Avid Bioservices Inc (CDMO)

[cjgaddy]

PR 5-27-09: Peregrine’s Two ASCO’09 Presentations

Clinical Data on Peregrine's Bavituximab Cancer Program to Be Discussed in Two Presentations at 2009 ASCO Annual Meeting
• Oral Presentation to Highlight Data from Phase II Study Evaluating Bavituximab in Advanced Breast Cancer
• Poster Presentation to Discuss Data from Phase I Study Evaluating Bavituximab in Multiple Tumor Types
http://ir.peregrineinc.com/releasedetail.cfm?ReleaseID=386101

TUSTIN, May 27, 2009: Peregrine Pharmaceuticals, Inc. (Nasdaq: PPHM), a clinical stage biopharmaceutical company developing monoclonal antibodies for the treatment of cancer and serious virus infections, today reported that data from two ongoing clinical trials assessing its lead compound bavituximab for the treatment of cancer will be discussed at the 45th Annual Meeting of the American Society of Clinical Oncology (ASCO) in Orlando, Florida. Preliminary data from a Phase II clinical trial evaluating bavituximab in combination with docetaxel in advanced breast cancer patients will be the subject of an oral presentation at 10:30 AM EDT on June 1, 2009. A second presentation detailing preliminary results from a Phase I clinical trial evaluating bavituximab as solo therapy in patients with advanced refractory cancer will be discussed in a poster session from 1:00 PM to 5:00 PM EDT, also on June 1, 2009.

Bavituximab Presentation Details:
Title: Phase II study of bavituximab plus docetaxel in patients with locally advanced or metastatic breast cancer.
Authors: D. Tabagari [Rep.GA. PI], G. Nemsadze, M. Jincharadze, M. Janjalia, J. Shan
Time: Monday June 1, 10:30am [oral presentation]
Location: Level 4, Valencia Room, W415A
Abstract No: 3005 [ http://tinyurl.com/qem2wg ]

Title: Phase I study of bavituximab, a novel anti-phosphatidylserine monoclonal antibody in patients with advanced refractory cancer: Preliminary results.
Authors: N. K. Ibrahim [MDAnderson PI], L. Wong, L. Rosen, J. Shan
Time: Monday June 1, 1:00pm to 5:00pm
Location: Level 2, West Hall C
Abstract No: 1080 [ http://tinyurl.com/pdpok5 ]

ABOUT BAVITUXIMAB
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 trials in combination with paclitaxel and carboplatin for the treatment of advanced breast cancer and non-small cell lung cancer, and in a third Phase II trial in combination with docetaxel in advanced breast cancer patients. A Phase I bavituximab monotherapy trial in advanced solid cancers is also continuing.

ABOUT PHOSPHATIDYLSERINE (PS)
The rapid and disorganized growth that is the hallmark of cancer results in the exposure of the lipid phosphatidylserine (PS) on the surface of tumor blood vessels. Since these phospholipids are typically not exposed on the surface of normal tissues, they represent a unique target for anti-cancer treatments. Bavituximab binds specifically to these phospholipids exposed on the surface of the cells lining tumor blood vessels. Once bound, bavituximab alerts the body's immune system to attack the blood vessels, inhibiting tumor growth and proliferation. In addition, a growing body of evidence supports the active role of PS in immune signaling, with recent research showing that exposed PS can have an immunosuppressive effect and dampen the body's normal immune response to cancer. By binding to and blocking PS, bavituximab is believed to boost the body's ability to combat cancer via this second mechanism. Further information on the role of exposed PS in the tumor environment can be found in the Anti-PS Technical Backgrounder posted on Peregrine's homepage at www.peregrineinc.com.

ABOUT PEREGRINE PHARMACEUTICALS
Peregrine Pharmaceuticals, Inc. is a biopharmaceutical company with a portfolio of innovative monoclonal antibodies in clinical trials for the treatment of cancer and serious viral infections. The company is pursuing 3 separate clinical programs in cancer and hepatitis C virus 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 biomanufacturing 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, [e-mail]
Media: Barbara Lindheim, 212-918-4650
*end*

= = = = = = = = = = = = = = = =
May29-June2: “45th ASCO Annual Meeting”, Orlando http://tinyurl.com/pkbq59
...1) June1 10:30am #3005: Ph.2 Bavi+Doce/MBC/GA updated prelim. data - oral presentation!
. . . . . . Abstract #3005, released 5-14-09: http://tinyurl.com/qem2wg
...2) June1 1-5pm #1080: USA Ph.1 Bavi-Monotherapy updated prelim. data (poster)
. . . . . . Abstract #1080, released 5-14-09: http://tinyurl.com/pdpok5

= = = = = = = = = = = = = = =
E. Phase II Bavi+CP vs. Adv./Met. Breast Cancer in INDIA:
India’s DCGI protocol (init=8-2008): http://clinicaltrials.gov/ct2/show/NCT00669565
…Early ORR% comp. vs. SOC: Bavi+CP/64% n=14, Avastin+PAC/37% Ph.2/ABC n=347
4-27-09: After full 24wk combo regimen, 9 of 14 (64%) achieving OR http://tinyurl.com/c9hna4
…Also, Dosing Underway in Stage2 (addl. 31 patients).
3-12-09 CC, J.Shan: since the 2-11-09 PR, “we have seen addl. tumor responses.” http://tinyurl.com/cwyo6f
2-11-09: At 8wks (of 24wk combo regimen), 7 of 14 (50%) achieving OR, incl. one C.R. http://tinyurl.com/aquf8r
10-7-08: 1st-15 enrolled http://tinyurl.com/47kvj8 , 8-11-08: 1st-dosed http://tinyurl.com/5ogfxa
1-23-08: Ph.2 protocol approved by DCGI, “looking fwd to study initiation in the near future.” http://tinyurl.com/2rks5y
9-10-07: Protocol Submitted to Indian Drug Controller General: http://tinyurl.com/yqm8e7
…”15 patients with MBC initially; exp. to 46 if promising results are observed in the 1st cohort; primary obj: assess overall response.”

D. Phase II Bavi+CP Adv./Met. Lung Cancer (NSCLC) in INDIA:
India’s DCGI protocol (init=6-2008): http://clinicaltrials.gov/ct2/show/NCT00687817
4-20-09: Prelim. data, 17 evaluables at 18wks (6 of 6 cycles): 8 OR’s = 47% ORR http://tinyurl.com/cwytaf
…Note: 11 of 17 (65%) have achieved OR, but 3 of those not yet ‘confirmed’ with followup 4wk scans.
…Also, Dosing Underway in Stage2 (addl. 28 patients).
...Final StageA ORR (after confirmation scans): 47% or 53% or 59% or 65%? http://tinyurl.com/dmyduk
…Early Ph.2/Adv.Lung ORR% comp. of Bavi+CP/47% n=17 vs. Avastin+CP/32% n=35.
2-4-09: Prelim. data, 17 evaluables at 12wks (4 of 6 cycles): 6 PR’s + one C.R. = 41% ORR http://tinyurl.com/dlotdx
10-20-08: 1st-21 enrolled http://tinyurl.com/5wnhog , 6-30-08: 1st-dosed http://tinyurl.com/69aut8
1-22-08: Ph.2 protocol approved by DCGI, “looking fwd to study initiation in the near future.” http://tinyurl.com/2t6k7j
7-11-07: Protocol Submitted to Indian Drug Controller General: http://tinyurl.com/yoxpjl
…"21 patients with Adv. NSCLC initially; exp. to 49 if 1st cohort results positive; primary obj: assess overall response."

C. Phase II Bavi+Docetaxel vs. Adv./Met. Breast Cancer in E.EUR.(Georgia):
Georgia Ministry of Health protocol (init=1-2008): http://clinicaltrials.gov/ct2/show/NCT00669591
5-4-09: Stage2 Enrollment Complete (15+31=46 total): http://tinyurl.com/cp737p
…”Prelim. data (updated!) accepted for oral-presentation at ASCO’09 May29-June2.”
10-21-08: “10 of 14 (71%) evaluables achieved an objective tumor response.” http://tinyurl.com/6qx4gp
…Mojo’s early comp of Bavi+Doce Ph.2 vs. Avastin+Chemo trials - PFS% chart: http://tinyurl.com/5rergk
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 (50%) achieving PR”
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 (45%) achieving PR”
4-29-08: 1st-15 enrolled http://tinyurl.com/47o85x , 2-12-08: 1st-dosed 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, Rep. 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.”

A. Phase 1A Monotherapy Trial in USA - Advanced Solid Cancers:
Trial protocol (init. 6-2005): http://clinicaltrials.gov/ct/show/NCT00129337
...Per Nov’08 MDA 'Extension-Protocol', appears at least 1 OTR as of Mar'09: http://tinyurl.com/dgpyvx
4-15-09: ASCO grants $200k to UTSW’s Dr. David Gerber for Bavi/NSCLC ‘Pilot Study’ http://tinyurl.com/c6426y
4-3-09: Added 6th site: The West Clinic/Memphis (PI: Dr. Lee Schwartzberg): http://tinyurl.com/dj7htq
4-3-09: Added 5th site: UTSW/Dallas (PI: Dr. David Gerber): tinyurl.com/c5upa7
2-8-08: Dr. Alison Stopeck (Ariz C.C.) presents Interim Ph.1 data at Angio2008 http://tinyurl.com/2qa3jf
12-9-05: Added 4th site: Scott & White Hospital/Temple TX (PI: Dr. Lucas Wong) http://tinyurl.com/dgtu3n
10-21-05: Added 3rd site: M.D.Anderson/Houston (PI: Dr. Nuhad K. Ibrahim) http://tinyurl.com/7ekld
9-2-05: Added 2nd site: Premiere Oncology/SantaMonica (PI: Dr. Lee Rosen): http://www.premiereoncology.com
6-10-05: Initial site: Arizona Cancer Center/Tucson (PI: Dr. Linda Garland): http://www.arizonacancercenter.org
6-10-05: Ph.1A trial initiated at Arizona CC: http://tinyurl.com/96wdf - "will enroll up to 28 patients with advanced solid tumors that no longer respond to std. cancer treatments. Patients who demonstrate an objective response may be offered continued treatment on an extension protocol."
1-27-05 Bavi Cancer IND Approval: http://www.investorshub.com/boards/read_msg.asp?message_id=5239833