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Thursday, 06/03/2010 10:38:08 AM

Thursday, June 03, 2010 10:38:08 AM

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PR 6-3-10 ASCO’10: Cotara/GMB Ph1+Ph2 Trial Updates

Glioblastoma Multiforme Data From Peregrine's Novel Brain Cancer Therapy Cotara(R) to Be Reported at ASCO
• Enrollment Over 75% Complete in Recently Expanded Phase II Trial in Recurrent GBM
http://ir.peregrineinc.com/releasedetail.cfm?ReleaseID=476190

TUSTIN, June 3, 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 data to be presented on June 6, 2010 at the ASCO Annual Meeting from a Phase I trial of Cotara(R) in patients with relapsed glioblastoma multiforme (GBM), the deadliest form of brain cancer. Cotara is a targeted monoclonal antibody linked to a radioisotope that is administered directly into the tumor, destroying the tumor from the inside out, with minimal exposure to healthy tissue. Final data from this dose confirmatory and radiation dosimetry trial confirm Cotara's targeting capabilities, delivering 300-fold higher radiation levels to the tumor than to normal organs.

"A unique approach to treating brain cancer, Cotara localizes to brain tumors with minimal exposure to surrounding tissue," commented William R. Shapiro, M.D., principal investigator of the study and chief of Neuro-Oncology at The Barrow Neurological Institute at St. Joseph's Hospital. "The Phase I study demonstrates the most effective dose appears safe to administer using dual catheter convection-enhanced delivery. Since brain tumors are typically not spherical in shape, using two catheters to deliver Cotara may enhance anti-tumor effects, as this approach shows potential for improved drug coverage within irregularly shaped tumors."

Stephen W. King, president and chief executive of Peregrine Pharmaceuticals, commented, "Verifying the safety and localization of Cotara's optimal dose using dual catheter administration further supports the dose administration protocol of our ongoing Phase II GBM trial. Enrollment is over 75% complete and we recently opened 3 additional U.S. sites to enroll the last of the 40 planned patients in this trial. We continue to monitor patient survival in this open-label trial and plan to report interim data once mature as we aim to complete this trial before the end of the year."

ABOUT PEREGRINE'S ONGOING PHASE II TRIAL
Peregrine's ongoing Phase II open-label trial is enrolling up to 40 recurrent GBM patients at 7 sites in the U.S. and India. The primary endpoint is safety and tolerability of the maximum tolerated dose, a single 25-hour interstitial infusion of 2.5 mCi/cc of Cotara. Secondary endpoints include overall survival, progression free survival, and proportion of patients alive at 6 months after treatments. For additional information, visit http://www.clinicaltrials.gov/ct2/show/NCT00677716?term=Cotara&rank=1.

ABOUT PEREGRINE'S PHASE I TRIAL WITH DATA REPORTED AT ASCO
The Phase I, open-label, dose confirmatory and radiation dosimetry trial was conducted in three U.S. centers. The primary objective was to confirm the dose limiting toxicities and maximum tolerated dose of Cotara administered as a single 25-hour interstitial infusion in patients with recurrent GBM. Final data confirm Cotara's targeting capabilities, delivering 300-fold higher radiation levels to the tumor than to normal organs. Median radiation dose to the tumor was 573 cGy/mCi.

12 patients with recurrent GBM were enrolled in this study with the first receiving an imaging dose (3 mCi) of Cotara infused via 2 interstitial catheters. Two to four weeks after imaging, patients were eligible to receive a single therapy dose of Cotara at 1.5, 2.0 or 2.5 mCi/cc using a "3+3" dose escalation scheme. Dose escalation was permitted after a six week observation period. Ten patients received a therapy dose, including 8 of the 10 imaging patients. Cotara was generally well tolerated in this study, with one dose-limiting toxicity of cerebral edema reported at the high dose of 2.5 mCi/cc. Cotara's excellent localization only in the tumor with minimal systemic radiation was demonstrated by images acquired up to 168 hours after therapy.

ABOUT BRAIN CANCER
There are an estimated 21,810 new cases of brain cancer diagnosed annually and this cancer accounts for approximately 13,070 deaths annually in the U.S. The most common type of brain cancer is glioblastoma multiforme (GBM), which accounts for 60% of all brain tumors. An aggressive form of cancer, GBM is the deadliest form of brain cancer, with a five-year survival rate of only 3%.

ABOUT COTARA
Cotara is an experimental treatment for brain cancer that links a radioactive isotope to a targeted monoclonal antibody designed to bind to the DNA histone complex that 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 using convection-enhanced delivery (CED) that targets the specific tumor site in the brain. In brain cancer studies, Cotara has demonstrated encouraging patient survival data and a Phase II GBM trial is currently ongoing. 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.

Cotara is currently being evaluated for recurrent GBM patients in a Phase II trial, which was expanded recently with additional U.S. sites. To date, more than 100 recurrent GBM patients have received Cotara and localization and accumulation of the drug to the tumor have been excellent. Longer-term survivors of greater than one year from the time of Cotara treatment have been observed in all of the trials. Some patients are still alive more than 9 years after treatment with Cotara in earlier studies.

Poster at ASCO -- Sunday, June 6, 2010, 8:00am - 12:00pm CT
Open-label, dose confirmation, and dosimetry study of Cotara for the treatment of recurrent GBM: Final results
(Abstract #48393), Author: William R. Shapiro, Poster Board 1G, 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 3 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 .
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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ASCO’10 #2039: ”Open-Label, Dose Confirmation & Dosimetry Study of Interstitial 131I-chTNT-1/B MAb for the Treatment of Recurrent Glioblastoma Multiforme (GBM): Final Results
William R. Shapiro, Sunday, 6-6-10, 8:00am-12:00pm
http://clinicaltrials.gov/show/NCT00509301 (U.S.)
ABSTRACT: Background: Interstitial 131I-chTNT-1/B MAb (Cotara) is a radioiodinated chimeric monoclonal antibody specific for DNA and histone H1 complex, which is exposed in the necrotic areas of gliomas. We are reporting on a dose confirmation and radiation dosimetry trial which examines safety and biodistribution of Cotara. Methods: Patients with recurrent GBM and clinical target volume of 5-60 cc were eligible. Cotara was infused via 2 interstitial catheters. 10 patients received a 3 mCi imaging dose of Cotara. 2-4 weeks after imaging, patients were eligible to receive a therapy dose. Three cohorts consisting of 3-4 patients each received a therapy dose of 1.5, 2.0 or 2.5 mCi/cc. Dose escalation was permitted after all patients in a cohort had been observed for 6 weeks, and all treatment-related toxicities were = grade 2. Biodistribution was determined using sequential whole body images and counting blood samples. Uptake and clearance of Cotara in tissues were quantified and radiation doses were determined based on medical internal radiation dose schema. Results: The most common AEs (>= 25%) were: headaches, nausea, constipation, brain edema, incision site complications, seizures, hemiparesis, fatigue, hyperglycemia and hypertension. 13 serious adverse events (SAEs) were observed in 8 patients, 3 had drug-related SAEs at 1.5 mCi/cc (none of which were considered DLTs) and 1 had a drug related SAE at 2.5 mCi/cc. The administered therapeutic radiation dose ranged from 15-85 mCi and 1 dose-limiting toxicity (brain edema) was observed at 2.5 mCi/cc. Images acquired up to 168 hours post infusion demonstrated Cotara was concentrated only in tumor; minimal uptake of Cotara could be faintly visualized in stomach, heart, and thyroid only for some patients. Median tumor-to-body dose ratio was 719 (range 320-3,470). Conclusions: Cotara was well-tolerated, with a single DLT observed at the 2.5 mCi/cc dose level. Dosimetry assessments indicate that Cotara localized only in tumor with minimal systemic radiation exposure. These clinical and dosimetry findings support clinical trials of Cotara over 25 hrs via 2 interstitial catheters at or below 2.5 mCi/cc.

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TUMOR NECROSIS THERAPY (TNT/COTARA/VEA’s) NEWS:

Highlights of Cotara/GBM Trials History 1998-2009: http://tinyurl.com/y8fyl2r
5-3-10: PPHM Licenses TNT rights in “Certain APEC Countries” to STASON http://tinyurl.com/29x433b
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
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
...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) - articles & updates: http://tinyurl.com/24gkml
.....Update 12-29-08: Phil posts on iHub that he's doing OK (34 mos. since diag.): http://tinyurl.com/8r5fnz
.....Update 10-14-09: Phil posts on YASG.com that he’s doing well, 44 mos. after diagnosis: http://tinyurl.com/yfbpk57

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
...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

EUR. LICENSEE MERCK-KGAA’S TNT/CYTOKINE FUSION PROTEIN PH.1 TRIAL:
...4-2009: 2nd SELECTIKINE Ph.1 trial added: SELECTIKINE+RAD/NSCLC: http://tinyurl.com/pzl9j8
...5-2007: 2nd SELECTIKINE Ph.1 site added, Univ. of Lausanne, Switz: http://tinyurl.com/2l933s
...Ph.1 Trial Protocol (Merck KGaA/Germany, PI=Dr. R.Stupp): http://tinyurl.com/2f4u2t
...2-22-07: TNT-based European Cancer Trial initiated by ‘Licensee’: http://tinyurl.com/2zcjqr
...Clearly, it's Merck-KGaA's 'SELECTIKINE' (NHS-IL2-LT/EMD521873): http://tinyurl.com/yud7pw
VEAs:
...5-1-08 Dr. Missag Parseghian (Dir/R&D) presents VEAs at PEGS/2008: http://tinyurl.com/66onj2
...NOTE: Drs. Parseghian (Dir.R&D) & Luhrs, key PPHM TNT/VEA researchers: http://tinyurl.com/2ahhdp
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