CLEVELAND – A new anti-cancer drug developed at the Ireland Cancer Center of University Hospitals Case Medical Center and Case Western Reserve University was used for the first time to treat a cancer patient. The Phase One study at the Ireland Cancer Center of TRC102, a novel anti-cancer drug intended to reverse resistance to chemotherapy by targeting a specific DNA repair pathway, has the potential to improve the lives of many patients.
“This new therapy has the promise of overcoming a major mechanism of drug resistance which is good news for cancer patients,” says Panos Savvides, MD, oncologist with the Ireland Cancer Center, assistant professor of medicine at Case Western Reserve University and primary investigator for the trial. “Resistance to chemotherapy prevents many patients from benefiting, but this new “first-in-class” agent, used in combination with Temodar®, uniquely reverses resistance to chemotherapy.”
TRC102 (introduced as Methoxyamine) is a small molecule that has been shown to reverse resistance to the chemotherapy agent Temodar® in models of human cancer, by targeting a newly identified pathway used to repair chemotherapy-induced DNA damage. TRC102 was developed by researchers Stanton Gerson, MD, Director of the Ireland Cancer Center and the Case Comprehensive Cancer Center, and Lili Liu, PhD, Assistant Professor of Medicine at CWRU School of Medicine. The team was the first to show its therapeutic potential in combination with other agents.
CWRU’s Technology Transfer Office entered into a worldwide exclusive licensing agreement in 2006 with TRACON Pharmaceuticals, Inc. (TRACON) of San Diego, CA, a privately-held biopharmaceutical company focused on the development of products for oncology treatment, to develop TRC102.
“After discovering a novel form of cancer therapy targeted to a new class of cancer resistance, we are gratified that the drug can safely reach the clinic with FDA allowance and with strong NIH, institutional and commercial support,” said Dr. Gerson. “This is a perfect example of fulfilling our mission to bring new therapies from the laboratory to the patient bedside as quickly and safely as possible. The potential for helping cancer patients is huge at this point in drug development.”
The Phase 1 trial is designed to assess the safety, tolerability and pharmacokinetics, as well as preliminary anti-tumor activity, of TRC102 in patients with advanced cancer who are also receiving Temodar®. TRC102 is also being developed to reverse resistance to the chemotherapeutic Alimta® and a second Phase 1 trial of TRC102 combined with Alimta® is expected to begin later this year.