Phase II Clinical Trial Combining Oncoprex™ With Tarceva®
A phase I/II clinical trial has been designed and accepted by FDA to evaluate intravenous Oncoprex in combination with Tarceva (erlotinib) in stage IIIB/IV lung cancer patients without an activating EGFR mutation and in patients with an activating EGFR mutation whose cancer has progressed on erlotinib therapy. Patients without the EGFR mutation represent the vast majority of lung cancer patients. However, such patients are generally not candidates for Tarceva therapy. Information for clinicians and patients will be made available as the clinical trial initiates and opens for enrollment.
More information can be found at ClinicalTrials.gov.
Phase I Clinical Trial Evaluating the Safety of Oncoprex monotherapy
A phase I dose escalation trial was conducted at The University of Texas MD Anderson Cancer Center (UTMDACC) evaluating intravenous Oncoprex (TUSC2/FUS1) monotherapy in stage IV recurrent, metastatic lung cancer patients. The study showed for the first time that a tumor suppressor gene can be delivered intravenously and selectively to a patient’s cancer cells using a systemic nanovesicle vector, express high levels of mRNA and protein in cancer cells in both primary and distant metastatic tumor sites, alter relevant pathways in the cancer cell and mediate clinically beneficial anti-cancer activity. Oncoprex was well tolerated with tumor responses noted in primary lung tumors and metastatic tumors, including liver and pancreas. UTMDACC investigators reported the positive data in abstract form at the 2011 Annual Meeting of the American Association for Cancer Research with publication in the international, peer-reviewed journal of the Public Library of Science. The publication is available here.
Tarceva® is a registered trademark of Astellas and the Roche Group of companies.