Avid Bioservices Inc (CDMO)

[cjgaddy]

PR 10-6-10: Cotara/GBM Ph.2 Data to be presented Oct16-21 at AIIMS

Data From Peregrine's Phase II Cotara Brain Cancer Trial to Be Presented at 2010 Congress of Neurological Surgeons Annual Meeting [Oct 16-21 2010]
http://ir.peregrineinc.com/releasedetail.cfm?ReleaseID=515301

TUSTIN, Oct. 6, 2010: 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 upcoming presentation of interim data from an ongoing Phase II clinical trial evaluating the company's investigational brain cancer therapy Cotara(R) in patients with recurrent glioblastoma multiforme (GBM), the deadliest form of brain cancer. The data will be presented in a poster session at the 2010 Congress of Neurological Surgeons Annual Meeting in San Francisco, California, October 16-21, 2010.

A poster titled "Glioblastomas: Recent Developments and Lessons Learned from Collateral Targeting Agent Therapy in Recurrent High grade Gliomas: A Single Center Experience" will be presented by Deepak Gupta, M.D., assistant professor of neurosurgery at the All India Institute of Medical Sciences (AIIMS) in New Delhi, India, the Phase II trial's lead clinical site.

For additional information on this conference, please visit http://w3.cns.org/meetings/2010/attendees/prelim.asp .
[ Conf. Home: http://w3.cns.org/meetings/2010/index.asp ]

ABOUT COTARA
Cotara is an investigational 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. Peregrine's ongoing Phase II open-label trial is enrolling up to 40 GBM patients at first relapse at 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, please visit http://clinicaltrials.gov/ct2/show/NCT00677716?term=cotara&rank=1 .

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(R). 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 .
Contact:
Amy Figueroa, Peregrine Pharmaceuticals, [phone], [e-mail]

= = = = = = = = = = =
TUMOR NECROSIS THERAPY (TNT/COTARA/VEA’s) NEWS: (see http://PeregrineTrials.com )

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
...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 headed by Dr. Eugene Mechetner will be formed which will focus on commercializing TNT technologies."
…Stason spin-off for TNT/APEC Dev: Stonsa Biopharm (CEO Dr. Eugene Mechetner) http://tinyurl.com/29r7one
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
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) - 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
.....Update 6-2010: Phil posts on LinkEdin that he’s working at MIT, 51 mos. after diagnosis: http://tinyurl.com/378syk3

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