Avid Bioservices Inc (CDMO): PR 7-11-07: Protocol Submitted for Ph.II...

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Wednesday, 07/11/2007 7:55:10 AM

Wednesday, July 11, 2007 7:55:10 AM

PR 7-11-07: Protocol Submitted for Ph.II Bavi+ TaxolCarbo Trial in India

“Peregrine Pharmaceuticals Submits Clinical Protocol to Initiate Bavituximab Phase II Trial in Lung Cancer Patients”
http://www.peregrineinc.com/content.php?mi=MTc=&appAction=--PRINT&Id=MTAyNDgxNw

TUSTIN, CA., July 11 2007: Peregrine Pharmaceuticals, Inc. (Nasdaq: PPHM), a clinical stage biopharmaceutical company developing monoclonal antibodies for the treatment of cancer and hepatitis C virus (HCV) infection, today announced that it has submitted a clinical protocol with the Drug Controller General of India (DCGI) for a Phase II trial of bavituximab in combination with chemotherapy in patients with non-small cell lung cancer (NSCLC). The multi-center trial is expected to begin enrolling patients once the protocol regulatory review is completed.

The trial has a two-stage design. Up to 21 NSCLC patients will be enrolled initially and the study will be expanded up to a total of 49 patients if positive results are observed in the first cohort. The primary objective of the Phase II study is to assess overall response rate to the combination of bavituximab and chemotherapy. Secondary objectives include measuring time to tumor progression, duration of response, overall patient survival and safety parameters. Patients will receive up to 6 cycles of chemotherapy with weekly administration of bavituximab until their cancer progresses.

"Submitting this Phase II clinical protocol represents a significant milestone for the bavituximab cancer program," said Steven W. King, president and CEO of Peregrine. "This trial builds on data generated from a recently completed Phase Ib clinical study in which bavituximab was administered in combination with chemotherapy, including carboplatin and paclitaxel. Results from that study indicated that the combination of bavituximab with paclitaxel and carboplatin [Bristol-Myer’s “TaxolCarbo”] was particularly promising, with encouraging signs of anti-tumor activity and a safety profile that appeared to be consistent with chemotherapy alone. We look forward to assessing its potential in this larger trial in patients with non-small cell lung cancer, a condition that currently lacks effective treatment options."

Tumor response will be evaluated every other month using Response Evaluation Criteria in Solid Tumors (RECIST) criteria. The trial is being conducted according to International Conference on Harmonization (ICH) and Good Clinical Practices (GCP) guidelines.

Bavituximab is a monoclonal antibody that binds to a phospholipid called phosphatidylserine (PS), normally located inside normal 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. Bavituximab is believed to help mobilize the body's immune system to destroy the blood vessels needed for tumor growth and spread. In a Phase Ib trial to assess its safety in combination with common chemotherapy agents in advanced cancer patients with metastatic disease, bavituximab plus chemotherapy appeared to have a safety profile consistent with chemotherapy alone and showed positive signs of clinical activity, achieving objective response or disease stabilization in 50% of the evaluable patients. Bavituximab is currently in clinical trials in the U.S. in patients with advanced solid tumors and in patients co-infected with HCV and HIV.

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 five separate clinical trials in cancer and HCV infection in the U.S. and India 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: 800-987-8256, info@peregrineinc.com
Media: Barbara Lindheim, 212-918-4650
*end*

= = = = = = = = = = FYI:
Carboplatin/Paclitaxel = = > Bristol-Myers Squibb (TaxolCarbo), OFF-PATENT!
This regimen, which combines the chemo agents carboplatin (PARAPLATIN) & paclitaxel (TAXOL), is used to treat ovarian & lung cancer. Carboplatin is a platinum-based compound, which interferes with DNA structure & inhibits production of DNA. This leads to prevention of cell division & eventual cell death. Paclitaxel is an antimetabolite agent known as a taxane. Taxanes interfere with the formation of microtubules, structures in the cell that are vital for cell division. Paclitaxel causes the formation of dysfunctional microtubules that cannot be dismantled by the cell. Unable to divide, the cell is stranded mid-cycle and dies. The combination of the 2 agents aims to kill more cancer cells than 1 agent alone because of the different moa’s. Regimen Cycle: Taxol infused ~3 hrs, then carboplatin infused ~1hr, then 3 wks with no chemo. Usually 6–8 cycles are given over a period of 5–6 mos.
CARBOPLATIN (PARAPLATIN): BMS gained FDA approval for Carboplatin (PARAPLATIN) in 1989; it went generic in 2004. There are also generic versions of the drug available from APP, Bedford, Sicor (Teva), Mayne Pharma, Pharmachemie, Pliva, Sandoz, Spectrum.
PACLITAXEL (TAXOL): Paclitaxel is a widely used chemo agent for cancers of the lung, breast, ovary, esophagus and other types of cancer, Together with Docetaxel, Paclitaxel, it forms the drug category of the Taxanes. Paclitaxel was brought to the market by BMS in 1993 as Taxol, and went generic in 2000, when sales peaked at US $1.6bb.
http://www.cancerbackup.org.uk/Treatments/Chemotherapy/Combinationregimen/Paclitaxelcarboplatin
http://en.wikipedia.org/wiki/Carboplatin http://en.wikipedia.org/wiki/Paclitaxel
Bristol-Myers Squibb (NYSE: BMY) mktCap=$51bb, rev=$19bb (#9 worldwide), cash=$2.8bb (9-30-06)
http://finance.yahoo.com/q?s=BMY http://www.bms.com
BMY worldwide sales of CARBOPLATIN (PARAPLATIN) reached a peak of $905mm in 2003, before generic competition began.
BMY worldwide sales of PACLITAXEL (TAXOL) reached a peak of $1.6bb in 2000 before generic competition began.

= = = = = = =
B. PHASE 1B COMBO-THERAPY TRIAL IN INDIA: (INIT=11-2006 COMP=5-2007)
5-31-07: Top-Line Data for 12 Evaluable Indian patients http://tinyurl.com/2rzeen
…”ALL12: 50%=OTR/SD… Bavi+GEM: 75%=OTR/SD… Bavi+CARB: 50%=OTR”
…OTR=Objective-Resp(>30% Red.), SD=Stable-Disease(20% Inc. – 30% Red.)
…”advanced cancer patients with metastatic disease who had failed prior therapy”
3-22-07: Enrollment complete; 'glimpse' at data for 1st 9 Evaluables http://tinyurl.com/25x9g4
..."Bavi+chemo safety profile similar to chemo alone. Top-line results as soon as patient followup & data analysis are complete."
11-17-06: Dosing Underway in India Ph.1B Combo Trial http://tinyurl.com/tg46h
...”Up to 12 patients will rec. bavi along with Docetaxel, Gemcitabine, or Carboplatin/Paclitaxel for 8wks, at 3 sites in India, with 4wk followup. May continue with chemo according to SOC guidelines. Will help support advancing bavi into Ph.2 combo-therapy cancer trials in 2007."
9-11-06: Bavi+Chemo Cancer Trial Planned for India (Breast, Lung, Pancreatic) http://tinyurl.com/g4ndv
###BP Possibilities for 2007 Ph.II Bavi+Chemo AC Trials: http://tinyurl.com/2ecnuv