ImmunoCellular Therapeutics (NYSE: IMUC) today announced that the U.S. Food and Drug Administration (FDA) has given clearance to a physician sponsored investigative new drug (IND) application to initiate a Phase I clinical trial of ICT-121, IMUC's novel dendritic-cell-based vaccine targeting CD-133, an antigen that is highly expressed by multiple solid tumors.
The trial, which will be conducted at a leading Los Angeles based medical center, will initially test the vaccine in up to 20 patients with recurrent glioblastoma multiforme (GBM), the most common and aggressive form of brain cancer.
From July 2nd company press release: "There are currently 231 patients enrolled in the study and more than 105 patients have either been treated or are scheduled to be randomized and treated over the next few weeks. The Company expects to complete the expanded enrollment within the next 60 days."
Yes, this is a high risk/high reward project, but at least they have the funding to progress it so that we'll be better informed by 4Q 2012/1Q 2013.
IST? Trials must be company sponsored, not 3rd party IMO. Now, this is all messed up. As far as I know, IST are for expanded use (ie for consideration of reimbursement by med isurance co.)and not part of co. Briefing Docs for FDA approval.
Another link to the news of IMUC's IND.