Hard to imagine AVAN getting much mileage out of this:
>>NEEDHAM, Mass.--(BUSINESS WIRE)--April 29, 2003--AVANT Immunotherapeutics, Inc. (Nasdaq: AVAN - News) today released additional analysis of clinical data from a Phase II adult cardiac surgery clinical trial of the company's lead complement inhibitor, TP10. Further analysis of the study results suggest a treatment benefit to male patients participating in the trial, with no significant treatment benefit to female patients. The study results have been submitted to the American Society of Anesthesiologists annual scientific meeting in San Francisco, CA from October 11-15, 2003 for presentation by Paula Bokesch, M.D., who was a member of the Data Safety Monitoring Board for the study.
AVANT announced in February 2002 that TP10 had not achieved a significant reduction in the primary endpoint of death, myocardial infarction (MI), prolonged intubation or prolonged intra-aortic balloon pumping in the prospectively defined intent to treat population of 564 patients. Further analysis of the data from this trial has shown that the male population experienced a statistically significant 36% (p=0.01) reduction in the primary endpoint as well as a significant 43% (p=0.02) reduction in the combined endpoint of death or MI. A similar treatment effect was not seen in the female population (approximately 28% of the patients). TP10 was well tolerated in the overall population. Adverse events reported following treatment with TP10 were generally similar to those seen in placebo treated patients. The most commonly reported adverse events included anemia, platelet disorders and disturbances of cardiac function and rhythm, all of which are routinely observed following cardiopulmonary bypass.
"The finding of a very real treatment benefit in the male population is a very important step forward in understanding the mechanisms of mortality and morbidity following open heart surgery," said Dr. Bokesch. "It is unclear why the benefits would not be seen in female patients but the reduction in death and heart attacks in male patients could lead to new treatment options."
Alistair Wheeler MD, Vice President of Medical Affairs at AVANT Immunotherapeutics commented, "We know that complement activation was equally inhibited in male and female patients which makes these findings difficult to understand. It is well known that outcomes following cardiopulmonary bypass are different in male and female patients and given the similarity in inhibition of complement activation it would seem more likely that these findings are related more to the surgery than to TP10. We expect to submit the full results of the study for publication in a peer reviewed journal in the near future."
"We are pleased to have found some value from this very important clinical trial," said Dr. Una Ryan, Ph.D., President and Chief Executive Officer of AVANT Immunotherapeutics. "It is unfortunate that the benefit was not seen in the overall population, but we are hopeful this further analysis will be helpful in partnering this program and realizing the financial value of our complement program." <<
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Some value? If the results seem related to surgery, I doubt the FDA or a partner would be much interested in TP10.
Cheers, Tuck |
