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12-5-12: FDA OK’s Ph3 Pivotal Trial Design for Cotara/GBM

Peregrine Pharmaceuticals Announces Significant Progress in Advancing Its Cotara Program Into a Pivotal Phase III Trial
• Agreement Reached With FDA on Pivotal Trial Design for Its Novel Targeted Therapy Cotara for the Treatment of Recurrent Brain Cancer
• Agreement Allows for Phase III Trial Planning While Advancing Partnering Discussions
http://ir.peregrineinc.com/releasedetail.cfm?ReleaseID=725023

TUSTIN, 12/5/2012: Peregrine Pharmaceuticals (NASDAQ: PPHM), a biopharmaceutical company developing first-in-class monoclonal antibodies focused on the treatment and diagnosis of cancer, today announced that it has made significant progress in advancing its Cotara program into late-stage development through its agreement with the U.S. Food and Drug Administration (FDA) on the design of a single registration trial for Cotara in patients with recurrent glioblastoma multiforme (GBM). The FDA has agreed with the company's proposed randomized trial design comparing two dose levels of Cotara in up to 300 patients. The trial design allows for multiple interim data analyses with the potential to stop patient accrual early based on predicted success or futility. Cotara has been granted orphan drug status and Fast Track designation for the treatment of GBM and anaplastic astrocytoma by the U.S. Food and Drug Administration (FDA) and orphan drug designation by the European Medicines Agency (EMA).

"We appreciate the input that the FDA has provided to us during the course of our discussions in order to arrive at this mutually agreed upon design, that, if successful, should be sufficient to support a full marketing submission," said Robert Garnick, Ph.D., Peregrine's head of regulatory affairs. "Our next steps include the engagement of other regulatory agencies, where we plan to run the trial as part of a global registration study."

Cotara is a targeted loco-regional therapy that delivers a high dose of radiation directly into the brain tumor while sparing radiation exposure to healthy brain tissue. Cotara is being studied as a one-time treatment that in previous clinical trials has shown promising overall survival in patients with recurrent GBM.

"Our goal going into these discussions with the FDA was to agree upon a clinical trial design that would be appropriate for this orphan indication and one which we could enroll within a two-year timeframe," said Joseph Shan, VP of Clinical & Regulatory Affairs at Peregrine. "Having achieved this goal, we are now beginning to plan for this global registration study while continuing partnering discussions."

"Having established a clear clinical path forward for this novel and targeted delivered drug candidate, we can now escalate our business development activities to secure a partnership, recognizing the great interest by companies in drug candidates within the orphan and rare disease space," said Steven W. King, president and CEO of Peregrine. "Cotara and our lead oncology therapeutic candidate, bavituximab both represent significant opportunities. With key data from Phase II bavituximab clinical trials in several oncology indications set to read out in the coming months and the opportunity to advance Cotara into a pivotal trial, we have number of potentially significant value drivers on the horizon. We look forward to updating you further as we continue to make progress in our late stage clinical programs."

ABOUT COTARA
Based on Peregrine's Tumor Necrosis Therapy (TNT) platform, Cotara is a novel therapy for the treatment of recurrent GBM. Cotara links a radioactive isotope (iodine 131) to a monoclonal antibody that targets DNA/histone H1 complex which is exposed by dead and dying cells found at the center of solid tumors. Cotara's targeting mechanism enables it to bind to the dying tumor cells, delivering its radioactive payload to the adjacent living tumor cells and essentially destroying the tumor from the inside out, with minimal radiation exposure to healthy tissue. Cotara is delivered in a single dose using convection-enhanced delivery (CED), an NIH-developed method that targets the specific tumor site in the brain.

Data from Peregrine's prior Phase II clinical trial of a single intratumoral infusion of Cotara in 41 patients with recurrent GBM demonstrated promising median overall survival (OS) of 9.3 months, with 4 patients surviving at least 3 years.

ABOUT BRAIN CANCER
According to the Central Brain Tumor Registry of the United States, an estimated 24,620 new cases of primary malignant brain and CNS system tumors are expected to be diagnosed in the United States in 2013. The most common type of brain cancer is glioblastoma multiforme (GBM), which accounts for 60% of all malignant brain cancers. An aggressive form of cancer, GBM is the deadliest form of brain cancer, with a five-year survival rate of only 3%.

ABOUT PEREGRINE PHARMACEUTICALS, INC.
Peregrine Pharmaceuticals, Inc. is a biopharmaceutical company with a portfolio of innovative monoclonal antibodies in clinical trials, focused on the treatment and diagnosis of cancer. The company is pursuing multiple clinical programs in cancer 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:
Christopher Keenan or Jay Carlson
Peregrine Pharmaceuticals, Inc. [phone] [e-mail]

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TUMOR NECROSIS THERAPY (TNT/COTARA/VEA's) NEWS:
Also see: http://www.peregrineinc.com/technology/cotara-oncology.html
Highlights of Cotara/GBM Trials History 1998-2009: http://tinyurl.com/y8fyl2r
12-5-12: FDA OK’s Ph3 Pivotal Trial Design for Cotara/GBM http://tinyurl.com/czjy6mf
…SK: ”We can now escalate our business development activities to secure a partnership, recognizing the great interest by companies in drug candidates within the orphan and rare disease space."
5-3-10: PPHM Licenses TNT rights in "Certain APEC Countries" to STASON(Stonsa Biopharm) http://tinyurl.com/29x433b
Stonsa's website: http://stonsabio.com
...Harry Fan/CEO/Stason, "This agreement represents a unique opportunity to acquire a novel, cutting-edge pharmaceutical technology package and bring innovative & promising treatments to millions of cancer patients in Asia & the Pacific Rim. We will also continue developing new applications & bioproducts based on TNT technologies to complement Peregrine's activities in the glioblastoma arena and will aggressively pursue new, diverse biotechnology markets. To advance these efforts, a new spin-off biopharmaceutical company (Stonsa Biopharm Inc.) headed by Dr. Eugene Mechetner will be formed which will focus on commercializing TNT technologies."
7-20-11: Dr. Missag Parseghian now VP/R&D at Stonsa Biopharm; pub's article in Jrnl/Chromatography http://tinyurl.com/m3c69w
…6-2010: More on PPHM-Stason Collab., "TNT For Tumors", Lloyd Dunla, Drug Disc. News http://tinyurl.com/28vmkzm
…5-27-10: Stonsa's CEO Dr. Eugene Mechetner presents TNT at Taiwanese Bio-Seminar http://tinyurl.com/29r7one
...12-16-10: "Stason Inks Deal to use Lonza's GS Gene Expression System with TNT Antibody Platform" http://tinyurl.com/2dzz4b5
7-1-09 Eur. Patent #1638989 for 'In-Line Labeling' (used in Cotara GBM trials) & JNM Article: http://tinyurl.com/mlgz8p

India (expanded Jan'10 to U.S.) Cotara/Brain Ph.2 Trial (40 patients, 1st relapse):
India's DCGI protocol (init=7-2007): http://clinicaltrials.gov/ct2/show/NCT00677716
7-2011 BRIT (India Radiolabelling co.) says: "(Cotara) Ph2 completed; another order is expected from Peregrine to enable them to go ahead with Ph3" http://tinyurl.com/43vb4ax
10-11-11: SIRO Clinpharm is Peregrine's Indian CRO for GBM/Cotara Ph.2 Trial: http://tinyurl.com/3eobdca
6-3-11 ASCO'11: Dr. William Shapiro (Barrow) presents Cotara N=41 Data http://tinyurl.com/3g7oz55
…"Interim MOS=8.8mos(38wks); we are eager to meet with the FDA in Q4'11 to determine the optimal registration pathway for Cotara."
...NOTE: In 12-12-2011 QtlyCC, S.King reported MOS at 9.3 mos., up from in "interim" 8.8mos reported at ASCO'11. http://tinyurl.com/75rfwrv
…Dr. Shapiro's Cotara Poster #2035 (PDF & Images) http://tinyurl.com/3wetx5r
5-19-11: ASCO'11 preview; Dr. Vladimir Evilevitch (ex-Novartis) hired as Med.Dir. "to execute Cotara Reg&Clin. strategy" http://tinyurl.com/3av4red
12-20-10: Treatment Complete in Cotara/GMB Ph.2 Trial http://tinyurl.com/2844wrq
…J.Shan: "We expect top-line data by mid-year 2011 and plan to meet with the FDA to define the optimal registration pathway for Cotara."
10-18-10: Interim Ph.2 update (n=14) at CNS'10: http://tinyurl.com/349kvca
...PI Dr. Deepak Gupta, "MOS of 86 weeks far exceeded our expectations in this very difficult to treat patient pop. where treatment options are few and rarely extend med.survival beyond 6mos."
…Roth's Joe Pantginis: "Physicians know how long these patients are expected to survive on avg. and that's why these data are very, very promising. Because there is a huge unmet medical need for new treatments for this type of brain cancer, Peregrine may seek an accelerated approval that could avoid lengthy Phase III clinical trials."
...Link to Dr. Gupta's CNS'10 Poster (6pg PDF): http://tinyurl.com/26b8sp9
...6-3-10/ASCO: Cotara/Ph.2 Trial 75% enrolled; 3 more U.S. sites added: http://tinyurl.com/33z8ggo
...1-28-10 U.S. site (Barrow/Phoenix) added formerly India-Only Ph.2 trial: http://tinyurl.com/yk565jy
…Per 3-11-10 QtlyCC, VP/ClinAffairs J.Shan said also exp. UPenn & Univ. of S.Car. http://tinyurl.com/yl4befh
…9-2-09 Interim Ph.2 data (10 pts) presented at AANS Annual Mtg/Boston: http://tinyurl.com/mxzbzm
……P.I. Dr. A.K. Mahapatra: "Most importantly, Cotara has demonstrated promising signs of efficacy."
...8-2-07 1st Patient Dosed in Indian Cotara/Brain Ph.2 Trial: http://tinyurl.com/296mcj
...The obvious desire is to compare Cotara vs. SOC Temodar for GBM therapy: http://tinyurl.com/yttt99

USA Cotara/Brain 'Dosimetry & Dose Confirmation Trial' (originally funded by NABTT):
U.S.A. Cotara Brain Cancer trial protocol (added 8-14-07): http://clinicaltrials.gov/show/NCT00509301
6-6-10/ASCO: Final Results of Cotara/GBM Ph.1/Dosimetry trial (n=12): http://tinyurl.com/24qjxxh
......"Final data confirm Cotara's targeting capabilities, delivering 300-fold higher radiation levels to the tumor than to normal organs."
...2-11-10: "Current Cancer Therapy Reviews" article on Cotara/GMB http://tinyurl.com/yg2on8f
......the cases of "2 patients who have survived more than 9 years" are also reviewed.
...12-2-09: U.S. Trial Enrollment Complete http://tinyurl.com/yez7lzd
...6-16-09: Cotara/Brain Oral-Pres. at SNM Annual Meeting http://tinyurl.com/lmhkw2
......Dr. Sui Shen (U-Alabama), "With a mean dose ratio showing 300-fold greater delivery of radiation to the tumor as compared to other organs, Cotara represents a potentially valuable new therapy for GBM patients."
…9-23-08: Article in Cleveland paper - comments by P.I. Dr. Andrew Sloan (Case Western/CLEV) http://tinyurl.com/3mkmas
...5-31-08: Cotara USA Ph.1B data presented at ASCO/2008: http://tinyurl.com/68apro
...8-29-05: NABTT Initiates Cotara/Brain Trial (28 patients/4 sites): http://tinyurl.com/9w3cr
...Orig. NABTT protocol, "6-2007, completed": http://www.clinicaltrials.gov/ct/show/NCT00128635
...The Phil (Marfuta) Bannister Story (NABTT Cotara/GBM patient #1, diag. 2-4-06): http://tinyurl.com/24gkml
......4-22-10: Phil reports on YASG that his GBM was misdiagnosed; he has a GrIII Oligodendroglioma, which carries a MLE of 12yrs! http://tinyurl.com/23mhboa

Previous USA Cotara/Brain Ph.1-2 Trials, completed in 2003:
...Slides showing correlation between Cotara dosage levels and MST vs. Temodar(curr.SOC): http://tinyurl.com/26s265
...4-27-08 update: The Jerod Swan Cotara/Brain Success Story (10 years after diag.): http://tinyurl.com/68ofsv
...5-22-07 update: The Freddie Sanford Cotara/Brain Success Story (7 years after diag.): http://tinyurl.com/2du2e5
...6-1-05: Cotara w/CED Brain Delivery pub. in Neurosurgery Jrnl: http://tinyurl.com/anmaa
..."Cotara Holds Promise for Treating Brain Cancer - P1/P2 Data Suggests Extended Survival in a Number of Patients"

TNT3 (Vivatuxin) Lung Cancer Approval/Launch in China:
...Shanghai MediPharm Biotech's TNT/China website: http://www.vivatuxin.com
...8-2010 Profile of Shanghai MediPharm Biotech by WallStreetResearch (Alan Stone): http://tinyurl.com/2fn3nvk
...3-2010: New Vivatuxin+MicrowaveAblation NSCLC trial (n=2000) http://tinyurl.com/2ccghvr
...1-16-07: Medipharm Launches TNT in China for Lung Cancer http://tinyurl.com/ttlne
...6-19-02: TNT Interim Lung Data from China: http://tinyurl.com/ggcba & http://tinyurl.com/em6da

Peregrine v. CTL Lawsuit - Settled 6-19-09:
...6-19-09: Form 8-K, Peregrine & CTL Settle: http://tinyurl.com/mhgcg7
...3-29-07 CTL countersues PPHM over TNT/China licensing dispute: http://tinyurl.com/39k8sx
...3-30-07 PPHM comments on CTL's 3-29-07 countersuit: http://tinyurl.com/33xzzq
...1-12-07: New China Subsidiary; Suit Filed Against Cancer Therapeutics Labs (CTL) http://tinyurl.com/y4vzbj