Living Cell meets with FDA to prepare for cell therapy trials

By E. Janene Geiss

Philadelphia, Feb. 16 - Living Cell Technologies Ltd. said Thursday that it has held positive meetings with the Food and Drug Administration regarding its NeurotrophinCell product.

"The meetings have provided strong reassurance that xeno-based cell therapies have a clear and defined pathway to market," Living Cell chief executive officer David Collinson said in a company news release.

Representatives from the company attended the pre-Investigational New Drug meeting with members of the National Institutes of Health and reviewers from the Center for Biologics Evaluation and Research, the group within the FDA responsible for the evaluation of biologics, including cell and gene therapies, officials said.

"This is a very important step in completing the roadmap to satisfy regulatory requirements and moves the company one step closer in its pursuit of an IND application for its cell therapy treatment for Huntington's disease," Collinson added.

The meeting was based upon the submission of a pre-IND dossier for Living Cell's Neurotrophin Cell program.

The FDA demonstrated its willingness to provide guidance and feedback throughout the process by providing a written response containing draft comments on Living Cell's pre-IND meeting information package and Neurotrophin Cell development program prior to the meeting, officials said.

Company representatives took the opportunity to clarify the FDA's comments on the specialized medical-grade pig herd, the manufacturing of cell products, the preclinical data and clinical trial design. There were no objections with the program as presented in Living Cell's package, officials said.

The company said its first targeted application of NeurotrophinCell is Huntington's disease and it is completing toxicity studies and characterizing shipping and procedures.

Living Cell's representatives also met with the New Zealand regulator, MedSafe, in mid-February to discuss the resumption of a phase 1 clinical trial for the company's diabetes product, DiabeCell.

In discussion with MedSafe, Living Cell has filed a letter of intent to apply for resumption of the phase 1 trial, potentially starting as early as 2006.

Longevity studies to optimize and document the therapeutic duration of the product are continuing, officials said.

Living Cell, based in Providence, R.I., develops live cell therapy products to treat life threatening human diseases such as Huntington's disease, insulin-dependent diabetes and hemophilia.

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