A Phase I/II, multi-center trial designed to test the safety and preliminary efficacy of a first in class cancer treatment opened worldwide today at the Virginia G. Piper Cancer Center Clinical Trials at Scottsdale Healthcare, a partnership between Scottsdale Healthcare and the Translational Genomics Research Institute (TGen). PR610 is designed to become activated in tissues with low levels of oxygen, which is characteristic of many cancers. This "targeted" approach should deliver more active drug to cancer tissue and less active drug to normal tissue.
The two-part trial, sponsored by the drug's manufacturer, Proacta Inc., will first determine acceptable dose levels of PR610 in patients with various types of advanced cancer. After determining acceptable dose levels, the study will evaluate the safety and efficacy of PR610 when given to patients with non-small cell lung cancer whose tumors contain a certain genetic mutation. Other goals of the study are to measure levels of PR610 in the blood.
"PR610 is a promising and innovative compound that merges delivery of a drug to the cancerous, oxygen depleted tissue and it also targets the communication functions that govern the growth and behavior that drive certain cancers," said Dr. Glen Weiss, Clinical Associate Professor at TGen and Director of Thoracic Oncology at Virginia G. Piper Cancer Center Clinical Trials at Scottsdale Healthcare.
Research has shown that some cancer tissue has lower levels of oxygen than normal tissue. This lower level of oxygen appears to make the cancer tissue more resistant to radiation and chemotherapy, which allows the cancer to become more aggressive and spread. PR610 is designed to become active in cancer tissue with low levels of oxygen.
"Proacta is very excited to be working with Virginia G. Piper Cancer Center Clinical Trials and TGen on this important study. We purposely limited participation in this study to those cancer centers with extensive experience and expertise in conducting clinical oncology trials," said Dr. John Gutheil, CEO of Proacta.
Non-small cell lung cancer is a disease in which cancerous cells form in the tissues of the lung. There are several types, and chances of recovery are determined by many factors, such as smoking and lifestyle. Unfortunately, current treatments options do not cure the majority of patients with non-small cell lung cancer.
About 44 people will participate in this study at research sites in the U.S. and New Zealand, with the Virginia G. Piper Cancer Center at Scottsdale Healthcare being the first to enroll a patient.