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ahead with plans for a larger mid-stage trial that would provide a better sense of the overall response rate of the pracsinostat-azacitidine combo. “The two compounds seem to interfere and disrupt cancer cell metabolism,” Gold said.
Acquiring pracinostat has relieved some of the pressure on MEI to advance development of its early pipeline drugs, ME-143 and ME 344, as fast as possible, De Spain said.
The pracinostat deal also helped MEI raise $27.5 million in early November through a private stock placement. Two new investors, New Leaf Venture Partners and Vivo Ventures, led the financing, and were joined by RA Capital Management and Three Arch Opportunity Fund. (Before the deal, Gold estimated the company had previously raised a total of between $10 million and $12 million.)
Since Nov. 5, when the company disclosed the new financing, shares of MEI have risen from 39 cents a share to $1.30.
Most of the financing will go to initiating a new clinical trial of pracinostat, Gold said. The company intends to also formulate its plans to take ME-143 and ME-344 into a randomized mid-stage trial as a therapy for patients with ovarian cancer, or perhaps certain forms of breast cancer.
The progress so far helps to explain why the company is a little more willing to take the stage these days, and should make 2013 an interesting year for MEI Pharma.
Working to restore investor confidence in MEI became the key mission since 2010, said De Spain. But much now depends on Gold’s success as a turnaround CEO.
“He helped to raise more than $200 million to fund the development of Favrille’s cancer immunotherapy drug candidate,” and that equates to credibility with Wall Street, De Spain wrote in an e-mail. “He helped to usher that drug candidate from pre-clinical, to IND up through a Phase III registration trial = clinical development expertise. Unfortunately, the drug just didn’t show the clinical efficacy we’d hoped for…
“Fast forward two and a half years, and he’s managed to acquire all of the IP surrounding our drug candidates, get two INDs approved, persuade the former Head of Medical Affairs at Genentech to join us, execute two Phase I clinical trials, acquire a third clinical asset… and raise approximately $40 million in the process.”
Moving forward, De Spain and Gold say they want MEI to be like other biotech companies. They want to work on collaborating with Big Pharma partners. They want to continue presenting at conferences. It was hard to do that as Marshall Edwards. But now they’re MEI Pharma.