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Gold/Mining/Energy : Nuvo Research Inc -- Ignore unavailable to you. Want to Upgrade?

To: DaveAu who wrote (7530)	7/20/2001 9:26:06 PM
From: DaveAu	Respond to of 14101

Hey Bluejay, What's up? The news release below is from Cangene last week. It's interesting for a few reasons. For one, the trial was stopped following interim analysis by the Independent Monitoring Board due to lack of efficacy even though there were no safety issues. I wasn't really sure that these boards looked at efficacy. I think we were told that an independent board took at least 4 looks at the WF10 data so it must have been at least showing a trend to efficacy as well as safety. A second reason I find this release interesting is that WF10 is also being tested on Hep C which few companies seem to be having much success against. It's a large and very much open market. There seem to be a lot fewer drug choices than for AIDS. So here's the big IF: If WF10 were to be approved for AIDS salvage therapy and if WF10 phase 2 hep C results were good, how many doctors might go ahead and prescribe WF10 for hep C (off label but no paper work involved once it's approved for AIDs). That's my hype for today. Time for a beer. Dave Cangene stops pilot Phase II Hepatitis C trial due to lack of efficacy under trial conditions Listed TSE, Symbol: CNJ TORONTO and WINNIPEG, July 12 /CNW/ - Cangene today announced that it has stopped its Phase II trial of anti-Hepatitis C hyperimmune in liver transplant recipients. After a preliminary review of data from 18 patients enrolled in the trial, an independent monitoring board found no statistical difference between patients receiving drug and those receiving placebo. However, the product exhibited a favourable safety profile and there were no adverse events associated with its use. Since data from the trial has not yet been un- blinded, Cangene has not conducted a full analysis of the results. "We are disappointed with these results; however, we knew when we started the trial that Hepatitis C has been a notoriously difficult virus to target. Importantly, the product was safe, and once we have access to all the data we will determine our next steps." said Dr. John Langstaff, Cangene's president and chief executive officer. "This was a very small trial in a limited number of patients, and we will look at further approaches to evaluate this product as an immunoprophylactic in liver transplantation," he concluded. Chronic Hepatitis C infection is the leading reason for liver transplantation. Recipients of liver transplants face a near 100% re-infection rate in the new liver; there is currently no effective prevention. Hepatitis C infection becomes chronic in about 85% of cases, and in the U.S. about 2.7 million people live with chronic Hepatitis C infection. As high as 70% of these may go on to develop some form of liver disease. Approximately 4,000 liver transplants are performed annually in each of the U.S. and Europe; Canadian numbers are about one tenth. Hepatitis C poses severe medical risk. It is widely believed to be the most serious of the five identified hepatitis viruses, and like the others can become chronic and produce severe liver problems. There is no effective prevention for infection in exposed individuals. Hepatitis C is transmitted primarily through contact with infected blood. Healthcare workers risk infection from accidental needle-stick injuries, 800,000 of which are reported annually in the U.S. The World Health Organization (WHO) estimates that there may be a staggering 170 million chronically infected carriers of the virus worldwide. Hyperimmunes are highly purified antibodies made from specialty human plasma used for therapeutic purposes. Cangene is well known for its ability to manufacture high quality hyperimmune products - its first commercial product, WinRho SDF(TM) was the first plasma product to incorporate a combination of solvent-detergent and nanofiltration steps for viral inactivation during its manufacture. Cangene is one of Canada's largest and most profitable biotechnology companies. Founded in 1984 in Mississauga, Cangene is now headquartered in Winnipeg but carries on research and development activities in both cities. It uses patented manufacturing processes to produce plasma-derived and recombinant therapeutic proteins. The Company currently has two approved products and a clinical trial program that is progressing well, including three products nearing completion of Phase III clinical trials. Using its drug-manufacturing expertise and its wholly-owned subsidiary Chesapeake Biological Laboratories, Inc., Cangene is also developing contract manufacturing business. Its FDA-licensed, ISO 9001-registered manufacturing facilities are located in Winnipeg, Manitoba and Baltimore, Maryland. Cangene's website, www.cangene.com, includes product and investor information, including past news releases. Chesapeake's website is www.cblinc.com.