GenVec cancer therapy approved by key panel

September 13, 1995|By Mark Guidera | Mark Guidera,Sun Staff Writer

Rockville-based GenVec, a bio-tech company, said yesterday it won a key government agency approval to clinically test a possible new therapy for the spread of colon cancer to the liver, a common complication of the late stages of the disease.

GenVec's clinical trial was approved yesterday by the National Institutes of Health's Recombinant DNA Advisory Committee (RAC). All gene therapy trials in the U.S. that have NIH funding must be approved by the RAC, an NIH spokesman said.

GenVec still needs approvals from the directors of the NIH and the Food and Drug Administration before it can launch the trials. The 2-year-old company is hoping to receive those approvals in a month.

GenVec is one of at least a dozen companies that have received approvals for clinical trials of gene therapy for diseases, though no one has developed a successful therapy yet, said Dr. John Stevens, an Atlanta-based cancer expert and vice president for research and grants for the American Cancer Society.

"There is a great deal of promise with this research, but much yet needs to be worked out," he said.

Thomas D'Alonzo, president and chief executive officer of GenVec, said, "We are in the early stages of this technology and so we don't want to get any cancer patients' hopes up unnecessarily. But it has powerful potential. The market could be much larger than just liver and colon cancer."

In layman's terms, said Mr. D'Alonzo, GenVec has developed a "missile," called a vector in medicine, that can find its way with a gene-loaded "warhead" into a cancer cell. GenVec has selected viruses as the missiles because viruses have been around for thousands of years and have developed sophisticated ways for finding their way around the human body, said Mr. D'Alonzo. Such therapy is called adenovirus-based therapy.

If given the regulatory green light, GenVec would test its new gene therapy of colon cancer on 18 patients at the New York Hospital/Cornell Medical Center and Memorial Sloan Kettering Cancer Center, both in New York City, and then study how well it worked. If the results prove promising, GenVec would ask regulators to approve wider human studies.

GenVec would profit from the development if the therapy showed strong promise as an alternative therapy for colon cancer patients.

The company likely would market it to a large pharmaceutical company that had the resources to develop and market it for wide use, said Mr. D'Alonzo.

Dr. Stevens, of the American Cancer Society, said that doctors have had success treating colon cancer when the disease is diagnosed early.

However, the prognosis drops considerably if the disease metastasizes to the liver.

"The promise of this therapy if they are successful is that it might stop the cancer from moving around or even cure it," he said.

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