Clinical
Trials
Genervon is currently conducting a Phase 2 clinical trial evaluating GM6 for patients who have experienced an acute ischemic stroke within 18 hours. The study is taking place at the UCLA stroke center and three other sites under the direction of principal investigator Sid Starkman, M.D and Jeff Saver, M.D. This study has also received fast track designation from the FDA. Additional information can be found using the identifier NCT01221246 at clinicaltrials.gov.
A previous Phase 1 clinical study demonstrated that GM6 was
safe at all doses in 32 healthy volunteers. In the randomized,
placebo-controlled, single dose-escalation study healthy volunteers
received .5, 1.5 and 5.0 mg/kg doses as well as three consecutive daily
doses of 5.0 mg/kg of the therapeutic.
A Phase 2 study evaluating GM6 in Parkinson’s patients
has been approved by the FDA. The study will be conducted at Columbia
University Medical Center under the direction of principal investigator
Stanley Fahn, M.D.
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