Orphan Drug Designation Granted to PTX-252 by
PTX-252 (previously referenced as a Plecoid™Agent) is a novel molecular entity developed in collaboration with Pleco Therapeutics
Liège,
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.
About Acute Myeloid Leukaemia (AML)1
AML is a type of heterogenous haematological malignancy that originates from immature white blood cells (blasts) in the bone marrow, which may be derived from either a hematopoietic stem cell or a lineage-specific progenitor cell. AML generally spreads quickly to the bloodstream and can then spread to other parts of the body including lymph nodes, spleen, central nervous system, and testicles. AML is primarily a disease of the adulthood; the median age of newly diagnosed AML patients is around 67 years. Additionally, AML is more common in males. AML can arise de novo or secondarily either due to the progression of other diseases or due to treatment with cytotoxic agents. GlobalData estimates that in 2022, there were 148,351 diagnosed prevalent cases of AML in major markets and expects that the number will increase to 185,323 by 2032.
About
Hyloris is a specialty biopharma company focused on innovating, reinventing, and optimizing existing medications to address important healthcare needs and deliver relevant improvements for patients, healthcare professionals and payors. Hyloris has built a broad, patented portfolio of 17 reformulated and repurposed value-added medicines that have the potential to offer significant advantages over available alternatives. Two products are currently in initial phases of commercialization with partners: Sotalol IV for the treatment of atrial fibrillation, and Maxigesic® IV, a non-opioid post-operative pain treatment. Outside of its core strategic focus, the Company also has 1 approved high barrier generic product launched in the
About Pleco Therapeutics
Pleco Therapeutics is a clinical stage specialty biopharmaceutical company that aims to improve the survival rate of cancer patients through its novel Plecoid™ therapies that increase the effectiveness of current cancer treatments. As private company, Pleco is headquartered in Nijmegen,
For more information, contact Hyloris:
Stijn.vanrompay@hyloris.com
+32 (0)4 346 02 07
Jean-luc.vandebroek@hyloris.com
+32 (0)478 27 68 42
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.
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Attachment
- Pleco - AML - Orphan designation_final_EN
Source:
2024 GlobeNewswire, Inc., source