) announced that it has re-initiated dosing in the single-agent
clinical trial on pipeline candidate, CUDC-427.
The candidate is being evaluated for the treatment of patients
suffering from advanced and/or refractory solid tumors or
We remind investors that Curis initiated an open label phase I
trial on CUDC-427 in patients suffering from advanced
relapsed/refractory solid tumors or lymphomas in Jul 2013. Curis
initiated the trial to determine the maximum tolerated dose and
recommended dose of CUDC-427 for the phase II trial. However, in
Nov 2013, the U.S. Food and Drug Administration (FDA) put the trial
on partial clinical hold following reports of the death of a
patient who progressed to liver failure approximately one month
after the discontinuation of CUDC-427 dosing.
Thereafter, in Feb 2014, Curis provided the FDA with additional
information and also submitted an amendment to the current
protocol. Curis received good news in Mar 2014 when the FDA
completed its review of the complete response submission by Curis.
The FDA then determined that it was safe to proceed with the trial
and lifted the partial clinical hold on the single agent phase I
The primary objective of the study under the amended protocol is
to determine the safety and recommended phase II dose for CUDC-427
when administered orally once daily for two weeks, followed by a
one week rest period in 21-day cycles until disease progression or
Meanwhile, Curis expects to initiate a separate trial on
CUDC-427 in combination with standard-of-care chemotherapy regimens
including capecitabine later in 2014. We note that Curis licensed
worldwide rights for the manufacture, development and
commercialization for CUDC- 427 from
Curis currently carries a Zacks Rank #3 (Hold). Investors
looking for better-ranked stocks in the healthcare sector may
consider companies like
). Both carry a Zacks Rank #1 (Strong Buy).
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