Tolero Pharmaceuticals announced the first patient has been enrolled in a Phase 1b/2 study, Zella 102, evaluating the investigational agent alvocidib, a cyclin-dependent kinase 9 (CDK9) inhibitor, plus decitabine in patients with myelodysplastic syndromes (MDS). The Phase 1b/2, open-label, dose-escalation study will evaluate the safety and preliminary clinical activity of alvocidib when administered in sequence after decitabine in patients with MDS.
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"We are pleased to initiate this Phase 1b/2 clinical trial of alvocidib in myelodysplastic syndromes," said David J. Bearss, Ph.D., Chief Executive Officer of Tolero Pharmaceuticals. "We hypothesize that downregulation of MCL-1 via CDK9 inhibition following decitabine exposure may result in enhanced antileukemic activity. We believe that there are some patients with MDS that may have disease dependent on MCL-1. This milestone supports our commitment to understanding the potential of alvocidib in this patient population."
The primary objective of the Phase 1b study is to determine the incidence of dose-limiting toxicities and treatment emergent adverse events over the course of 28 days. Once the maximum tolerated dose or preliminary recommended Phase 2 dose is identified, the study will progress to Phase 2. The primary objective of the Phase 2 study is to determine the objective response rate. The trial is being conducted at sites in the United States.
MDS is a form of cancer that can occur when cells in the bone marrow are abnormal, resulting in the production of defective blood cells that often die earlier than normal cells. In one of three patients, MDS can progress into acute myeloid leukemia (AML), a rapidly growing cancer of bone marrow cells.