Immunotherapy, the science of corralling the power of the immune system to fight disease, is hot-button as one of the most promising approaches for the future of medicine. That said, it's been a bumpy road for many pharmas in the space, including Cel-Sci Corp. (NYSE MKT:CVM), whom the U.S. Food and Drug Administration (FDA) put a partial hold on their late-stage trial of Multikine last September and followed that with a complete hold in May.
After going back and forth with the regulatory agency, Cel-Sci finally got the break it needed, saying on Monday that it had met the FDA's wishes and all clinical trials under an Investigational New Drug application for Multikine are green-lighted again.
Amongst other things, the FDA wanted to see an updated investigator's brochure and a list of deviations from protocol.
In this case, Cel-Sci is developing the treatment, more formally known as injectible Leukocyte Interleukin, as a front-line therapy for head and neck cancer patients. The phase 3 study has enrolled and treated 928 newly diagnosed, treatment-naive patients wither with standard of care or with Multikine.
A separate study evaluating Multikine for HPV was filed under a different IND and not subject to any of the restrictions imposed by the FDA with regards to the head and neck cancer study.
Cel-Sci will not know if the trial meets its primary endpoint of at least a 10% increase in overall survival compared to standard of care until about one-third of the enrolled patients succumb to the disease (298 deaths). Current standard of care for head and neck cancer patients is surgery, then either radiation alone or a combination of chemotherapy and radiation.
If they can improve outcomes and eventually garner FDA approval, it would be a major breakthrough for a disease that claims some 300,000 lives each year and sees about 500,000 new diagnoses. The FDA hasn't approved a new treatment for advanced primary head and neck cancer in more than five decades.
Shares of CVM are up about 28% at $2.96 with about two hours left in the trading day on about 10x their average volume over the last two weeks.
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