Kinex Pharmaceuticals, LLC and Hanmi Pharm. Co., Ltd. announced that the first patient has been enrolled in Hanmi's Phase Ib /IIa clinical trial in Korea. Kinex's dual Src/pretubulin Inhibitor, KX01, is being combined with intravenous (IV) paclitaxel to treat solid tumor patients in Phase Ib and then gastric and breast cancer patients in Phase IIa.

KX01 (KX2-391) is an once daily, orally administered potent small molecule Src kinase/pretubulin dual mechanism inhibitor discovered by Kinex Pharmaceuticals using its proprietary technology platforms Mimetica(TM)and Opal(TM). KX01 differentiates itself as a non-ATP competitive Src signaling inhibitor and, therefore, offers excellent efficacy as well as safety profile. KX01 has been shown to be very effective against a broad range of cancers in both in vitro experiments and in animal cancer models.

Importantly, the compound has synergistic activities with most taxanes, including paclitaxel which is combined with KX01 in the current Phase Ia /IIb trial. A completed Phase I study, in patients with end-stage cancer and twice daily dosing, showed a desirable safety profile and clinical stable diseases in approximately 25% of the patients. An ongoing KX01 AML mono-therapy Phase I trial has shown that once daily dosing allows much higher KX01 blood levels to be achieved while still maintaining and excellent safety profile.

The composition of matter, use and synthesis/formulation of KX01 is covered by issued and pending patents globally.