CEL-SCI Corporation (NYSE MKT: CVM) announced today that an interim review of
the safety data from its open label, randomized, controlled, pivotal Phase III
study of Multikine (Leukocyte Interleukin, Injection) investigational
immunotherapy by an Independent Data Monitoring Committee (IDMC) raised no
safety concerns. The IDMC also indicated that no safety signals were found
that would call into question the benefit/risk of continuing the study.
CEL-SCI considers the results of the IDMC review to be important since studies
have shown that up to 30% of Phase III trials fail due to safety
considerations and the IDMC's safety findings from this interim review were
similar to those reported by investigators during CEL-SCI's Phase I-II trials.
Ultimately, the decision as to whether a drug is safe is made by the FDA based
on an assessment of all of the data from a trial.
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