December 3, 2013

Acceleron to start trial in liver cancer patients early next year

Dec 3, 2013, 1:45pm EST

Don Seiffert
BioFlash Editor-Boston Business Journal
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Newly-public biotech Acceleron Pharma says that it’s planning to start a trial of its cancer drug in patients with liver cancer early next year, based on promising early results of the same drug in kidney cancer patients.

The Cambridge company (Nasdaq: XLRN) gave on update Tuesday on its drug, dalantercept, which inhibits the formation of new blood vessels from existing ones, at the Piper Jaffray health care conference in New York. The drug is aimed primarily at patients with advanced cancer who have not responded to other drugs. That drug is currently in mid-stage trials to test its effectiveness against renal cell carcinoma, ovarian cancer and cancers of the head and neck.

The drug is also the only one now in human trials that is being developed solely by Acceleron. The biotech’s two other clinical-stage drugs (sotatercept and ACE-536) are both anemia drugs which are in trials in collaboration with Acceleron’s partner, Celgene.

In today’s presentation, Acceleron said that its on track to start the placebo-controlled portion of the dalantercept trial against renal cell carcinoma by the end of March 2014. But it also said that “based on the activity and tolerability” seen in that trial, it has decided to start a combination study in hepatocellular cancer patients in which dalantercept would be administered along with the existing drug for that kind of cancer, Nexavar (marketed by by Bayer and Onyx Pharmaceuticals).

Acceleron had previously planned to start its next clinical trial of dalantercept in the late summer or early fall of next year, but now expects to start the Phase 2 trial in HCC by next spring.

The company also said it will report data from a Phase 2 trial of sotatercept in patients with beta-thalassemia on Dec. 9 at the American Society of Hematology annual meeting in New Orleans.

In an interview earlier this year, Steve Ertel, chief business officer for Acceleron, said the company’s strategy is to run several concurrent trials against various diseases rather than focus on bringing a single drug to market quickly.

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