Syndax Moves Closer to Pivotal Trials of Selective Lung Cancer Treatment

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in combination with 5-azacitidine (Vidaza), a drug marketed by Summit, NJ-based Celgene (NASDAQ: CELG). The Celgene product, which is what’s known as a “demethylation” agent,” destroys abnormal cells in the bone marrow and helps generate normal blood cells But it is also believed to reverse DNA methylation, thereby reactivating tumor-suppressor genes that have been silenced in the course of the disease.

Data from a Phase 2 trial of the combination in advanced non-small cell lung cancer will be presented in Amsterdam today. The study, which included 27 patients, showed a median overall survival of eight months. One patient, whose cancer spread to the liver despite previous therapies, responded so well to the experimental treatment that his liver disease resolved. And, says Horobin, “To our surprise, one patient had a complete tumor shrinkage. We often see stabilization, but not shrinkage.”

The entinostat-azacitidine combination is being tested in conjunction with Johns Hopkins University and Stand Up to Cancer—a Hollywood-funded initiative that’s aimed at encouraging research collaborations across companies and academic institutions. Horobin calls the project’s leaders “a dream team in epigenetics,” which includes Stephen Baylin, Hopkins researcher and Syndax advisor.

The next milestone for Syndax will come in the fall, when it present data from a Phase 2 study of entinostat plus aromatase inhibitors in breast cancer patients. The company is also planning a Phase 3 program for that combination. All in all, says Horobin, “We’re very excited. The whole premise of Syndax was to take the promise of epigenetics into solid tumors. This is very cool science.”

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