The US-based CEL-SCI Corporation, in collaboration with its development partners Teva Pharmaceutical Industries and Orient Europharma, is planning to start Phase III clinical trials for its cancer immunotherapy drug candidate Multikine in the third quarter of 2010.
The company, together with its development partners, has already selected 40 of the planned 50 global medical centers where the Multikine phase-III study will be conducted and all major vendors for the study have now been chosen, updated the company in an announcement.
Earlier, the US Food and Drug Administration (FDA) gave the go-ahead for a phase-III clinical trialand granted orphan drug status to Multikine in the neoadjuvant therapy of patients having squamous cell carcinoma (cancer) of the head and neck.
The trial is expected to be the largest head and neck cancer clinical study ever conducted, with more than 800 patients expected to be enrolled worldwide. It will also be the first phase-III study in the world in which cancer immunotherapy is given to treatment naïve patients - before surgery, radiation and/or chemotherapy. This is believed to be the best time to stimulate an anti-tumour immune response as the immune system is still competent.
"We are eager to commence the pivotal study to validate Multikine as the standard of care for newly diagnosed head and neck cancer patients," said Geert Kersten, CEL-SCI's chief executive officer. "We look forward to confirming the promising results that Multikine has already demonstrated in earlier clinical trials. We have taken every step to both minimize risk and maximize our chances for success."
Kersten continued, "If the huge success of Dendreon's Provenge has defined the first generation of cancer immunotherapy, we expect our Multikine to define the second generation. Multikine is an off the shelf product making large commercial production possible, it contains both passive and active immunity and is given before any other cancer therapy, a time when cancer immunotherapy should be most successful."
In phase-II clinical trials Multikine was shown to be safe and well-tolerated, and to eliminate the tumour in 12 per cent of the patients after only three weeks of treatment. Follow-up showed an improvement in the Multikine treated patients' overall survival by 33 per cent at a median of three and a half years following surgery.
Multikine, a patented defined mixture of naturally derived cytokines, is the first immunotherapeutic agent in a new class of drugs called "Immune Simulators".
CEL-SCI Corporation is developing products that empower immune defenses. Its lead product is Multikine which is being readied for a global phase-III trial in advanced primary head and neck cancer.