(Adds details, analysts' comments; updates shares)
March 31 Curis Inc said the U.S. Food
and Drug Administration allowed it to resume testing of its
experimental cancer drug, lifting a November order halting
enrolment in an early-stage trial.
The drugmaker's shares rose as much as 13 percent in morning
trading on the Nasdaq.
Enrolment for the study was halted after the death of a
patient with advanced breast cancer, who experienced acute liver
failure about a month after the drug, codenamed CUDC-427, was
The trial began in the third quarter of 2013 in patients
with advanced solid tumors or lymphomas.
The drug is designed to neutralize major inhibitors of
apoptosis or programmed cell death - a process that ensures
defective, damaged or superfluous cells are eliminated.
Inhibition of apoptosis helps cancer cells persist and grow.
Many other cancer therapies, including chemotherapeutic
agents, radiation and immunotherapy, also work by inducing
Curis acquired the license to develop and market the
treatment from Genentech, a unit of the Roche Holding AG
, for an upfront payment of $9.5 million in November
Curis said it intended to continue testing the drug as a
monotherapy and evaluate its use in combination with
chemotherapy drug, capecitabine, in patients of a type of
advanced breast cancer.
Brean Capital analyst Daniel Brims said he expected the
drug's breast cancer study to begin in the second quarter of
Other pharmaceutical companies, including Novartis AG
and Ascenta Therapeutics Inc, are also developing
therapies to regulate apoptosis.
Roth Capital Partners analyst Joseph Pantginis raised the
drug's projected chance of success to 15 percent from 5 percent
following the regulator's decision. He raised his price target
on Curis stock to $10 from $9.
The Lexington, Massachusetts-based company's shares were up
5.7 percent at $2.90 on Monday morning on the Nasdaq.
(Reporting by Natalie Grover in Bangalore; Editing by Kirti