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Investing.com -- CERo Therapeutics Holdings Inc (NASDAQ:CERO) stock surged 191.6% after the U.S. Food and Drug Administration (FDA) granted Orphan Drug Designation (ODD) for the company’s lead drug candidate CER-1236, which treats acute myeloid leukemia (AML).
The designation provides CERo with several benefits, including assistance in designing clinical trials, access to the FDA Orphan Drug Grants Program, exemption from drug approval application fees, and potential seven-year marketing exclusivity if approved.
CER-1236 is currently in Phase 1 clinical trials for AML. The therapy engineers a patient’s own T cells to deploy phagocytic mechanisms that enable the cells to "eat" cancer targets alongside other cell-destroying mechanisms.
"Orphan Drug Designation underscores the importance of developing new treatments for AML, and the potential for CER-1236 to provide a new and differentiated approach toward treatment," said Chris Ehrlich, CERo CEO. "We believe that we are at the forefront of innovation in immuno-oncology and are grateful for the recognition from FDA."
The ongoing first-in-human, multi-center Phase 1/1b study is evaluating CER-1236 in patients with various forms of AML, including relapsed/refractory cases and newly diagnosed patients with specific mutations. The study includes dose escalation to determine the highest tolerated dose, followed by an expansion phase to evaluate safety and efficacy.
The FDA’s Orphan Drug program is designed for drugs treating conditions affecting fewer than 200,000 U.S. patients annually where the treatment represents a significant benefit over existing options.
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