AUSTIN, Texas, May 31, 2018 /PRNewswire/ -- Genprex, Inc. (Nasdaq: GNPX), a clinical stage gene therapy company developing a new approach to treating cancer based upon a novel proprietary technology platform, announced today that it entered into a Master Services Agreement with WIRB-Copernicus Group, Inc. ("WCG"), through which WCG will serve as the Institutional Review Board (IRB) and Institutional Biosafety Committee (IBC) of record for new clinical trial sites that Genprex anticipates adding to participate in its Phase I/II clinical trial of lead product candidate, OncoprexTM, in combination with erlotinib (Tarceva®) in non-small cell lung cancer.
WCG is a leading provider of regulatory and ethical review services for clinical research, and through its affiliates, provides a range of services including ethical review, compliance, consulting, biosafety, education and technology.
"This is an important preliminary step in preparation for expanding our Phase I/II clinical trial to anticipated additional clinical trial sites," said Julien Pham, MD, MPH, President and Chief Operating Officer of Genprex. "We believe that having centralized IRB and IBC services will save time and money in the conduct of the clinical trial, including accelerating enrollment and simplifying the IRB process."
Genprex, Inc. is a clinical stage gene therapy company developing a new approach to treating cancer based upon a novel proprietary technology platform, including Genprex's initial product candidate, Oncoprex™ immunogene therapy for non-small cell lung cancer (NSCLC). Genprex's platform technologies are designed to administer cancer fighting genes by encapsulating them into nanoscale hollow spheres called nanovesicles, which are then administered intravenously and taken up by tumor cells where they express proteins that are missing or found in low quantities. Oncoprex has a multimodal mechanism of action whereby it interrupts cell signaling pathways that cause replication and proliferation of cancer cells, re-establishes pathways for apoptosis, or programmed cell death, in cancer cells, and modulates the immune response against cancer cells. Oncoprex has also been shown to block mechanisms that create drug resistance.
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 addition of clinical trial sites for our clinical trial, the services we expect to receive from WCG and the effect of those services on the development of Oncoprex. Risks that contribute to the uncertain nature of the forward-looking statements include our ability to add clinical trial sites for our clinical trial, WCG's ability to provide services to us and our ability to utilize WCG's services, the ability of WCG's services to influence the development of Oncoprex, as well as the timing and success of our clinical trials and planned clinical trials of Oncoprex and our other potential product candidates and the timing and success of obtaining FDA approval of Oncoprex and our other potential product candidates. These and other risks and uncertainties are described more fully under the caption "Risk Factors" and elsewhere in our filings and reports with the United States Securities and Exchange Commission. All forward-looking statements contained in this press release speak only as of the date on which they were made. We undertake no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made.
SOURCE Genprex, Inc.