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Clinical Trials Approved for Titan's AN-9 and its MDR Gene Therapy

Clinical Trials Approved for Titan's AN-9 and its MDR Gene Therapy

MENLO PARK, Calif--Ansan, Inc., an operating company of Titan Pharmaceuticals, has received FDA approval to start a phase I trial of its butyric acid derivative AN-9 in patients with solid tumors. In preclinical studies, AN-9 demonstrated broad anticancer activity and may have less toxicity than standard chemotherapeutic agents, the company said.

The agent is a form of differentiation therapy, ie, it causes rapidly growing immature cells to become growth-regulated, differentiated cells, Titan said. It may also induce apoptosis in some types of cancer cells. The trial will be conducted at San Antonio's Cancer Therapy and Research Center.

Another Titan operating company, Ingenex, Inc., along with The University of Texas M.D. Anderson Cancer Center, has received the FDA go-ahead for a pilot study of its multidrug resistance (MDR) gene therapy in 10 patients receiving paclitaxel (Taxol) for advanced breast cancer. The therapy had previously received approval for testing in ovarian cancer patients.

The MDR-1 gene will be inserted into the patients' peripheral blood stem cells, to protect against the dose-limiting side effects of chemotherapy.

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