Starton Therapeutics Inc has reported that the US Food and Drug Administration (FDA) has cleared an investigational new drug (IND) application for candidate STAR-OLZ for treating chemotherapy-induced nausea and vomiting (CINV), setting the ball rolling for a clinical development program to begin later this year.
TROPIC-I will be a Phase 2 dose-optimization study in highly emetogenic chemotherapy (HEC) comparing STAR-OLZ with or without STAR-OLZ for CINV in around 120 cancer patients receiving HEC. The study is expected to enroll at over 20 clinical sites in the US.
CINV is among the most debilitating side-effects of cancer treatment, and currently in the USA, three or four-drug regimens are recommended to prevent CINV for the million patients receiving HEC each year but 60% to 70% still struggle with nausea, noted Starton.
The study later in 2022 will assess STAR-OLZ superiority in total control (defined as no nausea, no vomiting, and no use of rescue medications) and no difference in the control of vomiting compared to the current treatment with combinations containing a 5-HT3, dexamethasone and NK1 antagonist.
READ: Starton Therapeutics says STAR-LLD study successfully demonstrates continuous drug delivery of lenalidomide from a transdermal patch
"STAR-OLZ represents the first product to be developed for FDA approval using the Total Control primary endpoint, potentially improving outcomes and quality of life for patients," Dr. Jamie Oliver, chief medical officer at Starton, told investors in a statement.
"Total Control is a measure of no nausea, no vomiting, and no rescue medications; existing antiemetics have been approved using a Complete Response (CR) endpoint which only measures vomiting and the need for rescue medications."
STAR-OLZ has previously completed Phase 1 in-human bioavailability (BA) studies which demonstrated the transdermal patch has acceptable local tolerability over the five-day dosing interval and delivers around 60% less drug than the oral form.
Starton Therapeutics is focused on transforming standard of care therapies with proprietary continuous delivery technology, so people with cancer can receive continuous treatment to live better, longer. Its proprietary transdermal technology is intended to increase efficacy of approved drugs, to make them more tolerable and expand their potential use.
Starton licensed the rights to develop and commercialize STAR-OLZ in Mainland China to Haisco Pharmaceutical Group. The company intends to retain the rights in the United States and is exploring partnerships in the rest of the world.
Contact the writer at giles@proactiveinvestors.com