 |
 |
This should be good news, but unfortunately these clinical trials and further development of GDNF treatment by infusion has been halted since September 2004 by Amgen inc., the producer of synthetic gDNF and sponsor of the Phase II trial. Even though as discussed in this article, patients in the phase I trial had substantial improvements, Amgen claimed the phase II trial was a failure. Many researchers believe this trial was not a failure and the results were inconclusive, due to the many differences in trial design from the successful phase I studies. Additionally Amgen claimed it halted the trials due to safety concerns - but still has not released the data to prove that these safety issues really exist. Earlier this month a group of Parkinson's advocates and GDNF trial participants wrote to the Amgen Board of Directors and CEO Kevin Sharer to implore them to release the safety data, to allow compassionate use of GDNF for the trial participants (which the FDA had already approved), and to release their patent to synthetic GDNF to another company, if they refuse to further develop it themselves. It is too promising a treatment to sit on the shelves in Amgen's labs! A copy of the letter to Amgen is at: http://www.pdpipeline.org/yy_gdnf/gdnf_resp_grass.htm Background information on the GDNF controversy is at: http://www.pdpipeline.org/yy_gdnf/gdnf_overview.htm Linda Herman -- Peggy Willocks <[log in to unmask]> wrote: Now we can say that a 1-year study shows a treatment both protective and restorative! (I copied the link and Conclusions below) Unilateral intraputaminal glial cell line-derived neurotrophic factor in patients with Parkinson disease: response to 1 year each of treatment and withdrawal Neurosurg Focus 20 (5):E1, 2006 ------------------------------------------------ Conclusions The results from 1-year intraputaminal GDNF infusion in our study are consistent with extensive animal data2,5,7,8,17,20 and the Bristol Phase I trial results,9,13,15 in which it has been stated that trophic factor treatment can be both protective protective and restorative. The recent inconclusive Phase II results12 may be the result of differences in GDNF dosing and delivery protocols. The two safety issues with GDNF-development of antibodies to exogenous GDNF and possible toxic injury to the cerebellum in nonhuman primates-require further study. In this patient group, however, neither clinical manifestations in response to GDNF antibodies nor clinical or imaging evidence of cerebellar lesions were evident. Given the following three considerations: 1) that advanced PD is profoundly debilitating and life-threatening; 2) that the known safety concerns can be closely monitored and medically managed; and 3) that the methodology used in the two Phase I trials shows strong indications of efficacy, we believe that additional Phase II clinical trials are warranted to continue developing the approach featuring intraputaminal delivery of trophic factors for treating PD. http://www.aans.org/education/journa...0-5-1-0976.pdf Peggy ---------------------------------------------------------------------- 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