Curis, Inc. (CRIS) 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 lymphomas.
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 trial.
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 study discontinuation.
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 Roche’s (RHHBY) Genentech.
Curis currently carries a Zacks Rank #3 (Hold). Investors looking for better-ranked stocks in the healthcare sector may consider companies like Allergan (AGN) and Gilead Sciences (GILD). Both carry a Zacks Rank #1 (Strong Buy).