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Biotech / Medical : Biotech Holdings -- Ignore unavailable to you. Want to Upgrade?

To: jacq who wrote (128)	10/31/1998 12:27:00 PM
From: Link Lady	Read Replies (1) \| Respond to of 224

Although news from 97 , should apply still. Seems intersting and a case for someone starting trials to be accepted in Canada & US. Diabetes is on the rise, for what reason I don't know, but it seems you hear of people having Type II and having difficulty controlling it. The side effects of Rezulin, do not sound very good. New York Times and Wall Street Journal report on potential liver-damage problems associated with Type II Diabetes drug "Rezulin" The New York Times reported November 3, 1997 that the U.S. Food and Drug Administration said that Rezulin might cause liver damage. Rezulin is an insulin-sensitizer that has been marketed in the United States since January, 1997. The Times noted: "The company [Warner-Lambert Company] has changed the labeling on the drug following 35 reports of liver injury - ranging from mildly elevated levels of certain enzymes to two cases of liver failure, one resulting in a transplant, one in death." The Times stated that the FDA said that it is not known whether the drug was solely responsible for all 35 reports of liver injury. "But," the Times continued, "the Parke-Davis unit of Warner, which manufactures and markets Rezulin, has issued new product inserts stating that patients taking the drug should have periodic blood test to monitor liver enzymes. Patients with elevated liver enzymes must stop taking the drug." A report in the Wall Street Journal, November 4, 1997, noted that while Rezulin got off to a fast start in the U.S. and has generated sales of $242 million through the third quarter of this year, "...the drug outlook is now cloudier because the new information adds additional risk and cost considerations for diabetes patients." The Wall Street Journal reported that, according to the FDA, "Based on clinical trials, approximately 2% of the patients on Rezulin can be expected to have to stop taking the drug because of elevated liver enzymes." The Journal also reported that a letter dated October 31 was mailed to 300,000 doctors and 12,000 other health-care professionals, reporting the instances of liver problems and recommending that doctors check patients' liver enzyme levels periodically with a blood test. The Wall Street Journal noted, "The rate of liver problems reported so far among the patients taking the drug since its introduction is much lower [than in the clinical trials of the drug], at less than 1%. But a Warner-Lambert spokesman said more reports may surface following the letter sent to doctors." BiOTECH's Type II Diabetes drug, trade-marked as DIAB II, can also be described as an insulin sensitizer though its mechanism of action is different from drugs classed as glitazones, such as Rezulin. Diab II has been sold as a prescription drug since January 1997 in one market, China. DIAB II appears to be a remarkably benign drug. Laboratory and animal trials did not indicate any mutagenicity or carcinogenicity. Testing indicated no toxicity in doses up to 10,000 times the therapeutic dosage. In clinical trials of DIAB II preceding regulatory approval, there were no adverse side-effects distinguishable from placebo. Ongoing patient use of DIAB II has not led to any reports of toxicity.

To: jacq who wrote (128)	11/25/1998 11:20:00 AM
From: Link Lady	Respond to of 224

Hi Jacq Just received an info pac from BIO. Very interesting in that Diab II was discovered by research on another project. "V-411 is the first of a new class of diabetic drugs. It was discovered in the research of a Canadian company, Biotech Holdings, Ltd in Vancouver (1992). Scientists were working on Human Choronic Gonadotropin at the time and not in diabetes at the time." I heard that great finds are often discovered this way. Here is hoping. The literature is interesting. There was reference to Help for Diabetes type I as well in that (if I understand correctly)it aids in the binding of insulin to the cells making the insulin last longer. I may have understood this wrong. >>This is from Deutsche Morgan Grenfell report, Apr. 22, 1998 Other Insulin Sensitizers Diab II: an insulin sensitizer with a novel mechanism of action THE ONLY INSULIN SENSITIZER THAT IS NOT A PPAR AGONIST IS BIOTECHS HOLDINS' DIAB II Diab II is a small molecule which enhances the binding of insulin to its cells surface receptors and their subsequent internalisation. thus cells are effectively resensitized to the actions of insulin, promoting the internalisation of glucose storage and utilisation. Diab II benefits from the same advantages that the PPAR agonists enjoy over sulphonylureas, including an effective reduction in the levels of cholesterol and fats circulating in the blood, which reduces the risk of atherosclerosis and coronary heart disease. Further more there are no reports of any problematic side-effects since marketing of the product since marketing in China in Feb. 1997 With a suitable marketing partner, the outlook for DiabII appears extremely promising, especially if further liver side effects problems with the PPAR agonists are discovered. Biotech Holdings plans to launch the product in South America and the Carribean by the end of 1998. Discussions are undeway to find partners in North America, Europe and Japan.<< Do you have any negative thoughts here. So far I've liked what I've read. It would be nice if they could get funding from The Juvenile TypeI people, To see if DiabII would be benefit to Type I diabetes. Maybe that is in the future works.