Genprex to Focus Clinical Efforts on Oncoprex Combination With Osimertinib >GNPX
9:45 am ET February 5, 2020 (Dow Jones) Print
By Michael Dabaie
Genprex Inc. (GNPX) said it is prioritizing the development of Oncoprex in combination with osimertinib for the treatment of non-small cell lung cancer.
In January, the company said it received U.S Food and Drug Administration Fast Track Designation for its Oncoprex in combination with osimertinib, AstraZeneca PLC's (AZN) Tagrisso, for the treatment of non-small cell lung cancer.
Genprex said it plans to file an amendment to its Investigational New Drug application with the FDA for the Oncoprex and osimertinib combination therapy trial in the first quarter of 2020.
Upon FDA acceptance of the amendment, the company said it expects to be in a position to enroll patients shortly thereafter.
Given the changing landscape in non-small cell lung cancer and the recent Fast Track Designation, Genprex said it believes prioritizing the combination therapy of Oncoprex with osimertinib represents the most efficient way to advance its lead drug candidate through the clinical process for FDA approval, to have the best commercial success in the lung cancer market and to make its treatment available to patients as soon as possible.
Genprex said it will also proceed with its plan to file an IND for the additional combination therapy of Oncoprex combined with the immunotherapy drug pembrolizumab, marketed as Keytruda by Merck & Co. (MRK) in the U.S., for non-small cell lung cancer.
Write to Michael Dabaie at michael.dabaie@wsj.com
(END) Dow Jones Newswires
February 05, 2020 09:45 ET (14:45 GMT)
Copyright (c) 2020 Dow Jones & Company, Inc.
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