“Though the survival response observed in the Ph1(phase one) trial was not fully replicated in the Ph2 trial, results are supportive of continued clinical development and of the Ph3 trial as designed.”
“We have a number of consulting agreements for clinical development, regulatory affairs, investor relations and business development. We outsource all of our drug discovery research, process development, manufacturing and clinical development to third parties with expertise in those areas."ImmunoCellular reports no revenues for the past several years. CIRM said, however, the firm has promised $34.4 million in co-funding for the clinical trial.
“(R)eviewers had feasibility concerns regarding the applicant’s ability to enroll the trial and maintain the reagent supply chain to support manufacturing of the product. Reviewers also had concerns with the trial design, which centered around selection of the patient population targeted in the registration trial and the lack of immune monitoring proposed in the trial.
“The applicant was provided the opportunity to address these concerns in a revised application, and their responses and modifications to the proposal reassured reviewers that the applicant could enroll and conduct the Ph3 trial as proposed and that, if endpoints are met, the trial design could support licensing approval by FDA.”The price of ImmunoCellular stock closed at $0.425 today, up nearly one cent. The 52-week high of the stock was $1.03 and the low 35 cents.