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July 8, 2014
08:15 EDTCVMCEL-SCI receives regulatory clearance to expand Phase III trial into Austria
CEL-SCI Corporation announced that it has received regulatory clearance from the Austrian Federal Office for Safety in Health Care to begin patient enrollment in the companyís Phase III Head and Neck Cancer clinical trial of its investigational cancer immunotherapy treatment Multikine. Austria is the 14th country to participate in CEL-SCIís trial which is already active in numerous clinics around the world. CEL-SCIís Phase III trial is assessing the use of the companyís Multikine immunotherapy as a first line treatment for patients diagnosed with advanced primary head and neck cancer, prior to standard of care, which involves surgery, chemotherapy, and/or radiation therapy. If approved for use following completion of CEL-SCI's clinical development program for head and neck cancer, Multikine would be a different type of therapy in the fight against cancer; one that appears to have the potential to work with the body's natural immune system in the fight against tumors. Further expansion of CEL-SCIís Phase III head and neck cancer trial is underway with a goal to have a total of 880 patients enrolled through about 100 clinical centers through by the end of 2015. Over 200 patients are already enrolled in, and being treated with Multikine.
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February 1, 2016
10:00 EDTCVMCEL-SCI says enrolled 29 patients in Phase 3 Multikine trial in January
CEL-SCI Corporation announced that during the month of January it has enrolled 29 patients in its ongoing Phase 3 trial of its investigational immunotherapy Multikine in patients with advanced primary head and neck cancer. Total patient enrollment for the trial is now 697 as of January 31, 2016 in the Phase 3 study in head and neck cancer. The current study goal is to enroll 880 patients through approximately 100 clinical centers in over 20 countries. The Multikine Phase 3 study is enrolling patients with advanced primary squamous cell carcinoma of the head and neck. The objective of the study is to demonstrate a statistically significant improvement in the overall survival of enrolled patients who are treated with the Multikine treatment regimen plus standard of care vs. subjects who are treated with SOC only.

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