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

To: Louis A. Rawden who wrote (27394)	1/13/1999 8:12:00 PM
From: Vector1	Respond to of 32384

Probably end of Sept. It is a complicated trial with a number of different arms. Unlikely the trial would be cut short. Based on preclinical data if Targretin is going to be effective for any tumor class Breast Cancer is it. FOr reasons way more important than financial gain lets hope it does. V1

To: Louis A. Rawden who wrote (27394)	1/14/1999 7:49:00 AM
From: Henry Niman	Read Replies (1) \| Respond to of 32384

Louis, I think that many investors are taking a look at Biotechs, so if you have a question, you can be fairly certain that many more would also like more info. For clinical trials, the three Phases are divided up to provide info for a NDA (New drug Application) and results from one phase are used to design the trial for the next phase. Phase I is designed to see if the compound is safe in humans (and a fair amount of animal is a prerequisite for the start of a Phase I trial). If the compound is safe, then Phase II trials are designed to determine the optimal concentration. Phase III is designed to used the optimal concentration on a larger population. If the data is very positive in Phase III (as it was in the International topical trial for Panretin), then the company may elect to halt the trial because they have enough data to submit in their NDA application, and it would be unethical to continue to treat patients with the inferior treatment (for Panretin the control arm received a placebo, but sometimes the control gets the gold standard).

To: Louis A. Rawden who wrote (27394)	1/14/1999 8:20:00 AM
From: Henry Niman	Respond to of 32384

Louis, There would be no advantage for LGND to cut the Phase II breast cancer trial short. It is a fairly complicated trial using Targretin at several concentration, with and without Tamoxifen, so they would want to get as much data as possible before starting Phase III trial(s). I think that an explanation of "Off Label" use might be appropriate at this time. After Phase III trials are completed with Targretin oral for CTCL, they will submit their NDA, probably later this year. If it receives a "priority review" then the FDA will have to make a decision within 6 months (it is likely that at the time of NDA submission, the only approved treatment for CTCL will be ONTAK, which will probably be labeled for advanced cases, and Targretin will probably get a priority review since it will be submitted for treating CTCL patients whose disease is not as advanced). LGND could get a Targretin approval for CTCL by the end of the year. The market will be relatively small, and the label will determine which CTCL patients would be considered in the labeled category. For those patients, LGND will be able to promote Targretin use, but once approved, a physician can prescribe the drug for any indication. For oncology, off label use is fairly common. Although Targretin is not currently approved for anything, some physicians are already using it on a compassionate use basis for patients who are not responding to approved treatments. Under the FDA reform act, LGND can actually promote off label use after publication of clinical data (I think that it is publication in two peer reviewed journals). LGND has already published Targretin treatment and prevention of breast cancer in animal models, but I believe that the FDA requires clinical data. Targretion is already in several clinical trials for various cancers (breast, lung, CTCL, and I believe ovarian) as well as diabetes (in Europe), psoriasis, and actinic keratosis. Thus if any of the above data is publishable, LGND could actually start promoting Targretin for those indications as soon as it was approved for CTCL (and the above data was published). Thus, there would be no advantage for shortening Phase II trials for breast cancer. If the data looks good enough to halt a trial, then they good enough to publish, and LGND would publish the partial data and set the stage for off-label promotion, especially if the clinical data bore any resemblance to the outstanding animal model data for treatment and prevention of breast cancer.