Peregrine Pharmaceuticals, Inc 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 labelling, was developed for the production of radiolabelled 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 labelling can dramatically reduce the complexity and cost of producing radiolabelled cancer drugs. In-Line labelling is already being used for the production of Peregrine's radiolabelled antibody Cotara, currently in phase-II trials for the treatment of glioblastoma multiforme, a deadly form of brain cancer.

Radiolabelled drugs are important for the diagnosis and treatment of multiple cancers. However, the labelling 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' labelling 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 labelling process occurs. The In-Line process can prepare enormous amounts of radiolabelled product by simply keeping the constituents flowing continuously along the tube.

Missag H Parseghian, 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 labelling 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 labelled 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.

Peregrine Pharma is a biopharmaceutical company with a portfolio of innovative monoclonal antibodies in clinical trials for the treatment of cancer and serious viral infections.