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It is very confusing. the statement that "neurturin failed" comes from the news reports, not science,Te treatment did not meet te endpoints after 12 months, that were identified as a significant improvement in UPDRS compared to the sham surgery group. Te article reports however,... Patients who received AAV2-neurturin did not show signifi cant improvement with respect to the primary outcome measure at 12 months compared with those who received sham surgery. At 18 months, AAV2-neurturin treatment was associated with modest, but signifi cant,benefits in the primary outcome compared with controls,but the sample size was small. Several secondary measures favoured AAV2-neurturin at 12 and 18 months but none favoured the sham procedure at either timepoint. Clinically signifi cant diff erences in the UPDRS motor score (part 3) have been estimated to be about 2·5 points for minimal, 5·2 for moderate, and 10·8 for large eff ects. 25 The diff erence between groups at 18 months was about7·6 UPDRS points, and could be classed as moderate on the basis of these criteria. However, this was not the primary analysis and the sample size was small, so these data should be interpreted with caution. ...." So the researchers saw te beginnings of improvement, but the changes took longer than the usual 6-12 monts. In the past the first phaseII trial results would have shelved CERE120. But by reanalyzing the results and sponsoring a new pase II trial, Ceregene may have saved a potential treatment (also finded by te MJFF) future gene terapy trials hopfully will learn from this one there's a good explanation of te second trial at http://www.michaeljfox.org/newsEvents_parkinsonsInTheNews_article.cfm?ID=675 www.pdpipeline.org ---------- Original Message ---------- From: Kathleen Cochran <[log in to unmask]> To: [log in to unmask] Subject: Re: NEURTURIN FAILS CLINICAL TRIALS FOR PARKINSON'S DISEASE Date: Fri, 29 Oct 2010 11:15:38 -0400 Wait a minute...recruitment is currently under way for a Ceregene clinical trial to be conducted at a number of sites. From Movement Disorder News, the newsletter of the Beth Israel Parkinson's Disease and Movement Disorders Research Center (Fall 2010, Issue No. 2): "...CERE-120 has been shown to be safe in animals and in people with PT, and it has been shown to protect and improve the function of damaged brain cells. CERE-120 has the potential to improve PD symptoms and possibly slow disease progression." There is nothing about this that says "failure" to me. And about the so-called failure of GDNF: well... Kathleen Clinical Drug Trials: Growth Factor and Parkinson's Disease On 27 October 2010 13:51, mschild <[log in to unmask]> wrote: > NEURTURIN FAILS CLINICAL TRIALS FOR PARKINSON'S DISEASE > > Lancet Neurology [2010] Oct 20 [Epub ahead of print] (Marks WJ Jr, Bartus > RT, > Siffert J, Davis CS, Lozano A, Boulis N, Vitek J, Stacy M, Turner D, > Verhagen > L, Bakay R, Watts R, Guthrie B, Jankovic J, Simpson R, Tagliati M, Alterman > R, > Stern M, Baltuch G, Starr PA, Larson PS, Ostrem JL, Nutt J, Kieburtz K, > Kordower JH, Olanow CW.) Complete abstract > > Neurturin was hailed by its sponsors Ceregene and the Michael J Fox > Foundation > as having great potential in the treatment of Parkinson's Disease, but has > been found to be completely ineffective. Neurturin (CERE-120) is an > experimental drug that contains the human gene for a growth factor called > neurturin. It is used to deliver the neurturin gene by surgical means, > directly into the brain of people with Parkinson's Disease. It was found to > be > worse than doing nothing, as it was as ineffective as sham surgery (doing > nothing) yet still caused severe adverse events in a third of the patients. > Neurturin is the same type of treatment as GDNF reference. GDNF was also > previously hailed as a great breakthrough in the treatment of Parkinson's > Disease. Yet all major clinical trials of GDNF and Neurturin have failed. > > > www.viartis.net > > ---------------------------------------------------------------------- > To sign-off Parkinsn send a message to: mailto: > [log in to unmask] > In the body of the message put: signoff parkinsn > ---------------------------------------------------------------------- To sign-off Parkinsn send a message to: mailto:[log in to unmask] In the body of the message put: signoff parkinsn ---------------------------------------------------------------------- To sign-off Parkinsn send a message to: mailto:[log in to unmask] In the body of the message put: signoff parkinsn