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

To: David Bogdanoff who wrote (15008)	2/13/1998 12:54:00 PM
From: Henry Niman	Read Replies (1) \| Respond to of 32384

David, Most of the posts merely pointed out that LGND had indicated that they were looking into aggressively pursue Phase II trials in breast cancer patients. LGND extensively discusses clinical trials with the FDA before the trials begin. Targretin has been in hundreds of cancer patients (male and female) and has also been tested in diabetes patients in Europe. The safety profile has been excellent, and there would be little benefit to starting a monotherapy breast cancer trial at the Phase I level. LGND has started several combination trials with FDA approved compounds and these trials have begun at the Phase I level because the affect of the combinations are not known. However, the safety of Targretin is well established in adult populations, and new monotherapy cancer trials would begin at the Phase II level (and with the Euopean data, I suspect that most if not all adult monotherapy trials would begin at the Phase II level). I fact one of the reasons that Ligand began its diabetes trials in Europe was the European regulatory agency's willingness to allow LGND to start at the Phase II level in the new patient population (the trial was announced about a year ago and at that time LGND felt it would be to difficult to get the FDA to approve a Phase II diabetes trial in the US).