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ImmunoCellular Therapeutics Issues Shareholder Letter Providing Update on ICT-107 Program in Newly Diagnosed Glioblastoma
Date:1/9/2014

LOS ANGELES, Jan. 9, 2014 /PRNewswire/ -- ImmunoCellular Therapeutics, Ltd. ("ImmunoCellular") (NYSE MKT: IMUC) today issued the following letter to shareholders providing an update on the Company's ICT-107 clinical program in patients with newly diagnosed glioblastoma (GBM).

(Logo:  http://photos.prnewswire.com/prnh/20140109/AQ43875LOGO)

To Our Shareholders:

Since the December 11, 2013 announcement of results from the exploratory phase II trial of ICT-107, we have continued to analyze the data set from the trial and consulted with experts in the field of neuro-oncology with the goal of informing our next development and regulatory activities for this program. We would like to update shareholders on three key topics:

  • Our determination that overall survival (OS) was the appropriate primary endpoint for our development program. Although we did not meet the OS endpoint, we are enthusiastic about meeting our progression free survival (PFS) endpoint because we think it supports the presence of an OS signal, which may clarify, and potentially strengthen, as we collect more survival data;
  • Our review of additional immunological data from the trial. To date, we have found two hallmark indicators of dendritic cell activation in the ICT-107 vaccines that are predictive of survival benefit. This finding is important to developing manufacturing assays and informing our phase III trial design; and
  • Our plan, in the next two to three quarters, to communicate additional phase II trial data, and to meet with the US FDA and the European Medicines Agency (EMA) to discuss next steps in the development of ICT-107.

The primary goals of this exploratory trial were to assess safety and the effect that ICT-107 has on clinical outcomes in patients with newly diagnosed GBM, and t
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SOURCE ImmunoCellular Therapeutics, Ltd.
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