FDA lifts partial hold on OncoMed’s cancer drug trials

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 OncoMed Pharmaceuticals Inc said the .. Food and Drug Administration lifted a partial on patient enrolments for three trials testing its experimental cancer drug, vantictumab.

The drugmaker’ stock rose as much 9 percent early trade.

Enrolment of new patients is expected to resume the next few weeks after the revised trial protocol are approved, the company said.

OncoMed had voluntarily halted enrollments on June 13 as a “precautionary measure”, after that of its drugs, vantictumab and ipafricept, were causing mild-to-moderate bone-related side effects.
On the same day, the FDA formally placed a partial on vantictumab, which is being tested combination -of-care chemotherapy in three studies in patients forms of advanced lung, breast and pancreatic cancer.

Vantictumab and ipafricept are being developed in Germany’ Bayer AG and are in early-stage tests.

OncoMed on Thursday said the amendments to the trials include modified dosing regimens, risk mitigation measures, and modified enrollment criteria.

The company has various anti-cancer drugs in its pipeline and is developing antibodies and other agents that target biological pathways critical to tumor-initiating cells, also known as “cancer stem cells”.

The Redwood City, California-based company’s shares were up 4.4 percent at $20.50 in early trading on the Nasdaq. Up to Wednesday’s close, stock had fallen 21 percent since the trails were halted. (Reuters)[eap_ad_3]