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Biotech / Medical : Ligand (LGND) Breakout! -- Ignore unavailable to you. Want to Upgrade?

To: Torben Noerup Nielsen who wrote (20822)	5/14/1998 9:54:00 PM
From: RXGOLF	Read Replies (2) \| Respond to of 32384

Torben, You are on target here. But the FDA will closely look at the exact things you are discussing, and that is risk vs benefit. Of course, it would be nice for this ratio to be as large as possible with the possible benefit far out weighing the possible risk. Hope that is how the FDA will see it. Regards, Greg

To: Torben Noerup Nielsen who wrote (20822)	5/14/1998 10:51:00 PM
From: Peter Singleton	Respond to of 32384

Torben, Greg, My question about the toxicity in the oral Panretin KS trial is more to the issue of toxicity of LGND's retinoids in general. From what I understand, they've had a generally excellent safety profile in the trials to date, although I don't have the data before me. The levels of toxicity exhibited in the KS trial may be acceptable for late-stage KS patients, if in fact that's what these patients are. However, the bigger markets are for chronic conditions, where the level of toxicity is a very big concern. And among the chronic conditions I would class cancer, since many are predicting we are moving into an era where we'll see cancer as a treatable disease with patients taking some form of long-term, orally available, daily combination therapy ... There has been some indication of elevated lipids with Targretin. In cancer, vs. current chemo, probably no big deal. In metabolic disorders, or long-term cancer treatment ... more of a concern. Along these lines, note the following 5/2/98 Reuters article on triglyceride levels as risk factors in cardiovascular disease. Even "normal" fat levels may be bad, study finds WASHINGTON, May 2 (Reuters) - People who think they have healthy levels of cholesterol may still be at risk of heart disease, researchers said on Saturday. They said even "normal" levels of blood fats known as triglycerides were high enough to make heart disease likely. "Previously, nobody thought triglyceride was a major risk factor at these lower levels," Dr. Michael Miller, a cardiologist at the University of Maryland, said in a statement. So-called normal levels of triglyceride are anywhere between 100 and 200 milligrams per deciliter of blood. This is a standard measurement used around the world. But Miller's team followed 350 men and women for 18 years, and found those with triglycerides at those levels were 50 percent more likely to have a heart attack, to need heart bypass surgery or angioplasty to treat clogged arteries, or even to die from heart disease. "This study is the first to look at such a low level of triglyceride. It turned out to be an important predictor of future heart disease," Miller said. Writing in the Journal of the American College of Cardiology, Miller recommended that guidelines for desirable triglyceride levels be set lower. "Any level above 100 appeared to increase the risk. It is not like cholesterol, where the higher the level, the higher the risk," Miller said. Triglycerides can be broken down with regular exercise, a diet low in fat, and eating food rich in omega-3 fatty acids which include flax or linseed oil, canola oil and some fish. In a second study, Miller found that women with heart disease are much less likely to get cholesterol-lowering drugs than men are. He looked at the cases of 825 men and women with coronary artery disease across the United States and Canada and found half had dangerously high levels of LDL, the so-called "bad" cholesterol. Twenty percent of them were women. In 1994, about equal numbers of men and were offered cholesterol-lowering drugs -- 38 percent of the women and 42 percent of the men. But by 1997, 54 percent of the men and only 35 percent of the women were being given the drugs. This was despite a number of studies that have shown cholesterol-lowering drugs can save lives. "We were baffled as to why medication use was not increased in women with heart disease, since all of the recent trials that have shown improvement in heart attack rates and death from heart disease included women," Miller said. "We do need to do more to increase awareness among both physicians and patients," he added. 07:57 05-02-98 Copyright 1998 Reuters Limited. All rights reserved. Republication or redistribution of Reuters content, including by framing or similiar means, is expressly prohibited without the prior written consent of Reuters. Reuters shall not be liable for any errors or delays in the content, or for any actions taken in reliance thereon. All active hyperlinks have been inserted by AOL.a