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Biotech / Medical : Depotech(depo) -- Ignore unavailable to you. Want to Upgrade?


To: chirodoc who wrote (649)12/22/1997 9:55:00 AM
From: Sector Investor  Read Replies (3) | Respond to of 887
 
=DepoTech-3: Analyst: FDA Panel Assessment Not Entirely Fair

Dow Jones News Service via Dow Jones

According to Vector Securities Inc. analyst Michael King, such declines are even more striking when he considers the FDA panel assessment "was not entirely fair."

A research note from the firm stated "the toxicity issue ... was skewed heavily against DepoCyt. First, the average number of cycles of chemotherapy given to the DepoCyt group was greater than that given to the MTX (methotrexate) arm. This, combined with the superior survival of the DepoCyt-treated patients, almost insured that more adverse events would take place in the DepoCyt arm."

King told Dow Jones that DepoCyt patients suffered arachnoiditis, an
inflammation of the arachnoid membrane in the brain, more often than those treated with the standard anticancer drug MTX.

"The thing that really sunk (DepoCyt's) chances was when the FDA said this thing is no better than methotrexate, but it's more toxic," he said. "The reason that was not entirely fair is because the incidents of arachnoiditis were cut down with the use of steroids."

King said steroids weren't used in enough of the DepoCyt trials to adequately prove to the FDA panel that co-use cut down on adverse effects.

In related news, while DepoTech shares reached lows Friday, its DepoCyt marketing partner Chiron Corp. (CHIR) edged down only 3/8, or 2.1%, to 17 3/4.

Ironically, Chiron shares may have been shored up by news that the FDA's Oncologic Drugs panel recommended the company's Proleukin for approval for the additional indication of the treatment of metastatic melanoma.
- By Charlene Oldham; 201-938-5173