ImClone Systems initiates IMC-3C5 Phase 1 trial in patients with advanced solid tumours

Circadian Technologies (ASX.CIR) announced today that its licensee ImClone Systems, a wholly-owned subsidiary of Eli Lilly and Company, has advised that it has commenced the first Phase 1 clinical trial of its fully-human monoclonal antibody IMC-3C5.

IMC-3C5 is a fully-human IgG1 monoclonal antibody being developed by ImClone as a treatment for cancer.  ImClone has exclusive rights from Circadian's 100%-owned subsidiary Vegenics to develop the VEGFR-3 antibody in return for annual license fees and royalties on potential future product sales.

The Phase 1 study will examine the safety and tolerability of escalating doses of IMC-3C5 in patients with advanced solid tumours that are refractory to standard therapy or for which no standard therapy is available.

Scientists from ImClone together with Vegenics' collaborator scientists have discovered that VEGFR-3 plays a role in directing the formation of blood supply to tumours as well as to the neonatal retina (i.e., it has a role in mediating the signals that control blood vessel 'sprouting', an event crucial to angiogenesis). These findings were published in the prestigious scientific journal Nature in July 2008.

The research team found that using antibodies to block both receptors VEGFR-2 and VEGFR-3 resulted in an additive anti-angiogenic effect, which inhibited tumour growth in animals by effectively starving the cancer cells.  

Mr. Robert Klupacs, CEO of Circadian Technologies, said: "ImClone is one of the most experienced developers of monoclonal antibodies designed to treat cancer in the world today.  We are delighted that they have been able to bring IMC-3C5 to this very important milestone and look forward to the ongoing clinical development of this molecule for the treatment of cancer."

"This is an important step forward for Circadian as we advance our strategy to become an international biologics drug development company based on our VEGF technology."

Circadian's wholly owned subsidiary, Vegenics, owns worldwide rights to an extensive intellectual property portfolio covering angiogenesis targets VEGF-D, VEGF-C and the receptor protein VEGFR-3.