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Saturday, 05/31/2008 8:23:51 AM

Saturday, May 31, 2008 8:23:51 AM

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PR 5-31-08: ASCO/2008 – Cotara Ph.1B/USA

Data To Be Presented at ASCO Supports Potential of Peregrine's Cotara for the Treatment of Brain Cancer
• Study Results Show 100-Fold More Radiation Delivered to Tumor as Compared to Other Organs
• All Patients Surpassed Expected Median Survival Time at Lowest Planned Dose Level

http://ir.peregrineinc.com/releasedetail.cfm?ReleaseID=313241

CHICAGO & TUSTIN, May 31, 2008: Peregrine Pharmaceuticals, Inc. (Nasdaq: PPHM) today reported that clinical researchers from the Abramson Cancer Center of the University of Pennsylvania will present data showing that its brain cancer agent Cotara(R) specifically localizes to brain tumors at high concentrations with minimal radiation exposure to other organs. Cotara is a targeted monoclonal antibody linked to a radioisotope being developed as a potential new treatment for glioblastoma multiforme (GBM), a deadly form of brain cancer. Cotara specifically targets cells at the center of brain tumors, so its radioactive payload is able to kill cancer cells while leaving healthy tissue largely unaffected. The study results show that the concentration of Cotara in brain tumors was at least 100-fold higher than in other organs, and all of the GBM patients in the study cohort discussed in this presentation have surpassed the expected median 6-month survival time for this patient population.

No dose-limiting toxicities were reported in this dosimetry study, confirming other clinical data showing that Cotara appears to have a good safety profile. The Cotara data will be presented on Sunday at the 44th American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago, Illinois [ http://www.asco.org/annualmeeting ] .

"These findings confirming Cotara's potential to target its radioactive payload to brain tumors while minimizing radiation exposure to healthy organs have enabled us to advance this Cotara trial to the next stage," said Dr. Kevin Judy, associate professor neurosurgery at the University of Pennsylvania School of Medicine and a principal investigator of the Cotara dosimetry trial. "Cotara's good safety profile to date is especially encouraging in view of the toxicity of the treatment options currently available to GBM patients. We look forward to further assessing its safety and anti-tumor activity at the higher doses we plan to use in the next stages of the trial."

The open label dose confirmation and dosimetry study at U.S. brain cancer centers is enrolling GBM patients with recurrent disease. Patients in this trial receive an initial imaging dose of Cotara before receiving the therapeutic dose.

"These positive data validate a key principle underlying the Cotara program, confirming its ability to specifically concentrate in and deliver a high radiation dose to brain tumors," said Steven W. King, president and CEO of Peregrine. "These results also further confirm the key targeting attribute of Cotara, showing it results in minimal radiation exposure to other organs, including the thyroid. We also are encouraged that patients in this initial, low-dose cohort have already lived longer than the expected median survival time for GBM patients at first relapse, and we look forward to reporting further data on Cotara in the coming months."

The dosimetry study's main objectives are to confirm the maximum tolerated dose of Cotara, to determine radiation dosimetry and to assess overall patient survival, progression-free survival and the proportion of patients alive at 6 months following Cotara administration. In addition to the University of Pennsylvania Medical Center, the Medical University of South Carolina in Charleston and the Barrow Neurological Institute in Phoenix, Arizona are participating in the trial. A 4th study site was recently initiated at Case Western Reserve University in Cleveland, Ohio. Peregrine is also conducting a Cotara Phase II safety and efficacy trial in India in GBM patients at first relapse. In patients treated to date, Cotara appears to be safe and well tolerated.

ABOUT COTARA(R)
Cotara is an experimental treatment for brain cancer that links a radioactive isotope to a targeted monoclonal antibody. This monoclonal antibody is designed to bind to a type of DNA that is exposed only on dead and dying cells, and solid tumors have many dead and dying cells at their center. Cotara's targeting mechanism enables it to home in on these cells, delivering its radioactive payload directly to the center of the tumor mass and thereby destroying it "from the inside out," with minimal radiation exposure to healthy tissue. Cotara is delivered using convection-enhanced delivery (CED), an NIH-developed method which targets the specific tumor site in the brain. In a previous clinical study, a subset of patients with recurrent glioblastoma treated with Cotara achieved a median survival of 38 weeks, a 58% increase over the median survival time of 24 weeks for patients treated with standard of care therapy. In this study, 25% of 28 recurrent patients survived for more than a year post-treatment and 10% of patients survived for more than 3 years. These data are considered a promising development in this deadly disease. Cotara has been granted orphan drug status and fast track designation for the treatment of glioblastoma multiforme and anaplastic astrocytoma by the U.S. FDA. Cotara is in a Phase I dosimetry trial in GBM patients in the U.S. and a Phase II safety and efficacy trial in GBM patients in India. For more information on the U.S. clinical trials, visit http://www.clinicaltrials.gov

Poster Number: 5B, Abstract No: 2072:
S. Shen, R. Lustig, K.D. Judy, J.B. Fiveash, J. S. Shan
"Open-label, dose confirmation and dosimetry study of Interstitial I 131 I-chTNT-1/ B MAB for the treatment of recurrent glioblastoma multiforme (GBM)."
Sunday, June 1, 2008 2:00PM - 6:00PM CDT.

ABOUT PEREGRINE PHARMACEUTICALS
Peregrine Pharmaceuticals, Inc. is a biopharmaceutical company with a portfolio of innovative product candidates in clinical trials for the treatment of cancer and hepatitis C virus (HCV) infection. 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 bio-manufacturing services for both Peregrine and outside customers. Additional information about Peregrine can be found at http://www.peregrineinc.com.

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

= = = = = = =
COTARA/Brain - SUNDAY, 6/1/2008, 2-6pm:
“Open-Label, Dose Confirmation and Dosimetry Study of Interstitial 131I-ChTNT-1/B Mab for the Treatment of Recurrent Glioblastoma Multiforme (GBM)”
Poster #5B, Abstract #2072
Category: Central Nervous System Tumors
Meeting: 2008 ASCO Annual Meeting
Citation: J Clin Oncol 26: 2008 (May 20 suppl; abstr 2072)
Author(s): S. Shen, R. Lustig, K. D. Judy, J. B. Fiveash, J. S. Shan
Abstract:
BACKGROUND: 131I-chTNT-1/B MAb (Cotara [C]) is a radioiodinated chimeric monoclonal antibody specific for DNA and histone H1 complex, which becomes exposed in the necrotic areas of gliomas. This is the first report on biodistribution and dosimetry of C for treatment of recurrent glioma. In a prior phase I trial with a single catheter, C was infused over ~25 hrs using convection enhanced delivery (CED). This current trial assesses the use of 2 interstitial catheters to deliver C via CED.
METHODS: Patients with recurrent GBM and tumor volume of 5-60 cc are eligible. Patients receive 3 mCi of C for imaging and dosimetry followed 2-4 weeks later with a therapy dose. Cohorts of 3-6 patients will be enrolled to receive a therapy dose of 1.5, 2.0 or 2.5 mCi/cc. Biodistribution and dosimetry of C is determined using 5 sequential whole body images and counting 9 blood samples. Uptake and clearance of C in tissues were quantified and radiation doses were determined based on Medical Internal Radiation Dose schema.
RESULTS: Three patients received an imaging dose and then a therapy dose at 1.5 mCi/cc, both infused over ~25 hrs with 2 interstitial catheters. The administered therapeutic radiation dose ranged from 17- 74 mCi and no dose limiting toxicities (DLT) were observed. From images acquired immediately and up to 168 hours post infusion, Cotara was concentrated only in tumor. Minimal uptake of Cotara could be faintly visualized only in stomach, heart, and thyroid. The peak uptake ranged from 1.1-3.3 %ID for stomach, 0.4-1.2 %ID for heart, 0.05-0.26 %ID for thyroid, 0.0009-0.0017 %ID/mL for blood, and 30-55.7 %ID for tumor. Radiation doses ranged 1.8-3.3 cGy/mCi for stomach, 0.9-1.6 cGy/mCi for heart, 0.7-4.4 cGy/mCi for thyroid, 0.9-1.6 cGy/mCi for contralateral healthy brain, 0.64-1.1 cGy/mCi for marrow from radioactivity in blood, and 179-598 cGy/mCi for tumor. Mean tumor-to-body dose ratio was 551 and ranged 223-732.
CONCLUSIONS: CED administered C specifically localized only in tumor with minimal systemic radiation exposure. No DLTs were observed at the 1.5 mCi/cc dose level. These clinical and biodistribution/dosimetry findings are encouraging and support further dose escalation.
http://www.abstract.asco.org/AbstView_55_33972.html

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

USA Cotara/Brain ‘Dosimetry & Dose Confirmation Trial’ (originally funded by NABTT):
...3-11-08: Update on USA/Dosimetry & India/Ph2 GBM trials: http://tinyurl.com/6llfzf
...3-2008: New site: Barrow Neurological Institute (PI: Dr. William Shapiro): http://tinyurl.com/4pp4u8
...6-26-07: New U.S. Cotara/Brain Site: MUSC/Dr. Sunil Patel http://tinyurl.com/3cx9jv
...8-29-05: NABTT Initiates Cotara/Brain Trial (28 patients/4 sites): http://tinyurl.com/9w3cr
...New MUSC/UPCC protocol added 8-14-07, “currently recruiting”: http://clinicaltrials.gov/show/NCT00509301
...Orig. NABTT protocol, “6-2007, completed”: http://www.clinicaltrials.gov/ct/show/NCT00128635
...The Phil Marfuta Story (NABTT Cotara/GBM patient #1) - articles and updates: http://tinyurl.com/24gkml
...5-20-07 WPVI-TV(Phily) Story/Interview with Phil (video): http://tinyurl.com/2vomle
...5-2006: UAB's Dr. Louis Nabors gets $185k contract w/PPHM to study Cotara/GMB http://tinyurl.com/zx8bs

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"

India Cotara/Brain Ph.2 Trial (40 patients, 1st relapse):
India’s DCGI protocol (init=7-2007): http://clinicaltrials.gov/ct2/show/NCT00677716
...8-2-07 1st Patient Dosed in Indian Cotara/Brain Ph.2 Trial: http://tinyurl.com/296mcj
...6-25-07 Enrollment Begins in Indian Cotara/Brain Ph.2 Trial: http://tinyurl.com/2v6bae
...10-12-06 Cotara/Brain Ph.2 Trial to begin in India: http://tinyurl.com/ybf5u2
...6-2006 $91k contract to BRIT/India to radio-label TNT (for Cotara trial in India?): http://tinyurl.com/2r7jaf
...The obvious desire is to compare Cotara vs. SOC Temodar for GBM therapy: http://tinyurl.com/yttt99



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