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

March 1, 1995

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.

MENLO PARK, Calif--Ansan, Inc., an operating company of TitanPharmaceuticals, has received FDA approval to start a phase Itrial of its butyric acid derivative AN-9 in patients with solidtumors. In preclinical studies, AN-9 demonstrated broad anticanceractivity and may have less toxicity than standard chemotherapeuticagents, the company said.

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

Another Titan operating company, Ingenex, Inc., along with TheUniversity of Texas M.D. Anderson Cancer Center, has receivedthe 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 receivedapproval for testing in ovarian cancer patients.

The MDR-1 gene will be inserted into the patients' peripheralblood stem cells, to protect against the dose-limiting side effectsof chemotherapy.