CEL-SCI Corporation (NYSE AMEX: CVM) provided an update today of the progress of its Phase III clinical trial of Multikine (Leukocyte Interleukin, Injection)*, which is currently being investigated in an open-label, randomized, controlled, multi-center study. Notable highlights include:
- Arrangements have been completed with leading clinical investigators and institutions from 8 countries on 3 continents to conduct the study. So far thirty five (35) clinical centers have met all legal, regulatory, and protocol requirements to screen and enroll patients. Ten of these centers in the study are controlled by CEL-SCI's partners Teva Pharmaceuticals Industries Ltd. (Israel) and Orient Europharma (Taiwan). Both companies manage their parts of this Phase III trial under procedures provided by CEL-SCI’s global Clinical Research Organization (CRO). CEL-SCI is currently arranging to bring on line an additional 10 centers to ensure rapid enrollment of the study.
- MD Anderson Radiological Physics Center, the contractor that CEL-SCI hired to assess that each clinical center is adequately equipped to accurately and precisely deliver the radiotherapy dosage regimen prescribed by CEL-SCI’s protocol to the study subjects as part of their standard care and assess that each center has an established a satisfactory Radiotherapy Quality Assurance (RTQA) program so as to assure that the radiotherapy delivered to the subjects which meets the requirements of our Phase III protocol and is consistent and comparable between patients and centers worldwide, has concluded its assessment of all 35 clinical centers. Each center has demonstrated these capabilities to the satisfaction of MD Anderson Radiological Physics Center.
- CEL-SCI has produced multiple lots of its investigational therapy Multikine (Leukocyte Interleukin, Injection) for the Phase III trial in its manufacturing facility and has supplied the product to the clinical sites in the U.S. and Canada, and six other countries around the world. CEL-SCI has sufficient manufacturing capacity in its manufacturing facility to produce the entire drug supply that will be needed for all the subjects in the trial who will receive Multikine.
- The cold chain distribution and storage methods used during shipping and storing Multikine at the clinical centers have been established and validated, and also tested in numerous shipments of Multikine around the world.
- Multiple subjects have been enrolled in the Phase III trial and have received either Multikine followed by standard therapy (surgery followed by radiation or surgery followed by radiation plus chemotherapy), or only standard therapy, the control group for the Phase III trial.
- The Company also extended the existing licensing agreements with Teva Pharmaceuticals to include the countries of Croatia and Serbia.
- CEL-SCI also entered into a licensing agreement with IDC-GP Pharm for Argentina and Venezuela.
"We are pleased by the progress we have made in moving this study forward. Having brought on-line 35 clinical centers in 8 countries on 3 continents in less than one year took great effort," said Geert Kersten, CEL-SCI's Chief Executive Officer. “With this work behind us, enrollment is accelerating and will hopefully continue to accelerate further. While it may have taken somewhat longer to set this study up on three continents than it would have taken if the study were run only in the US, the demographics of the disease we are attempting to treat with Multikine are such that the study could not be enrolled and completed in a reasonable period of time if the study were conducted only in the U.S. By conducting the study in countries that have many more patients concentrated in fewer clinical centers, enrollment should be much faster and result in a reduction in the time required to complete the study. There will also be the added benefit that includes the acceptance of the study results from a study which has tested Multikine on a diverse world-wide population.”
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