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Saturday, 06/12/2010 12:57:28 PM

Saturday, June 12, 2010 12:57:28 PM

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ASCO’10: Ph.2 Bavi+CP/NSCLC (India n=49), #7589, 6-6-10 – Interim Results

SUMMARY OF PH.2 BAVI+CP/NSCLC RESULTS (N=49) FROM PEREGRINE’S WEBSITE:
”In a Phase II trial [India] assessing bavituximab in combination with carboplatin/paclitaxel in NSCLC patients, Overall Response Rate (ORR) was 43% (21 of 49 patients). Median PFS was 6.1 months. These results compare favorably with data from a published study showing an ORR of 19% and median PFS of 4.2 months in a similar patient population receiving carboplatin/paclitaxel alone.”
http://www.peregrineinc.com/index.php?option=com_content&task=view&id=22&Itemid=39
Protocol (dosed 6/2008-10/2009 n=49): http://clinicaltrials.gov/ct2/show/NCT00687817

COMMENT FROM PI DR. R.DIGUMARTI, FROM 6-4-10 ASCO PR:
"The objective response and median PFS data from bavituximab in combination with chemotherapy are very encouraging, as this response rate is more than double the typical response observed with chemotherapy alone," commented Raghunadharao Digumarti, M.D., professor and head of the Dept of Medical Oncology at Nizam's Institute of Medical Sciences, Hyderabad, India. "There is an urgent need for new therapies that may extend patient survival for this aggressive, prevalent form of cancer. Bavituximab's broad-spectrum potential, demonstrated by promising clinical data in this patient setting and use in various combination therapy applications, support further development of this novel monoclonal antibody for cancer."

PPHM’s ASCO POSTER #7589 (6-6-10 Ph.2 Bavi+CP/NSCLC India n=49), specifically ‘Figure1’, shows these addl. statistics for ‘Best Tumor Response% Achieved’ by the 40 Evaluable patients:
• 2 100% tumor reductions (2/49=4.1%) – Abstract ref’s as ‘Clinical Complete Response’
• 11 tumor reductions>50% (11/49=22.4%)

See PDF: http://www.peregrineinc.com/media/siteFiles/Peregrine701.pdf

IMAGES OF PPHM’s NSCLC ASCO’10 POSTER #7589:











Re: Figure1: Note there are 40 BARS shown – that’s one for EVERY “Evaluable” patient in the trial – recall, Stage1/n=21 had 4 non-evaluables, so Stage2/n=28 obviously had 5. They took each of those Patient’s “BEST RESPONSE”, sorted them Best-to-Worse, and showed them in the Fig1 graph. Now, these Resp%’s are “BEST” (MAX) observed (I would assume RECIST ‘Confirmed’ too) for each patient, regardless of When in the 6x3wk dosing cycles they occurred. Also, for each Tumor Resp. on Fig1, it’s obvious that the patients regressed at some point – presumably the 2 100%’ers as well (??). Oh, the dotted line: that’s the 30% mark that starts the “Partial Response” category – note that there are 21 patients below and to the left of it – that’s your 43% Overall Response Rate for the NSCLC trial (“intent-to-treat” basis). One more, thing: there are DEFINITELY 2 100% Tumor Reductions (2/49=4.1%) showing on that graph!! (((ASCO Abstract #7859 calls the 1st one in Stage1 a ‘Clinical Complete Response’))) Also, 11 of the 49 (22.4%) reached tumor reductions > 50%.





ANALYSIS OF RECIST DATA:
• CR (Complete Response), all lesions have disappeared
• PR (Partial Response), shrinkage >30% compared to baseline
• PD (Progressive Disease), >20% increase compared to any assessment
• SD (Stable Disease), an evaluable assessment that is neither CR, PR or PD
• NE (Non-Evaluable), generally study specific

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PR 6-4-10: Positive Phase II Lung Cancer Data to Be Presented at ASCO Support Recently Opened Registrational Phase IIb Trial for Bavituximab
• 43% Objective Tumor Response, 6.1 Months PFS for Front-Line Non-Small Cell Lung Cancer Patients Treated With Bavituximab and Paclitaxel/Carboplatin
TUSTIN, June 4, 2010: Peregrine Pharmaceuticals, Inc. (NASDAQ: PPHM), a clinical-stage biopharmaceutical company developing innovative monoclonal antibodies for the treatment of cancer and viral infections, today announced positive data from a Phase II clinical trial treating front-line non-small cell lung cancer (NSCLC) patients with bavituximab in combination with paclitaxel and carboplatin. 43% (21 of 49 patients) of patients achieved an objective tumor response. Median progression-free survival (PFS) was 6.1 months and median overall survival will be reported once these data mature. These results are superior to data showing an objective response rate of 19% in a similar patient population receiving the same treatment regimen of carboplatin and paclitaxel alone from the published study upon which Peregrine's trial was based. Peregrine's Phase II data will be highlighted in a poster presentation on June 6, 2010 at the ASCO Annual Meeting.

Peregrine's registrational Phase IIb trial in refractory NSCLC is open for patient enrollment, with a second randomized Phase IIb trial in front-line NSCLC planned to begin by mid-year. For additional information on this randomized, double-blinded, placebo-controlled trial, visit http://www.clinicaltrials.gov/ct2/search and type in the key word "bavituximab."

"The objective response and median PFS data from bavituximab in combination with chemotherapy are very encouraging, as this response rate is more than double the typical response observed with chemotherapy alone," commented Raghunadharao Digumarti, M.D., professor and head of the Department of Medical Oncology at Nizam's Institute of Medical Sciences, Hyderabad, India. "There is an urgent need for new therapies that may extend patient survival for this aggressive, prevalent form of cancer. Bavituximab's broad-spectrum potential, demonstrated by promising clinical data in this patient setting and use in various combination therapy applications, support further development of this novel monoclonal antibody for cancer."

Bavituximab is a first-in-class phosphatidylserine (PS)-targeting monoclonal antibody that represents a new approach to treating cancer. PS is a highly immunosuppressive molecule usually located inside the membrane of healthy cells, but "flips" and becomes exposed on the outside of cells that line tumor blood vessels, creating a specific target for anti-cancer treatments. PS-targeting antibodies target and bind to PS and block this immunosuppressive signal, thereby enabling the immune system to recognize and fight the tumor.

ABOUT THE PHASE II TRIAL
In Peregrine's Phase II trial assessing bavituximab in combination with paclitaxel and carboplatin, 43% (21 of 49 patients) of patients achieved an objective tumor response. Median PFS in the trial was 6.1 months and median overall survival will be reported once these data mature. 73% (36 of 49 patients) of the patients enrolled in this study had Stage IV disease. These results compare favorably to data from a separate published study showing an objective response rate of 19% and a median time to progression of 4.2 months in a similar patient population receiving carboplatin and paclitaxel alone.

Peregrine's multi-center, open-label Phase Il NSCLC trial was designed to assess overall response rates to bavituximab combined with the front-line standard of care chemotherapy regimen of carboplatin and paclitaxel. Secondary objectives of the study included measuring progression-free survival, duration of response, overall patient survival and safety parameters. Patients in the study were evaluated regularly for tumor response according to RECIST criteria.

ABOUT LUNG CANCER
Lung cancer is the leading cause of cancer death. According to the American Cancer Society, lung cancer is the second most commonly diagnosed cancer, with approximately 219,440 new cases and 159,000 deaths reported in 2009 in the U.S. alone. NSCLC is the most common type of lung cancer, accounting for approximately 85-90% of lung cancer cases. The five-year survival rate for NSCLC patients is only 1%.

Poster at ASCO -- Sunday, June 6, 2010, 8:00-12:00pmCT
Phase II study of bavituximab plus paclitaxel and carboplatin in untreated locally advanced or metastatic non-small cell lung cancer: Interim results
(Abstract #7589), Author: Raghunadharao Digumarti, Poster Board 40H, S Hall A2

Peregrine will also have a booth (#19114) for the duration of the 2010 ASCO Annual Meeting. For more information on the ASCO conference, visit http://chicago2010.asco.org/Home.aspx .

ABOUT PEREGRINE PHARMACEUTICALS
Peregrine Pharmaceuticals, Inc. is a clinical-stage biopharmaceutical company with a portfolio of innovative monoclonal antibodies in development for the treatment of cancer and serious viral infections. The company is pursuing three 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 biomanufacturing services for both Peregrine and outside customers. Additional information about Peregrine can be found at http://www.peregrineinc.com .
Safe Harbor *snip*
Contact:
Amy Figueroa, Peregrine Pharmaceuticals, info@peregrineinc.com 800-987-8256

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These were some comments by CEO Steve King about the Ph.2 NSCLC data prior to today’s ASCO PR (recall, Stage1 ORR% was 52% n=21):
“the one we’re most excited about” 7-30-09 http://tinyurl.com/lqwedd
“the most outstanding results to date” 9-1-09 http://tinyurl.com/n6gq7y
“perhaps the most remarkable results” 1-13-10 http://tinyurl.com/yb7v2u4
”the NSCLC data is really just outstanding” 3-17-10 http://tinyurl.com/ye9v7jq

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FYI, SUMMARY OF THE BAVI+CP/NSCLC PH.2 TRIAL RESULTS PRESENTED AT ASCO’10, FROM CFO PAUL LYTLE’S 6-9-10 TALK AT NEEDHAM/NYC ( http://tinyurl.com/2wt2gc7 ):


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ASCO’10 #7589: ”Phase II Study of Bavituximab + Paclitaxel/Carboplatin in Untreated Locally Advanced or Metastatic Non-Small Cell Lung Cancer: Interim Results”
Raghunadharao Digumarti, Sunday, 6-6-10, 8:00am-12:00pm
http://clinicaltrials.gov/ct2/show/NCT00687817 (India, 21+28=49)
ABSTRACT: Background: Bavituximab, a novel chimeric IgG1 monoclonal antibody which targets the membrane phospholipid, phosphatidylserine complexed with B2-glycoprotein I on tumor vasculature, was tested in combination with paclitaxel and carboplatin in a multicenter open label, phase II trial to examine the clinical response rate and safety in adults (n = 49) with untreated locally advanced or metastatic non-small cell lung cancer. Methods: Subjects received intravenous administration of weekly doses of 3 mg/kg bavituximab until disease progression and up to 6 cycles of carboplatin at a dose of AUC = 5 and paclitaxel 175mg/m2 on day 1 of 21-day cycles in a Simon 2-stage design. Tumor response was determined by use of the Response Evaluation Criteria in Solid Tumors (RECIST) criteria. Results: 49 Asian (India) subjects, median age 55 yrs, range 33-72, 71% male were treated. Overall response rate (CR+PR) seen in the initial group of subjects was 11/21 (52.4%, 95% C.I. 29.8-74.3) with clinical complete response in 4.8% and partial response in 47.6%. To date, median progression free survival (PFS) in the initial 21 treated is 6.2 mos (95% CI, 5.2-7.7); median duration of response and median overall survival are pending as follow-up is continuing. AEs have been reported by 44/49 (89.8%) treated subjects with the majority mild or moderate in severity. The 6 most common AEs have been pyrexia (28.6%), diarrhea (26.5%), alopecia (26.5%), anemia (22.4%), neuropathy (20.4%) and pain (20.4%). Safety analysis revealed 45 SAEs in 19 subjects (incl. 2 deaths due to myocardial infarctions and one death due to hemoptysis in 1 of 8 subjects with squamous histology). Accrual of squamous cell carcinoma was discontinued. Conclusions: Bavituximab a unique phosphatidylserine targeting monoclonal antibody which induces immune enhancement (He, et al., Clin Cancer Res 2009 http://tinyurl.com/y8kdz2m ) and immune cell-mediated destruction of tumor vasculature appears to be safe and well tolerated when given in combination with paclitaxel and carboplatin and has produced a promising 52% overall response rate using RECIST criteria in an initial group of patients with locally advanced or metastatic non-small cell lung cancer.
http://abstract.asco.org

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D. PHASE II BAVI+CP ADV./MET. LUNG CANCER (NSCLC) IN INDIA (1ST-LINE):
Protocol (dosed 6/2008-10/2009 n=49): http://clinicaltrials.gov/ct2/show/NCT00687817
…Early Ph.2/Adv.Lung ORR% comp. of Bavi+CP/43% n=49 vs. Avastin+CP/32% n=35.
6-6-10 ASCO’10: ORR=43% (21/49), PFS: 6.1mos (n=49) http://tinyurl.com/2g5cqof
…Plus, Fig1 of Poster #7589 shows: 1) 2 100% Red’s (4.1%) and 11 Resp>50% (22.4%)
10-5-09: S2(28pts) enrollment comp; MedianPFS=6.5mos in Stage1/n=21 http://tinyurl.com/y9wnh5p
6-3-09: Ph.2 highlights: 11 of 21 [52.4%] of Stage1's 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."

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 => 100.1wks a/o 6-1-10
ALL-21-ENROLLED-Stage1: 10-20-08 => 84.1wks a/o 6-1-10 (1.3/wk)
1st-DOSED-Stage2(28): 4-20-09 => 58.1wks a/o 6-1-10
ALL-28-DOSED-Stage2: 10-5-09 => 34.1wks a/o 6-1-10 (1.2/wk)

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III. ADV./MET. NSCLC CANCER (India) - MAB + PACLITAXEL/CARBOPLATIN:
Ph.2 Bavi+CP n=49: 43% ORR (Med.PFS=6.1mos), interim data. http://tinyurl.com/2g5cqof
• Ph.2 Avastin+CP n=35: 31.5% ORR (‘intent-to-treat’ basis). 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 (ASA404 Fails - *Trial Halted 3-29-10*)
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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ORR% UPDATE HISTORY FOR PH.2/BAVI+CP/NSCLC/INDIA:
2-4-09 PR: “7 of 21 (33%) achieving PR (CR=1)” (after 4 of 6 3wk cycles)
=> 6-3-09 PR: “11 of 21 (52%) achieving PR” (after 6 of 6 3wk cycles)
==> 6-4-10 PR: “21 of 49 (43%) achieving PR” (after 6 of 6 3wk cycles)
*end*
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