Avid Bioservices Inc (CDMO)

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PR 10-21-08: GA.Ph.2/BREAST update – 71% achieved O.T.R.

Peregrine Pharmaceuticals Reports Progress in Its Phase II Trial of Bavituximab Plus Docetaxel in Patients With Advanced Breast Cancer
• Data Update Shows 71% of Evaluable Patients in the Trial's First Stage Achieved Objective Tumor Responses
• Patient Enrollment is Open in the Trial's Second Stage
http://ir.peregrineinc.com/releasedetail.cfm?ReleaseID=342032

TUSTIN, Oct 21, 2008: Peregrine Pharmaceuticals, Inc. (Nasdaq: PPHM), a clinical stage biopharmaceutical company developing monoclonal antibodies for cancer and serious viral infections, today announced that updated preliminary data from the first stage of its Phase II trial evaluating bavituximab in combination with docetaxel showed that 10 of 14 (71%) evaluable breast cancer patients achieved an objective tumor response according to RECIST criteria. The company also reported that patient screening has begun in the second stage of this trial, which will enroll 31 patients.

"Early data from the first stage of this bavituximab Phase II cancer study had already exceeded our expectations, so the positive updated results reported today are especially encouraging as we proceed with patient enrollment in the second stage of the trial," said Steven W. King, president and CEO of Peregrine. "We look forward to reporting more results from this study and a second ongoing Phase II breast cancer trial as we continue to learn more about bavituximab's potential in this important, hard-to-treat disease."

The main objective of the multi-center, open label Phase II study is to assess patients' overall response rate to bavituximab and docetaxel. In the trial's Simon two-stage design, 15 patients with advanced breast cancer were enrolled in Stage A. With 10 Stage A patients demonstrating objective tumor responses, the results have exceeded the pre-specified primary efficacy endpoint of 6 patients with objective tumor responses needed to proceed to Stage B. In Stage B, the trial is being expanded to include an additional 31 patients, for a total of 46 patients overall. Secondary objectives of the study include assessing time to tumor progression, duration of response, overall patient survival and safety parameters. Patients in the study are evaluated regularly for tumor response according to RECIST criteria.

The World Health Organization reports that breast cancer is the most commonly diagnosed cancer in women, and is second only to lung cancer as a leading cause of female cancer deaths. The National Cancer Institute estimates that approximately 182,460 U.S. women will be diagnosed with breast cancer in 2008 and 40,480 women will die of the disease.

Bavituximab is a monoclonal antibody that binds to the cellular membrane component phosphatidylserine (PS) that is usually located inside cells, but which becomes exposed on the outside of the cells that line the blood vessels of tumors, creating a specific target for anti-cancer treatments. By binding to PS, bavituximab is believed to help mobilize the body's immune system to destroy the tumor and the tumor blood vessels. Bavituximab currently is in two separate Phase II combination therapy trials for the treatment of advanced breast cancer and a Phase II combination therapy trial for the treatment of non-small cell lung cancer. A Phase I bavituximab monotherapy trial in advanced solid cancers is also continuing.

ABOUT PEREGRINE PHARMACEUTICALS
Peregrine Pharmaceuticals, Inc. is a biopharmaceutical company with a portfolio of innovative product candidates in clinical trials for the treatment of cancer and hepatitis C virus (HCV) infection. The company is pursuing 3 separate clinical programs in cancer and HCV infection with its lead product candidates bavituximab and Cotara(R). Peregrine also has in-house manufacturing capabilities through its wholly owned subsidiary Avid Bioservices, Inc. (http://www.avidbio.com ), which provides development and bio-manufacturing services for both Peregrine and outside customers. Additional information about Peregrine can be found at http://www.peregrineinc.com.

Safe Harbor *snip*
Contacts: GendeLLindheim BioCom Partners
Investors - [e-mail] 800-987-8256
Media – Barbara Lindheim 212-918-4650
*end PR*
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RECIST Criteria:
1. COMPLETE RESPONSE (CR) = 100% reduction
2. PARTIAL RESPONSE (PR) = 30-99% reduction
. . . [OBJECTIVE RESPONSE (OR) = CR + PR = 30-100% red.]
3. STABLE DISEASE (SD) = 29% reduction – 19% increase
4. PROGRESSIVE DISEASE (PD) = 20% increase or more
**ALSO: "to be assigned to SD or PR, patients cannot have the appearance of any new lesions."
http://ctep.cancer.gov/guidelines/recist.html

C. PHASE II BAVI+DOCETAXEL VS. ADVANCED OR METASTATIC BREAST CANCER IN E.EUR.(GEORGIA):
Georgia M.O.H. protocol (init=1-2008): http://clinicaltrials.gov/ct2/show/NCT00669591
==> 10-21-08: “10 of 14 (71%) evaluables achieved an objective tumor response.” http://tinyurl.com/6qx4gp
9-9-08 SK: “We have now seen addl. patients with tumor responses, with 9 of the 14 evaluables (64%) having achieved PR.” http://tinyurl.com/5q9phf
7-2-08: Ph.2 Bavi+Doce/Breast update. http://tinyurl.com/5tvfhy
…”At 8wks (of 24wk combo regimen), 100% of [1st 14] evaluables showing OR/SD; 7 of 14 achieving PR”
...PR=Partial-Resp(30-99% Red.), SD=Stable-Disease(29% Red.-19% Incr.), OR=Obj-Resp(PR+CR)
…Early comp of Bavi+Doce Ph.2 vs. Ph.2 Avastin+Doce - PFS% chart: http://tinyurl.com/6c58md
6-2-08: ASCO/2008 Ph.2 Bavi+Doce/Breast Update: http://tinyurl.com/5xll6f
…”At 8wks (of 24wk combo regimen), 100% of [1st 11] evaluables showing OR/SD; 5 of 11 achieving PR”
4-29-08: 1st-15 enrolled. http://tinyurl.com/47o85x , 2-12-08: 1st-dosage http://tinyurl.com/36c28s , 1-29-08 Enroll. begins http://tinyurl.com/22ecb2
11-16-07: Ph.2 protocol approved. “Patient Enrollment expected by early 2008.” http://tinyurl.com/3aavzh
10-22-07: Protocol Submitted to Ministry of Health, Republic of Georgia: http://tinyurl.com/2xjjgp
…”15 patients with MBC initially; exp. to 46 if promising results are observed in the 1st cohort; primary obj: assess overall response.”