Phytopharm: Commencement of Clinical Study of Cogane in Patients with PD
 

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.

Important study
 

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.[/QUOTE]

[/QUOTE]


Perry,

I have applied to go on this trial and have received the application papers.

I am not sure how much can be disclosed publicly so I don't want to say too much. It is a 10 week trial and the purpose is stated as "to find out if Cogane is safe and well tolerated in both healthy volunteers and (PD) patients and to determine if there is any difference in the way that the body deals with Cogane between these two groups".

If I am accepted onto the trial then I will let you know and if you forward me any questions I will endeavor to get some answers if I am allowed.

Take care,
Neil.

Cogane trial
 

Neil,
Did you complete the screening & if so were you accepted for the trial?
I was screened unsuccessfully & I still have no real understanding why. The whole process seemed very rushed - as though if you have Parkinson's you will have few commitments & can decamp at a moment's notice.
Yesterday I attended the launch of 'Healthtalk online' -clinical trials module as one who was filmed. This issue ie patients not getting sufficient information or feedback was raised in the presentation by professionals & by
clips from the site of different patients' experiences. As I see my future health resting on Cogane &/or similar treatments I was probably a lot more emotional about not meeting the (covert) criteria. I hope you can make sense of this feedback.
Angela.

Perry,

I have applied to go on this trial and have received the application papers.

I am not sure how much can be disclosed publicly so I don't want to say too much. It is a 10 week trial and the purpose is stated as "to find out if Cogane is safe and well tolerated in both healthy volunteers and (PD) patients and to determine if there is any difference in the way that the body deals with Cogane between these two groups".

If I am accepted onto the trial then I will let you know and if you forward me any questions I will endeavor to get some answers if I am allowed.

Take care,
Neil.[/QUOTE]

Hi how does one apply to be considered to take part in these trials?
I have heard a little about Cogane & it seems very interesting.

early stages?
 

We heard this trial was for those who are early on in the disease. please let me know if this is untrue...neil? or anyone who knows?

thanks,
paula

Paula ...
 

hope things are going well for you.

I never made it onto the trial, purely a matter of logistics, they had enough people apply who lived close to Cambridge so no hotel/travelling costs.

From memory this was not limited to early onset. I think it was minimum 5 years post dx with no maximum time limit. However like most trials they attempt to get the healthiest patients and exclude potential complications by excluding certain symptoms.

Tom Isaacs (CPT) is doing a lot of work with Cogane and is really high on it, (or was 18 months ago).

Take care,
Neil.

de novo only
 

I contacted the study coordinator and was told that the trial in the States is for de novo pwp only.

Jean

Cogane Trial II
 

...I've got an assessment date in May for inclusion in the UK trial. You have to have taken no meds.....
Peter