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July 19, 1999
AVI BioPharma cancer drug enters critical testing phase
Kristina Brenneman Business Journal Staff Writer
In the race to be first to market with a breakthrough cancer-fighting vaccine, Portland's AVI BioPharma thinks it has reached a crucial milestone.
AVI is one of six biopharmaceutical companies competing directly to put a multiuse cancer vaccine on the billion-dollar drug market, and one of five which are either set to begin or are undergoing Phase III clinical trials. Phase III tests are followed by the make-or-break U.S. Food and Drug Administration approval process, where a drug is either approved for use or rejected.
For investors in the company, which in 19 years has never reported a profit, AVI's trials bring them one step closer to the big payoff they have long anticipated. Now in sight are a potentially lucrative partnership with a major pharmaceutical company and, further down the Yellow Brick Road, the glittering sales from a major new cancer-fighting drug.
AVI's competitors include Progenics Pharmaceutical Inc., Tarrytown, N.Y.; Corixa Corp. of Seattle; Biomira Inc. of Edmonton, Alberta, Canada; Imclone Systems Inc., Somerville, N.J.; and Aphton Corp. of Miami, Fla. AVI, Aphton, Imclone Systems, Progenics and Biomira are at the Phase III trial stage.
Who gets to the marketplace first depends on the outcome of final-stage clinical tests conducted on patients, and FDA approval. AVI's CEO Denis Burger says AVI's Avicine vaccine for treatment of colorectal and other types of cancer is the ticket to a major pharmaceutical contract and first marketable product.
"It's a very long and difficult and expense process," said Meredith Art, a spokesman for the Pharmaceutical Research and Manufacturers of America (PhRMA), an industry trade group. "There are a couple of vaccines in final stages that have potential to be very powerful drugs. We don't have the cure yet, but we have the environment and the will to find treatment."
AVI and its competitors were among the 354 companies with new medicines in the pipeline to fight cancer, according to a recent survey by PhRMA. Of the 354 cancer drugs in development, 162 of those have reached the last phase of clinical trials or are awaiting approval at the U.S. Food and Drug Administration, Art said.
The majority of the drugs are targeted at breast cancer, skin cancer and lung cancer.
Death rates from cancer are falling, mainly due to better treatment and more powerful pharmaceutical drugs, according to the federal Centers for Disease Control and Prevention. Still, an estimated 560,000 people a year die from the various forms of cancer.
Each vaccine-in-development differs in its approach to halting cancer, and the body part it targets. For instance, one vaccine is made from a patient's own surgically removed colon tumor that is reinjected into the patient to boost the immune system. Another for prostate cancer is made from irradiated prostate cancer cells.
AVI's Avicine has been shown to extend the survival rate in patients in the latter stages of colorectal cancer. AVI believes it also has the potential to slow the advance of prostate and pancreatic cancer.
Its closest competitor is Aphton Corp., which is developing Gastrimmune, a vaccine that neutralizes hormones in the gastrointestinal system and reproductive system to fight colorectal and pancreatic cancer.
Biomira, by contrast, is working on Theratope, a vaccine for treating patients with advanced breast cancer, and potentially colorectal and ovarian cancer. Progenics' GMK, a therapeutic vaccine to treat melanoma, a deadly form of skin cancer, is in the midst of two Phase III clinical trials. Imclone's BEC2 product treats small-cell lung cancer. Its C225 product battles bladder, breast, colon, ovarian and four other cancers. Both Imclone products are undergoing latter phase clinical trials.
AVI's chief financial officer Alan Timmins said competition is not a huge factor in what the Portland biopharmaceutical company does.
"Our approaches are different, but certainly we try to keep aware of their progress and developments they may have because it may benefit or affect us," he said. |
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