LCT Reports Positive Meetings With FDA And Medsafe
LCT Reports Positive Meetings With Fda And Medsafe - Preparing For Cell Therapy Trials
AUCKLAND, Feb. 16 /MediaNet International-AsiaNet/ --
Living Cell Technologies Limited (ASX:LCT) today reported it has held positive meetings with the US Food and Drug Administration (FDA) and New Zealand’s MedSafe, regarding its NeurotrophinCell and DiabeCell products.
“The meetings have provided strong reassurance that xeno-based cell therapies have a clear and defined pathway to market,” said LCT CEO, Mr David Collinson.
Representatives from LCT attended the pre-IND meeting with members of the National Institutes of Health (NIH) and reviewers from the Centre for Biologics Evaluation and Research (CBER), the group within the FDA responsible for the evaluation of biologics, including cell and gene therapies.
“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 (Investigational New Drug) application for its cell therapy treatment for Huntington’s disease,” said Mr Collinson.
The meeting was based upon the submission of a pre-IND dossier for LCT’s Neurotrophin Cell program.
The FDA demonstrated their willingness to provide guidance and feedback throughout the process by providing a written response containing draft comments on LCT's pre-IND Meeting Information Package and Neurotrophin Cell development program prior to the meeting. This document enabled an efficient and productive meeting, indicating that LCT’s product development strategy is on the right track.
LCT representatives took the opportunity to clarify the FDA’s comments on the specialised medical-grade pig herd, the manufacturing of cell products, the pre-clinical data and clinical trial design and were pleased to see no objections with the program as presented in LCT’s Pre-IND package. The FDA also extended the courtesy to LCT of ongoing involvement in the preparation of the IND.
LCT is pioneering new products in the xenotransplanation field and is pleased that the FDA has invited LCT to communicate directly with the FDA’s various sections and experts prior to submitting the original IND application. Such involvement is indicative of the support demonstrated by the FDA and LCT will continue to engage the Agency on a regular basis to progress NeurotrophinCell to clinical trials.
“We are grateful to the CBER team for their constructive comments and assistance in defining the most appropriate strategy for the NeurotrophinCell product, and we look forward to further positive interaction with the FDA and the NIH as NeurotrophinCell progresses towards the clinic.”
LCT’s first targeted application of NtCell is Huntington’s disease and the company is currently completing toxicity studies and characterising shipping and QA/QC procedures.
Targeting a continuation of DiabeCell phase 1 trial:
LCT representatives also met with the New Zealand regulator, MedSafe, in mid February to discuss the resumption of a phase 1 clinical trial for LCT’s diabetes product, DiabeCell.
In 1996, a phase 1 study was suspended on the basis of the potential for pig virus transfer (PERV porcine endogenous retroviruses). Considerable recent evidence and monitoring now suggests that the concerns over PERV were unjustified.
In discussion with MedSafe, LCT has filed a letter of intent to apply for resumption of the phase I trial, potentially starting as early as 2006. Longevity studies to optimize and document the therapeutic duration of the product are continuing.
“LCT’s cell therapies are pioneering development programs and therefore we believe collaboration between LCT and the regulatory authorities is critical in defining the safety and performance criteria for the therapies,” said Mr Collinson.
LCT will hold a General Meeting in Sydney at the NSW Trade and Investment Centre on 24 February 2006 at 2.45pm, which will include a clinical program update.
About Living Cell Technologies: www.lctglobal.com
Living Cell Technologies Ltd (ASX: LCT) develops live cell therapy products to treat life threatening human diseases such as Huntington’s disease, insulin-dependent diabetes and haemophilia.