin resistance, and obesity. The triglyceride-lowering effects of MC-1 were evaluated in an industry-standard cholesterol model. The in-vivo model involves feeding a high cholesterol diet to the subject animals thereby inducing high levels of triglycerides, total cholesterol and LDL cholesterol. Treatment with MC-1 (10 mg/kg) for 7 weeks was associated with a 72% reduction in triglyceride levels vs. control (p=0.03). In addition to the significant improvement shown relative to placebo, MC-1 also demonstrated an improvement versus an approved, widely prescribed triglyceride reduction agent in this model.

Tm Bioscience receives FDA clearance for Cystic Fibrosis DNA test

Tm Bioscience Corporation (Toronto), a leader in the commercial genetic testing market, announced that its Tag-It(TM) Cystic Fibrosis (CF) Kit is the first multiplexed human disease genotyping test to be cleared by the U.S. Food and Drug Administration (FDA) as an in vitro device (IVD) for diagnostic use in the United States. This DNA based test is used to simultaneously detect and identify mutations and variants in the cystic fibrosis transmembrane conductance regulator (CFTR) gene in human blood specimens in order to determine CF carrier status in adults, as an aid in newborn screening, and in confirmatory diagnostic testing in newborns and children. Performance testing has established that the Tag-It(TM) CF Kit operates with 100% accuracy and greater than 99.9% reproducibility and precision.

MedMira Receives FDA Approval for Enhancements to Rapid HIV Test

MedMira Inc., (Halifax) the global market leader in rapid flow-through diagnostic technology, announced that it has received approval from the United States Food and Drug Administration (FDA) to provide new features in its Reveal(TM) G2 Rapid HIV-1 Antibody Test. These enhancements will continue to heighten the competitiveness of Reveal(TM) G2 in the marketplace and further increase customer satisfaction. This latest FDA approval enables MedMira to provide external control material with an extended shelf-life and additional flexibility, answering the emerging challenges and needs of the market. US laboratory professionals are subject to strict quality control requirements, and MedMira's enhancement to the external controls will improve cost-effectiveness and versatility for the customer. Reveal(TM) G2 is currently the fastest rapid HIV test, at only 3-minutes, available in the United States and according to an independent study by the US Centers for Disease Control and Prevention (CDC), is the number one rapid HIV test used in US hospitals.

Sex, gender and heart disease - MUHC researcher leads Canada-wide team

A new research project involving more than thirty investigators from across Canada has just been launched. The project, known as GENESIS, is Canada's largest multidisciplinary initiative to study the causes of cardiovascular disease-the leading cause of death in Canada. GENESIS will investigate key unknowns in the way cardiovascular disease is manifested between men and women. Specifically, the project will address both the biological and genetic factors (sex) and social and behavioral factors (gender) involved in cardiovascular disease.

NIR Diagnostics awarded FDA clearance to market HemoNIR(TM)

NIR Diagnostics Inc. (Campbellville), an innovative developer of handheld reagentless medical instruments based on its proprietary near-infrared light technology, announced that its 510(k) submission for HemoNIR(TM)LAB (for laboratory use) has been awarded clearance by the United States Food and Drug Administration (FDA). FDA clearance allows NIR Diagnostics to market the HemoNIR(TM)LAB device and coincides with the Company's European CE Mark compliance, and the Company's most recent ISO 13485 global accreditation, a prerequisite for Canadian Health Protection Branch (HPB) approval.

Isotechnika granted permission for Phase IIb kidney transplant trial

• Genizon BioSciences, Inc., (Montreal) a gene and drug target discovery company, announced it has acquired the majority of the assets and staff of Sweden-based Global Genomics AB. Through this transaction, Genizon has gained access to a novel sequencing technology, five related patents/patent applications and proprietary algorithms for data analysis. Dr. John Hooper, President and CEO of Genizon commented: "The platform and staff of Global Genomics provide great potential for Genizon to reduce from months to weeks the time required to identify disease causing mutations at gene locations identified in our whole genome association studies. We expect this acquisition will produce substantial additional value-generating capability for our company. The Global Genomics technology also shows considerable promise for inexpensive whole genome resequencing."……
• MedMira Inc., (Halifax) the global market leader in rapid flow-through diagnostic technology, announced that it has received a monthly standing order for the next year from Goodman Medical Supplies Ltd, its Hong Kong distributor, for its MiraCare(TM) Rapid HIV Test (MiraCare(TM)), as part of a three year distribution agreement. MiraCare(TM), an over-the-counter (OTC) rapid HIV test, is distributed to pharmacies in Hong Kong and Macao, in the People's Republic of China…….
• Neuromed Technologies Inc., (Vancouver) a biopharmaceutical company developing a new generation of chronic pain drugs, announced the appointment of Dr. Barry Sachais to Vice President, Clinical Development, Mr. Sean Cunliffe to Vice President, Commercial Development and Dr. Simon Li to Vice President, Medical Research. All three positions are newly created…….
• MEDICAL VENTURES CORP. (Richmond) announced the signing of its first distribution agreements and sales of Performance Medical Devices' PeriPatch(TM) Sheet in the United States. Agreements have recently been completed with: Corthomed Inc., covering New York, Connecticut and New Jersey; Kand Medical Inc., covering Southern California and Nevada; and Coast BioSystems Medical Corporation, covering Northern California. …….
• Tm Bioscience Corporation (Toronto), a leader in the commercial genetic testing market, announced it has signed an agreement with McMaster University to collaborate on the development of an Upper Respiratory Viral Panel using the Tag-It(TM) technology from Tm…….
• VSM MedTech Ltd. (Vancouver) announced that it is supporting Canadian activities associated with World Hypertension Day on Saturday, May 14, 2005. As part of the World Hypertension Day activities, representatives from VSM will visit Parliament Hill in Ottawa and measure the blood pressure of staff and dignitaries using the Company's BpTRU(TM) family of automated, non-invasive blood pressure monitors.

本文章對你有幫助嗎？ 歡迎來信指教
For the further information, please contact Vanessa Chen (Commercial Officer)
Tel: 02-2544-3553, Fax: 02-2544-3595, e-mail: Vanessa.Chen@international.gc.ca

生醫推動小組業界資訊合作廣宣