​​​​​​​Cel-Sci, in trying to escape clinical hold, creates new problems for Multikine R&D program at the FDA

FDA
Cel-Sci tried to get its partial FDA clinical hold lifted, and ended up under complete clinical hold.

Cel-Sci’s pitch to get a partial clinical hold lifted by the FDA has gone awry. The drugmaker set out a plan to get clinical development of Multikine moving forward again, only for the FDA to pick its proposal apart and switch up its clinical hold from a partial restriction to a full blockade.

The FDA placed Multikine under a partial clinical hold in September. Cel-Sci met with the FDA to talk about the clinical hold in February and left the meeting thinking it could get the restrictions lifted by providing two things: An updated investigator’s brochure and a list of major deviations from the protocol. Cel-Sci’s summary of the first task highlighted the need for procedures that comply with FDA regulations covering sponsor and investigator responsibilities.

Cel-Sci has now revealed its response failed to live up to the FDA’s expectations.

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“We have completed the review of your April 19, 2017, submission and have concluded that removal of the clinical hold is not warranted since item 3 of the October 15, 2016 letter has not been resolved. In addition, we have identified new deficiencies in your April 19, 2017, submission,” the agency wrote in its response to Cel-Sci.

In a letter to shareholders to disclose the setback, Cel-Sci said the FDA wants it to add statements and data to the investigator brochure and “Dear investigator” letter. Cel-Sci also said the FDA has asked it to remove some of the statements it did include in the documents.

The correspondence also informed Cel-Sci it is now under a full clinical hold. When the FDA first hit Cel-Sci with the regulatory restrictions, it allowed physicians to continue to treat patients already enrolled in a phase 3 head and neck cancer trial with Multikine. Now, with all those patients having completed their planned treatments, the FDA has moved from a partial to full clinical hold. The change means Cel-Sci is banned from resuming treatment in previously-enrolled patients.

That decision means development of Multikine, with the exception of a HPV trial being run under a separate IND, is stopped until Cel-Sci can fix the problems with its previous attempt to resolve the hold. CEO Geert Kersten told investors the company is revising the documents now and hopes to send them to the FDA “very soon.”

How much the lifting of the clinical hold will help Cel-Sci is questionable. The biotech closed out the last quarter with $1.5 million in the bank, and the status of its phase 3 aside from the hold is uncertain. Cel-Sci hit its enrollment target last year—six years after starting the study—but then decided it needed to recruit more patients to reach its primary endpoint in a reasonable amount of time. The FDA clinical hold curtailed that recruitment drive. And Cel-Sci now thinks it may not need to add more patients after all.

The regulatory dialogue is advancing in parallel to an arbitration case between Cel-Sci and its former CRO, inVentiv Health. Cel-Sci accused inVentiv of fraud and breach of contract, prompting the CRO to riposte that the biotech was trying to “avoid paying an outstanding debt” by making meritless claims.

Cel-Sci is seeking upward of $50 million. InVentiv has countersued for $20 million. For a company with a dwindling bank balance and a market cap of $23 million, the case is critical.

Shares in Cel-Sci fell 32% in premarket trading.