Orphan Drug Designation Granted to PTX-252 by U.S. FDA for the Treatment of Acute Myeloid Leukaemia (AML)
16 Janeiro 2024 - 3:30PM
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)1AML 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 Pharmaceuticals SAHyloris 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 U.S. and 2 high barrier generic product candidates
in development. The Company’s development strategy primarily
focuses on the FDA’s 505(b)2 regulatory pathway, which is
specifically designed for pharmaceuticals for which safety and
efficacy of the molecule have already been established. This
pathway can reduce the clinical burden required to bring a product
to market, and significantly shorten the development timelines and
reduce costs and risks. Hyloris is based in Liège, Belgium. For
more information, visit www.hyloris.com and follow-us
on LinkedIn.
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, the Netherlands, with a U.S.
subsidiary, Pleco Therapeutics USA Inc, based in Newark, New
York.
For more information, contact Hyloris:Stijn Van
Rompay, CEOStijn.vanrompay@hyloris.com+32 (0)4 346 02 07
Jean-Luc Vandebroek, CFOJean-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.
1 Datamonitor Healthcare April 2021; Leukemia & Lymphoma
Society, 2019; WHO classification of AML, 2016
- Pleco - AML - Orphan designation_final_EN
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