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Biotech / Medical : VD's Model Portfolio & Discussion Thread -- Ignore unavailable to you. Want to Upgrade?


To: Vector1 who wrote (7249)12/4/1999 6:38:00 PM
From: WTDEC  Read Replies (1) | Respond to of 9719
 
Sample size a little small???



To: Vector1 who wrote (7249)12/4/1999 7:56:00 PM
From: scaram(o)uche  Read Replies (2) | Respond to of 9719
 
>> Someone, Rick, Biowa, PB, Peter, David K., Gordon, RW Reeves, Bob L, bring me back to earth. <<

Isn't going be me, just watching and learning. As described in the release, looks awfully good.

Naive questions, not questions with an agenda.... I don't own "either stock", and I want both companies to be successful......

Fourteen of the 38 patients were evaluable for response.... is this low? Have they indicated what happened to the other 24 patients? Does this mean that, on an intent to treat basis, the response was low? That may not be a fair question, as patients were 16-18 weeks into the protocol before they saw iodine (correct?).

At the thirteenth week, following treatment with tositumomab, iodine I 131 tositumomab, the rate of complete
response increased to 43 percent (six out of 14 patients). At approximately six months, 71 percent of patients (10 out of 14)
had experienced a complete response.


Any oncologists out there? Hmmmm....... four patients continued to "respond" at beyond 13 weeks. A new species of iodine.

Due to the immunosuppressive effect of fludarabine, only one patient developed human anti-mouse antibodies

I won't question that only one patient made HAMA, but I'd like to know what the definition of a response was in relationship to the stringency of assay. Also, does it strike anyone else as curious that humans can't make good antibody responses at 6-8 weeks post fludarabine?



To: Vector1 who wrote (7249)12/4/1999 9:33:00 PM
From: Bob L  Read Replies (1) | Respond to of 9719
 
Earth to V1, earth to V1, ... enter safe mode ... switch to backup systems ... begin error diagnostics now ... reorient antenna towards earth ...

To me, the fact that Reuters played this as news story, rather than just a company press release, gives some support to the idea that there may be a pop Monday. Will it hold until the BLA is finally resubmitted and approved? That is still the big factor. The Reuters story did mention the BLA in the final paragraphs. The complete Reuters version follows.
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Saturday December 4, 10:45 am Eastern Time
Coulter's lymphoma drug shows promising results
NEW ORLEANS, Dec 4 (Reuters) - Bexxar, Coulter Pharmaceutical Inc.'s (NasdaqNM:CLTR - news) drug for treating lymphoma, showed promising results in Phase II studies when used in combination with conventional chemotherapy, according to a study on Saturday.

The study by Cornell University showed that all patients with low grade non-Hodgkin's lymphoma went either into complete remission or saw partial response when on a regime of chemotherapy agent fludarabine followed by Bexxar.

The Cornell study, funded by Coulter, said that following an initial five week treatment with only fludarabine, 14 percent of patients, or two out of 14, went into complete remission.

Three months into the study, following treatment with Bexxar, 43 percent of patients went into complete remission. After about six months, 71 percent of patients had the same result.

The remaining patients who did not go into complete remission saw a reduction in the signs and symptoms of lymphoma, such as a reduction in the number of cancer cells.

The study, which was released at the annual American Society of Hematology in New Orleans, included only patients who had never been treated for their disease.

Last summer, Coulter applied for U.S. marketing approval for Bexxar as a stand alone treatment for patients with low-grade lymphoma who have failed other therapies or who have responded and then relapsed.

The approval process has been delayed because of modifications in the marketing applications requested by the U.S. Food and Drug Administration.

Saturday's study is not related to the modifications request by the FDA. Bexxar is to be co-marketed with SmithKline Beecham Plc
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