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ImmunoCellular Therapeutics says enrollment ahead of schedule for phase 2 ICT-07 trial

ImmunoCellular Therapeutics says enrollment ahead of schedule for phase 2 ICT-07 trial

ImmunoCellular Therapeutics (OTCBB:IMUC) provided Monday an update on its phase two clinical trial of ICT-107, its cancer vaccine for a specific type of brain tumour.

The company has started the trial in 23 centres, and has received Institutional Review Board (IRB) approval from a total of 24 trial sites.

The double-blind, placebo-controlled study is expected to enroll roughly 160 to 200 patients, to treat 102 subjects with specific immunological subtypes, testing the safety and efficacy of the drug in newly diagnosed patients.

There are 115 patients enrolled in the study to date, ahead of the company’s own schedule, it said.

Enrollment for the trial is expected to be completed by the second quarter of 2012, and an interim analysis is expected when 50 percent of events (32 deaths) have been observed.

ICT-107, the company’s lead product candidate, is a dendritic cell-based vaccine that works by activating a patient's immune system against specific tumor-associated antigens for glioblastoma multiforme (GBM), an aggresive type of brain cancer.

This is done by extracting dendritic cells from a patient, loading them with the tumour-related antigens, and re-injecting them back into the patient's body to trigger an immune response against cancer cells exhibiting these antigens.

Rather than simply targeting a single tumor-specific antigen, ImmunoCellular's vaccine pursues multiple different antigens found on cancer stem cells (CSCs). Cancer stem cells are thought to be the originators of common tumor cells, and lead to cancer’s re-growth after chemotherapy. It is believed that destroying the CSCs will allow for longer survival, without relapse.

"We are pleased with the progress we have made in enrolling patients for the Phase II trial,” said president and CEO, Manish Singh, Ph.D.

"The strong interest and support from the medical community, especially from leading oncologists, has allowed us to enroll patients in many of the top medical centers in the country, reflecting the potential that ICT-107 has demonstrated in treating GBM.”

The phase one clinical trial saw 16 patients with newly diagnosed GBM receive three injections of ICT-107, in addition to standard treatment, which includes surgery, radiation and chemotherapy. ImmunoCellular reported a two-year overall survival rate of 80.2 percent from phase one trial results, compared to 26.5 percent with standard care alone.

At three years, 55 percent of patients achieved overall survival, compared to 16 percent with standard care alone. The median overall survival was 38.4 months, versus 14.6 months for the historical standard of care.

After three years, 38 percent of patients continue to show no tumour recurrence, compared to six percent without the aid of ICT-107.

After more than four years, nearly 19 percent of patients remain disease-free.

Los Angeles-based ImmunoCellular is a clinical-stage company that is developing immune-based therapies for the treatment of brain and other cancers.

Shares were up over 3.3 percent Monday, trading at $1.24 as of 1:08pm ET. The company's stock has gained more than 12.7 percent in the last five days.

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