Nerviano Medical Sciences’ partner Ignyta, Inc. (Nasdaq: RXDX), an oncology precision medicine biotechnology company, presented interim results from the first-in-human ALKA-372-001 Phase I clinical trial of RXDX-101 in a poster discussion session at the 2014 Congress of the European Society for Medical Oncology (ESMO) in Madrid, Spain.
Ignyta reports that: "We continue to be encouraged by the data we have seen to date from this Phase I clinical trial of RXDX-101, which has shown promising signs of antitumor activity and no dose-limiting toxicities," said Jonathan Lim, M.D., Chairman and CEO of Ignyta. "We recently observed our first complete response in the study, in a patient with ROS1-positive non-small cell lung cancer after two cycles of treatment. We have now also seen a total of five partial responses in patients with each of TrkA, ROS1 and ALK alterations and across three different tumor histologies, and another two patients with prolonged stable disease."
"We are also in the early stages of dose escalation in evaluating two alternate dosing schedules in this clinical trial," Dr. Lim continued. "Between those evaluations and the continuous daily dosing schedule we are assessing in our recently-initiated STARTRK-1 Phase I clinical trial of RXDX-101 under our U.S. IND, we are making solid progress toward the determination of a recommended Phase II dose of RXDX-101."
The ALKA-372-001 dose escalation study was designed to determine the maximum tolerated dose (MTD) and recommended Phase II dose, as well as preliminary anti-cancer activity of single agent RXDX-101 in patients with solid tumors with molecular alterations in the TrkA, ROS1 or ALK tyrosine kinase receptors. In the initial dosing schedule, Schedule A (20 patients enrolled, 19 patients treated), for each of the first three weeks of each 28-day dosing cycle, patients received RXDX-101 for four consecutive days in fasted conditions, followed by three days without dosing. During the fourth week of each such dosing cycle, patients were not dosed. In dosing Schedule B (three patients treated), RXDX-101 was dosed once-daily for each day of each 28-day dosing cycle. In dosing Schedule C (three patients treated), patients received RXDX-101 for four consecutive days, followed by three days without dosing, in each week of each 28-day dosing cycle. In both Schedule B and Schedule C, RXDX-101 is administered in fed conditions.
See further details on the interim findings on the Ignyta website www.ignyta.com.