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Gaithersburg, MD), entered into a research collaboration with the Cordis Cardiology Division of Cordis Corporation, a Johnson & Johnson (New Brunswick, NJ) company, to study the clinical benefit of BIOBYPASS in a procedure involving guided delivery of the angiogenic agent directly into targeted regions of the heart in patients with severe coronary artery disease using the Cordis NOGASTAR Mapping Catheter and MYOSTAR Injection Catheter.
GenVec has already received $54 million based on developments with Biobypass, its blood vessel growth stimulator and gene therapy drug designed to bypass clogged arteries and prevent coronary artery disease and peripheral vascular disease.
As a result of its decision to focus resources on the clinical development of TNFerade, GenVec has decided, in agreement with its collaborator Cordis Corporation, to curtail enrollment of patients in the Phase II trial of BIOBYPASS for the treatment of severe coronary artery disease.
The company combines its patented gene transfer technologies with proprietary therapeutic genes to create product candidates, such as TNFerade for cancer, BIOBYPASS for coronary artery disease, and AdPEDF for macular degeneration.
Many of these patients are too ill for bypass surgery, and biobypass or TMLR [transmyocardial laser revascularization] is just about the only therapy left," says Summers.
Research and development efforts for the company's proprietary gene-based therapeutic product candidates were focused on the continued clinical testing of TNFerade, BioBypass and AdPEDF.
The company combines its patented gene transfer technologies with proprietary therapeutic genes to create product candidates, such as BioBypass angiogen for cardiovascular disease, TNFerade for cancer and AdPEDF for macular degeneration and diabetic retinopathy.
GenVec's lead cardiovascular product candidate is BioBypass angiogen, which is in late-stage randomized Phase II studies in collaboration with Pfizer, Inc.
In addition to GenVec's PEDF discovery program for the prevention of blindness, the company is developing BIOBYPASS angiogen, a novel gene-based therapy that induces the formation of new blood vessels in the heart and other areas affected by inadequate blood flow.
This patent adds an additional layer of proprietary protection for our growing product portfolio, that includes our therapeutic angiogenesis product candidate, BIOBYPASS angiogen, which is now in Phase II clinical studies for the treatment of coronary artery disease.
Activities under our funded vaccine programs performed by GenVec's internal quality, process development and manufacturing staff as well as the qualification of our manufacturing process to rigorous FDA standards will be directly transferable to TNFerade and BIOBYPASS as these product candidates move into late stage clinical trials.
BIOBYPASS will be administered directly into targeted regions of the heart using the Cordis NOGASTAR(R) Mapping and MYOSTAR(TM) Injection Catheter System.
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