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

To: Gordon James who wrote (243)	8/20/1999 1:39:00 PM
From: Gordon James	Respond to of 666

By the way... In my previous post, I didn't mean to imply that I believe that some sort of Bexxar + fludarabine combination will necessarily result in some cures for low-grade NHL - only trial results could tell us that, and so far lgNHL has been quite resistant to any curative therapy. But I would suspect that, like many cancers, if we want to get some cures here we will be looking toward hitting it early and hard, with the strongest regimens available (once you've developed some resistant cell populations the going gets so much tougher). So if one believes that Bexxar represents one of the strongest weapons currently in the arsenal, we should expect to see solid ongoing interest in working with Bexxar in first-line therapy, especially in combinations, IMHO. I did find it interesting that the researcher in the fludarabine article that I cited was hopeful that fludarabine might eventually be involved in some lgNHL cures... GJ

To: Gordon James who wrote (243)	8/20/1999 4:03:00 PM
From: Gordon James	Read Replies (1) \| Respond to of 666

P.S. Re: my speculation about the Bexxar/fludarabine trial being at Fred Hutchinson - now that I think of it, that's unlikely unless the protocol is myeloablative+BMT/stem cell rescue, I think that's the specialty there. There is a first-line trial mentioned on the Coulter website, but I had understood it was a single-agent protocol, that's where I may be mistaken... GJ

To: Gordon James who wrote (243)	8/21/1999 2:05:00 PM
From: Bob L	Read Replies (1) \| Respond to of 666

Thanks for the review of what little is available on combination use of fludarabine and monoclonals. One small point. In regard to the problems with rituxan and fludarabine, you said "it looked like they got good results with the lower dose anyway". It looks to me like they reduced the dose for future study and the very preliminary encouraging results were for the old higher dose. Medscape had this summary: "A total of 9 patients have completed at least three courses of therapy. Although the data set is too preliminary for any real conclusion to be drawn, 1 CR was seen and 8 PRs. However, unexpectedly severe hematologic toxicity has been seen, necessitating a 40% reduction of the fludarabine dose (25 mg/m2 x 3 days) in future protocols. Because of severe neutropenia, two chemotherapy naïve patients were removed from study. Further, 8 of 10 patients experienced grade 3 or 4 neutropenia, requiring growth factor support. Two patients were hospitalized for neutropenic fever, and two patients developed grade 3 thrombocytopenia, which required platelet transfusions. This study demonstrates quite nicely that unexpected toxicity can occur when licensed drugs are used in combination. Further results are awaited." In any event, I will modify my question to "why Bexxar+fludarabine instead of Rituxan+(CHOP or fludarabine) for first-line treatment?" Obviously this can't be answered now, but it will be very interesting to see how this unfolds. Thanks again for your post.

To: Gordon James who wrote (243)	8/22/1999 12:51:00 PM
From: Biomaven	Read Replies (3) \| Respond to of 666

Welcome to SI! Here's a site that lists a number Bexxar trials, including a Bexxar/Fludarabine for low-grade NHL: lymphoma.org Here's the trial: Fludarabine + Iodine-131 Anti-B1 Antibody (Bexxar) for Untreated Low Grade, Advanced Stage NHL (CP-98-025) December, 1998.This study is for low grade or transformed low grade Non-Hodgkin's lymphoma with stage III or IV of the disease. The following cell types are eligible: small lymphocytic, follicular small-cleaved, follicular mixed, follicular large-cell and monocytoid B-cells. Patients must not have had ANY previous therapy, never received systemic steroids within 1 week of study entry, no HIV or active infections, no brain metastases and no prior non-lymphoma malignancies. Patients will receive 3 cycles of fludarabine, then unlabeled anti-B1 antibody followed by labeled anti-B1 antibody. Antibodies are given intravenously: 2 injections given about a week apart. Hospitalization may be required for several days after the second injection. For more information, please contact Dr. John Leonard, New York University - Cornell Medical Center at (212) 746-2095. Peter