Avid Bioservices Inc (CDMO): 9-24-12 PR: Major Discrepancies found in...

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Monday, 09/24/2012 8:43:28 AM

Monday, September 24, 2012 8:43:28 AM

9-24-12 PR: Major Discrepancies found in 2nd-Line NSCLC Ph.2B Treatment Group Coding conducted by Indep. Third-Party Vendor…

”Peregrine Pharmaceuticals Announces That It Has Discovered Major Discrepancies in Treatment Group Coding by an Independent Third-Party Vendor Responsible for Distribution of Blinded Investigational Product Used in Its Bavituximab Phase II Second-Line Non-Small Cell Lung Cancer Trial”
• The Company Is Currently Conducting a Detailed Review, Including Assessing Its Impact on Overall Trial Results; Investors Should Not Rely on Previously Reported Clinical Data Disclosed From This Phase II Trial at This Time; These Recent Findings Do Not Impact Other Ongoing Bavituximab Clinical Trials
http://ir.peregrineinc.com/releasedetail.cfm?ReleaseID=708954

TUSTIN, 9/24/12: Peregrine Pharmaceuticals (NASDAQ: PPHM) announced today that during the course of preparing for an end-of-phase II meeting with regulatory authorities and following recent data announcements from its randomized, double-blind placebo-controlled Phase II trial of bavituximab in second-line non-small cell lung cancer, it discovered major discrepancies between some patient sample test results and patient treatment code assignments. Due to the double-blind nature of the trial, Peregrine was not permitted to have access to either patient group assignments or related product coding information. As part of the trial's execution, Peregrine contracted with independent third-party contractors to execute treatment group assignments and oversee clinical trial material coding and distribution according to established procedures. A subsequent review of information has determined that the source of these discrepancies appear to have been associated with the independent third-party contracted to code and distribute investigational drug product.

This discrepancy is specific to this trial and will have no impact on other ongoing bavituximab trials.

Peregrine intends to communicate further as soon as it is able to determine the impact of this issue. In the meantime, investors should not rely on clinical data that the company disclosed on or before Sept. 7, 2012 from its Phase II bavituximab trial in patients with second-line non-small cell lung cancer or any presentations or other documents related to this Phase II trial.

ABOUT PEREGRINE PHARMACEUTICALS, INC.
Peregrine Pharmaceuticals, Inc. is a biopharmaceutical company with a portfolio of innovative monoclonal antibodies in clinical trials focused on the treatment and diagnosis of cancer. The company is pursuing multiple clinical programs in cancer with its lead product candidate bavituximab and novel brain cancer agent Cotara®. Peregrine also has in-house cGMP manufacturing capabilities through its wholly-owned subsidiary Avid Bioservices, Inc. ( http://www.avidbio.com ), which provides development and biomanufacturing services for both Peregrine and outside customers. Additional information about Peregrine can be found at http://www.peregrineinc.com .
Safe Harbor *snip*
Christopher Keenan or Jay Carlson
Peregrine Pharmaceuticals (800) 987-8256 info@peregrineinc.com