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Pleco Therapeutics Announces €8.7m Strategic Partnership with Hyloris to Progress its Novel Plecoid™ Agent in Acute Myeloid Leukaemia and Small Cell Lung Cancer

The Plecoid FDC product is a patented, innovative, clinical-stage candidate drug that combines chelating agents with different characteristics. Previous studies demonstrate that elevated levels of toxic metals are associated with inferior survival in patients with AML. Exploratory clinical studies are currently ongoing in AML patients to evaluate the metal rebalancing effect of chelating agents administered concomitantly with chemotherapy. Interim results from these exploratory studies indicate high complete remission rates and improved rates of survival.
Netherlands, (informazione.news - comunicati stampa - scienza e tecnologia)

The Plecoid FDC product is a patented, innovative, clinical-stage candidate drug that combines chelating agents with different characteristics. Previous studies demonstrate that elevated levels of toxic metals are associated with inferior survival in patients with AML. Exploratory clinical studies are currently ongoing in AML patients to evaluate the metal rebalancing effect of chelating agents administered concomitantly with chemotherapy. Interim results from these exploratory studies indicate high complete remission rates and improved rates of survival.

The R&D funding from Hyloris is subject to feedback from the US FDA on the feasibility of the future clinical development requirements, to cover pre-defined R&D activities through to submission for approval in AML, plus exploratory development work in SCLC.

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Pleco retains all rights in its other R&D activities outside of the AML and SCLC programmes, with the potential to scale its Plecoid fixed-dose combination platform into treatments for other cancers, including PTX-081, as well as neurodegenerative disorders where aberrant metal patterns have been shown to play a role.

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 an orphan disease and is the most common type of acute leukaemia in adults and 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 or secondarily either due to the progression of other diseases or due to treatment with cytotoxic agents. Datamonitor Healthcare estimates that in 2018, there were 158,400 incident cases of AML worldwide and expects that the number will increase to 169,000 by 2027.

[1] The University of Texas MD Anderson Cancer Center is devoted exclusively to cancer patient care, research, education and prevention and ranks No. 1 in cancer care in the U.S. News & World Report's 2020-21 "Best Hospitals" survey

[2] Ohanian et al, Journal of Hematology, January 2020

[3] Datamonitor Healthcare April 2021 ; Leukaemia & Lymphoma Society, 2019; WHO classification of AML, 2016

Pleco Therapeutics is a specialty biopharmaceutical company which aims to extend the life span and enhance the quality of life of patients through its novel Plecoid™ therapies that have been designed to dramatically increase the effectiveness of current cancer treatments. Our novel Plecoid™ therapies have the potential to positively change the balance of protein expression within the cancer microenvironment, removing the burden of toxic metals within the cell, thereby improving the effectiveness of existing chemotherapy. Pleco is based in Nijmegen, the Netherlands . For more information visit www.plecotherapeutics.com. Follow us on LinkedIn and Twitter

Hyloris is a specialty biopharma company focused on innovating, reinventing, and optimising 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 14 reformulated and repurposed value-added medicines that have the potential to offer significant advantages over available alternatives. Outside of its core strategic focus, the Company also has 3 high barrier generic products in development and registration phase. Two products are currently in initial phases of commercialisation with partners: Sotalol IV for the treatment of atrial fibrillation, and Maxigesic® IV, a non-opioid post-operative pain treatment. 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 ., visit www.hyloris.com and follow-us on LinkedIn.   

Sue Charles , Charles Consultants – sue@charles-consultants.com +44 (0)7968 726585

Investor Relations and Media - investorrelations@hyloris.com  

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