Washington Editor

On learning that it missed primary and secondary endpoints in a Phase II study of BioBypass in peripheral arterial disease, GenVec Inc. decided against further development of the product in that disease.

However, company representatives, including Henrik Rasmussen, senior vice president, clinical research and regulatory affairs, were quick to point out that failure in PAD (poor blood flow in the legs) has no impact on development of BioBypass in coronary artery disease (CAD).

In fact, back in November the Gaithersburg, Md., company released positive data from a Phase II of BioBypass in CAD. Rasmussen didn't give a timeline as to when a Phase III in CAD will commence.

Rather, he said the company is trying to determine what went wrong in the PAD indication.

"We believe it could have failed for a number of reasons, like the number of injections may have been inadequate, or maybe we didn't inject in the right place, or the other thing that really surprised us was the placebo effect," Rasmussen told BioWorld Today.

Mary Sundeen, GenVec's vice president of corporate communications, told BioWorld Today the placebo effect was "incredible."

"Whether they got the drug or not, they improved," she said.

The Phase II randomized, placebo-controlled trial included 107 patients at 20 U.S. sites. The primary endpoint was improvement in peak walking time after 12 weeks of treatment, and the secondary endpoints were a variety of quality-of-life measures as well as improvement in walking time at 26 weeks and an improvement in intermittent claudication (pain in the leg due to poor blood flow).

BioBypass uses vascular endothelial growth factor (VEGF) to stimulate the growth of new blood vessels in the leg for PAD patients, and in the heart for CAD patients.

BioBypass was well-tolerated in PAD Phase I studies, Sundeen and Rasmussen said.

GenVec regained all rights to BioBypass from New York-based Pfizer Inc. about six months ago. Pfizer in January 2002 informed GenVec that it was discontinuing the venture to develop BioBypass, an arrangement it had inherited by way of its Warner-Lambert acquisition. (See BioWorld Today, Jan. 25, 2002.)

Pfizer announced its plans prior to learning the outcome of Phase II studies in either indication.

Sundeen said GenVec is actively seeking a partner for BioBypass-CAD.

GenVec's stock (NASDAQ:GNVC) closed Tuesday at $2.84, down 26 cents.