Avid Bioservices Inc (CDMO)

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PR 12-20-10: Treatment Complete in Cotara/GBM Ph.2 Trial

Peregrine Completes Treatment of Last Patient in Phase II Cotara Brain Cancer Trial
• Top-Line Survival Data Expected Mid-2011; Company Plans for FDA Meeting to Determine Registrational Pathway
http://ir.peregrineinc.com/releasedetail.cfm?ReleaseID=537946

TUSTIN, 12/20/10: 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 in the company's Phase II dose confirmation trial of Cotara in patients with recurrent glioblastoma multiforme (GBM) [ http://clinicaltrials.gov/ct2/show/NCT00677716 ], the deadliest form of brain cancer. Cotara is a targeted monoclonal antibody linked to a radioisotope that is administered as a single dose directly into the tumor, irradiating the tumor from the inside out, with minimal exposure to healthy tissue.

Interim median overall survival for patients treated with Cotara has ranged from 38 to 41 weeks, with 86 weeks from 14 patients at a single medical center [ 10-18-10 CNS’10: http://tinyurl.com/349kvca ]. Expected survival is only approximately 24 weeks for recurrent GBM patients. 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.

"As currently approved therapies have failed to improve overall survival for recurrent GBM patients, the interim overall survival reported to date from our Cotara trials has been quite remarkable and we are eager to advance our treatment into a registrational trial," said Joseph S. Shan, VP of Clinical & Regulatory Affairs at Peregrine. "We expect top-line data to be available by mid-year 2011 and plan to meet with the FDA to define the optimal registration pathway for Cotara."

ABOUT COTARA
Cotara is an investigational targeted monoclonal antibody linked to a radioisotope that is administered as a single dose directly into the tumor, irradiating the tumor from the inside out, with minimal exposure to healthy tissue. Peregrine's Phase II open-label trial was designed to enroll 40 GBM patients at first relapse at multiple 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.

ABOUT BRAIN CANCER
According to the American Cancer Society, in 2010 there will be an estimated 22,000 malignant tumors diagnosed and approximately 13,000 deaths attributed to brain or spinal cord cancer in the United States. 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 5-year survival rate of only 3%. Currently approved therapies include Temodar (temozolomide) and Avastin (bevacizumab), both of which have modest effect on patient survival.

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*
Peregrine Contact:
Amy Figueroa, Peregrine Pharmaceuticals, [phone], [e-mail]

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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
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"