EMERYVILLE, Calif. (AP) – Shares of Onyx Pharmaceuticals spiked nearly 18 percent Tuesday following strong results for its blood cancer drug candidate.
The company said it plans to file for Food and Drug Administration approval of carfilzomib as soon as next year, sending shares of Onyx Pharmaceuticals Inc. up $4.37 to $33.71.
Shares earlier hit a 52-week high of $33.72.
The company reported full results from a mid-stage clinical trial that studied carfilzomib as a treatment for multiple myeloma that has recurred or not responded to other therapies. Onyx said patients had median overall survival of 15.5 months from the start of the trial. The patients’ cancer was progressing when they entered the trial, and Onyx has previously said similar patients usually live for six to 10 months.
Onyx said it has not yet been able to calculate success for patients who responded to carfilzomib, leaving out those who did not respond. However it expects median survival for those patients will be more than 19 months.
All the patients in the trial had been treated with at least two other therapies before the start of the trial and who were not helped by their most recent treatment. Onyx said 20,000 cases of multiple myeloma are diagnosed in the U.S. each year.
A total of 266 patients were enrolled in the study and 257 were evaluated for response. Onyx said 24.1 percent of patients in the study had a significant reduction in cancer, and that response lasted an average of 8.3 months. It said 34.2 percent of patients had at least a minimal response.
The most common serious side effects in the trial were anemia, in which the body does not have enough red blood cells, neutropenia and lymphopenia, which are decreases in two different types of white blood cell, and thrombocytopenia, or low levels of blood platelets.
Onyx said that at the start of the trial, 77 percent of patients had peripheral neuropathy, or damage to the peripheral nervous system. It said new or worsening neuropathy was uncommon during treatment with carfilzomib, and more severe neuropathy occurred in less than one percent of patients.
The data was presented the annual meeting of the American Society of Hematology in Orlando. Onyx reported preliminary results from the study on July 26. At the time it said median duration of response to carfilzomib was 7.4 months, and 36 percent of patients had at least a minimal response. It shares climbed 21.1 percent that day.
Date: December 7, 2010
Source: Associated Press