Genprex Updates Agreement with University of Texas MD Anderson Cancer Center to Resume Patient Enrollment in Phase I/II Study Evaluating Oncoprex/Erlotinib Combination Therapy in Non-Small Cell Lung Cancer
Oncoprex is a TUSC2 gene encapsulated in a positively charged nanovesicle made from lipid molecules and injected intravenously, which can specifically target cancer cells and insert wild-type TUSC2 into cellular DNA, effectively increasing expression of the TUSC2 protein and promoting tumor cell death.
Previously announced interim data from nine patients from the Phase II portion of this Phase I/II clinical trial showed a disease control rate of 78%, with seven out of nine patients achieving stable disease or better, including one complete response. In a previous Phase I clinical trial at MD Anderson evaluating Oncoprex as a monotherapy, five of 23 patients with late-stage NSCLC achieved stable disease or better, with one durable metabolic response.
“We look forward to completing the Oncoprex/erlotinib trial and
expanding the study of Oncoprex in combination with other targeted and
immunotherapies in the future,” said
A subset of NSCLC patients (approximately 10% of NSCLC patients of North American and European descent and approximately 30% to 50% of NSCLC patients of Asian descent) carry an EGFR mutation that makes their tumors sensitive to tyrosine kinase inhibitors, or TKIs, such as erlotinib. However, even for these patients, tumor resistance to TKIs frequently develops within two years, resulting in eventual disease progression. While next generation TKIs show promise in targeting resistant EGFR positive tumors that carry a mutation known as T790M, only about one-half of EGFR positive patients (5% to 7.5% of all NSCLC patients of North American and European descent and 15% to 25% of NSCLC patients of Asian descent) carry the T790M mutation. This leaves a significant majority of NSCLC patients—those who are EGFR negative and those who are EGFR positive but have become resistant to erlotinib and do not have the T790M mutation—without a targeted therapy for their cancer.
Combination therapies targeting multiple anti-cancer pathways represent a promising approach to achieving greater response rates, and may also allow the expanded use of targeted therapies and immunotherapies in a larger population of cancer patients who are not currently candidates for these treatments.
About Lung Cancer
According to the
Statements contained in this press release regarding matters that are
not historical facts are "forward-looking statements" within the meaning
of the Private Securities Litigation Reform Act of 1995. Because such
statements are subject to risks and uncertainties, actual results may
differ materially from those expressed or implied by such
forward-looking statements. Such statements include, but are not limited
to, statements regarding the effect of TUSC2 and Oncoprex on cancer,
alone or in combination with other drugs, whether and if so, when our
clinical trials might be undertaken, expanded or completed, the safety
of Oncoprex, the services we expect to receive from MD Anderson and the
effect of those services on the development of Oncoprex. Risks that
contribute to the uncertain nature of the forward-looking statements
include the presence and level of TUSC2’s and Oncoprex’s effect on
cancer, alone or in combination with other drugs, the safety of
Oncoprex, MD Anderson’s ability to provide services to us and our
ability to utilize MD Anderson’s services, the ability of MD Anderson’s
services to influence the development of Oncoprex, as well as the timing
and success of our clinical trials and planned clinical trials of TUSC2
and Oncoprex and our other potential product candidates and the timing
and success of obtaining