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Biopharmaceutical company Onconova Therapeutics announced today that it has submitted a research new drug application (IND) for ON 123300 to the U.S. Food and Drug Administration (FDA).
ON 123300 is a CDK4/6 inhibitor used to treat recurring/refractic advanced cancers, including HR-HER2-metastasis breast cancer that is resistant to second-generation CDK4/6 inhibitors.
Onconova CEO Steven M. Fruchtman said, "ON 123300, based on its novel mechanism of work, provides an innovative way to study advanced cancer, including patients with HR-HER2-metastassic breast cancer who have developed resistance to CDK4/6 inhibitors.
we are pleased to be submitting IND on time and look forward to our partner HanX Biopharmaceuticals recruiting patients in the U.S. to supplement the Ongoing Phase I Dose Incremental Study in China.
we believe that the data from these two studies will generate important information to provide information for later research."
As currently envisaged, Phase I clinical trials in the United States will assess the safety, toerability and pharmacodynamics of ON 123300, with doses starting at 40 mg or higher per day and increasing over a 28-day cycle.
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