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 . . .
>>GAITHERSBURG, Md., Nov. 18 /PRNewswire-FirstCall/ -- GenVec, Inc. (Nasdaq: GNVC - News), a biopharmaceutical company developing gene-based medicines, today announced that it will present Phase II clinical data on its lead cardiovascular product candidate, BIOBYPASS® angiogen, in patients with severe coronary artery disease on November 20, 2002 at the 75th Annual Scientific Sessions of the American Heart Association in Chicago, Illinois. Data from the randomized, multi-center, 26-week study will be presented in a Late Breaking Session from 2:00-3:20 Central Time on Wednesday by Dr. Duncan Stewart, Chief of Cardiology at St. Michael's Hospital in Toronto and the principal investigator for the BIOBYPASS® clinical trial.
BIOBYPASS®, which contains the Vascular Endothelial Growth Factor, or VEGF, gene is injected directly into ischemic areas of the heart. Based upon preclinical mechanism of action studies, the gene stimulates localized production of the VEGF protein to promote angiogenesis, or growth of new blood vessels, and to improve blood flow.
The study involved 20 clinical trial sites in North America where 71 people with severe coronary artery disease, and no other option for revascularization, were enrolled. It is the largest, randomized, controlled study reported to date with intramyocardial injection of genes coding for angiogenic growth factor.
In this Phase II clinical trial, GenVec tested BIOBYPASS® in patients with highly advanced coronary artery disease. These patients generally have severe chest pain despite maximal medical treatment and their medical condition prevents them from being candidates for standard revascularization procedures, such as angioplasty and coronary bypass grafts.
Patients enrolled in the study were randomized into two groups where 36 patients received best available medical treatment plus BIOBYPASS® and 35 patients received best available medical treatment only and served as a control group. Several endpoints were used to measure the impact of BIOBYPASS® treatment, including a change in Exercise Treadmill Time (ETT), which measures the length of time a patient can walk on a treadmill before experiencing chest pain known as angina. Data were collected at 3 and 6 months after treatment.
Dr. Duncan Stewart's presentation at the AHA meeting is entitled, "A Phase 2, Randomized, Multi-center, 26-Week Study to Assess the Efficacy and Safety of BIOBYPASS® (AdVEGF121.10) Delivered Through Minimally Invasive Surgery Versus Maximum Medical Treatment in Patients with Severe Angina, Advanced Coronary Artery Disease, and No Options for Revascularization," and will be available through a link on GenVec's web site, genvec.com , approximately 24 hours after the presentation. The presentation may also be accessed directly at scientificsessions.org .<<
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Cheers, Tuck |
