Genprex Inc. (NASDAQ:GNPX) has initiated the first phase of branding for its lead drug candidate, Oncoprex immunogene therapy for non-small cell lung cancer, 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.
The clinical-stage gene therapy company said, upon receiving feedback from the USAN Council - which is expected later this year – it 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.
Rodney Varner, chairman and chief executive officer of Genprex commented: “Developing and obtaining regulatory approval of a non-proprietary drug name is a requirement for bringing our lead drug candidate to market.”
“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.
Two-word nomenclature scheme.
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.
Genprex is developing potentially life-changing technologies for cancer patients, based upon its unique proprietary technology platform.
At the start of July, Genprex said a study of Oncoprex, completed at the University of Texas in April, showed positive results.
The study had examined the effects of the tumor suppressor gene TUSC2 found in Oncoprex in combination with immunotherapy treatment.