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

To: Czechsinthemail who wrote (733)	2/18/1998 12:56:00 AM
From: Jasman	Read Replies (1) \| Respond to of 887

Depo Stockholders, Looking GOOD! Hey, I think I sold too soon. Never should listen to doctors... As to your worries about the Phase IV trials , let me also share something... I think your worries are well-grounded but I still think the the meeting with the FDA would result in a conditional approval if DEPO can give legitimate reasons for the side effects. I agree, "blown out of proportion" is the wrong answer by a company representative. I'm considering getting back in but am hesitant because of the big rise in price. But I think you can be assured of more profits up till the FDA meeting. Enjoy the ride.

To: Czechsinthemail who wrote (733)	3/2/1998 10:30:00 PM
From: Dr. John M. de Castro	Read Replies (2) \| Respond to of 887

DEPO was right. Arachnoiditis is blown out of proportion and should not be a major concern. Baird's concerns with the arachnoiditis side effect of DepoCyt were very legitimate and they also concerned me. So I thought that I'd do some research. I looked in the PDR for the side effects of methotrexate and discovered that it is a cause of chemical arachnoiditis also and either oral or injected Dexamethasone treatment is used to ameliorate the symptoms. Arachnoiditis appears to be a common side effect of chemotherapeutic agents administered intrathecally. DEPO presented the Phase III results at the 20th annual breast cancer symposium in San Antonio in Dec. 98. It took a little while, but I was able to get a copy of the paper that was presented. In their presentation was a discussion of chemical arachnoiditis and the following table was included. Table 4: Severity of Chemical Arachnoiditis Across Cycles; Percent of Episodes. Number of Cycles DepoCyt (n=102) Methotrexate (n=69.5) with DEX w/out DEX with DEX w/out DEX Severity n = 92 n = 10 n = 60 n = 9.5 Mild 9% 20% 3% 11% Moderate 5% 30% 5% 53% Severe 2% 10% 3% 0% Life-Threatening 2% 0% 0% 0% TOTAL 19% 60% 12% 63% It should be noted that there were more cycles for DepoCyt than for Methotrexate because the patients survived longer to receive more cycles with DepoCyt. Also note that with a little calculation you can see that in fully 75 of the 92 DepoCyt cycles in which Dexamethasone treatment was used there was no arachnoiditis at all. If DEX is not used the problem is much more prominent but it is for both DepoCyt and MTX equivalently. I did a Chi Square analysis on these data and there are no significant differences between DepoCyt and MTX in the production of chemical arachnoiditis. Also, the slightly higher percentage for DepoCyt is almost entirely accounted or in the mild headache category. My conclusion from these data is, as I stated in my headline, IMO the problem is way overblown and is, in fact, not a major problem for DepoCyt. This is a great relief for me, as the chemical arachnoiditis side effect was a complete surprise to me and many others and seemed to be taken very seriously by ODAC. I can now see from the data that the problem is one that is common to intrathecal chemotherapy, DepoCyt is not different from other agents, and that the problem can be significantly reduced by Dexamethasone treatment. John de C