Stem Receives No Objection Letter From DCGI To Initiate Phase IIb Trial

Stem Cell Therapeutics (SCT) has received a No Objection Letter (NOL) from the Drug Controller General of India (DCGI), to initiate the phase IIb acute ischemic stroke trial.

The investigational new drug’s (IND) study is a double-blind, randomized, placebo-controlled clinical trial of NTx-265. The drug is intended for the treatment of acute ischemic stroke.

Alan Moore, president and CEO of STC, said: Approval from the DCGI to initiate recruitment for the modified REGENESIS stroke trial in India is an exciting milestone for SCT. Jurisdictional approvals have now been granted in India, US and Canada therefore we will begin recruiting patients as soon as possible.