Advaxis given go-ahead to start phase 1/2 trials of cancer vaccine

New York, Feb. 21 - Advaxis, Inc. said it has received regulatory approval to begin phase 1/2 clinical testing of its lead compound, listeria-based cancer vaccine Lovaxin C.

The trials will be the first in humans for the drug, which is aimed at cervical cancer in women.

"It is important to all women that we have finally been given authorization to test a cancer vaccine in humans that has been so potent in animal models," said Roni Appel, president and chief executive officer of Advaxis, in a news release.

"This phase 1/2 trial is the first step in a comprehensive plan that will build on the strong pre-clinical results we have seen in more than a decade of development work.

"This is the first time a proprietary, modified, disease-specific listeria will be tested in human patients. We expect that Lovaxin C will be the first in a long line of products brought to the clinic."

Pre-clinical data for Lovaxin C demonstrates an extremely robust immune response to tumors upon administration of the drug and eradication of tumors in more than half of the animals tested.

Unlike other products in late clinical trials, which are preventative vaccines against the HPV virus (the virus which causes cervical cancer), but cannot benefit woman already infected with the virus, Lovaxin C is designed to treat women who have developed cervical cancer as a result of an HPV infection.

Dosing is expected to begin by the end of February.

The study will be conducted at Hadassah Hospital in Jerusalem, The Institute of Oncology and Radiology in Belgrade, which treats several hundred cervical cancer patients every year, and at two facilities in Mexico.

The first regulatory approval has been received for Belgrade, with approvals for Israel and Mexico in review and anticipated shortly.

Advaxis expects to announce results in the second half of 2006.

Advaxis, based in North Brunswick, N.J., is developing proprietary listeria cancer vaccines based on technology developed by Dr. Yvonne Paterson, professor of microbiology at the University of Pennsylvania, and chairperson of Advaxis' Scientific Advisory Board.

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