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Ignyta Announces Initiation of STARTRK-1 Global Phase I/II Clinical Trial of RXDX-101

SAN DIEGO--(BUSINESS WIRE) July 21, 2014 -- Ignyta, Inc., an oncology precision medicine biotechnology company, today announced the multicenter initiation of the company's global Phase I/II clinical trial of RXDX-101, its proprietary oral tyrosine kinase inhibitor targeting multiple solid tumor indications. This clinical trial is called STARTRK-1, which stands for Study Targeting ALK, ROS1 or TRKA/B/C, and is a Phase I/IIa, multicenter, single-arm, open-label clinical trial of continuous daily dosing of oral RXDX-101 in adult patients with locally advanced or metastatic cancer confirmed to be positive for relevant molecular alterations.

"We are excited to be able to expand the clinical dosing of this product candidate to patients at leading cancer centers in the U.S., Europe and Asia," said Jonathan Lim, M.D., Chairman and CEO of Ignyta. "The initiation of the STARTRK-1 trial builds on the momentum of our presentation of interim data from the ongoing RXDX-101 Phase I clinical trial at the ASCO annual meeting, where we reported partial responses in patients with each of TrkA, ROS1 and ALK alterations, as well as in three different tumor types."

"The emergence of cancer therapies targeted to specific genetic alterations is an important advance in the treatment of solid tumors," said Alexander Drilon, M.D., a medical oncologist in the Thoracic Oncology Service at Memorial Sloan Kettering Cancer Center and a principal investigator in the STARTRK-1 trial. "This trial will help elucidate the clinical effects of RXDX-101, which inhibits pan-Trk, ROS-1 and ALK proteins, and allow us to better understand the drug's potential to help these very sick patients."

The trial will involve multiple clinical sites in the U.S., Europe, and Asia. Sites that Ignyta anticipates will dose patients in the Phase I portion of the trial include Chao Family Comprehensive Cancer Center at UC Irvine, Lombardi Comprehensive Cancer Center at Georgetown, Massachusetts General Hospital/Dana Farber Cancer Institute, Memorial Sloan Kettering Cancer Center, Sarah Cannon Research Institute, and the University of Texas M.D. Anderson Cancer Center.

About RXDX-101

As a novel, orally available, selective tyrosine kinase inhibitor of the Trk family of tyrosine kinase receptors (TrkA, TrkB and TrkC), ROS1 and ALK proteins, RXDX-101 is designed as a targeted therapeutic candidate to treat patients with cancers that harbor activating alterations to TrkA, TrkB, TrkC, ROS1 or ALK. RXDX-101 has demonstrated in vivo antitumor activity against various TrkA, ROS1 or ALK-driven mouse xenograft models of different human cancers, and has demonstrated oral bioavailability and been observed to efficiently cross the blood brain barrier in three animal species.

In addition to the STARTRK-1 clinical trial, RXDX-101 is currently in a Phase I/II clinical trial, called the ALKA-372-001 trial, at two clinical sites in Italy in patients with solid tumors who are positive for alterations in TrkA, ROS1 or ALK.

As of the May 2014 clinical update presented at ASCO, 20 patients had been enrolled in the ALKA-372-001 trial, with 19 having been dosed in six dose cohorts on an intermittent dosing schedule. The interim findings as of such date showed:

  • no dose-limiting toxicities had been observed, no drug-related serious adverse events had been observed and no patients were discontinued from the study due to adverse events; and
  • the following signs of antitumor activity were observed, with each patient remaining active in the study:
    • a patient with TrkA-positive metastatic colorectal cancer had a partial response;
    • a patient with ROS1-positive non-small cell lung cancer (NSCLC) had a partial response;
    • a patient with ALK-positive NSCLC had a partial response;
    • a patient with ALK-positive neuroblastoma had a partial response;
    • a patient with ROS1-deletion pancreatic cancer had achieved prolonged stable disease; and
    • a patient with ALK-positive NSCLC had achieved prolonged stable disease.

About Ignyta, Inc.

Ignyta, Inc., located in San Diego, California, is a biotechnology company developing precision medicine with integrated Rx/Dx solutions for cancer patients. The company's goal is to discover and develop revolutionary new drugs that target activated genes in cancer cells for the customized treatment of cancer patients. Ignyta's present focus is on the development of RXDX-101, its proprietary oral tyrosine kinase inhibitor that targets multiple solid tumor indications, and advancing its novel Spark discovery programs that leverage its proprietary cancer genomic and epigenomic knowledge bases. For more information, please visit:

Forward-Looking Statements

This press release contains forward-looking statements as that term is defined in Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Statements in this press release that are not purely historical are forward-looking statements. Such forward-looking statements include, among other things, references to the initiation and expansion of the company's STARTRK-1 clinical trial, the dosing of patients in such trial and the continuation of dosing of patients in the ALKA-372-001 trial. Actual results could differ from those projected in any forward-looking statements due to numerous factors. Such factors include, among others, the potential for final results of the ongoing Phase I/II clinical trials of RXDX-101, or any future clinical trials, to differ from preliminary results; the inherent uncertainties associated with developing new products or technologies and operating as a development stage company; regulatory developments in the United States and foreign countries; Ignyta's ability to develop, complete clinical trials for, obtain approvals for and commercialize any of its product candidates; changes in Ignyta's plans to develop and commercialize its product candidates; Ignyta's ability to raise any additional funding it will need to continue to pursue its business and product development plans; Ignyta's ability to obtain and maintain intellectual property protection for its product candidates; the loss of key scientific or management personnel; competition in the industry in which Ignyta operates; and market conditions. These forward-looking statements are made as of the date of this press release, and Ignyta assumes no obligation to update the forward-looking statements, or to update the reasons why actual results could differ from those projected in the forward-looking statements. Investors should consult all of the information set forth herein and should also refer to the risk factor disclosure set forth in the reports and other documents the company files with the SEC available at, including without limitation Ignyta's Annual Report on Form 10-K for the year ended December 31, 2013 and subsequent Quarterly Reports on Form 10-Q.

Source: Ignyta, Inc.

Posted: July 2014