>>GNVC has had a string of good news recently. TNFerade showed good safety and some efficacy in tumor shrinkage in PIb trial. Now BioBypass, which was returned to them by Pfizer, is on the front burner. Good results here would lend credence to the theory that PFE returned the rights because it was narrowing focus, not because it thought TNFereade didn't work. And this makes GNVC nicely leveraged . . .<<
Spell checkers can't prevent brain failure. That paragraph is OK if the last use of "TNFereade (sic)" is changed to BioBypass. Today's news implies that PFE saw risk in BioBypass. However, other indications might be OK, such as severe coronary artery disease & angina, for which the PII data seemed OK . . .
>>GAITHERSBURG, Md., Jan. 7 /PRNewswire-FirstCall/ -- GenVec, Inc. (Nasdaq: GNVC - News), a biopharmaceutical company developing gene-based medicines, today announced top line findings from a Phase II study with its product candidate for the treatment of poor blood flow in the legs, also known as Peripheral Arterial Disease, or PAD. In the randomized, placebo-controlled study, patients treated with GenVec's investigational drug candidate, BIOBYPASS-PAD, did not benefit significantly more than patients receiving a placebo on any of the primary and secondary clinical endpoints.
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GenVec has another, similarly named product candidate, BIOBYPASS-CAD, which is not the subject of today's announcement. BIOBYPASS-CAD is GenVec's product candidate designed to stimulate the growth of new blood vessels in the heart. In November, GenVec reported positive Phase II clinical trial results on BIOBYPASS- CAD in patients with severe coronary artery disease. GenVec remains optimistic about the promise of BIOBYPASS-CAD for the treatment of severe coronary artery disease.
Dr. Henrik S. Rasmussen, Senior Vice President, Clinical Research and Regulatory Affairs for GenVec stated, "Despite positive findings in our Phase I study of BIOBYPASS-PAD for peripheral arterial disease, the drug failed to perform well in broader Phase II testing. This well-planned, well-conducted, double-blind, placebo-controlled study did not show any difference between BIOBYPASS-PAD and placebo on any of the primary or secondary endpoints. We plan to complete a full analysis of the data and will submit the findings to an appropriate scientific meeting, or journal, later this year."
The 107-patient, Phase II clinical trial of BIOBYPASS-PAD was conducted in 20 clinical sites throughout the United States.<<
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Cheers, Tuck |
