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Onconova Therapeutics announces that the first patient had been dosed in the Company's proprietary, novel multi-kinase inhibitor, ON 123300, in the United States.
FREMONT, CA: Onconova Therapeutics, Inc., a clinical-stage biopharmaceutical organization determined on researching and developing novel products for cancer patients, has announced that the first patient had been dosed in the Company's proprietary, novel multi-kinase inhibitor, ON 123300, in the United States. The trial is predicted to include three U.S. sites that will enlist patients with advanced cancer but not restricted to HR+ HER 2- metastatic breast cancer patients who have been refractory to or are advancing on currently approved CDK 4/6 inhibitors.
The Phase 1 trial will evaluate the safety, tolerability, and pharmacokinetics of ON 123300 when given orally as monotherapy at increasing doses beginning at 40 mg regularly for consecutive 28-day cycles. Following the completion of the trial's dose-escalation phase and the establishment of the recommended Phase 2 dose (RP2D), additional patients with HR+ HER 2- metastatic breast cancer who have received at least one prior line of therapy, including approved CDK 4/6 inhibitors, will be registered in the trial to identify efficacy signals. Additional cancer indications are being considered for research and will be selected based on preclinical and developing data.
"We are excited to begin dosing patients in this Phase 1 study and are pleased to be advancing ON 123300s clinical development in the United States," said Steven M. Fruchtman, M.D., President and Chief Executive Officer of Onconova Therapeutics. "Our goal is to provide an innovative treatment option for patients with advanced breast cancer who have become resistant to the commercial CDK 4/6 inhibitors, and other refractory solid tumors driven by the overexpression of tyrosine kinases targeted by ON 123300. Notably, ON 123300s ability to target multiple kinase pathways that are overexpressed in cancer may allow for single-agent efficacy and better tolerability compared to existing treatment regimens."
Dr. Fruchtman added, "We are also pleased by the progress our partner HanX Biopharmaceuticals is making with their ongoing Phase 1 trial with ON 123300 in China. While the administration schedule differs between these two Phase 1 trials, the maximum tolerated dose has not yet been reached in the first two dose-escalation cohorts of this trial, which is a promising sign for ON 123300s safety profile. Collectively, we expect these two complementary Phase 1 studies to provide important insights that will inform the design of subsequent trials."