San Diego (PRWEB) December 03, 2013
Tragara Pharmaceuticals, Inc. today announced the initiation of a phase 1b clinical trial of TG02, in combination with the poteosome inhibitor carfilzomib (Kyprolis®), in patients with relapsed or refractory multiple myeloma. TG02 is a potent oral inhibitor of CDK9, which leads to the depletion of key survival proteins, such as Mcl-1, resulting in p53-independent apoptosis across a wide range of tumor cells. The study is being led by Craig C. Hofmeister, M.D., at The Ohio State University Comprehensive Cancer Center, and is open for enrollment at multiple centers in the U.S.
This study is an open-label dose-escalation phase 1b trial in which TG02 is combined with carfilzomib in patients with relapsed or refractory multiple myeloma. The trial will include patients who have one or more cytogenetic abnormalities that predict poor prognosis and reduced responsiveness to current standard-of-care therapies, including deletion of chromosomes 17p or 1p, amplification of chromosome 1q, or the chromosomal translocation t(4:14). Patients who have received at least two prior therapies, including a proteasome inhibitor and an immunomodulatory agent, will also qualify for enrollment. The primary objective of the trial is to determine the dose-limiting toxicity, maximum-tolerated dose, and recommended phase II dose of TG02 in combination with carfilzomib. The secondary objectives include the assessment of safety, tolerability, pharmacokinetics, and the evaluation of exploratory biomarkers, in addition to evidence of anti-tumor activity.
“A meaningful percentage of patients with multiple myeloma have disease characterized by cytogenetic abnormalities, and the prognosis for these cases is typically poor,” said Craig C. Hofmeister, M.D., Assistant Professor at The Ohio State University, College of Medicine, and principal investigator. “The treatment options for this subset of patients ar
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