AUSTIN, Texas and CAMBRIDGE, Mass., May 8, 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, has selected Accenture to provide clinical data management services to help accelerate the clinical development of Genprex's lead drug candidate, Oncoprex™, for the treatment of non-small cell lung cancer (NSCLC).
"Data traceability is critically important when interacting with the FDA," said Julien Pham, MD, MPH, President and COO of Genprex. "Rigorous data management is essential, not just in late-stage trials, but throughout the clinical development process."
Under the agreement, Accenture, a leading global professional services company, is supporting Genprex with clinical data management and submission-compliant CDISC deliverable activities for the Phase I/II clinical trial combining Genprex's Oncoprex and the EGFR-inhibitor erlotinib (Tarceva®) in stage IV lung cancer. Accenture's Clinical Data Management team has executed thousands of clinical trials in a variety of therapeutic areas, supported by experienced industry professionals who understand the importance of a standards-fueled, data-centric approach across each phase of drug development. Clinical data services are a core offering in Accenture's R&D services business, and the company places a strong emphasis on providing high quality data management using a variety of electronic data capture systems.
"Accenture looks forward to supporting Genprex with the second phase of their Phase I/II clinical trial," said Thomas Lehmann, managing director, Accenture Accelerated R&D Services. "Our team is committed to bringing our Clinical Data Management services to innovative organizations like Genprex, which are focused on the development of cutting-edge, impactful therapies that promise to improve patient lives."
About Genprex, Inc.
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. Visit the company's web site at www.genprex.com or follow Genprex on Twitter at https://twitter.com/genprex and Facebook at https://www.facebook.com/genprexinc/.
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 services we expect to receive from Accenture and the effect of those services on the development of Oncoprex. Risks that contribute to the uncertain nature of the forward-looking statements include Accenture's ability to provide services to us and our ability to utilize Accenture's services, the ability of Accenture'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.