Healthcare Industry News: U.S. Food and Drug Administration
News Release - February 5, 2018
Trethera Corporation Announces FDA Clearance of Investigational New Drug Application for TRE-515LOS ANGELES, Feb. 5, 2018 -- (Healthcare Sales & Marketing Network) -- Trethera Corporation, a biopharmaceutical company committed to developing novel drugs targeting cellular nucleotide metabolism for the treatment of cancer, today announced that the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application for TRE-515, a novel, first-in-class inhibitor of deoxycytidine kinase for the treatment of patients with myelodysplastic syndromes (MDS). Under this IND, Trethera plans to initiate a Phase 1 study designed to evaluate the safety, pharmacokinetics, and pharmacodynamics of TRE-515 as well as validate several biomarkers in relapsed and/or refractory MDS patients who have no available alternative therapy.
TRE-515 is a small molecule that has demonstrated efficacy in treating disease models in a variety of aggressive leukemias when used in combination with certain approved and investigational DNA modulating drugs. Trethera has developed an orally-available form of TRE-515 to address the needs of patients and providers.
"The FDA's clearance of this IND application is an important milestone for Trethera as we accelerate our development toward a novel combination therapy with TRE-515 that potentially could improve treatment of blood cancers," said Monica Alfaro Welling, chief executive officer of Trethera. "Our team is excited about developing the first therapeutic to target the salvage pathway of nucleotide synthesis, a metabolic pathway that may be contributing to the progression of a variety of oncology and inflammatory disorders."
TRE-515 is an oral, first-in-class inhibitor of deoxycytidine kinase (dCK). dCK catalyzes the rate-limiting reaction in the deoxyribonucleoside salvage pathway, one of two biosynthetic pathways that generate the precursors of DNA. The other biosynthetic pathway is the de novo pathway. Trethera's founders discovered that certain cancer cells can dynamically shift production between these two pathways, allowing the cancer cells to escape single pathway inhibition. Trethera has developed TRE-515 for use in combination with de novo pathway inhibitors, thereby enabling a dual-blockade of nucleotide synthesis that precisely targets a metabolic vulnerability of these cancer cells. This approach holds the potential to improve treatment efficacy and minimize the development of drug resistance.
About Myelodysplastic Syndromes (MDS)
MDS is a type of cancer with significant morbidity and high mortality. MDS consists of a heterogeneous group of hematologic neoplasms in which blood-forming cells in the bone marrow are damaged. The disease leads to bone marrow failure and about one-third of patients develop acute myeloid leukemia (AML). MDS primarily afflicts the elderly with a median age of diagnosis of 76 years. There were over 18,000 newly diagnosed cases of MDS in the U.S. in 2016 with new cases projected to increase nearly 3% annually through 2026.
Trethera is a privately-held biopharmaceutical company dedicated to developing novel treatments for orphan blood cancers with high unmet needs. The Company is led by an experienced management and drug development team and was founded by prominent UCLA faculty. Trethera's innovative approach to targeting cancer metabolism led to the development of a first-in-class drug, TRE-515. For more information, visit trethera.com.
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