Peregrine Pharmaceuticals Announces Results From Phase II ClinicalTrial of Bavituximab in Stage IV Pancreatic Cancer

Top-Line Results Demonstrate Signs of Anti-Tumor Activity in Difficult to Treat Patient Population; Company Evaluating Next Steps for Advancing Bavituximab Pancreatic Program

TUSTIN, CA, Feb 13, 2013 (Menafn - MARKETWIRE via COMTEX) --Peregrine Pharmaceuticals PPHM today announced resultsfrom its 70 patient open-label, randomized Phase II clinical trial ofbavituximab used in combination with gemcitabine in patients withpreviously untreated, advanced Stage IV pancreatic cancer. The trialincluded the enrollment of patients with advanced metastatic diseaseincluding significant liver involvement and poor performance statusassociated with rapid disease progression. Results showed that thecombination of bavituximab and gemcitabine resulted in more than adoubling of overall response rates (ORR) and an improvement inoverall survival (OS) when compared with gemcitabine alone (controlarm). In the trial, patients treated with a combination ofbavituximab and gemcitabine had a 28% tumor response rate as comparedto 13% in the control arm. Median OS, the primary endpoint of thetrial, was 5.6 months for the bavituximab plus gemcitabine arm and5.2 months for the control arm (hazard ratio = 0.75).

"We are pleased with the results seen in this very difficult to treatpatient population," said Kerstin Menander, MD, PhD, head of medicaloncology at Peregrine. "Although the median overall survivalimprovement is modest, further analysis of the data includingsubgroups shows some very interesting and potentially promisingtrends. We look forward to presenting the full data set from thistrial later this year at an upcoming scientific meeting."

The pancreatic cancer trial is a randomized, open-label Phase IItrial evaluating bavituximab with gemcitabine versus gemcitabinealone in up to 70 patients with previously untreated stage IVpancreatic cancer. The trial allowed the enrollment of patients 18and older without any age limit, distant organ involvement and ECOGperformance status of 0-2. In this trial, bavituximab was generallysafe and well tolerated in combination with gemcitabine with similaradverse events occurring in both arms.

"In light of this data, as well as other recent developments in thetreatment of pancreatic cancer, we are actively evaluating the nextsteps for advancing the bavituximab pancreatic program," said JosephShan, vice president of clinical and regulatory affairs at Peregrine."Subgroup analyses from the trial are yielding additional informationthat we believe will be important in guiding the anticipated futuredevelopment of bavituximab in this challenging indication. We areconsidering potential development pathways that would allow us totake advantage of bavituximab's broad potential when combined withother cancer agents. We look forward to providing updates as theseplans come together."

Bavituximab is being evaluated by Peregrine and individual clinicalinvestigators in a variety of treatment settings for patients withnon-small cell lung cancer in both the front and second-linesettings, as well as breast, prostate, liver and rectal cancers incombination with approved chemotherapies and radiation.

About Bavituximab

Bavituximab is a first-in-class phosphatidylserine (PS)-targetingmonoclonal antibody that represents a new approach to treatingcancer. Bavituximab is the lead drug candidate from the company's PStechnology platform and is currently being tested in seven clinicaltrials, including two randomized Phase II trials in front-line andsecond-line non-small cell lung cancer, and fiveinvestigator-sponsored trials (ISTs) in additional oncologyindications. PS is a highly immunosuppressive molecule usuallylocated inside the membrane of healthy cells, but "flips" and becomesexposed on the outside of cells that line tumor blood vessels,creating a specific target for anti-cancer treatments. PS-targetingantibodies target and bind to PS and block this immunosuppressivesignal, thereby enabling the immune system to recognize and fight thetumor.

About Peregrine Pharmaceuticals, Inc. Peregrine Pharmaceuticals,Inc. is a biopharmaceutical company with a portfolio of innovativemonoclonal antibodies in clinical trials focused on the treatment anddiagnosis of cancer. The company is pursuing multiple clinicalprograms in cancer with its lead product candidate bavituximab andnovel brain cancer agent Cotara(R). Peregrine also has in-house cGMPmanufacturing capabilities through its wholly-owned subsidiary AvidBioservices, Inc. ( www.avidbio.com ), which provides development andbiomanufacturing services for both Peregrine and outside customers.Additional information about Peregrine can be found at www.peregrineinc.com .

Safe Harbor Statement: Statements in this press release which are notpurely historical, including statements regarding PeregrinePharmaceuticals' intentions, hopes, beliefs, expectations,representations, projections, plans or predictions of the future areforward-looking statements within the meaning of the PrivateSecurities Litigation Reform Act of 1995. The forward-lookingstatements involve risks and uncertainties including, but not limitedto, the risk that, due to the nature of this very difficult to treatpatient population and the company's continued efforts to advanceother bavituximab programs in its current pipeline, the company maydefer development in this indication pending receipt of sufficientadditional financial resources or the consummation of a partnershipinvolving the bavituximab program. It is important to note that theCompany's actual results could differ materially from those in anysuch forward-looking statements. Factors that could cause actualresults to differ materially include, but are not limited to,uncertainties associated with completing preclinical and clinicaltrials for our technologies; the early stage of product development;the significant costs to develop our products as all of our productsare currently in development, preclinical studies or clinical trials;obtaining additional financing to support our operations and thedevelopment of our products; obtaining regulatory approval for ourtechnologies; anticipated timing of regulatory filings and thepotential success in gaining regulatory approval and complying withgovernmental regulations applicable to our business. Our businesscould be affected by a number of other factors, including the riskfactors listed from time to time in the our SEC reports including,but not limited to, the annual report on Form 10-K for the fiscalyear ended April 30, 2012 and quarterly report on Form 10-Q for thequarter ended October 31, 2012. The company cautions investors not toplace undue reliance on the forward-looking statements contained inthis press release. Peregrine Pharmaceuticals, Inc. disclaims anyobligation, and does not undertake to update or revise anyforward-looking statements in this press release.

Contact:
Christopher Keenan or Jay Carlson
Peregrine Pharmaceuticals, Inc.
(800) 987-8256
info@peregrineinc.com

SOURCE: Peregrine Pharmaceuticals

mailto:info@peregrineinc.com

Copyright 2013 Marketwire, Inc., All rights reserved.