TAIPEI, Taiwan, R.O.C.—September 13, 2011 -- InnoPharmax Inc. announced that the U.S. Food and Drug Administration (FDA) approved its Investigational New Drug (IND) application for Gemcitabine Hydrochloride Oral Formulation (D07001-F4).
FDA has completed its review of the Company's submissions and concluded that it is reasonably safe for the planned clinical study to proceed. The planned clinical trial is an open-label, exploratory, limited dose escalation study to evaluate the pharmacokinetics, safety and tolerability of D07001-F4 in solid tumor subjects.
Dr. CS Hsu, InnoPharmax’s President said, "FDA's acceptance of our IND represents a major milestone to the Company. We are very pleased to be able to initiate clinical studies with D07001-F4 in a short time."
The Company will now proceed with clinical site initiation and plans to begin patient recruitment activities in Q4 of 2011.
About Gemcitabine Hydrochloride Oral Formulation (D07001-F4)
Gemcitaine (2',2'-difluorodeoxycytidine) is a fluorine-substituted deoxycytidine analog with a broad spectrum of antitumor activity. It is rapidly and extensively deaminated by cytidine deaminase to the inactive metabolite, 2',2'-difluorodeoxyuridine (dFdU). It has been reported in a reported clinical study that the systemic exposure to oral gemcitabine was low due to extensive firstpass metabolism to dFdU.
D07001-F4 was developed based on InnoPharmax’s proprietary formulations to overcome the problem of low bioavailability of oral gemcitabine. In dog pharmacokinetic study, gemcitabine was well absorbed from the D07001-F4 formulation with oral bioavailability over 70%. Preclinical studies have shown that D07001-F4 shows efficacy in pancreatic as well as other selected tumor models.
About InnoPharmax
InnoPharmax is a specialty pharmaceutical company focused in the development and commercialization of products for the treatment of infectious diseases, immunology and oncology. It develops and acquires potential drug candidates for further development as well as commercialization, and uses internally developed drug delivery technology platforms for improving the safety and effectiveness of currently available drugs to provide better medical choices in these specific disease categories.
