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Celldex Therapeutics Inc. has announced it has launched a Phase 2 clinical trial for its potential vaccine targeting bladder cancer.
The Needham-based company’s study will enroll approximately 60 patients, including those newly diagnosed with a certain form of bladder cancer and those who have not previously received any chemotherapy for the disease. The first data to come out of the study is expected by the end of 2011.
The antibody-based vaccine candidate, called CDX-1307, targets hCG-beta, an antigen that is thought to help spread cancer and is associated with a poor prognosis. It received positive results in October from its Phase 1 studies.
“The CDX-1307 vaccine regimen provides a personalized and targeted intervention for hCG-beta expressing bladder cancer,” said Tom Davis, chief medical officer of Celldex Therapeutics, in a statement. “This vaccine offers the potential for an off-the-shelf technology capable of utilizing each patient’s own dendritic cells. Newly diagnosed bladder cancer is an immunologically sensitive disease, and we believe the adjuvant setting provides the best opportunity for a vaccine to interfere with the disease process.”
Until now, cancer vaccines have been an elusive target for researchers and biotechnology companies. However, the first cancer vaccine, for prostate cancer, called Provenge and produced by Seattle-based Dendreon Corp. was approved last month after its clinical trials showed it could extend life for late-stage patients by an average of four months.
Neither Demdreon’s vaccine nor Celldex’s vaccine candidate is currently designed to prevent cancer but rather to provoke the immune system to fight off already-existing tumors.
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