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PFS In New GBM Patients Not Enough For Approval In Europe

|Includes: ImmunoCellular Therapeutics, Ltd. (IMUC), NWBO, RHHBY

The CHMP has recommended that Avastin (bevacizumab) should not be approved to treat newly diagnosed glioblastoma (GBM) stating the following reasons:

"Although there was an improvement in progression-free survival, it could not be considered clinically relevant because of limitations in the methods available to measure the size of brain tumors. In addition, there was no improvement in overall survival."

The CHMP recommendation is consistent with previous statements made by the FDA.

"…progression free survival (NYSE:PFS) as an endpoint is acceptable for hypothesis testing, but not as a primary endpoint for a phase 3 trial to support a BLA."

Unfortunately, the CHMP recommendation does not bode well for IMUC and NWBO. For either company to get their DC vaccines approved, the companies will probably have to show that their therapies can improve overall survival (OS). That means both companies will have to conduct additional registrational clinical trials with OS as the primary endpoint. Unless the companies can find a partner to help fund the registrational trials, expect another round of financing.

Share price of either company has not reacted negatively to the CHMP announcement yet. Investors may be expecting positive news from ASCO. Investors may already be expecting that addtional registrational trials would be required.