Bloomberg News

Peregrine Soars on Confirmed Lung Cancer Study Results

January 07, 2013

Peregrine Pharmaceuticals Inc. (PPHM:US) soared the most in 11 years after the company said flaws in a study of its experimental lung cancer drug bavituximab didn’t extend to the highest treatment dose.

Peregrine rose (PPHM:US) 80 percent to $2.43 at the close in New York, the biggest single-day increase since October 2001. The shares have gained 167 percent in the past 12 months.

An internal review found that discrepancies in a mid-stage study were limited to the placebo and low-dose treatments, the Tustin, California-based biotechnology company said today in a statement. There were no issues with the higher 3 milligram dose that was shown last year to double survival from non-small cell lung cancer. Peregrine had said the positive results were unreliable because of questions about the treatment codes assigned to individual patients.

The review of the study from the second of three phases needed for U.S. Food and Drug Administration approval shows bavituximab has a “favorable” tumor response rate and overall survival when the high dose is compared to a combination of the low-dose and placebo arms, the company said. Peregrine didn’t provide updated results. More details about the findings will be given once the re-analysis is complete, the company said.

“We believe that these results of our internal review and subsequent data analysis support advancing bavituximab into Phase III development for the treatment of second-ling non-small cell lung cancer,” said Joseph Shan, vice president of clinical and regulatory affairs at Peregrine. “We are now preparing for discussions with the FDA and worldwide regulatory agencies.”

To contact the reporter on this story: Michelle Fay Cortez in Minneapolis at mcortez@bloomberg.net

To contact the editor responsible for this story: Reg Gale at rgale5@bloomberg.net


Soul Searcher
LIMITED-TIME OFFER SUBSCRIBE NOW

(enter your email)
(enter up to 5 email addresses, separated by commas)

Max 250 characters

Companies Mentioned

  • PPHM
    (Peregrine Pharmaceuticals Inc)
    • $1.69 USD
    • 0.00
    • 0.0%
Market data is delayed at least 15 minutes.
 
blog comments powered by Disqus