Ignyta reports preliminary results from ongoing Phase 1 clinical trial of RXDX-101

Feb 21 2014

Ignyta, Inc. (OTCQB:RXDX), an oncology precision medicine biotechnology company, announced today that Justin Gainor, M.D., of the Massachusetts General Hospital Cancer Center, presented preliminary results from the ongoing Phase 1 dose escalation portion of a Phase 1/2 clinical trial of RXDX-101, Ignyta's proprietary oral tyrosine kinase inhibitor targeting solid tumor indications, at the International Association for the Study of Lung Cancer (IASLC) 14th Annual Targeted Therapies for the Treatment of Lung Cancer Meeting. The trial is ongoing, with final results for the Phase 1 portion of the trial expected later this year.

The dose escalation study was designed to determine the maximum tolerated dose (MTD) and recommended Phase 2 dose, as well as preliminary anti-cancer activity of single agent RXDX-101 in patients with solid tumors with activating alterations in the TrkA, ROS1 or ALK tyrosine kinase receptors. At the time of data cut-off for Dr. Gainor's presentation, 18 patients were enrolled, with 17 having been dosed in six escalating dose cohorts. The preliminary findings show:

• the rate of enrollment has increased since Ignyta assumed responsibility for the study from its licensee in late 2013;
• no dose limiting toxicities have been observed to date;
• seven patients remain on active treatment in the study, with some patients having received 12 cycles of treatment; and
• promising signs of antitumor activity have been observed.

Ignyta has filed a Form-8-K with the U.S. Securities and Exchange Commission containing the materials presented by Dr. Gainor.