Genprex, Inc. (NASDAQ: GNPX), a clinical-stage gene therapy company, today announced it has initiated the first phase of branding its lead drug candidate, Oncoprex™ immunogene therapy, and has completed the creation and submission of non-proprietary drug name selections to the American Medical Association’s United States Adopted Names (USAN) Council.
Upon receiving feedback from the USAN Council, which is expected later this year, Genprex will submit its non-proprietary drug name selections to the World Health Organization for International Nonproprietary Names (INN) status. The company expects to obtain an approved non-proprietary drug name by mid-year 2020.
“Developing and obtaining regulatory approval of a non-proprietary drug name is a requirement for bringing our lead drug candidate to market,” said Rodney Varner, Chairman and Chief Executive Officer of Genprex. “We’re one step closer to achieving this regulatory milestone. An approved non-proprietary drug name will also make our lead drug candidate more widely recognizable to clinicians and physicians and most importantly, to patients living with non-small cell lung cancer.”
The development of non-proprietary and proprietary drug names is based on regulatory requirements by several governing bodies, including the American Medical Association’s USAN Council, the World Health Organization’s INN Programme, the European Medicines Agency (EMA) and the U.S. Food and Drug Administration (FDA).
Non-proprietary drug names are typically designated based on the active ingredient or molecular composition of the drug. Specific to gene therapy, the nomenclature for products produced by insertion of genetic material into a vector where altered genetic material is administered to patients as a biologic drug is based on the drug candidate’s gene composition and the vector used to deliver the gene, thus requiring a two-word nomenclature scheme.
Upon creation and submission of the non-proprietary name selections, each governing body reviews the drug name submissions based on several criteria and guidelines, including similarity or conflicts with existing drug names and trademarks, prefixes that imply certain meanings or chemical elements, specific letter combinations and usage, and international language pronunciation considerations among other requirements.
About Genprex, Inc.
Genprex, Inc. is a clinical stage gene therapy company developing potentially life-changing technologies for cancer patients, based upon a unique 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. For more information, please visit the company’s web site at www.genprex.com or follow Genprex on Twitter, Facebook and LinkedIn.
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 effects of Oncoprex on cancer, and statements regarding Genprex’s anticipated receipt of a non-proprietary drug name, including the timing of receipt of such a name. Risks that contribute to the uncertain nature of the forward-looking statements include risks relating to the effects of Oncoprex, alone and in combination with immunotherapies, and risks relating to the criteria and timing of granting non-proprietary names for drug candidates. Other risks and uncertainties associated with Genprex and its lead product candidate Oncoprex 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.
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