CEL-SCI Corporation (NYSEMKT:CVM) did not have a happy farewell for 2016 because of so much happening within the company. In September 2016, the company got its much-needed, long-awaited settlement against InVentiv. But, what was awaiting the company was more like a blow. While, the settlement did offer a sense of relief, but the same day, FDA put on hold, the company’s Phase III Trial. What prompted FDA’s action was the company’s proposal of introducing changes to Phase III study, which meant that the trial would have taken another year.
Indecisive future of Multikine treatment’s Phase I trial for HPV-related warts
Meanwhile, the Multikine treatment’s Phase I trial for HPV-related warts also has the fate that lies in the womb of future. The Anal Warts in immunocompromised patients is claimed to be treated by company’s Multikine treatment. But, when? Perhaps, the answer lies in its bleak future. From what is learnt recently, the Phase I clinical trial of this treatment was conducted under the guidance of US Navy Hospital CRADA. However, low enrolment of patients in the trial led to its termination.
However, it was also found that perhaps, CVM’s management was continuing the trial with the University of San Francisco.
The FDA’s action on Multikine treatment’s Phase III trial
Until August 2016, the company had reported that as many as 877 patients were enrolled in the trial, albeit the requirement was 880 patients. Over the due course of months, there were approximately 30 more patients into the group.
Everything then went downhill for the company since the founder; Maximilian de Clara resigned, citing his health issues. Eventually, the company made changes to its Phase III trial program and decided to add hundreds of more patients.
This perhaps did not go well with the FDA, which in turn, decided to put a partial clinical hold on company’s Phase III trial.
Until October 2016, the company was planning to work on the response to FDA, but without luck. While all this has clearly upset the shareholders, what 2017 will bring in for the company, is yet to see.