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Biotech / Medical : IDPH--Positive preliminary results for pivotal trial of ID

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To: Roudy who wrote (1599)10/27/1998 7:38:00 PM
From: Maurice Winn1 Recommendation  Read Replies (1) of 1762
 
IDEC has shown Y2B8 to be a good product though not much information was available in the intermediate grade results.

biz.yahoo.com

"Patients with intermediate grade lymphoma treated on the Phase I/II trial exhibited an overall response rate of 43% [6/14], with a complete response rate of 29% [4/14] and a partial response rate of 14% [2/14]. There were no responses to treatment in three patients with mantle cell disease."

"Complete response" in this case means tumour reduction to not more than 10mm x 10mm. [They say 1 cm x 1 cm which I suppose allows up to 1.48 cm x 1.48 cm as still fitting the complete response category since there is only one significant figure quoted, which seems pretty sloppy to me].

They say "The objectives of the PhaseI/II trial were to evaluate the safety and activity of IDEC-Y2B8 used in tandem with Rituxan therapy in 51 patients with a variety of types of non-Hodgkin's [sic] lymphoma. Three dose levels of IDEC-Y2B8 were investigated: 0.2mCi, 0.3mCi and 0.4mCi per kilogram of patient body weight."

It seems that first they treat people with Rituxan, then Y2B8. This seems odd to me and quite counterproductive in Intermediate Grade where Rituxan is said to be ineffective. By using Rituxan first, the CD20 antigen bearing cancer cells are going to get coated with Rituxan, which results in the cancer cells not all being killed off, though it certainly seems to result in B-cells freely flowing in the bloodstream being killed and presumably that includes the cancerous ones. But for tumour cancer cells, it seems the Rituxan would act as a protective coating which would then prevent the subsequently given Y2B8 from attaching to the tumour or at least reducing the number of attachments substantially.

So for intermediate grade, they should first of all lay waste to tumours by surgery and CHOP, then give a concurrent dose [a few weeks later] of Oncolym and Y2B8, thereby getting cancer cells with either/or/or both of the antigens. Forget the Rituxan altogether for Intermediate grade.

Anyone who knows something might like to comment. It seems so obvious that they should have thought of it, but maybe they were more worried about having a common treatment protocol across all the patients to get an apples to apples comparison.

No mention of tuberculosis, so I assume that Dr Saven's concerns last February about it and experience of a couple of cases in conjunction with Rituxan has been trivial overall in the thousands of cases where Rituxan has been used. Safety and efficacy results would include tuberculosis cases I suppose.

Maurice

PS: Don, don't worry about the share price. If it is too cheap and you get some money, buy some more. If it stays cheap and you own the stock, too bad, just bank all the dividends as they come in and smile. Of course it is much nicer to have full value recognized just in case you need to sell for some reason.
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