[paula_w]

Three years after cancellation of GDNF, Amgen has finally published its animal toxicity data. Depending on what version you read, monkey lesion was one of the safety reasons given. The mumbo jumbo, along with the full article, could be used as justification to continue, according to one neurologist. It's assumed that most people don't read more than the abstract.

We tried very hard to get this information two years ago - but there was much to keep confidential - like the extreme danger described below.


Toxicol Pathol. 2007;35(5):676-92.
Six-Month Continuous Intraputamenal Infusion Toxicity Study of Recombinant Methionyl Human Glial Cell Line-Derived Neurotrophic Factor (r-metHuGDNF) in Rhesus Monkeys.
Hovland DN Jr, Boyd RB, Butt MT, Engelhardt JA, Moxness MS, Ma MH, Emery MG, Ernst NB, Reed RP, Zeller JR, Gash DM, Masterman DM, Potter BM, Cosenza ME, Lightfoot RM.
Amgen Inc., Thousand Oaks, California.
Recombinant human glial cell line-derived neurotrophic factor (r-metHuGDNF) is a potent neuronal growth and survival factor that has been considered for clinical use in the treatment of Parkinson's disease (PD). Here we present results of a 6-month toxicology study in rhesus monkeys conducted to support clinical evaluation of chronic intraputamenal infusion of r-metHuGDNF for PD. Monkeys (6-9/sex/group) were treated with 0 (vehicle), 15, 30, or 100 mu g/day r-metHuGDNF by continuous unilateral intraputamenal infusion (150 mu l/day flow rate) for 6 months; a subset of animals (2-3/sex/group) underwent a subsequent 3-month treatment-free recovery period. Notable observations included reduced food consumption and body weight at 100 mu g/day and meningeal thickening underlying the medulla oblongata and/or overlying various spinal cord segments at 30 and 100 mu g/day. In addition, multifocal cerebellar Purkinje cell loss (with associated atrophy of the molecular layer and, in some cases, granule cell loss) was observed in 4 monkeys in the 100-mu g/day group. This cerebellar finding has not been observed in previous nonclinical studies evaluating r-metHuGDNF. The small number of affected animals precludes definitive conclusions regarding the pathogenesis of the cerebellar lesion, but the data support an association with r-metHuGDNF treatment.
PMID: 17763282 [PubMed - in process]

[pegleg]

yes, K can see how extremely dangerous it would have been to let thhis therapy continue (quote: The small number of affected animals precludes definitive conclusions regarding the pathogenesis of the cerebellar lesion, but the data support an association . . .
)

What a crock!
Peggy

[lou_lou]

Amgen sucks! sorry but it does... and the FDA can kiss my **** as well

however - thank you dear Paula for the Amgen BS -lies -damn lies and stats !

[chasmo]

that Amgen would be aggressively pursuing GDNF given their dismal earnings and lack of viable product.

Who are the idiots in charge anyway?

Charlie