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Wednesday, 06/10/2009 8:47:00 AM

Wednesday, June 10, 2009 8:47:00 AM

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PR 6-10-09: ASCO Award to UTSW for New Bavi/NSCLC Study

“ASCO Research Foundation Grant Will Support Study of Peregrine's Bavituximab in Lung Cancer”
• Career Development Award to Study Biology of Bavituximab and Chemotherapy in Lung Cancer Awarded to Dr. David Gerber of UT Southwestern Medical Center
• New Study Complements Ongoing Bavituximab + Carboplatin/Paclitaxel Phase II NSCLC Trial that has Shown Promising Preliminary Results
http://ir.peregrineinc.com/releasedetail.cfm?ReleaseID=388927

TUSTIN, June 10 2009: Peregrine Pharmaceuticals, Inc. (Nasdaq: PPHM) today announced that the ASCO Research Foundation has awarded one of its 2009 Career Development Awards to David Gerber, MD, of the University of Texas Southwestern Medical Center for a study of the biologic effects of bavituximab & chemotherapy in patients with advanced lung cancer. Bavituximab is a monoclonal antibody with a unique mechanism that allows the body's own immune system to recognize and act on the tumor and its supporting blood vessels, resulting in anti-cancer effects.

This new study will supplement Peregrine's Phase II clinical trial [India] evaluating bavituximab in combination with carboplatin & paclitaxel in patients with advanced non-small cell lung cancer (NSCLC). In the first cohort of this trial, 11 of 17 evaluable NSCLC patients, or 64.7%, achieved an objective tumor response according to response evaluation criteria in solid tumors (RECIST). Enrollment of an additional 28 NSCLC patients is ongoing.

"We are delighted that the ASCO Research Foundation has selected Dr. Gerber's study for this prestigious award that nicely complements our ongoing Phase II NSCLC trial, which has already shown very promising results," said Steven W. King, president and CEO of Peregrine. "This clinical study should help us to better understand the biological effects of this new class of immunotherapeutic agents and generate data that will help guide the future clinical development and use of bavituximab."

Dr. Gerber, assistant professor at the Harold C. Simmons Comprehensive Cancer Center of UT Southwestern, will receive a 3-year award totaling $200,000 to support his original research, A Pilot Study of the Biologic Effects of Chemotherapy Plus Bavituximab in Patients with Advanced Non-Small Cell Lung Cancer. These competitive awards are available to promising physician researchers who are full-time faculty members in a clinical setting at an academic medical center.

Bavituximab is also currently being tested in combination with chemotherapy in two Phase II trials in advanced breast cancer. Preliminary positive results from one of these trials were the subject of an oral presentation at the 2009 ASCO Annual Meeting.

ABOUT PHOSPHATIDYLSERINE (PS)-TARGETING IMMUNOTHERAPIES
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 is a monoclonal antibody that 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 tumor 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 response to cancer. By binding to and blocking PS, bavituximab is believed to boost the body's ability to combat cancer via this second immunostimulatory mechanism. Further information on the role of exposed PS in the tumor environment can be found in the Anti-PS Technical Backgrounder posted at http://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®. 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, info@peregrineinc.com
Media: Barbara Lindheim, 212-918-4650
*end*

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Recall, on 4-3-09, the NCI Trials website showed UTSW/Dallas being added as a 5th site in the ongoing U.S. Ph.1 Bavi-Mono Solid Tumors trial, with Dr. Gerber as PI:

Ph.1 Trial: “Study of Bavituximab in Patients With Advanced Solid Tumor Malignancies”
Last Updated: April 3, 2009
TRIAL LOCATIONS:
ADDED:
University of Texas SW Medical Center/Dallas - Recruiting
Principal Investigator: David E Gerber, MD
http://clinicaltrials.gov/ct/show/NCT00129337

Dr. David Gerber’s UTSW Profile:
http://www.utsouthwestern.edu/findfac/professional/0,,53487,00.html

Dr. David Gerber authored this 2-2008 article in American Family Physician:
“Targeted Therapies: A New Generation of Cancer Treatments”
DAVID E. GERBER, MD
The two main types of targeted therapy, monoclonal antibodies and small molecule inhibitors, have revolutionized the treatment of cancer. With their distinct mechanisms of action and toxicities, these drugs require new approaches to determine optimal dosing, to assess patient adherence to therapy, and to evaluate treatment effectiveness…
http://www.aafp.org/afp/20080201/contents.html
http://www.aafp.org/afp/20080201/311.html
He has also presented at past ASCO meetings: http://tinyurl.com/d2pgq7

= = = = = = = = = = =
“The ASCO Cancer Foundation Awards $6.1mm to Further Progress Against Cancer”
FOR IMMEDIATE RELEASE: April 15, 2009
http://tinyurl.com/cqhuse
4-15-09, Alexandria, VA: The ASCO Cancer Foundation will award more than $6.1mm to support clinical & translational research designed to improve cancer prevention, treatment and care. The grants will be awarded to 63 researchers at the ASCO’s 45th Annual Meeting in Orlando, May29–June2…
• Translational Research Professorship: $500k, Merrill Egorin, UPitt
• Advanced Clinical Research Awards: $450k, S.Modi/Sloan-Kettering & I.Mellinghoff/Sloan-Kettering
Career Development Awards: $200k x 11 winners…
Career Development Awards are presented to physicians in their second, third or fourth year as full-time faculty members in a university setting. Each of this year's 11 winners will receive a 3-year grant totaling $200,000 to establish an indep. clinical cancer research program. The 11 2009 recipients are:
. . .
David Gerber, MD – Univ. of Texas, SW Medical Center
“A Pilot Study of the Biologic Effects of Chemotherapy Plus Bavituximab in Patients with Advanced Non-Small Cell Lung Cancer”

. . .
Supporting Organizations:
The 2009 Career Development Awards are supported by: Amgen, Genentech BioOncology (5), Lilly USA, Novartis Oncology, Sanofi-aventis U.S. (2), The Breast Cancer Research Foundation.
About The ASCO Cancer Foundation:
As the charitable arm of the American Society of Clinical Oncology (ASCO), The ASCO Cancer Foundation funds research, education and cancer care programs both in the U.S. and abroad. By harnessing the knowledge of ASCO’s 27,000 oncology professionals, we help deliver physician-approved information directly to those in need. Through these efforts, we improve the lives of those affected by cancer.

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EARLY COMPARISONS OF BAVI VS. AVASTIN TRIAL DATA
III. ADV./MET. NSCLC CANCER (India) - MAB + PACLITAXEL/CARBOPLATIN:
Ph.2 Bavi+CP n=17: 64.7% ORR, interim at ~18wks (6 of 6 cycles). http://tinyurl.com/pe923n
• Ph.2 Avastin+CP n=35: 31.5% ORR http://tinyurl.com/b3g4rf (D.H.Johnson)
...”Avastin+CP yielded longer median TTP (7.4 v 4.2 mos.) and a modest increase in survival (17.7 v 14.9 mos.)”
• Ph.2 Antisoma’s ASA404+CP n=30: 37.9% ORR http://tinyurl.com/pcraga
3-18-09/Cowen, P.Lytle comp. to:
• Avastin+CP (Johnson), 31.5% ORR – at best dosage/15mg (n=99 at both dosages) [ 2004 Ph2 http://tinyurl.com/b3g4rf ]
• Avastin+CP (Sandler), 35% ORR (133 of 381) – best resp. reported. [ 2006 Ph2/3 ‘E4599’ http://tinyurl.com/dbvh4e Excl. Squamous**]
**Note: “In prev. clinical experience with Avastin+CP in NSCLC, patients with ‘squamous’ cancer had a higher risk of experiencing life-threatening or fatal pulmonary bleeding. Squamous cells are a kind of cell that form in the lining of the air ducts in the lung. Because of the risk of bleeding attributed to this population, patients with NSCLC classified as predominantly squamous histology were not included in the E4599 trial.” http://tinyurl.com/cfk9ao
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**Another Ph.2 NSCLC trial to compare to…
5-21-09: PH.2 RESULTS FOR ANTISOMA’S ASA404+CP VS. NSCLC (N=30): ORR=37.9%
Antisoma announces that the journal Lung Cancer has published the results of a single-arm Ph.2 trial of ASA404 in NSCLC. The trial included patients with both major histological forms of NSCLC: squamous & non-squamous. Positive data from this trial supported the progress of ASA404 into Ph.3 trials in patients with NSCLC of all histologies. ASA404 is a Tumor-Vascular Disrupting Agent (VDA) that destroys tumors by selectively collapsing the tumor blood vessels on which they depend to survive & grow... In the newly published trial, a further 30 similar patients with NSCLC received std. chemo[carboplatin & paclitaxel] + ASA404 at a higher dose of 1800mg. Median survival was 14.9mos… [compared with 8.8mos. in patients receiving chemo alone]… Tumor response rate was 37.9%... TTP was 5.5mos…. Median survival was 14.9mos.
http://tinyurl.com/pcraga
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ORR% UPDATE HISTORY FOR PH.2/BAVI+DOCE/NSCLC/INDIA:
2-4-09 PR: “7 of 17 (41%) achieving PR (CR=1)” (after 4 of 6 3wk cycles)
=> 6-3-09 PR: “11 of 17 (64.7) achieving PR” (after 6 of 6 3wk cycles)

= = = = = = = Bavi+Chemo Ph.2 Trial WEEKS CALCS as of 6-2-09:
D. PH.2 BAVI+CP VS. ADV./MET. LUNG CANCER (NSCLC) - INDIA:
http://clinicaltrials.gov/ct2/show/NCT00687817 (21+28=49)
1st-DOSED: 6-30-08 => 48.1wks a/o 6-2-09
ALL-21-ENROLLED-Stage1: 10-20-08 => 32.1wks a/o 6-2-09
1st-DOSED-Stage2(28): 4-20-09 => 6.1wks a/o 6-2-09

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BAVITUXIMAB SOLID CANCERS PHASE 2 TRIALS:
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
…Early Ph.2/Adv.Lung ORR% comp. of Bavi+CP/65% n=17 vs. Avastin+CP/32% n=35.
6-3-09 PR: 11 of 17 (64.7%) of StageA evaluables achieved OR: http://tinyurl.com/pe923n
4-20-09: Prelim. data, 17 evaluables at 18wks (6 of 6 cycles): 8 OR’s = 47% ORR http://tinyurl.com/cwytaf
…Also, Dosing Underway in Stage2 (addl. 28 patients).
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."
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