Biomira Drug's on the Fast Track

Yesterday, small biotech Biomira (NASDAQ:BIOM) got quite a pop in its stock after announcing that the FDA gave its BLP25 liposome vaccine fast-track status. As a cancer vaccine, BLP25 is designed to help the immune system recognize tumor cells as entities that need to be destroyed. Thus, it differs from traditional chemotherapies, which directly kill tumor cells.

Data from a phase 2b trial in patients with non-small-cell lung cancer (NSCLC) was released back in April. The caveats of subset analyses notwithstanding, the data in patients with stage 3b NSCLC looked encouraging. Additional results from the phase 2b trial will be released on November 1 at the European Society for Medical Oncology meeting, and it will be interesting to get an update on the patient survival data.

Fast-track status generates such a buzz, as it is intended for drugs that are in development to treat very serious diseases. It comes with a few benefits such as early communication with the FDA to expedite drug development. So getting fast-track status is certainly never bad news. But as tends to be the case with small biotechs, the importance to investors seems to have been overstated. What fast track does not do is improve the odds that a drug will be successful, and that is what matters in the long run. (For a great rundown on this program, check out an eye-opening article from Signals.)

That being said, fast-track status for BLP25 shifts the focus away from the difficulties Biomira has had with its other cancer vaccine, Theratope. If Biomira and partner Merck KGaA can lay out a clear plan for developing BLP25, it may breathe some life back into this company. However, with an unproven technology, shaky financials, and a long development road ahead, Biomira remains a high-risk proposition for the adventurous.

For more on the biotech industry, read Charly's articles:

• The Case for Drug Stocks
• Surviving Biotech's Downturns
• What's a Drug Worth?

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