Thirty-one late-stage lung cancer patients, unresponsive to prior therapy, were treated with Oncoprex monotherapy at six escalating dose levels evaluating safety. Twenty-three patients received two or more doses of Oncoprex and were eligible for evaluation. Tumor growth was halted in five patients, with tumor shrinkage or reduced metabolic tumor activity observed in both primary and metastatic tumors in liver and pancreas. Before and after tumor biopsies showed 10- to 25-fold increases of TUSC2 protein after treatment. The authors concluded that Oncoprex can be safely administered intravenously in lung cancer patients to effect lung and metastatic tumors, demonstrating for the first time that a functioning tumor suppressor gene can be delivered intravenously to human cancer cells using a nanoparticle vector.
David J. Tomasso, chief operating and business officer at Genprex stated, "These data from our first clinical trial were encouraging and demonstrated that our novel nanoparticle formulation can safely, selectively and preferentially deliver the TUSC2 tumor suppressor to cancer cells."
Oncoprex is a nanomolecular therapy harnessing the TUSC2 (also known as FUS1) tumor suppressor. TUSC2 defects are associated with most major cancers and >85% of lung cancers. Intravenous Oncoprex induces apoptosis, and controls cell signaling and inflammation. A phase II clinical trial evaluating Oncoprex in combination with erlotinib will begin in 2012. The trial will enroll lung cancer patients without the EGFR mutation and patients unresponsive to erlotinib.
Genprex, Inc. is a privately held biopharmaceutical company developing nanomolecular therapies. Its novel technologies, including those licensed exclusively from The University of Texas MD Anderson Cancer Center, are protected by 15 issued patents and 9 pending applications and have been the subject of more than 30 peer-reviewed scientific publications in the fields of cancer, genomics and molecular biology.