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

To: Vector1 who wrote (361)	11/18/1999 12:25:00 AM
From: Vector1	Read Replies (1) \| Respond to of 666

From a Piper Jafray report about a week ago: 8-Nov-99 USBancorp Piper (Peter L. Ginsberg) CLTR CLTR: Bexxar Profile Looking Better & Better, Yet Regulatory Pro:Stng Buy;$36T Positive Combination Trial Results Should Enhance Breadth Of Bexxar's Target Patient Population: On Friday at the Chemotherapy Foundation Symposium in New York, Dr. John Leonard of Cornell presented the results of a 40-patient trial of Bexxar combined with Schering AG's Fludara, a popular chemotherapy employed in the treatment of NHL. In the study, previously untreated low grade/follicular NHL patients received three cycles of Fludara followed by a dose of Bexxar. To date, all evaluable patients have responded to the combination. According to Dr. Leonard, Bexxar induced a response in some patients for whom Fludara had been ineffective. In other cases, Bexxar treatment resulted in partial responses being converted into complete responses. Importantly, no HAMA (human anti-mouse antibody) responses were observed. (HAMA responses have been common when Bexxar has been employed as a single agent in the upfront setting.) In addition, induction therapy with Fludara enabled the inclusion of patients with significant bone marrow involvement; previous Bexxar trials have required that NHL patients have <25% bone marrow involvement. Dr. Leonard also spoke of a series of ongoing or soon-to-be-initiated Bexxar combination studies in previously untreated NHL, most of which we had been unaware. These trials include the study of: 1) CHOP chemotherapy followed by Bexxar (Southwest Oncology Group (SWOG) study); 2) CVP chemotherapy followed by Bexxar; 3) Fludara followed by the combination of Fludara and Bexxar; and 4) chemotherapy followed by Bexxar vs. Bexxar followed by chemotherapy. More Conservative Stance On Regulatory Timing: While activity in clinical trials continues to raise our confidence regarding the importance of Bexxar while also raising the drug's profile among clinicians, the refiling of the Bexxar BLA does not appear to be close at hand. In addition, SmithKline forecasts a refiling by the end of the first quarter (per a SmithKline conference call held in late October). While it still appears that the FDA will not request any new trials of Bexxar or even any additional patients in completed or ongoing trials, we have chosen to change our projected launch date for Bexxar to the end of 2000, rather than our previously projected launch date of mid-2000. This timing assumes a spring 2000 BLA refiling, followed by a six to nine month FDA review.