Shares of Argos Therapeutics Inc. fell by more than 65 percent in pre-market trading Wednesday after the drug development company said it received a recommendation from an independent data monitoring committee that the company discontinue the Phase 3 trial for a drug intended to treat kidney cancer.
In an 8-K released Wednesday morning, Argos said the planned review by the independent data monitoring committee concluded that rocapuldencel-T was unlikely to demonstrate statistically significant improvement in patient survival rates, the study’s primary measure of success. [argos]
“We are extremely disappointed with these results, which included seventy-five percent of the targeted events needed to permit the primary analysis and assessment of overall survival in the study,” said Argos Chief Executive Officer Jeff Abbey.
The company is analyzing the preliminary trial data and plans to discuss the data with the U.S. Food and Drug Administration. The trial will remain open while the company makes a determination as to the next steps for rocapuldencel-T.
Rocapuldencel-T is intended to treat metastatic renal cell carcinoma, the most common type of kidney cancer in adults. Renal cell carcinoma typically does not respond to chemotherapy and radiation treatments.
In the Phase 2 clinical trial, patients who took rocapuldencel-T in conjunction with the on-market kidney cancer drug sunitinib lived twice as long as patients who only took Sunitinib. The drug was generally well-tolerated in this trial.
Patients began enrolling in the Phase 3 trial in January 2013. A total of 462 patients enrolled.
Following the announcement at 8:05 a.m., the company’s stock price fell 65.91 percent, from $4.40 to $1.50, in pre-market trading.
Note: This story is from the North Carolina Business News Wire, a service of UNC-Chapel Hill’s School of Media and Journalism