CEL-SCI Corporation has announced positive results from a long-term follow-up study of head & neck cancer patients treated with its drug Multikine in a Phase II clinical trial.
The follow-up study indicated that Multikine treatment resulted in a substantial increase in the survival of patients. In addition, Multikine treatment also improved local regional control of the patients' tumors. Improved local regional control of the tumor is considered by many surgeons and oncologists to be an important measurement of the success of a head & neck cancer drug. Both survival and local regional control of the tumor are stated endpoints in CEL-SCI's planned Phase III clinical trial.
The Phase II study, which used the same Multikine treatment protocol as proposed for the Phase III trial, included advanced primary head & neck cancer patients who were scheduled for their first cancer treatment. The Multikine treatment was administered for 3 weeks prior to the standard treatment for head & neck cancer, surgery or surgery plus radiation/chemotherapy. Results from this study were published in a leading cancer publication, the Journal of Clinical Oncology (Timar et al, JCO, 23(15): May 2005).
The median follow-up period for the patients was 3.2 years. The results of the Phase II trial follow-up study showed that the Multikine-treated patients had substantially increased survival rates and achieved a higher rate of 2-year local regional control as compared to the survival and the 2-year local regional control rates published in the scientific literature (39 clinical trials between 1987 and 2004 in a similar population of head & neck cancer patients). At this time, CEL-SCI cannot provide the detailed results of this long-term follow-up study of Multikine treatment as the data are currently being prepared for publication.