Avid Bioservices Inc (CDMO)

[cjgaddy]

Interesting site: BiotechnologyEvents.com ( http://www.biotechnologyevents.com ) – extensive database of all sorts of things - edited by Joseph Sawicki, MD. One thing that caught my eye is an “Event” named “Cotara Corporate: Licensure & Partnership”, stamped with this date: 2013-01-01 - 2013-06-30, “Pending”.
I have to think Dr. Sawicki put together this “Event” from these comments in Peregrine’s 12-5-12 Cotara PR: “(this Ph3 design), if successful, should be sufficient to support a full marketing submission… 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.”

http://www.biotechnologyevents.com/what-we-offer

Peregrine Pharmaceuticals, Inc.
http://www.biotechnologyevents.com/node/6209

Compound/Device: Cotara (iodine I 131 monoclonal antibody TNT-1/B)
Specialty: Oncology
Indication: Glioblastoma Multiforme (GBM)
Compound Class: Tumor Necrosis Treatment (TNT) agent
Target: Histone H1 & DNA
MOA: Cotara (iodine I 131 monoclonal antibody TNT-1/B) is an iodine 131 labeled radioimmunoconjugate of monoclonal antibody (MOAB) TNT-1/B with radioimaging & antineoplastic properties. MOAB TNT-1/B was developed for radioimmunotherapy of solid tumors, designated as Tumor Necrosis Treatment (TNT). TNT exploits the presence of degenerating and necrotic cells within tumors by utilizing MOAbs directed against universal, intracellular nucleosomal determinants consisting of histone H1 & DNA. This MOAB was conjugated with biotin (B) molecules, which increase pharmacokinetic performance of the monoclonal antibody. MOAB TNT-1/B delivers I 131 to tumor cells and results in the targeted imaging and/or destruction of cells with exposed necrotic antigens.
• Phase of Development: II
• Event Type: Corporate: Licensure & Partnership
• Dates: 2013-01-01 - 2013-06-30
• Results: Pending

December 5, 2012
• 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
TUSTIN, CA, 12/5/12: Peregrine Pharmaceuticals (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. 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 2 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. FDA and orphan drug designation by the European Medicines Agency (EMA). More…
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12-5-12: http://investorshub.advfn.com/boards/read_msg.aspx?message_id=82140076