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 BIOSANTE PHARMACEUTICALS (BPA)

 In a Phase 3 clinical trial, researchers randomly gave 484 symptomatic menopausal women either Bio-E-Gel topical gel or a placebo. By 4 weeks and 12 weeks the treatment significantly reduced the number and severity of hot flashes experienced versus placebo. Specific numbers will be released at a medical conference in the fall and published in a peer-reviewed journal.

The Beef? The company plans to file a new drug application with FDA after completing analysis of the data.

Stephen M. Simes, BioSante president and chief executive, said in a statement that the company feels Bio-E-Gel "will be well positioned to compete in the U.S. estrogen therapy market," which he said has estimated annual sales of about $1.4 billion.

Comments Good news.

ENTREMED (ENMD)

 Panzem, the firm’s oral cancer treatment has shown in animal studies that it could help extend the lives of lung cancer patients.

According to Entremed, the trials demonstrated that Panzem NCD, the liquid version of the drug, blocked the in vitro growth of 19 different lung cancer cell lines. The drug also significantly increased survival in animals with non-small cell lung cancer, the most common form of the disease.

EntreMed is conducting a number of human trials evaluating Panzem, known chemically as 2-methoxyestradiol, in liquid and capsule form against a variety of cancers. This specific version, Panzem NCD, is in early human trials studying its effectiveness in patients with advanced cancers. The company plans to begin Phase 2 studies this year.

EntreMed said the 2-methoxyestradiol appears to block the formation of blood vessels, inhibiting tumor growth, while also killing tumor cells directly. The company is also studying it as a potential treatment for inflammatory diseases.

Comments: This firm was the first to come up with antiangiogenesis as a treatment approach for cancer. Yet, Genentech was able to put a product, Avastin, on the market while EntreMed couldn’t. The firm never stopped trying and developed a long pipeline that has one drug, Panzem in two forms in clinical trial and many products in preclinical trials. Yesterday’s results of Panzem are encouraging.     

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