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ImmunoCellular (NYSEMKT: IMUC) clinical data is 10% better than control but, doesn’t meet statistical significance before opening a P3 Trial for ICT-107 in glioblastoma (GBM) - SELL

November 20, 2015 10:06am

IMUC closed at $0.52 and is DOWN -$0.05 to $0.47 with 396.6 K shares traded by 10 am <3 month average = 543.3 K shares>. Never been impressed … with anything - SELL

IMUC’s P3 trial sites open, sees first patient treated “soon” in ICT-107 trial in HLA-A2+ glioblastoma patients.

The data from the P2 trial continues to indicate a survival advantage in the ICT-107 treated group compared to the control group … but, did not meet statistical significance;

The data also show a significant … association between immune response and survival, especially in HLA-A2 positive (HLA-A2+) patients, which is the target patient population for the phase 3 registration trial;

IMUC has reached agreement with the FDA on a Special Protocol Assessment relative to the primary and secondary endpoints as well as the statistical plan for the P3 trial;

ImmunoCellular has also been awarded a $19.9 M grant from the governing Board of the California Institute for Regenerative Medicine (CIRM), California's stem cell agency, to implement the P3 registration trial.

The Bottom Line: Updated data showed overall survival (OS) 1.6 months with ICT-107, 10% better than control, not meeting statistical significance;

Facts in evidence, on 1/14, IMUC treatment missed its OS endpoint, meets PFS on P2 Trial;

IMUC believes updated OS results … continue to support selecting subgroup of HLA-A2+ patients for p3 trial. For the MGMT methylated, HLA-A2+ PP population, median OS was 13.8 months with ICT-107 or 58% better versus control. MGMT unmethylated, HLA-A2+ per-protocol population, median OS was 4.0 months or 34% better;

Differences in survival curves for the two pre-specified sub-populations were NOT powered for, and did not achieve, statistical significance;

IMUC believes that the relationship between immune response, OS supports P3 design of adding more ICT-107 doses for patients in first year of protocol.

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