(Adds detail, share closing)
Aug 28 OncoMed Pharmaceuticals Inc said
the U.S. Food and Drug Administration lifted a partial hold on
patient enrolments for three trials testing its experimental
cancer drug, vantictumab.
The drugmaker's stock rose as much 9 percent in early trade.
Enrolment of new patients is expected to resume in the next
few weeks after the revised trial protocol are approved, the
OncoMed had voluntarily halted enrollments on June 13 as a
"precautionary measure", after reports that two 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 hold on
vantictumab, which is being tested in combination with
standard-of-care chemotherapy in three studies in patients with
forms of advanced lung, breast and pancreatic cancer.
Vantictumab and ipafricept are being developed in
collaboration with Germany's Bayer AG and are in
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
(Reporting by Natalie Grover in Bangalore; Editing by Saumyadeb
Chakrabarty and Savio D'Souza)