Onyx Drug Showing Promise
Shares of
Onyx Pharmaceuticals
(ONXX)
advanced on heavy volume after the company announced plans to apply for accelerated approval from the Food and Drug Administration for its kidney cancer drug, which did well in a late-stage trial.
The stock surged as much as 10% from Friday's $32.80 close, opening at $36.03 Monday morning, and traded 10 times its average volume. The action was driven by word that the company and its German partner,
Bayer
(BAY)
, will apply for accelerated approval of sorafenib, formerly known as BAY 43-9006.
In Phase III clinical trials, the last phase of studies before a drug is submitted for approval by the FDA, of 800 kidney cancer patients, sorafenib showed a statistically significant ability to stem the progression of kidney cancer over a placebo. The drug works by inhibiting tumor cell growth and the growth of new blood vessels, which can lead to tumor growth.
The results were reviewed by an independent data-monitoring committee and will be reported at the American Society of Clinical Oncology meeting to be held in May in Orlando, Fla.
With the FDA approval pending, Onyx and Bayer will continue their phase III trials to determine if the drug measurably extends patients' lives compared with a placebo. Current safety data show that sorafenib was well-tolerated and side effects were predictable and manageable.
In phase II clinical trials assessing the effectiveness of sorafenib, 70% of study participants with kidney cancer had tumor shrinkage or disease stabilization after 12 weeks.
In addition to the continuing phase III trials for kidney cancer, Onyx plans to begin studies on sorafenib as treatment for liver cancer and metastatic skin cancer, Onyx President and CEO Hollings Renton says.
Pending FDA approval, sorafenib could be launched as early as 2006, the company said in a conference call this afternoon.
Shares of Onyx eased to $33.25 by the end of the day.