Meeting with Repligen in Turin on 5th June, 2009
A meeting organised by GoFAR, of the European Clinical Network was held on 5th June, 2009 in Turin to discuss European participation in clinical trials to be conducted by Repligen, a US pharmaceutical company, developing HDACi drugs for use in treating FA. Dr. David Jacoby, Medical Director of Repligen attended the meeting and advised that it is anticipated that Phase I will commence towards the end of 2009, with, depending on outcome, hopefully Phases II and III of the defined HDACi beginning as soon as 2010.
Per Repligen website:
“We are also developing inhibitors of specific HDAC enzymes for Friedreich's Ataxia and Huntington's disease. And in the past quarter, we have chosen a clinical candidate in this program based on encouraging results of pharmacology and toxicology studies in animals. Our product candidate appears to have good bioavailability and was well tolerated in a seven-day repeat dose animal study. Based on these results, we have initiated the development of a scalable manufacturing process and we have requested a pre-IND meeting with the FDA to discuss our pre-clinical and clinical plans. Pending FDA approval and favorable results in the 28-day toxicology study, we expect to file an IND in the second half of 2009.”
While speakers at the meeting were practically uniquely from the medical profession, Barbara Flynn, FASI CEO, spoke briefly of Ireland’s high incidence of FA, the willingness of our members to participate in such trials and the availability and suitability of being part of such trials insofar as we already have an Ataxia Clinic, with a Consultant Neurologist, a full-time Ataxia Registrar and Ataxia Nurse and also a Trials Administrator in place. It was also emphasised that, being a small country, we would be able to organise transport for participants to the Ataxia Clinic from anywhere in the country.