Initiating another trial should be good for another round of bonuses for the boys. I asked Tustin what the criteria was for these bonuses but no one wants to answer. I did get a reply telling me not to address my emails to King but to IR. So I guess they got it.
ClinicalTrials.gov for Bavi+CP vs. 1st-Line NSCLC randomized Ph.2B trial updated 9-27-10 – went from 2 to 5 U.S. sites…
“Study of Paclitaxel/Carboplatin With or Without Bavituximab in Previously Untreated Non Small-Cell Lung Cancer” • NCT01160601 - This study is currently recruiting participants. http://clinicaltrials.gov/ct2/show/NCT01160601
LOCATIONS: American Institute of Research, Whittier, California - Recruiting Principal Investigator: Merrill Shum, MD
Southeast Nebraska Cancer Center, Lincoln, Nebraska - Recruiting Principal Investigator: Alan Berg, MD
San Juan Oncology Associates, Farmington, New Mexico - Recruiting Principal Investigator: Jeffrey Neidhart, MD
Gabrail Cancer Center, Canton, Ohio - Recruiting Principal Investigator: Nashat Gabrail, MD
Signal Point Clinical Research Center, Middletown, Ohio - Recruiting Principal Investigator: Nandagopal Vrindavanam, MD
Health Authority: USA: FDA; India: Drugs Controller General of India
= = = = = = = = = = = = G. Phase IIb Bavi+CP vs. 1st-Line NSCLC (randomized, unblinded, 'confirmatory') Protocol: http://clinicaltrials.gov/ct2/show/NCT01160601 (5 U.S. Sites as of 9-27-10) …Per J.Shan (VP/Clin+RegAffairs), 7-14-10 CC: "This trial is intended to confirm in a randomized setting the results from our Ph.2 signal-seeking NSCLC trial which showed 43% ORR, more than double the generally accepted chemo ORR of under 20% in numerous publications. Favorable results could then lead to an end of Ph.2 meeting with the FDA, with possibly a pivotal Ph/3 trial for front-line lung cancer, our 2nd potential regulatory pathway for bavituximab." ...7-14-10: U.S. Ph.2b randomized trial initiated http://tinyurl.com/27kxksl ……up to 86 front-line patients at ~20 clinical sites; goal: enrollment comp. by mid’11.
Two more U.S. sites added to the Frontline NSCLC trial. 45 total sites now for the 2 Ph2b randomized NSCLC trials. Note that the Frontline NSCLC trial, with its 24 sites, has now exceeded its stated goal of “~20 sites”.
G. PHASE IIB BAVI+CP VS. FRONT-LINE NSCLC (RANDOMIZED, UNBLINDED, 'CONFIRMATORY') Protocol: http://clinicaltrials.gov/ct2/show/NCT01160601 17 U.S. & 7 India Sites as of 1-18-11 (was 15 U.S., 7 India sites as of 1-13-11) …Per J.Shan (VP/Clin+RegAffairs), 7-14-10 CC: "This trial is intended to confirm in a randomized setting the results from our Ph.2 signal-seeking NSCLC trial which showed 43% ORR, more than double the generally accepted chemo ORR of under 20% in numerous publications. Favorable results could then lead to an end of Ph.2 meeting with the FDA, with possibly a pivotal Ph/3 trial for front-line lung cancer, our 2nd potential regulatory pathway for bavituximab." ...7-14-10: U.S. Ph.2b randomized trial initiated http://tinyurl.com/27kxksl ……up to 86 front-line patients at ~20 clinical sites; goal: enrollment comp. by mid’11. Site Growth: • 10-11-10: 7US/0India = 7 • 11-8-10: 8US/5India = 13 • 11-23-10: 12US/6India = 18 • 12-6-10: 12US/7India = 19 • 12-20-10: 13US/7India = 20 • 12-23-10: 14US/7India = 21 • 1-13-11: 15US/7India = 22 • 1-18-11: 17US/7India = 24
F. PHASE IIB BAVI+DOCE VS. REFRACTORY NSCLC (RANDOMIZED, DOUBLE-BLINDED, PLACEBO-CONTROLLED, N=120, ‘REGISTRATIONAL’) Protocol: http://clinicaltrials.gov/ct2/show/NCT01138163 21 U.S. Sites as of 12-20-10 (was 20 U.S. sites as of 12-6-10) …Per CEO S.King, 3-17-10/Roth: "We refer to this trial as a Registrational Phase II Study, because we believe that if we have results anywhere near approaching what we saw in the earlier [India] study, it could be a conduit for Accelerated Approval.” ...6-4-10: Ph.2b randomized reg. trial Open for enrollment: http://tinyurl.com/25v22qk ……up to 120 refractory patients at ~30 clinical sites; goal: fully-enroll by mid’11, topline data by y/e‘11. Site Growth: • 10-11-10: 13 U.S. • 11-8-10: 18 U.S. • 11-23-10: 19 U.S. • 12-6-10: 20 U.S. • 12-20-10: 21 U.S.
8-4-11: Per ClinicalTrials.gov, 13 new sites added in the ongoing Bavi+CP Frontline NSCLC trial, 28->41 sites (17 U.S., 24 Intl). That’s now 41+37=78 total sites for the 2 Ph2b randomized NSCLC trials.
G. PHASE IIB BAVI+CP VS. FRONT-LINE NSCLC (RANDOMIZED, UNBLINDED, 'CONFIRMATORY') Protocol: http://clinicaltrials.gov/ct2/show/NCT01160601 (17 U.S. + 9 India + 2 RepGA + 8 RussianFED + 5 Ukraine = 41 of 8-4-11) ...Also listed in: India's CTRI registry ctri.in#2190 and WHO's registry who.int#1402 ...7-14-11/CC: Enrollment was taking longer than expected; have amended protocol; expanding to 30+ sites, expect enroll. comp. "in coming weeks", interim data by Yr-end'11. http://tinyurl.com/6k6y2as …7-14-10/CC, J.Shan (VP/Clin+RegAffairs): "This trial is intended to confirm in a randomized setting the results from our Ph.2 signal-seeking NSCLC trial which showed 43% ORR, more than double the generally accepted chemo ORR of under 20% in numerous publications. Favorable results could then lead to an end of Ph.2 meeting with the FDA, with possibly a pivotal Ph/3 trial for front-line lung cancer, our 2nd potential regulatory pathway for bavituximab." ...7-14-10: U.S. Ph.2b randomized trial initiated http://tinyurl.com/27kxksl ……up to 86 front-line patients at ~20 clinical sites; goal: enrollment comp. by mid'11. Site Growth: • 10-11-10: 7US/0India = 7 • 11-8-10: 8US/5India = 13 • 11-23-10: 12US/6India = 18 • 12-6-10: 12US/7India = 19 • 12-20-10: 13US/7India = 20 • 12-23-10: 14US/7India = 21 • 1-13-11: 15US/7India = 22 • 1-18-11: 17US/7India = 24 • 5-24-11: 17US/9India/2RepGA = 28 • 8-4-11: 17US/2RepGA/9India/8RussianFed/5Ukraine = 41
F. PHASE IIB BAVI+DOCE VS. REFRACTORY NSCLC (RANDOMIZED, DOUBLE-BLINDED, PLACEBO-CONTROLLED, N=120, 'REGISTRATIONAL') Protocol: http://clinicaltrials.gov/ct2/show/NCT01138163 (24 U.S. + 11 India + 2 RepGA = 37 Sites as of 5-24-11) ...Also listed in: India's CTRI registry ctri.in#2191 (12 sites a/o 3-20-11) ...7-14-11/CC: Enrollment was taking longer than expected; have amended protocol; expanding to ~45 sites, expect enroll. comp. "early in Q4/2011", data unblinding 1H'12. http://tinyurl.com/6k6y2as …3-17-10/Roth, CEO S.King: "We refer to this trial as a Registrational Phase II Study, because we believe that if we have results anywhere near approaching what we saw in the earlier [India] study, it could be a conduit for Accelerated Approval." ...6-4-10: Ph.2b randomized reg. trial Open for enrollment: http://tinyurl.com/25v22qk ……"up to 120 refractory patients at ~30 clinical sites; goal: fully-enroll by mid'11, topline data by y/e'11." Site Growth: • 10-11-10: 13 U.S. • 11-8-10: 18 U.S. • 11-23-10: 19 U.S. • 12-6-10: 20 U.S. • 12-20-10: 21 U.S. • 2-8-11: 22US/9India = 31 • 3-14-11: 23US/9India = 32 • 5-24-11: 24US/11India/2RepGA = 37
PR 9-8-11: Enroll. Comp in Ph2/1stLine NSCLC Trial; Bavi article in Immunology…
Peregrine Completes Patient Enrollment in Randomized Phase II Trial for Bavituximab in Front-Line Non-Small Cell Lung Cancer • Interim Data Expected by Year End • Peer-Reviewed Publication of Bavituximab Clinical and Preclinical Data in Immunotherapy http://ir.peregrineinc.com/releasedetail.cfm?ReleaseID=604000
TUSTIN, 9/8/11: Peregrine Pharmaceuticals, Inc. (NASDAQ: PPHM), a clinical-stage biopharmaceutical company developing first-in-class monoclonal antibodies for the treatment of cancer and viral infections, today announced the completion of enrollment and randomization of 86 patients with previously untreated non-small cell lung cancer (NSCLC) in a Phase II trial evaluating bavituximab in combination with carboplatin and paclitaxel. Bavituximab is a phosphatidylserine (PS)-targeting monoclonal antibody with broad therapeutic potential and also is being evaluated in randomized Phase II trials for second-line NSCLC, pancreatic cancer, and hepatitis C virus (HCV) infection, as well as in four investigator-sponsored trials (ISTs) in additional oncology indications.
In a prior single-arm Phase II study in 49 patients, bavituximab in combination with carboplatin and paclitaxel demonstrated encouraging survival and tumor response data. Median overall survival (OS) of 12.4 months, median progression-free survival (PFS) of 6.1 months, and objective response rate (ORR) of 43% were promising compared to 10.3 months median OS, 4.5 months median PFS, and 15% ORR from a separate historic control trial using carboplatin and paclitaxel alone in a similar patient population.
"Completion of patient enrollment and randomization in this trial is an important milestone for our bavituximab oncology program, and paves the way for reporting interim data by the end of this year in this deadliest form of cancer," said Steven W. King, president and CEO of Peregrine. "I would like to thank the patients and families who chose to participate, our clinical investigators who share our dedication to advancing the development of new therapeutic options for their patients, and our hard-working team at Peregrine driving our multiple Phase II trials forward. We are eager to analyze the early tumor response data from this trial as well as to follow the longer-term survival of these patients, as we continue to evaluate bavituximab's broad therapeutic potential in additional ongoing clinical trials."
BAVITUXIMAB DATA PUBLISHED IN IMMUNOTHERAPY A manuscript titled "Development of Bavituximab, a Vascular Targeting Agent with Immune-Modulating Properties, for Lung Cancer Treatment" was recently published in the August 2011 edition of Immunotherapy[ http://www.futuremedicine.com/doi/abs/10.2217/imt.11.87 ]. Highlighting bavituximab's unique mechanism of action and promising prior clinical and preclinical data, authors conclude bavituximab has immune modulatory as well as vessel disrupting properties that may be beneficial for the treatment of lung cancer and other malignancies. "Development of Bavituximab, a Vascular Targeting Agent with Immune-Modulating Properties, for Lung Cancer Treatment", Paul DeRose et al., Immunotherapy. August 2011. This research was supported in part by an American Society of Clinical Oncology (ASCO) Career Development Award and the North and Central Texas Clinical and Translational Science Initiative (NIH KL2RR024983), both awarded to Dr. David E. Gerber, UT Southwestern Medical Center. ***[ MORE: 8-2011: Gerber/Thorpe IMMUNOTHERAPY article on Bavi+Chemo/NSCLC http://tinyurl.com/3gzd6g5 ...Obviously resulting from: 6-10-09 ASCO $200k Grant to UTSW's David Gerber for New Bavi/NSCLC Study: http://tinyurl.com/nt4na9 ]
ABOUT PEREGRINE'S RANDOMIZED PHASE II FRONT-LINE NSCLC TRIAL Peregrine's randomized Phase II front-line NSCLC trial is designed to compare the ORR of carboplatin and paclitaxel with or without bavituximab in up to 86 patients with previously untreated locally advanced or metastatic NSCLC. Secondary objectives of the study include median PFS, duration of response, median OS, and safety parameters. More information about this trial can be found at http://www.clinicaltrials.gov/ct2/show/NCT01160601?term=bavituximab&rank=4 .
RANDOMIZED, DOUBLE-BLINDED PHASE II SECOND-LINE NSCLC TRIAL Patient recruitment is ongoing in Peregrine's second-line NSCLC trial evaluating docetaxel with bavituximab or placebo in up to 120 patients with previously treated locally advanced or metastatic NSCLC. Patient enrollment is expected to be completed early in the fourth quarter of this year. More information about this trial can be found at http://www.clinicaltrials.gov/ct2/show/NCT01138163?term=bavituximab&rank=5 .
ABOUT BAVITUXIMAB 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 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 multiple clinical programs in cancer and hepatitis C virus infection with its lead product candidate bavituximab and novel brain cancer agent Cotara®. Peregrine also has in-house cGMP 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 or Jay Carlson, Peregrine Pharmaceuticals, (800) 987-8256, info@peregrineinc.com
= = = = = ONGOING BAVI+CHEMO PHASE 2 NSCLC TRIALS: G. Phase IIb Bavi+CP vs. Front-Line NSCLC (randomized, unblinded, 'confirmatory') Protocol: http://clinicaltrials.gov/ct2/show/NCT01160601 (17 U.S. + 9 India + 2 RepGA + 7 RussianFED + 5 Ukraine = 40 as of 8-12-11) ...Also listed in: India's CTRI registry ctri.in#2190 and WHO's registry who.int#1402 …9-8-11: Enrollment complete in Frontline NSCLC Ph.2 trial. http://tinyurl.com/3vv9zfx ...7-14-11/CC: Enrollment was taking longer than expected; have amended protocol; expanding to 30+ sites, expect enroll. comp. "in coming weeks", interim data by Yr-end'11. http://tinyurl.com/6k6y2as …7-14-10/CC, J.Shan (VP/Clin+RegAffairs): "This trial is intended to confirm in a randomized setting the results from our Ph.2 signal-seeking NSCLC trial which showed 43% ORR, more than double the generally accepted chemo ORR of under 20% in numerous publications. Favorable results could then lead to an end of Ph.2 meeting with the FDA, with possibly a pivotal Ph/3 trial for front-line lung cancer, our 2nd potential regulatory pathway for bavituximab." ...7-14-10: U.S. Ph.2b randomized trial initiated http://tinyurl.com/27kxksl ……up to 86 front-line patients at ~20 clinical sites; goal: enrollment comp. by mid'11.
F. Phase IIb Bavi+Doce vs. Refractory NSCLC (randomized, double-blinded, placebo-controlled, n=120, 'registrational') Protocol: http://clinicaltrials.gov/ct2/show/NCT01138163 (24 U.S. + 15 India + 2 RepGA + 7 RussianFED + 5 Ukraine = 53 as of 8-12-11) ...Also listed in: India's CTRI registry ctri.in#2191 (12 sites a/o 3-20-11) ...7-14-11/CC: Enrollment was taking longer than expected; have amended protocol; expanding to ~45 sites, expect enroll. comp. "early in Q4/2011", data unblinding 1H'12. http://tinyurl.com/6k6y2as …3-17-10/Roth, CEO S.King: "We refer to this trial as a Registrational Phase II Study, because we believe that if we have results anywhere near approaching what we saw in the earlier [India] study, it could be a conduit for Accelerated Approval." ...6-4-10: Ph.2b randomized reg. trial Open for enrollment: http://tinyurl.com/25v22qk ……"up to 120 refractory patients at ~30 clinical sites; goal: fully-enroll by mid'11, topline data by y/e'11."
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