Biotech: Funds Advance Experimental Vaccine
Toward FDA Approval
CARLSBAD , Carlsbad-based CancerVax Corp., led by San Diego’s biotech pioneer David Hale, announced it has raised $30 million in venture capital money.
The company said March 6 it will use the money to fund late-stage clinical trials for its melanoma vaccine.
Hale, who joined CancerVax last October as CEO and president, said he is looking forward to further developing an experimental vaccine to treat late-stage malignant melanoma, a deadly form of skin cancer.
“I am very excited about the potential of therapeutic vaccines in the treatment of cancer,” Hale said. “It will become as important as antibodies are becoming in the treatment of cancer.”
John McCamant, editor of the Berkeley-based Medical Technology Stock Letter, shares Hale’s enthusiasm.
“Cancer vaccines will be a very important tool in fighting cancers,” McCamant predicted.
Firms Developing Vaccines
Several biotech firms are developing cancer vaccines. Some firms develop customized vaccines which are created from the patient’s own tumor.
Other companies, including CancerVax, work on a genetically engineered version of a vaccine. Such a vaccine would have wider applications and, thus, greater marketing potential, he said.
CancerVax was founded by Dr. Donald L. Morton, medical director and surgeon-in-chief at the John Wayne Cancer Institute in Santa Monica.
The cancer institute funded Phase II trials from government grants.
After promising results, it needed the financial backing of a company to further develop the vaccine, Hale said.
Next Is Phase III Trials
The $30 million injection raised by San Diego-based Forward Ventures and other venture capital groups will provide the necessary funding for two Phase III trials , the last stage of human testing before a drug can be submitted for Food and Drug Administration approval.
Hale said, the money will help pay for a new Los Angeles-based manufacturing plant.
It will be used to intitiate a Phase II/III trial to test the vaccine in patients with colorectal cancer.
Most importantly, the money will help continue the late-stage melanoma trials at 35 sites in the United States, Europe and Australia.
The larger trial will encompass between 800 and 1,000 patients; the second, smaller trial will test between four and 500 patients, Hale said.
Preliminary results will not be available until 2003.
If the results are positive, CancerVax will then seek drug approval with the FDA.
Marketing Years Away
The earliest the vaccine would hit the market would be 2004, Hale said.
So far, however, no company has managed to get a cancer vaccine approved in the United States, McCamant said.
Seattle-based Corixa obtained regulatory approval for its melanoma vaccine, Melacine, in Canada.
Another firm, Kansas City, Mo.-based Avax Technologies, has an approved melanoma vaccine in Australia.
Still, because a firm managed to get approval outside the United States doesn’t mean it will be more successful with the FDA, McCamant said.
Hale said Corixa’s product is approved for patients in the earlier stages of melanoma, whereas CancerVax’s vaccine targets patients with late-stage melanoma.
It is estimated that 51,400 people will be diagnosed with malignant melanoma and 7,800 are expected to die this year in the United States alone.
Sadly, “melanoma is one of the most painful cancers,” McCamant said.
And, the number of worldwide melanoma cases rises between 3 percent and 5 percent as a result of prolonged sun exposure.
McCamant projects cancer vaccines that prevent melanoma from reoccurring and boost the immune response system as well as antibodies combined with chemotherapy will become powerful weapons in fighting cancer.