CEL-SCI Corporation announced that it has received approval to begin enrolment of patients in its phase III clinical trial of Multikine in India from the Directorate General of Health Services Office of Drug Controller General of India (DCGI) - the Indian equivalent of the FDA. India is an important country for this nine country clinical trial because about 15 of the 48 clinical centres for this global trial will be located in India and because India has the greatest number of head and neck cancer cases in the world.
It is expected that patient enrolment in India will be about 4-6 times faster than would be possible in US clinical centres. The global phase III trial for Multikine was started in the United States in late December 2010. CEL-SCI expects to commence the trial in other countries around the world within the next 30-60 days. Multikine is the company's flagship immunotherapy developed as a first-line standard of care in the treatment of head and neck cancer.
CEL-SCI's phase III clinical trial is an open-label, randomized, controlled, multi-centre study designed to determine if Multikine administered prior to current standard of care (surgery plus radiotherapy or surgery plus concurrent chemo radiotherapy) in previously untreated subjects with Advanced Primary Squamous Cell Carcinoma of the Oral Cavity/Soft Palate (Head and Neck cancer) will result in an increased overall rate of survival, versus the subjects treated with standard of care only.
CEL-SCI's 880 patient phase III trial is expected to be the largest clinical study of head and neck cancer ever conducted. It is also the first trial in which immunotherapy will be administered before any other traditional means of care are attempted. This is significant because conventional cancer therapy weakens the immune system and likely compromises the benefits of immunotherapy.
Phase II clinical trials of Multikine demonstrated that the product was safe and well-tolerated and eliminated tumours in 12% of the subjects less than a month into treatment. The Multikine treatment regimen was also shown to kill, on average, about half of the cancer cells in the subjects' tumours before the start of standard therapy. Follow-up studies of subjects enrolled in phase II trials showed a 33% improvement in the survival rate of those treated with Multikine at a median of three and a half years following surgery. The US Food and Drug Administration granted orphan drug status to Multikine in the neo-adjuvant therapy of patients with squamous cell carcinoma of the head and neck.
CEL-SCI Corporation is developing products that empower immune defenses. The lead product, Multikine is currently being tested in a global phase III clinical trial that started in December 2010. In phase II clinical trials Multikine was shown to be safe and well-tolerated and to improve the patients overall survival by 33 per cent at a median of three and half years following surgery.