Bionova starts phase 2 study of MF 101 to treat menopause hot flashes

By E. Janene Geiss

Philadelphia, May 8 - Bionova, Inc. said Monday that it has begun a phase 2 clinical study of its proprietary oral treatment, MF 101, an alternative to estrogen to treat hot flashes in menopausal women.

The multi-center, randomized, placebo-controlled study is designed to evaluate the change in frequency and severity of hot flashes in postmenopausal women from baseline to 12 weeks, according to a company news release.

Recruitment for the trial is taking place at the University of California in San Francisco, the University of Alabama, the University of Minnesota and the University of Tennessee, officials said.

The women in the trial, ages 40 to 60, experience seven or more hot flashes a day, or more than 50 a week. A total of 180 women will take the drug for three months. Sixty will be randomized to take dose one of MF101, 60 will take dose two, and 60 will receive a placebo, officials said.

The oral drug is designed to minimize a woman's vasomotor symptoms, such as hot flashes and night sweats. The non-steroidal estrogen-receptor beta compound is based on plant extracts discovered by company scientists. Clinical studies demonstrated that the novel plant-based therapy is safe and well-tolerated by menopausal women.

Bionovo is an Emeryville, Calif., pharmaceutical company developing drugs for cancer and women's health.

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