NTCELL clinical trial: Recruitment of further patients

NTCELL clinical trial: Recruitment of further patients approved

Living Cell Technologies Limited today announced that the independent data safety monitoring board (DSMB) has reviewed the safety data from the initial patient in the Phase I/IIa clinical trial of NTCELL and advised that implants for the additional three patients in the trial can proceed.

The Phase I/IIa clinical trial is an open label investigation of the safety and clinical effects of NTCELL in four patients who have been diagnosed with Parkinson’s disease for at least five years. The trial is being run at Auckland City Hospital under the guidance of Principal Investigator Dr Barry Snow.

Dr Andrea Grant, Managing Director of LCT, says “We are very pleased that the DSMB has given approval for us to proceed with implants for the remaining three patients in this Phase I/IIa trial. The initial safety data from the clinical trial is consistent with that documented in the preclinical trial with non-human primates which was recently published in the Journal of Parkinson's Disease. We understand from the clinical team that the patient is well, all things considered.”

The DSMB is a comprised of three experts in the field and provides independent, expert advice to LCT on the continuing safety of the trial participants, as well as on the continuing validity and scientific merit of the trial. In making the decision to approve implants for the additional three patients the DSMB primarily considered safety data obtained from the first patient implanted with NTCELL in September of this year. This data included clinical and biochemical assessments at both one week and one month post-implant as well as magnetic resonance imaging (MRI) of the patient’s brain at both one day and two months post-implant.

“The primary purpose of this Phase I/IIa study is to demonstrate the safety of NTCELL as a potential cell-therapy in the treatment of Parkinson’s disease.” says Dr Grant “The first opportunity we will have to obtain an indicative assessment efficacy will be when all four patients complete six months of follow-up post their first implant. Whilst this is some way off, we have met another significant milestone in being able to secure DSMB approval to go on and implant all four patients.”

LCT and Otsuka Pharmaceutical Factory (OPF) are co-developing NTCELL as a treatment for Parkinson’s disease. Under the terms of the agreement, LCT expects to receive a second cash payment of A$2m from OPF as a result of the DSMB authorising the recruitment of the remaining three patients. LCT has already received an A$3m cash payment from OPF in return for the option to license NTCELL. In addition, OPF is funding all of the research and development costs associated with the Phase I/IIa clinical trial, estimated at A$2.1m. Thus, this partnership provides both immediate income to LCT as well as funding for the ongoing clinical development of NTCELL in Parkinson’s, the latter provided the Phase I trial meets its endpoints.

www.lctglobal.com

ENDS

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