Avid Bioservices Inc (CDMO): PR 10-22-07: E.EUR. Ph.II Bavi+Doce/BREA...

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Monday, 10/22/2007 11:30:01 AM

Monday, October 22, 2007 11:30:01 AM

PR 10-22-07: E.EUR. Ph.II Bavi+Doce/BREAST Trial Protocol Submitted

“Peregrine Pharmaceuticals Submits Clinical Protocol for New Phase II Trial of Bavituximab in Patients With Metastatic Breast Cancer”
http://www.peregrineinc.com/content.php?mi=MTc=&appAction=--PRINT&Id=MTA2NTYwMg

TUSTIN, CA., Oct. 22 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 Phase II clinical protocol with the Ministry of Health of the Republic of Georgia to study bavituximab in combination with the chemotherapy drug docetaxel in patients with metastatic breast cancer. The open label, multi-center safety and efficacy trial will begin enrolling patients pending regulatory and ethics committee approvals.

The new trial has a two-stage design. Up to 15 patients with metastatic breast cancer will be enrolled initially and the study will be expanded up to a total of 46 patients if promising results are observed in the first cohort. The primary objective is to assess the overall response rate to the combination of bavituximab with docetaxel, a chemotherapy drug commonly used in the treatment for metastatic breast cancer. Secondary objectives include measuring time to tumor progression, duration of response, overall patient survival and safety parameters. The study is expected to enroll patients at a minimum of 3 clinical trial sites.

"The filing of this second breast cancer protocol continues our strategy of evaluating bavituximab in Phase II combination studies in specific cancer indications," said Steven W. King, president and CEO of Peregrine. "This study also marks our first clinical initiative in Eastern Europe, which has become a major venue for global clinical trials conducted according to International Conference on Harmonization (ICH) and Good Clinical Practices (GCP) standards. The sites we are working with have solid experience in conducting mid and late stage cancer trials that adhere to FDA and international standards. We have been impressed to date by the professionalism of their operations, the efficiency of their patient recruitment infrastructure and their commitment to patient welfare."

Tumor response in this new study will be evaluated using Response Evaluation Criteria in Solid Tumors (RECIST) parameters. The trial is being conducted according to ICH and GCP guidelines.

According to the World Health Organization, metastatic 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 178,480 U.S. women will be diagnosed with cancer of the breast in 2007 and 40,460 women will die of the disease.

Bavituximab is a monoclonal antibody that binds to a phospholipid called phosphatidylserine that is 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 lb trial in advanced cancer patients, 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. A protocol for a Phase ll trial of bavituximab in combination with the chemotherapy drugs paclitaxel and carboplatin in patients with metastatic breast cancer is currently undergoing regulatory review in India. A protocol for a Phase ll trial of bavituximab in combination with chemotherapy in patients with non-small cell lung cancer (NSCLC) is also under regulatory review in India. Bavituximab is in clinical trials in the U.S. in patients with advanced solid tumors and in patients co-infected with HCV and HIV.

Safe Harbor *snip*

Contacts: GendeLLindheim BioCom Partners
Investors - info@peregrineinc.com (800) 987-8256
Media – Barbara Lindheim (212) 918-4650
*end PR*

= = = = = = = = =
BAVITUXIMAB ALL SOLID CANCERS PHASE 1+2 TRIALS:

D. Phase II Bavi+TaxolCarbo vs. Breast Cancer in INDIA: (init=xx-2007)
9-10-07: Protocol Submitted to Indian Drug Controller General: http://tinyurl.com/yqm8e7
…”Up to 15 patients with metastatic breast cancer initially; expanded up to 46 if promising results are observed in the 1st cohort; primary objective: assess the overall response.”

C. Phase II Bavi+TaxolCarbo vs. Lung Cancer in INDIA: (init=xx-2007)
7-11-07: Protocol Submitted to Indian Drug Controller General: http://tinyurl.com/yoxpjl
…"21 patients; up to 6 cycles of chemo with weekly Bavi until cancer progresses; expanded to 49 patients if 1st cohort results positive; primary objective: assess overall response rate."

B. Phase 1B Combo-Therapy Trial in INDIA: (init=11-2006 comp=5-2007)
###10-10-07: MRI's of 2 India/1B Breast Cancer patients, B4 & 8Wk-Mark after Bavi+CP: http://tinyurl.com/23cskg
...Above MRI & comments from SK's 10-10-07 Bio'07 Talk in SanFran (Slide20): http://tinyurl.com/3cvze3
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

A. Phase 1A Monotherapy Trial in USA:
ALL SOLID CANCERS Trial protocol (init. 6-2005): http://www.clinicaltrials.gov/ct/show/NCT00129337
12-9-05 Added 5th site: Scott & White Hospital, Temple TX (PI: Dr. Lucas Wong) http://tinyurl.com/ag3am
10-21-05 Added 4th site: M.D.Anderson/Houston (PI: Dr. Nuhad K. Ibrahim) http://tinyurl.com/7ekld
9-2-05 Added 3rd site: Premiere Oncology/SantaMonica (PI: Dr. Lee Rosen): http://www.premiereoncology.com
6-10-05 Initial sites: ArizonaCC/Tucson (PI: Dr. Linda Garland) & Premiere Oncology/Scottsdale (PI: Dr. David Mendelson): http://www.azcc.arizona.edu
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 Bavituximab Cancer IND Approval: http://www.investorshub.com/boards/read_msg.asp?message_id=5239833

= = = = = = = = =
3-7-05: Bavi/3G4 pre-clin. data in 2-15-05 CLINICAL CANCER RES. [AACR]:
a. 3G4 as a monotherapy inhibits tumor growth by up to 90% in multiple tumor models.
b. 3G4+Docetaxel reduces growth of breast cancer tumors by 93%
http://tinyurl.com/c6u5m

2004: Susan Komen Breast Cancer Found. awards Thorpe $247k to study Bavi+Docetaxel vs. Breast Cancer:
“Since 3G4 is already chimerized ['Bavituximab'] and close to clinical trials, it should be possible to take the 3G4/Docetaxel combo rapidly into clinical trials in breast cancer patients.”
http://tinyurl.com/b5j8x

DR. THORPE’S 10-25-04 SHM PRESENTATION: “UNDERSTANDING BAVITUXIMAB”:
[slide42 COMBINATION THERAPY]
”And here I'll talk about our combination therapy, where we take Bavituximab or its forerunner 3G4, and we try it in combination with other cancer chemotherapies. It's pretty impressive. Here's a human breast tumor grown in the mammary tissues of a mouse. And the tumor would ordinarily grow to about the size of a nickel, and then the animals would be sacrificed. And then what we've done here is we've treated different tumors in a mouse with a drug called Docetaxel, shown in green.
Docetaxel is one of the most common drugs, one of the best drugs for treating human breast cancer. Roughly half of all women with breast cancer will receive this drug. 3G4 here is in yellow. And if you look at the red line at the bottom, those are the therapies in combination. So if you look at Docetaxel, this is a good drug, you can see that. It reduces the growth curve by what, 65-70 percent? However, it's (Docetaxel) also extremely toxic. Mice at this point will have lost 25% of their bodyweight and we can't give them any more drug without killing them. 3G4, slightly less effective as a tumor agent -- marginally slow, and not significantly different, really, is reducing tumor growth by about 60%. But the big difference (with 3G4) is there's no toxicity. At this dose there's absolutely no sign of toxicity. And most importantly when you combine 3G4 with Docetaxel, you get more than an additive antitumor effect, most of the animals, tumors don't develop, and in the others there is a 95% reduction in tumor growth rate. And there is no change in toxicity. 3G4 does not increase the toxicity of the Docetaxel; it simply makes the Docetaxel a better drug. It's therapeutically more effective. so its toxicity remains the same and its therapeutic effect goes up, and strongly so.”
http://tinyurl.com/38qjug