QualityStocks would like to highlight CEL-SCI (NYSE: CVM), dedicated to research and development directed at improving the treatment of cancer and other diseases by utilizing the body's own immune system. The company's lead investigational therapy, Multikine (Leukocyte Interleukin, Injection), is an immunotherapeutic agent being developed as a potential first-line treatment for advanced primary head and neck cancer. Data from Phase I and Phase II clinical trials suggest that Multikine simulates the activities of a healthy person's immune system, enabling it to use the body's own anti-tumor immune response.
In the company’s news yesterday,
Cel-Sci Corp. recently announced the results of 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) which cited no safety concerns. Additionally, the IDMC went on to indicate that no safety signals were found that would call into question the benefit/risk of continuing the study.
This comes as positive news for the company, as up to 30% of Phase III trials fail due to safety considerations. As such, these results are considered highly important, and the IDMC’s safety findings from this interim review were similar to those reported by investigators during the CEL-SCI’s Phase I-II trials. Ultimately, the FDA will make the final decision as to whether the drug is safe based on assessment of all the data from a completed trial.
“Our Phase III study is continuing to enroll patients on a continuous basis on three continents around the world,” said Geert Kersten, CEO of CEL-SCI Corporation. “We recently presented CEL-SCI and the Multikine head and neck cancer Phase III study at the 8th International Head and Neck Cancer conference in Toronto, Canada and interest was high among clinical investigators in joining our study. We continue to believe that adding our Multikine immunotherapy to the existing head and neck cancer treatments will create a new paradigm for the treatment of head and neck cancer.”
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