CEL-SCI Corporation receives approval of the Government in India to start phase III clinical trial of protein in head and neck cancer

Current article ratings:
Patients / public:2 (1 votes)healthcare Prof:
CEL-SCI Corporation (NYSE AMEX: CVM) today announced that it approval for the registration of patients in the clinical study of the phase III protein ® in India of the Directorate-General for health services Office of the drug Controller General (India) - the Indian equivalent of the FDA begin get has. India is an important country for these nine country clinical trial, as about 15 of the 48 Clinical Centers for this global study are in India and India has the largest number of head and neck cases in the world. It is expected that patients be registration in India about 4-6 times faster than is possible in the United States clinical centers. The global phase III study for protein began expected in the United States end of December 2010. CEL-SCI study in other countries around the world to start within the next 30-60 days. Protein is the company's flagship immunotherapy developed as first-line standard care in the treatment of head and neck cancer.

CEL-SCI phase III trial is an open, randomized, controlled, multi-center study designed to determine whether a higher overall rate managed protein before the current standard of care (surgery plus radiation therapy or surgery plus concurrent chemo radiotherapy) in previously untreated patients with advanced primary squamous cell carcinoma of oral cavity, the soft palate (head and neck cancer) leads the survival, only treated with standard therapy when compared to the topics. CEL-SCI 880 patients from phase III study the largest clinical trial of head and neck cancer ever be carried out. It is also the first study in the immune therapy before other traditional means care run, are managed. This is significant, because conventional cancer therapy benefits of the immunotherapy weakens the immune system and likely compromise.

Phase II studies of the protein shown that the product was safe and well tolerated and eliminated tumors in 12% of the subjects less than a month in treatment. The Multikine treatment regimen was also shown that on average about tumors prior to the standard of care will kill half of the cancer cells in the topics. Follow up studies on topics enrolled were treated with an average three and a half years after surgery a 33% improvement studies in phase II in the survival rate of those with protein. The U.S. food and Drug Administration granted orphan drug designation protein in neoadjuvant therapy of patients with squamous cell carcinoma of head and neck.

Source:
CEL-SCI Corporation