$IMUC $AVII Phase 2 News for today

ImmunoCellular Therapeutics (OTC:IMUC) said Thursday it has expanded the number of sites for its phase two clinical trial of ICT-107, a potential vaccine treatment for brain cancer.

Originally, the trial, which is now underway, was planned to be held at up to 15 clinical centres, but this number has now been increased to 20 or more, the Los Angeles-based company said.

ImmunoCellular has qualified 21 sites so far, and has submitted the trial to 12 prospective sites’ Institutional Review Board #IRB# for approval. Of these 12 sites, six have now received their IRB approval.

The phase two study is a double-blind, placebo-controlled test to determine the safety and efficacy in patients with newly diagnosed glioblastoma multiforme, an aggressive type of brain tumour.

The vaccine uses cancer stem cells to target multiple tumour-associated antigens, which generate an antibody response from the body’s own immune system.

via ImmunoCellular Therapeutics expands phase 2 trial for brain cancer treatment – Proactiveinvestors (NA).

BOTHELL, WA–(Marketwire – Jun 9, 2011) – AVI BioPharma, Inc. (NASDAQ: AVII), a developer of RNA-based therapeutics, today provided an update on the initiation of its Phase 2 clinical trial of eteplirsen, the Company’s lead therapeutic candidate for the treatment of Duchenne muscular dystrophy (DMD#.

On June 8th, following a meeting of the Institutional Review Board #IRB# of Nationwide Children’s Hospital in Columbus, Ohio, the site of the Phase 2 clinical trial, AVI received an IRB request to modify the clinical trial protocol. AVI is reviewing the request, which is not related to the safety or expected activity of eteplirsen, and anticipates submitting a revised Phase 2 clinical trial protocol to the IRB later this month. The U.S. Food and Drug Administration #FDA) has not communicated any concerns regarding the original design of the Phase 2 clinical trial at this time and the Company intends to provide any updates on this protocol to the FDA.

“We will work quickly and deliberately to address the IRB’s request, and we expect to initiate the Phase 2 trial in the third quarter,” said Chris Garabedian, AVI’s President and CEO. “Furthermore, we are confident that we will remain on track in initiating a pivotal trial in the second half of 2012. We remain fully committed to eteplirsen development and its potential as an important treatment for DMD.”

via AVI BioPharma Provides Update on Initiation of Eteplirsen Phase 2 Clinical Trial.