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.
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