When Curis (NASDAQ: CRIS) licensed a cancer drug from Genentech last year, it was hoping for a repeat performance of the development deal that led to its first FDA approval. Given the troubling signs it’s just seen in an early-stage trial, however, that might be a tougher task this time around.
Lexington, MA-based Curis said today that the FDA slapped a partial clinical hold on its experimental cancer drug, CUDC-427. The agency acted after a patient in Curis’ Phase 1 study died. The patient’s liver enzyme levels spiked under treatment, and didn’t subside after discontinuing the drug; the patient suffered liver failure about a month afterwards. Under the partial clinical hold, Curis can’t resume the study until it gives the FDA more data and analysis on patients dosed with CUDC-427, and proposes a new trial protocol.
Shares of Curis fell more than 17 percent in pre-market trading. Curis was to hold a conference call this morning to discuss the hold and its third-quarter results.
Curis paid South San Francisco-based Genentech $9.5 million up front in November 2012 to grab the rights to CUDC-427, an experimental drug that is supposed to block inhibitors of apoptosis proteins, which help shield cancer cells from programmed cell death. Curis also lined up $30 million in debt financing from a fund managed by New York-based Pharmakon Advisors to cover the R&D costs of moving the program forward. Curis started the Phase 1 trial in the third quarter of this year, testing CUDC in patients with advanced and refractory solid tumors or lymphomas and trying to determine the right dose for a mid-stage study. Curis said that while other patients have seen their liver enzyme levels increase during treatment—this happened with a few patients, for instance, in a Phase 1 study that Genentech ran before licensing the drug to Curis—this hadn’t led to any serious health problems before. However, Curis has stopped enrollment at the behest of the FDA, and no other patients are currently being dosed with the drug.
Curis had been hoping to duplicate the success it enjoyed with its previous deal with Genentech. The two worked together on vismodegib (Erivedge), a drug for basal cell carcinoma, a common form of skin cancer. The FDA approved the drug in January 2012. Curis got a $10 million milestone payment after the decision, another $6 million when the European Commission sanctioned the drug in July, and gets royalties on sales. Those sales numbers, however, haven’t been great: Curis booked just $1.1 million from the royalty stream from about $21.5 million in Erivedge sales in the third quarter.