A Rockville biotechnology company yesterday announced a deal that it hopes will lead to drugs that will complement, or in some cases replace, the role of bypass surgery in heart patients.
Genvec Inc. said it had acquired worldwide rights from California-based Scios Inc. to develop genetic therapies based on Scios' vascular endothelial growth factor. Genvec said VEGF 121 is produced by a gene that signals the body to create new blood vessels. The new vessels may restore the flow of blood and oxygen to parts of the heart that are being starved because vessels that normally feed the muscle are clogged with fat.
Researchers at Genvec said the goal is to learn how to use Genvec's drug delivery systems to target Scios' growth factor at the proper parts of the body, making the combination a potentially effective therapy for heart patients.
"This creates more pipes; that's the idea," said Ronald Crystal, Genvec's chief outside scientific consultant and a founder of the privately held firm.
"The biology is complex, but the concept is quite simple. The body makes new blood vessels because it is signaled to do so by molecules signaled by certain genes."
In bypass surgery, surgeons graft vessels from other parts of the RTC body to areas around the heart, using the transplanted vessels to carry blood around arterial blockages caused by poor diet or other factors, Crystal said. Surgeons may use artificial vessels in place of the grafts.
Crystal said the gene therapy will complement surgery in most cases. He said surgery is effective at bypassing large arteries but can fail to address blockages in smaller blood vessels. The genetic therapy will replace vessels too small for effective surgery and reduce the strain on larger, bypassed arteries, he said.
Terms of the licensing agreement were not disclosed. Scios is the company that bought Baltimore-based Nova Pharmaceutical Corp. in 1992.
The gene therapy will not be on the market for at least several years, however, even assuming the product Genvec dubbed BioBypass works in clinical trials.
Company officials said the firm will be doing preclinical research on BioBypass until early next year. The next step will be to apply to the U.S. Food and Drug Administration for permission to launch the first of three phases of clinical studies in selected patients. "It's conceivable that we could be in pivotal trials by 1999, but a lot of things have to happen," said Paul Fischer, Genvec research and development vice president.
Technical obstacles are not the only barriers between yesterday's announcement and commercial success. Genvec Chief Executive Thomas D'Alonzo said the company is also seeking marketing partnerships with larger drug companies.
Those deals would let a bigger company sell the product and split the profits with Genvec. Such arrangements are common in biotechnology because young research-oriented companies with no products on the market lack the money to build sales forces.
The marketing partnership also may help Genvec raise capital to pay for its research, D'Alonzo said.
Genvec has two other therapies that are in the first stage of clinical trials, D'Alonzo said. One is designed to treat cystic fibrosis, and the other is aimed at colon cancer that has spread to the liver.