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PR 7-1-09: Eur. Patent for ‘In-Line Labeling’ & JNM Article

Peregrine Awarded European Patent for Innovative Labeling Technology Featured in New Study in The Journal of Nuclear Medicine
• Versatile Technology Significantly Reduces Complexity, Cost and Time Needed to Manufacture Labeled Biological Agents
• Initially Developed for Radiolabeled Cancer Drugs but Also Potentially Applicable to Other Diagnostic and Therapeutic Agents
• Utility Already Proven with Peregrine's Phase II Brain Cancer Therapeutic Cotara(R)
http://ir.peregrineinc.com/releasedetail.cfm?ReleaseID=393378

TUSTIN, July 1, 2009: Peregrine Pharmaceuticals, Inc. (Nasdaq: PPHM) today announced that it has been awarded a European patent for a novel device and methods for linking biological agents to labels for diagnostic and therapeutic applications. The technology, which is known as In-Line labeling, was developed for the production of radiolabeled anti-cancer antibodies, but is applicable to other agents as well. A study published today in the July 2009 issue of The Journal of Nuclear Medicine confirms that In-Line labeling can dramatically reduce the complexity and cost of producing radiolabeled cancer drugs (1). In-Line labeling is already being used for the production of Peregrine's radiolabeled antibody Cotara(R), currently in Phase II trials for the treatment of glioblastoma multiforme, a deadly form of brain cancer.

Radiolabeled drugs are important for the diagnosis and treatment of multiple cancers. However, the labeling process itself has been complex, slow, expensive and challenging to scale-up, which may have contributed to the historic underutilization of these valuable agents. Peregrine's new process replaces the traditional "batch" labeling method with a continuous In-Line flow process, where the individual constituents are kept separate at the beginning and then are allowed to flow together in a reaction tube, where the labeling process occurs. The In-Line process can prepare enormous amounts of radiolabeled product by simply keeping the constituents flowing continuously along the tube.

Missag H. Parseghian, Ph.D., senior director of R&D at Peregrine and senior author of the new publication, commented, "The continuous In-Line process requires no sophisticated instrumentation and can be implemented in almost any radiation facility. Importantly, performance-related characteristics of the resulting drug product, such as binding potency and structural integrity, are maintained by the In-Line labeling process."

"This new In-Line labeling process is elegant in its simplicity but dramatic in the benefits achieved," said Steven W. King, president and CEO of Peregrine. "The process is extremely versatile and easy to use, and it can produce large quantities of labeled drug product rapidly, reliably and cost-effectively. We have been using the new process to produce Cotara for our ongoing brain cancer trials and can report that it works as well in clinical practice as it does in the lab. We believe it is significant that this innovative process has been granted a European patent and coincidently is featured in a newly released major peer-reviewed publication. We intend to make this exciting technology available for license on a worldwide basis."

The continuous In-Line manufacturing method has European patent protection under European Patent Number 1 638 989. It was developed by inventors at Peregrine and the Paul Scherrer Institute in Switzerland, which has exclusively licensed its rights in the technology to Peregrine Pharmaceuticals.

1. Harris, D., Pellikka, R., Gasser, O., Blaeuenstein, P., Waibel, R., Schubiger, P.A., King, S., Parseghian, M. (2009).
In-Line Radiolabeling: A Novel Continuous Flow System for Commercial-Scale Protein Labeling
Journal of Nuclear Medicine 50(7):1178-1186.

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 3 separate clinical programs in cancer and hepatitis C virus 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 .
Safe Harbor *snip*
Contacts: GendeLLindheim BioCom Partners
Investors: 800-987-8256, [e-mail]
Media: Barbara Lindheim, 212-918-4650
*end*

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The Journal of Nuclear Medicine - July 2009 (pub. online 6-12-09)
Basic Science Investigation
“In-Line Radiolabeling: A Novel Continuous-Flow System for Commercial-Scale Protein Labeling”
Debra A. Harris 1, Raimo Pellikka 2, Olga Gasser 2, Peter Blaeuenstein 2, Robert Waibel 2, P. August Schubiger 2,3, Steven W. King 1, Missag H. Parseghian 1
1 R&D, Peregrine Pharmaceuticals Inc., Tustin, CA
2 Center for Radiopharmaceutical Science, Paul Scherrer Institute, Villigen, Switzerland
3 Dept. of Chemistry & Applied Biosciences, Institute of Pharmaceutical Sciences, Swiss Federal Institute of Technology, Zurich, Switzerland
ABSTRACT:
A key limitation in developing radiotherapeutic proteins is the expense of manufacturing the drug in small batches using traditional reaction vessels. Removing limitations on the quantity of protein labeled at any one time significantly decreases the cost of production, and nowhere is the need for cost-effective radiotherapeutics more acute than in the treatment of cancer.
METHODS: We describe a novel method that can rapidly radiolabel, theoretically, unlimited amounts of protein, without causing significant damage to binding potency or structural integrity. Our process controls the reaction rate for the isotope and reactants as they simultaneously flow through a reaction tube.
RESULTS: We have demonstrated proof of principle by labeling nearly a gram of antibody with 481 GBq (13 Ci) of 131I during a single 30-min reaction run.
CONCLUSION: Simple to construct, our system is already used to manufacture a radiolabeled antibody, both in the United States and in India, as part of clinical trials to treat glioblastoma multiforme. Modified, this system may be also applicable for nonradioactive labeling.
http://jnm.snmjournals.org/cgi/content/abstract/50/7/1178

India Cotara/Brain Ph.2 Trial (40 patients, 1st relapse):
6-2006 $91k contract to BRIT/India to radio-label TNT (for Cotara trial in India?): http://tinyurl.com/2r7jaf

**Drs. Missag H. Parseghian (Dir.R&D) & Keith A. Luhrs, key PPHM TNT/VEA researchers: http://tinyurl.com/2ahhdp