Life Sciences News Brief
Vol. 5 no. 16 - June 1, 2005
　

Gemin X Biotechnologies Inc. Secures U.S. $65.2 Million In Financing

Gemin X Biotechnologies Inc., (Montreal) a privately held biotechnology company developing novel cancer treatments based on the regulation of apoptosis, announced that it has raised U.S. $65.2 million in financing, consisting of $50 million in private equity investment and up to $15.2 million through a loan facility. The funding will support Gemin X's continued clinical development of lead product candidate GX15-070, including an ongoing Phase 1/2 trial in patients with chronic lymphocytic leukemia (CLL) and a Phase 1 trial in patients with solid tumors. The funding will also be used to advance a second oncology compound in the company's pipeline into the clinic.

YM BioSciences Achieves Primary Objective With Norelin(TM) Study

YM BioSciences Inc. (Mississauga), the cancer product development company, announced that Norelin(TM), its anti-cancer vaccine targeting the gonadotropin releasing hormone (GnRH), has successfully completed a proof of concept study in men with hormone dependent prostate cancer (HDPC). The majority of patients with HDPC treated with Norelin(TM) developed antibodies to GnRH, demonstrating the development of an immunological response, which was the primary objective of the trial. The trial enrolled patients in two stages. In the first stage (results reported in June of 2003), 12 patients were enrolled and treated with the Company's proprietary formulation of Norelin(TM) and were followed for 90 days. In the second stage, four patients were enrolled starting in mid-2004 and followed for 180 days before determining whether or not they responded. YM originally planned to enroll a total of 12 patients in the second stage, but voluntarily terminated enrollment of the trial when delays in trial implementation resulted in clinical supplies of the drug exceeding stability time-limits. The drug substance demonstrated excellent stability for four years, more than sufficient to consider it commercializable.

Lorus publishes key findings for Virulizin(R)

Lorus Therapeutics Inc. (Toronto), a biopharmaceutical company specializing in the development and commercialization of pharmaceutical products and technologies for the management of cancer, has published peer-reviewed results from the Company's studies on the mechanism of Virulizin(R)-mediated anticancer activity. The study demonstrates that NK cells play a crucial role in the antitumor activity of Virulizin(R), as NK cells isolated from Virulizin(R)-treated mice had increased cytotoxicity against NK-sensitive cells and human melanoma cells, but not against NK-insensitive cells. Depletion of NK cells in CD-1 nude mice by an anti-NK specific antibody significantly compromised the antitumor activity of Virulizin(R). NK cell-mediated antitumor activity appears to rely on the activation of macrophages by Virulizin(R), further enhancing tumor killing effects. It was found that IL-12, a key NK cell stimulatory factor, was involved in NK cell activation in vivo. IL-12 was significantly increased in macrophages isolated from Virulizin(R)-treated mice. Levels of IL-12 alpha and IL-12 beta mRNA were increased in both peritoneal macrophages and in tumor xenografts as a result of increased numbers of macrophages following Virulizin(R) treatment. In addition, the level of IL-12 beta was also substantially elevated in the serum of mice treated with Virulizin(R).

Gold Helps With Arthritis When Usual Drug Fails

Although jewelry may be the first thing that springs to mind when someone says "gold," injecting a liquid form of the metal can help people with rheumatoid arthritis. In fact, gold therapy has been around for a while, and now new research shows it can be effective when combined with another treatment. In the study, reported in the journal Arthritis & Rheumatism, gold therapy reduced the severity of arthritis in patients who had a poor response with methotrexate, the standard drug used to treat the disease. Findings from several observation studies have shown that gold can augment the treatment response seen with methotrexate, but until now, this has not been investigated in a study in which patients were randomly selected to receive gold or inactive "placebo" injections. The study, which was conducted by Dr. John M. Esdaile, from the Arthritis Research Center of Canada in Vancouver, and colleagues, involved 65 patients who received weekly injections of gold or placebo. At 48-week follow-up, significantly more gold-treated patients had experienced a treatment response than those given placebo. In addition, the gold therapy was found to me more cost-effective. These results support previous findings indicating that combination therapy with gold and methotrexate is useful when the latter agent fails to provide an optimal response, the authors state. New and effective drugs called TNF blockers have recently become available for rheumatoid arthritis, but they are expensive. "Given the high costs of (newer anti-rheumatic drugs), we believe that there continues to be an important role for gold in combination with methotrexate, especially when cost is an issue," Esdaile's team concludes.

Vitamin E may protect against Parkinson's -study

A review of eight studies that looked into whether vitamins C and E and beta carotene had an impact on the odds of developing the progressive brain disease showed that a moderate intake of vitamin E lowered the risk. "Our data suggest that diets rich in vitamin E protect against the development of Parkinson's disease," said Dr Mayhar Etminan, of the Royal Victoria Hospital in Quebec, Canada, in a report in The Lancet Neurology journal. Neither vitamin C nor beta carotene seemed to have a protective effect against the illness. The researchers said they did not know whether vitamin E supplements would have any benefits. Parkinson's is a chronic, irreversible neurodegenerative disease that affects 1 percent of people over the age of 65 worldwide. In the United States alone at least 500,000 people suffer from the illness. Actor Michael J Fox and boxing legend Mohammed Ali are sufferers. The illness occurs when brain cells that produce a chemical called dopamine malfunction and die. Symptoms include tremors, stiffness, slow movement and poor coordination and balance. The scientists, who looked at relevant studies from 1966 to March 2005, said more research is needed to confirm their findings. Vitamin E is an antioxidant that protects cells from damage. Foods rich in the vitamin include nuts, seeds, wheat germ, spinach and other green leafy vegetables.

Welichem Biotech Inc. Commences Trading on the TSX Venture Exchange

Welichem Biotech Inc. (Vancouver) announced that it will begin trading under the symbol "WBI" on the TSX Venture Exchange at the market open, Wednesday, May 25, 2005. Welichem Biotech Inc. is a pioneering Canadian biopharmaceutical company that is developing proprietary small molecule drugs with large potential and significant competitive advantages. The first lead compound is in formal preclinical development for therapeutic application against psoriasis.

Bioniche Mycobacterial Cell Wall Extract (MCWE) Granted New Patent

Bioniche Life Sciences Inc. (Belleville), a research-based, technology-driven human and animal health biopharmaceutical company, announced that it has had another new patent issued by the United States Patent and Trademark Office (USPTO) on its core mycobacterial cell wall technology. More than 145 patents have now been issued or applied for related to this technology. The new patent relates to the Company's proprietary composition, Mycobacterial Cell Wall Extract (MCWE). MCWE, a potent immunomodulator, has now been shown to possess the ability to enhance the production performance of an animal. The new patent is entitled: "Method for enhancing production performance in an animal" (U.S. 6,890,541), inventors Bruce J. Nosky, Robert E. Pitts, and Dragan R. Rogan.

Magistral Biotech obtains Health Canada approval for Libracol

Magistral Biotech Inc. (Montreal) has been granted a Natural Product Number (NPN) from Health Canada for its cholesterol product Libracol. Magistral is among the first Canadian companies to obtain Health Canada approval for a non-traditional natural product which, pursuant to regulations that came into force in 2004, governs the quality, safety and marketing of non-prescribed products in Canada. The natural product number should help Magistral in its negotiations with commercial partners interested in marketing Libracol.

Biovail Receives Tentative Approval From FDA For Zolpidem ODT

Biovail Corporation (Toronto) announced that it has received tentative approval from the United States Food and Drug Administration (FDA) for its New Drug Application (NDA) for its oral disintegrating tablet (ODT) formulation of zolpidem tartrate, which is indicated for the short-term treatment of insomnia. The FDA's tentative approval is based upon its conclusion that Zolpidem ODT is safe and effective for use, according to the product labeling provided by Biovail. Final approval for Zolpidem ODT cannot be made effective until the expiration of patent protection for Ambien in October 2006, which is held by Sanofi-Aventis.

FDA approves 12-month shelf life for TAXUS(R) stent system

• Biophage Pharma (Montreal) named Mr. Myer Bentob to its Board of Directors. Mr. Bentob is the founder, Chairman & CEO of Montec Holdings Inc., a publicly traded Corporation on the TSX Venture (TSX: MTE.P). Biophage is also pleased to announce that Dr. Rosemonde Mandeville has been appointed Chairperson and that Mr. Jim Webster, Mr. Bob Burr and Mr. Bruce Schmidt have been re-elected to the Board of Directors…….
• MIV Therapeutics Inc., (Vancouver) a developer of next-generation biocompatible coatings and drug delivery technologies, announced that it has appointed successful business and biomedical technology innovator Dhirajlal Kotadia, founder and CEO of India-based advanced stent manufacturer Sahajanand Medical Technologies, to the position of Co-Chairman and Managing Director of International Operations for MIVT……
• CEDARA SOFTWARE CORP. (Toronto) announced that it has received a final order from the Ontario Superior Court of Justice approving the plan of arrangement under the Business Corporations Act (Ontario) to effect Cedara's merger with Merge Technologies Incorporated……
• TSO3 Inc. (Quebec City) received compatibility endorsement for its technology from two leading medical device manufacturers named Richard Wolf and Volk Optical. These manufacturers develop and market instrumentation for minimally invasive surgical procedures and ophthalmic procedures…….
• Dimethaid Research Inc. (Toronto) has received a ruling from the Patented Medicine Prices Review Board on the previously disclosed review of Pennsaid pricing in Canada. Under the review, the PMPRB has determined that the price of Pennsaid at the time of introduction in Canada was within PMPRB guidelines. On the basis of this determination, the previously estimated potential liability of CDN $5.3 million will now not exceed CDN $172,000. Dimethaid has submitted further evidence to the PMPRB in an effort to eliminate the CDN $172,000 potential liability…….
•  Biovail Corporation (Toronto) announced that it has successfully renewed its Revolving Term Credit Facility with its syndicate of Canadian and American banks. Biovail identified its cash-flow expectations and capital requirements for 2005 - based on the implementation of the first phase of the Company's new Strategic Plan and revised strategy for the commercialization of its products in the United States - and has therefore renewed the Credit Facility at US$250 million. The agreement is for renewable one-year terms, with a one-year term out option for Biovail. The interest rates charged under the facility remain the same in this renewed facility, as do the financial covenants……..
• ProMetic Life Sciences Inc. (Montreal) announced that it has filed a short form prospectus to issue Subordinate Voting Shares in Canada. The Company has entered into an agreement with Paradigm Capital Inc. to act as lead agent in connection with the proposed offering…….
• Chromos Molecular Systems Inc. (Burnaby) has entered into a Letter of Intent to acquire Targeted Molecules Corporation, a privately held San Diego based biotechnology company focused on the research and development of two antibody product candidates for treatment of multiple sclerosis and acute thrombosis…….
• IMI International Medical Innovations Inc. (Toronto) plans to change its name to PreMD Inc. later this year to better reflect the company's predictive medicine focus and growth direction, announced Dr. Brent Norton, President and Chief Executive Officer, at the company's annual shareholders' meeting today in Toronto. The new name will be officially launched in September 2005…..
• Response Biomedical Corp. (Vancouver), announced it has received both the 2005 Excellence in Technology of the Year Award and 2005 Product Innovation of the Year Award for its RAMP(R) System from Frost & Sullivan, a premier growth consulting company worldwide.

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