Originally Posted by Perryc

This is an important study, for an oral neurothropic growth factor. Other nerve growth factors (GNDF, NTN) that have been tested since neuroimmunophilins failed in clinical trials, have required surgery to get the large molecules into the brain past the blood-brain barrier. and have used gene therapy approaches, which have the advantage of being one shot treatment, and the disadvantage of being one shot treatment,i.e no adjustments can be made after the viral vectors are implanted. Several of us met the President of Phytopharm at the BIO conference 2 years ago in Boston. He was beginning preclinical studies at that time, so its good that the study is finally starting.

Tom Isaacs has been working with the company from the patient perspective, so they are in good hands for patient inputs. Tom, if you see this post could you bring us up to date with respect to what development workhas been going on during the past 2 years.

What is the study design to prove safety and efficacy? Are they using any of the alternative methods such as Baysian conditional probabilities to build in learning from early steps into choices for next steps for efficient dose finding

What is the plan going forward for studies outside of UK, and particularly plans for FDA approval. When you get to the FDA, and we hope it is soon, please keep in mind the Pipeline Project expertise including FDA appointed pwp consultants, in putting patiets' interests first to help design effective trials, that balance the regulators needs for certainty with patients' willingness to take risks as long as there is transparency and full disclosure of what those risks are.

Perry


QUOTE=Stitcher;498601]Phytopharm: Commencement of Clinical Study of Cogane in Patients with Parkinson's disease

http://www.pharmalive.com/News/index...&categoryid=21

GODMANCHESTER, Cambridgeshire, England, 20 April 2009, Phytopharm plc today announces the commencement of a safety, tolerability and pharmacokinetic (PK) study of its orally active neurotrophic factor inducer PYM50028 (Cogane•), which will involve both healthy volunteers and patients with Parkinson’s disease (PD). This follows approval from the Medicines and Healthcare Products Regulatory Agency (MHRA) and Research Ethics Committee to commence recruitment for the UK study.