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Biotech / Medical : Ligand (LGND) Breakout!
LGND 200.79-0.2%Nov 14 3:59 PM EST

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To: Sleepman who wrote (14646)2/11/1998 7:20:00 PM
From: Henry Niman  Read Replies (1) of 32384
 
Dan, you are correct about the Phases. If it's monotherapy, Targretin will definitely begin as Phase II for breast cancer, just as it did for the other cancers (it's already been shown to be safe in cancer patients). As far a approvals are concerned, oral Targretin is in three Phase II/III studies (early CTCL, advanced CTCL, and advanced lung cancer) and LGND (and analysts) expect an NDA filing THIS YEAR. Approval for CTCL will almost certainly lead to off-label use (which Robinson has said will be "significant") as long as there is any positive clinical data.

A combination trial with Tamoxifen and Targretin would probably be Phase I. However, two Phase I combination trials for Panretin and Tamoxifen for treating advanced breast cancer began in the middle of last year and should be ready to move into Phase II, if response is positive.
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