NIJMEGEN,
The FDA’s designation acknowledges the potential of PTX-252 in addressing AML, a rare blood cancer with a poor prognosis. Orphan Drug Designation is granted to medicines that treat or prevent life-threatening or chronically debilitating rare disease, and with either no currently approved method of prevention or treatment or with significant clinical benefit when compared with existing treatments.
Orphan Drug Designation qualifies companies for incentives, including tax credits for clinical trials, exemption of user fees, and seven years of market exclusivity after approval.
"We are very excited to receive this designation for PTX-252 from the FDA," states
In the development of the lead compound PTX-252, Pleco has collaborated with Belgian company
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About Acute Myeloid Leukaemia (AML)
AML is a heterogenous haematological malignancy that originates from immature white blood cells (blasts) in the bone marrow. 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 an orphan disease, and it is the most common type of acute leukaemia in adults. The median age of newly diagnosed AML patients is around 67 years. Worldwide the incidence of AML is estimated to be 350,000 cases per year (4.7 cases per 100,000 population, Globocan). In the US, there were an estimated 20,050 new cases of AML in 2022 and 11,540 deaths. It can arise de novo or secondary to the progression of other diseases or following treatment with cytotoxic agents.
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. A private company, Pleco is headquartered in Nijmegen,
For more information about Pleco Therapeutics and its work in rare diseases, including AML, visit www.plecotherapeutics.com
Follow us on LinkedIn: https://www.linkedin.com/company/pleco-therapeutics-bv/
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. Hyloris is based in Liège,
For more information, visit www.hyloris.com
Follow us on LinkedIn: https://www.linkedin.com/company/hyloris-pharmaceuticals/
A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/21824f03-e3b6-4adb-b65d-90899c54ce73
Ivo Timmermans , MD MBA, Chief Executive Officer
Ivo Timmermans , Chief Executive Officer, Pleco Therapeutics BV
2024 GlobeNewswire, Inc., source