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Orphan Drug Designation Granted to PTX-252 by U.S. FDA for the Treatment of Acute Myeloid Leukaemia (AML)Orphan Drug Designation Granted to PTX-252 by U.S. FDA for the Treatment of Acute Myeloid Leukaemia (AML) PTX-252 (previously referenced as a Plecoid™Agent) is a novel molecular entity developed in collaboration with Pleco Therapeutics Liège, Belgium – 16 January 2024, 07:30PM CET – Non-Regulated information - Hyloris Pharmaceuticals SA (Euronext Brussels: HYL), a specialty biopharma company committed to addressing unmet medical needs through reinventing existing medications, today announces that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation to PTX-252 for the treatment of Acute Myeloid Leukaemia (AML). This product candidate, developed in collaboration with Pleco Therapeutics BV incorporates a novel molecular entity that is a derivative of a known established molecule and is designed to enhance the responsiveness of cancer cells to chemotherapy. Obtaining an Orphan Drug Designation provides incentives and benefits to encourage the development of treatments for rare diseases. These include financial incentives, market exclusivity and support in navigating regulatory processes. Stijn Van Rompay, Chief Executive Officer of Hyloris, commented: “Securing orphan drug designation for a product candidate incorporating a novel molecular entity, not yet approved by any regulatory agency, underscores our unwavering commitment to advancing the frontiers of scientific discovery within the repurposing space.” Ivo Timmermans, Chief Executive Officer of Pleco Therapeutics, added: "This milestone underscores our commitment to innovative therapies for rare diseases and it brings hope to AML patients who have limited treatment options. Our team is dedicated to advancing this therapy through clinical development as swiftly as possible." About Acute Myeloid Leukaemia (AML)1 About Hyloris Pharmaceuticals SA About Pleco Therapeutics For more information, contact Hyloris: Jean-Luc Vandebroek, CFO Disclaimer and forward-looking statements Hyloris means “high yield, lower risk”, which relates to the 505(b)(2) regulatory pathway for product approval on which the Issuer focuses, but in no way relates or applies to an investment in the Shares. Certain statements in this press release are “forward-looking statements.” These forward-looking statements can be identified using forward-looking terminology, including the words "believes", "estimates," "anticipates", "expects", "intends", "may", "will", "plans", "continue", "ongoing", "potential", "predict", "project", "target", "seek" or "should", and include statements the Company makes concerning the intended results of its strategy. These statements relate to future events or the Company’s future financial performance and involve known and unknown risks, uncertainties, and other factors, many of which are beyond the Company’s control, that may cause the actual results, levels of activity, performance or achievements of the Company or its industry to be materially different from those expressed or implied by any forward-looking statements. The Company undertakes no obligation to publicly update or revise forward-looking statements, except as may be required by law. 1 Datamonitor Healthcare April 2021; Leukemia & Lymphoma Society, 2019; WHO classification of AML, 2016 Attachment |