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Biotech Calendar: Key Clinical Trial Dates

On a less positive note, Insmed (INSM) shares dropped from $2.33 to $1.08 after the company released negative results from a phase II study of its drug iPlex in muscular dystrophy. The stock was most recently trading at $1.09.

Now, the new clinical trials list:

Company: Myriad Pharmaceuticals (MYRXV)
Drug/indication: Azixa for cancer
Clinical trial event: Phase II results in brain cancer and metastatic melanoma
Timing: 2009

Myriad Pharmaceuticals is a new company focused on drug discovery and development that was spun out of genetics diagnostics maker Myriad Genetics (MYGN). The first test of strength for Myriad Pharmaceuticals' pipeline will come from the results of the phase II Azixa studies.

Company: Onyx Pharmaceuticals (ONXX)
Drug/indication: Nexavar for breast cancer
Clinical trial event: Phase II study results
Timing: 2009

Onyx believes Nexavar has more utility in cancer than just its current approvals for liver and kidney cancers. Two phase II studies in breast cancer patients that combine Nexavar with the chemotherapy drugs gemcitabine and paclitaxel, respectively, will help determine whether Nexavar's market potential can be expanded.

Company: Optimer Pharmaceuticals (OPTR)
Drug/indication: Fidaxomicin (OPT-80) for clostridium difficile infection
Clinical trial event: Phase III results
Timing: Fourth quarter 2009

In the first phase III study last year, fidaxomicin outperformed vancomycin, the current standard of care for patients infected with the clostridium difficile bacteria. Optimer is hoping that the second phase III study yields the same positive results, which will allow the company to seek the drug's marketing approval.

Company: Osiris Therapeutics ( OSIR)
Drug/indication: Prochymal for graft-vs.-host disease
Clinical trial event: Phase III results
Timing: Fourth quarter

I must acknowledge a negative bias with respect to Osiris because the stock was a short recommendation in my model portfolio. The reason is simple: I don't believe in the efficacy of Prochymal, a concoction derived from mesenchymal stem cells. Failed Prochymal studies in lung disease and Crohn's disease lend credence to my skepticism, I believe, but the ultimate judgment on Prochymal will come when data from two phase III studies in graft-vs.-host disease are released.

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