Fibrocell Science, Inc, a biotechnology company focusing on the development of autologous cell therapies for aesthetic, medical and scientific applications, has initiated a small histology study (IT-H-001) of azficel-T, an autologous cell therapy currently under review by the US Food and Drug Administration (FDA) for the treatment of moderate to severe nasolabial fold wrinkles. The study has a target enrolment of approximately 20 participants from the completed and statistically significant pivotal phase-III studies of azficel-T (IT-R-005 and IT-R-006).
The US FDA requested the comparative histological data from this study in a Complete Response letter issued to the Company on December 21, 2009 related to the Biologics License Application (BLA) for azficel-T for the treatment of moderate to severe nasolabial fold wrinkles in adults.
The histology study will evaluate tissue treated with azficel-T as compared to tissue treated with sterile saline (placebo). The study will also provide information about the skin after treatment, including evaluation of collagen and elastin fibrils, and cellular structure of the sampled tissues.
“Over the past several months, we have worked closely with the FDA and our clinical investigators to design this study protocol,” said David Pernock, chairman and CEO, Fibrocell Science Inc. “We intend to submit data from the study to the US FDA in the fourth quarter of 2010.”
According to milestones established in the Prescription Drug User Fee Act (PDUFA), the FDA will have six months to review the data submission once they deem Fibrocell’s response to their letter complete.