CEL-SCI Corporation announced that the Biologics and Genetic Therapeutics Directorate of Health Canada has issued a final “no objection” letter for CEL-SCI to be able to begin enrollment of patients for a phase III clinical trial of Multikine in Canada. This final approval was given after CEL-SCI was able to provide facility, manufacturing and stability data for the clinical batches of Multikine. Canadian centres are expected to start enrolling patients within the next month.
The phase III trial will be conducted in approximately 48 clinical centres in nine countries. CEL-SCI's partner Teva Pharmaceutical Industries will be conducting the trial at three clinical centres in Israel and its partner Orient Europharma will be conducting the trial at seven clinical centres in Taiwan. The phase III trial started in the United States in late December 2010 and in India on April 28, 2011. Multikine is the company's flagship immunotherapy developed as a first-line standard of care in treating head and neck cancer.
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 neoadjuvant therapy of patients with squamous cell carcinoma of the head and neck.
CEL-SCI Corporation is developing products that empower immune defences. It is also developing an immunotherapy (LEAPS-H1N1-DC) to treat H1N1 hospitalized patients and a vaccine (CEL-2000) for Rheumatoid Arthritis using its LEAPS technology platform.