Silicon Investor (SI) -- The First Internet Community

STOCKTALK

We've detected that you're using an ad content blocking browser plug-in or feature. Ads provide a critical source of revenue to the continued operation of Silicon Investor. We ask that you disable ad blocking while on Silicon Investor in the best interests of our community. If you are not using an ad blocker but are still receiving this message, make sure your browser's tracking protection is set to the 'standard' level.

Biotech / Medical : CLTR COULTER PHARMACEUTICAL -- Ignore unavailable to you. Want to Upgrade?

To: Bob L who wrote (383)	11/20/1999 11:43:00 PM
From: WTDEC	Read Replies (2) \| Respond to of 666

Bob, Below is a quote from Eric Ende MD, the IDEC bull who V1 also quoted at Message 12013304. It is quite clear Ende sees the greater efficacy and lower toxicity of Bex. vs. Zev., but he explains it away. V1 didn't buy the argument and I judge the other three analysts (PhD in science types) I referenced in my earlier post - - siliconinvestor.com - - probably wouldn't buy it either. The numbers and toxicity comparisons I mentioned were drawn from summary numbers in Ende's report. "Although the data suggests that Zevalin has greater toxicity and lower efficacy than Bexxar, a potentially competing drug from Coulter, controlling for the number of prior therapies, there are 2 key differences between the patients in the studies. These include age and type of prior treatments. The median ages of patients that received Bexxar and Zevalin are 49 and 56, respectively. Older patients tend to develop greater blood toxicity than younger patients, which may help to explain the higher number of grade 4(serious) low platelet and white blood cell counts for Zevalin." If CLTR has been purposely vague on adverse effects, we will eventually know that and management should and likely will pay a heavy price. Since there is a major short position in CLTR stock, I think one needs to be at least somewhat skeptical of 'negative' rumors. I too hope the products get to market soon...there are sick people who would be the beneficiaries. Best regards, Walter

To: Bob L who wrote (383)	11/22/1999 11:47:00 PM
From: Gordon James	Read Replies (1) \| Respond to of 666

Bob, Thrombocytopenia has also been a problem with bexxar. For this the bexxar abstract said <10K in 4%, but 10K is too low a threshold to compare. (The Zev abstract used Grade 4, which is platelets <25K.) FYI, FWIW, etc. - a few years ago, the NCI definition of grade 4 thrombocytopenia was changed from the <25K platelets that you mention to a new standard of <10K (as reported by the Bex investigators). So I think we may have apples/apples comparisons here we can do on hematological AE's between Bex and Zev, at least in terms of criteria reported (that is, assuming that the Zev "Grade 4" is indeed based on the new <10K standard, not certain of that because they don't say in the abstract). We can do some level of apples/apples on neutropenia as well because Bex investigators report based on ANC < 500, which is NCI grade 4. BTW, link junkies may want to check out the following - NCI has a great site for their CTEP (Cancer Therapy Evaluation Program) - ctep.info.nih.gov One of the things you can find here is the NCI "CTC" (Common Toxicity Criteria), the NCI standards for grading treatment toxicity (it's here that I saw that the grade 4 platelets standard had been lowered from <25K to <10K). Here's a direct link to the CTC: ctep.info.nih.gov Click on "Common Toxicity Criteria Document" to download all the criteria. Click on "Common Toxicity Criteria Manual" to download some good info on how to interpret the criteria. Anyway, back to Bex vs. Zev hematological adverse events... I think the results point toward a superior profile for Bexxar, although perhaps not as superior as I had expected, and there are some differences in the patient populations involved in the samples we have to look at from ASH so we don't truly have apples/apples (this is based on assumption that Zev results were reported based on current NCI CTC of gr4 platelets defined as <10K): Zev ("Rituxan refractory" study) vs. Bex ("overall" report) gr4 platelets <10K: Zev 8% vs. Bex 3% gr4 ANC <500: Zev 23% vs. Bex 17% More I look at this, more I wish there were better publicly available data (like this) reported from earlier Bex and Zev results, but it seems hard to come by. Would make possible some more refined comparisons, closer to apples/apples... Cheers, Gordon