Biomira Soars On Hopes For Vaccine
Edmonton company's breast cancer drug receives fast-track approval status from FDA
LEONARD ZEHR
Biotechnology Reporter
Tuesday, May 9, 2000
Hopes for early approval of a highly touted vaccine for breast cancer sent shares of Biomira Inc. soaring 37 per cent yesterday.
But analysts warn that Biomira's Theratope vaccine is still years away from reaching patients, if ever. "It will be some time yet before we see any data to know whether this is effective," Cameron Groome of National Bank Financial Inc. said.
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Biomira spokesman Bill Wickson said fast-tracking will allow the company to submit clinical data to the FDA as it is collected, rather than waiting and submitting it in a package when testing concludes at the end of 2002.
"This will accelerate the approval process," he added.
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Biomira began a major Phase III trial with Theratope in September, 1998. So far, it has rounded up only half of the 900 patients needed to show whether the drug can delay the progression of the disease and improve survival rates.
Biomira's Mr. Wickson said the company believes it will complete patient enrollment by the end of this year. "Six months after that, if we've seen a statistical significance in the time to disease progression, then we will apply for accelerated approval of Theratope and will continue the trial for the survival data," he said.
If the FDA reviews Theratope under accelerated approval status, the drug could be approved for marketing in early 2002, he added.
But analysts remain skeptical. "I don't see how they can finish the patient enrollment before the second half next year," said one biotech source, who asked to remain anonymous. "There are a lot of breast cancer therapies in clinical trials, which is creating a tremendous demand for patients," he added. |
