Genprex Selects 4Clinics To Provide Clinical And Regulatory Support For Oncoprex Development Program
June 26, 2018
AUSTIN, Texas AND CAMBRIDGE, Mass., June 26, 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 4Clinics Group Sprl to provide support for the clinical development of the Company’s lead drug candidate, Oncoprex™, for the treatment of non-small cell lung cancer (NSCLC).
“This is an important step forward for Genprex as we expand the scope of the Oncoprex clinical development program to build on the encouraging data we’ve compiled to date,” said Julien Pham, MD, MPH, President and Chief Operating Officer of Genprex.
4Clinics is a global contract research organization that provides comprehensive clinical expertise to clients across data management, biostatistics, statistical programming, scientific writing, regulatory affairs and clinical operations services for clinical, observational and epidemiological studies. As part of 4Clinics’ initial engagement with Genprex, it will assist with biostatistics, statistical programming and analysis for the ongoing Phase I/II clinical trial evaluating Oncoprex in combination with erlotinib (Tarceva®) for the treatment of NSCLC. Additional services provided by 4Clinics will include medical and scientific writing support.
“4Clinics is pleased to begin this important work with Genprex as we leverage the skills and experience of our team of clinical development professionals to support the advancement of Oncoprex as a novel treatment option for patients with NSCLC,” said Xavier Ghyssens, Chief Executive Officer of 4Clinics. “Our team is committed to bringing quality clinical and regulatory affairs services to innovative life science companies like Genprex.”
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.
4Clinics is a contract research organization providing data management, biostatistics, statistical programming, medical and scientific writing, regulatory affairs and clinical operations services with a particular expertise in vaccines, immuno-oncology, immunotherapeutics and medical devices. 4Clinics serves pharmaceutical, biotechnology and medical devices companies as well as NGOs, hospitals and researchers with tailor-made services including remote biometry and medical writing platforms. 4Clinics has offices in Belgium, France, USA and Morocco and has a global coverage.
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 scope of our Oncoprex clinical development program, the services we expect to receive from 4Clinics 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 expand the scope of our Oncoprex clinical development program, 4Clinics’ ability to provide services to us and our ability to utilize 4Clinics’ services, the ability of 4Clinics’ 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.