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Data from trial of EP-2101 released at ASCO.

Vaccine Weekly

| July 07, 2004 | COPYRIGHT 2004 NewsRX. This material is published under license from the publisher through the Gale Group, Farmington Hills, Michigan.  All inquiries regarding rights should be directed to the Gale Group. (Hide copyright information)Copyright

2004 JUL 7 - (NewsRx.com & NewsRx.net) -- Epimmune, Inc., (EPMN) provided preliminary data from ongoing phase I/II clinical trials of its EP-2101 therapeutic vaccine in non-small cell lung (NSCL) cancer and colorectal cancer patients in a poster presentation at the American Society of Clinical Oncology (ASCO) meeting in New Orleans.

The initial data from 10 patients who have completed treatment indicates that the vaccine was safe and well tolerated, and induced a multi-epitope response with 60% of the patients responding to at least five of the nine epitopes included in the vaccine. The company will complete analysis of the final data once the remaining patients enrolled in the trials have completed treatment.

Epimmune is conducting two phase I/II clinical trials of its EP-2101 cancer vaccine candidate at approximately 10 clinical sites in the U.S. One trial enrolled stage IIB/IIIA NSCL cancer patients, and the other trial enrolled stage III colorectal cancer patients.

The cancer vaccine candidate used in these trials includes nine cytotoxic T lymphocyte (CTL) epitopes from four tumor-associated antigens (TAA) including two proprietary native epitopes and seven modified, or analog, epitopes. The analog epitopes are designed to break the immune system's tolerance of the cancer, or failure to recognize the cancer as diseased tissue, and enhance the potency of the T cell response.

PADRE, the company's proprietary universal helper T lymphocyte (HTL) epitope, is also included in the vaccine as an immunostimulant. Patients enrolled in the trials have previously had surgery to remove all detectable cancer cells and, as a result, are generally expected to have normal immune system function. Each patient who completes the trial receives six injections of the vaccine at 3-week intervals.

To date, the company has enrolled a total of 24 patients combined in the two trials and expects that approximately 16 of the 24 patients will complete the treatment and be evaluable at the end of the trials based on pre-determined study criteria. Based on 10 patients who have completed treatment and been evaluated to date, EP-2101 appears to be safe and well tolerated.

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Source: HighBeam Research, Data from trial of EP-2101 released at ASCO.

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