Clinical Trials

U.S. FDA requests additional information regarding company's clinical trials

Published in Medical Letter on the CDC and FDA, March 13th, 2005

Stem-cell biotechnology and immunotherapy company CyGenics, Ltd., (CYN) announced that it has been in detailed communications with the U.S. Food & Drug Administration (FDA), on its phase I/II clinical trials, using T cells produced in its T-cell growth platform, to restore the damaged immune systems of patients.

The investigational new drug application filing, made on November 21, 2004, underwent the customary initial review by the FDA. The FDA has requested additional information beyond what is currently available to be included for review. CyGenics expects it will require 6-8 months to furnish this information. In addition, a review of the trial design for the phase...

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Source: Medical Letter on the CDC and FDA (2005-03-13)

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