Cesca Says FDA Seeks Addl Info On Pivotal IDE Application For Treating CLI

(RTTNews) - Cesca Therapeutics, Inc. (KOOL) announced that it has received a letter from the U.S. Food and Drug Administration responding to the company's investigational device exemption (IDE) application for its pivotal CLIRST III clinical trial.

The IDE application, filed on November 20, sought approval to begin a pivotal, randomized, placebo-controlled study of 224 late stage CLI patients at up to 60 clinical sites in the U.S. and India.

In its letter, the FDA noted several deficiencies in the company's submission, requesting, among other things, additional information on characterization of the output of the SurgWerks - CLI and VXP system, a plan for testing device output for conformity to predefined intra-operative release criteria prior to administration, modifications to the management of potential adverse events and a strengthening of the language in the risk clauses in the Informed Consent Document.

However, the FDA noted no deficiencies relating to the company's overall trial design, including the patient population size of 224, the 3:1 randomization and the use of a blinded independent committee for determination of amputation decisions.

Cesca believes that, upon FDA approval, its study will be one of the first CLI trials to use a blinded independent committee review to assess the primary endpoint.