After Strikeout, San Diego’s MEI Pharma Looks to Rebuild Confidence

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majority ownership of the firm among its own shareholders, and selling the isoflavonoid drug assets to the newly independent company. “My mandate was to take the company to the U.S. and develop a true oncology company that would be separate from Novogen,” Gold says. “We started over basically from scratch.”

He stopped development of phenoxodiol, closed down Marshall Edwards’ Australian research group, and terminated the company’s service contracts with Novogen.

After relocating to San Diego in 2010, Marshall Edwards officially changed its name to MEI Pharma just over five months ago. De Spain, who also handles investor relations, says changing the name was the culmination of a year-long effort “to go out and reintroduce the company, even though people still associate you with a failed phase 3 trial.”

When Gold assessed the Novogen’s library of isoflavonoid compounds, he saw two compounds he liked. ME-143 is a next-generation analog of phenoxodiol and ME-344 is a first-generation compound with anti-tumor activity against a broad panel of human cancer cell lines in preclinical studies. Both are at an early stage of development, however. So Gold was immediately interested earlier this year to learn that a biotech company based in Singapore was liquidating assets that included a late-stage oral compound with a validated anti-cancer target.

The drug, known as pracinostat, inhibits histone deacetylase, a molecule that turns genes on and off. MEI Pharma acquired the compound in August, and presented preliminary data from a small, early stage trial last week at the annual American Society of Hematology meeting in Atlanta. The findings indicate that combining pracsinostat with azacitidine (Vidaza), a chemotherapy drug, was well-tolerated and yielded a response by eight of the nine patients in the study. The patients were being treated for myelodysplastic syndrome, a bone marrow disease that often leads to leukemia.

Results of the pilot study are encouraging, and MEI is moving … Next Page »

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