Maxim Group Maintains Bullish Stance on ImmunoCellular (IMUC) Following Review of SNO Data and Plans for Phase III

Maxim Group analyst Jason Kolbert reiterated a Buy rating and $4 price target on ImmunoCellular Therapeutics (NYSE: IMUC) after the company held a conference call following the Society for Neuro-Oncology (SNO) meeting to discuss phase II data presentations from the trial of ICM-107 in glioblastoma multiforme (GBM) and its plans for phase III.

Kolbert notes the company recently met with the EMEA to discuss the design of phase III trials for European registration and expects to receive guidance by the end of the month. It plans to design a phase III program that would allow for registration in both the US and Europe.

Further he noted "the company recently met with the FDA and received guidance for the phase III trial in HLA-A2 GBM patients (about 50% of GBM patients). The company is considering running two trials consisting of two distinct patient populations separated by MGMT status (methylation of a gene for a DNA repair enzyme that contributes to temozolomide resistance) or a single trial with patients stratified by MGMT status. We anticipate n=400 per trial (single or double)."

"Data from either trial demonstrating efficacy combined with the current phase II data should satisfy requirements for a BLA submission. Key decision factors in the phase III design will be comments from the EMEA, the cost and funding requirements, and the timeframes for the trials. Planning continues, and the company stressed that it would not run an underpowered or poorly designed phase III. We continue to expected the trial to start in mid-2015."

For an analyst ratings summary and ratings history on ImmunoCellular Therapeutics click here. For more ratings news on ImmunoCellular Therapeutics click here.

Shares of ImmunoCellular Therapeutics closed at $0.62 yesterday.

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