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Print Edition StoriesMonday, December 14, 2009
Celldex study brings good news for hard-to-treat breast cancer
By Julie M. Donnelly
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Celldex Therapeutics Inc. has announced positive results of a clinical trial targeting hard-to-treat breast cancers. The company says that the Phase 2 study showed significant anti-tumor activity for a sub-set of patients whose tumors express a certain protein. In addition, Celldex found encouraging results for patients with “triple-negative disease,” an extremely difficult-to-treat form of breast cancer that disproportionately affects African-American women.
The intravenous drug target, CDX-011, delivers a toxin directly to tumor cells, targeting a protein known as GPNMB. It is the first target from a platform of potential Celldex drug targets using the same technology.
“As seen in this study, treatment with CDX-011 can induce disease regression and stabilization,” said Thomas Davis, senior vice president and chief medical officer of Celldex Therapeutics, in a statement. “We are very encouraged to see such positive results in patients with triple negative disease — or those with advanced, refractory and heavily pre-treated breast cancers — where there is a clear unmet medical need. Moving forward, we are planning expanded Phase 2 development focused on patients with tumors expressing GPNMB.”
The study included 32 patients total. The company’s goal was to see 20 percent of the patients without a progression in their disease. Company officials say that, to date, 9 of 26 patients who could be evaluated — 35 percent — are without progression of disease at twelve weeks.
The company is currently evaluating CDX-011 in two Phase 2 trials assessing the safety and efficacy in the treatment of melanoma and for the treatment of metastatic breast cancer, and in a Phase 1 trial to evaluate the safety and activity of alternate dosing schedules.
Breast cancer is the most common cancer in women. According to the American Cancer Society, 40,000 women will die of the disease in 2009.
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