APOSCIENCE AG completes secretome-based Phase I trial in diabetic foot ulcer (DFU) - DSMB recommends initiation of multinational Phase II trial of MARSYAS II

AposecTM (APO-2) is a secretome-based investigational medicinal product (IMP) derived from stressed peripheral blood mononuclear cells (PBMCs). APO-2 was tested in a multinational Phase I trial in DFU patients. The Data Safety Monitoring Board (DSMB) uniformly recommended proceeding with the main phase of the MARSYAS II trial.

AposecTM

AposecTM is based on a cutting edge technology in drug development and comprises the secretome of stressed peripheral blood mononuclear cells (PBMCs), a current waste product of transfusion units.
The investigational medicinal product does not contain any cells or cellular components, but rather consists of the filtered supernatant (secretome) containing proteins, lipids, extracellular vesicles, and antimicrobial peptides. This new technology harnesses the power of PBMCs, immunology, and biotechnology to overcome tissue damage and impaired wound healing.
APOSECTM is manufactured by the Blood Transfusion Service of the Red Cross Upper Austria in compliance with good manufacturing practice (GMP).

MARSYAS II

MARSYAS II is the first clinical trial to test a secretome-based therapy in DFU. It is designed as a Phase II trial preceded by a Phase I safety trial. APO-2 (Aposec for wound healing) is a „first in class“ IMP mixed with hydrogel for topical application and applied 3 times a week for 4 consecutive weeks. Three different doses of APO-2 will be evaluated in the main phase (Phase II) of the clinical trial. Aposcience AG conducts the MARSYAS II trial together with its experienced partners FGK Clinical Research GmbH (Munich, Germany) and ABF Pharmaceutical Services GmbH (Vienna).

Univ.-Prof. Dr. Ankersmit, CEO of APOSCIENCE AG: „Our Phase I trial has confirmed that this novel drug substance is safe for patients with Diabetic Foot Ulcers. Only Phase II trial data will evidence whether the massive investment in preclinical research as well as product science was worth the effort“.

The burden of diabetes

According to the International Diabetes Federation (IDF), 8.9% of adults aged 20–79 years (59.3 million people) in the European Region suffered from diabetes in 2019 (IDF diabetes atlas 2019). A further 296 500 children and adolescents under the age of 20 live with type 1 diabetes. Diabetes is also among the top-10 leading causes of non-communicable disease-related deaths in the region (Findings from the Global Burden of Disease Study 2017, Institute for Health Metrics and Evaluation; 2018). Major complications of diabetes mellitus are impaired wound healing and the development of foot ulcers. Non-healing foot ulcers may lead to amputation(s) and premature death.

Aposcience AG

Aposcience AG s a privately held Austrian clinical stage company founded by HJ Ankersmit in 2008. Aposcience AG evolved as a „spin off“ of the Clinical Department of Surgery of the Medical University of Vienna. The close cooperation between Aposcience AG and the Medical University of Vienna was supported by the Christian Doppler Society, the Austrian Research Promotion Agency FFG, and the Vienna Business Agency and is a perfect example of a well-organized public-private-partnership (PPP).

Contact

Aposcience AG
Dresdner Straße 87/A 21
1200 Vienna, Austria
P: +43 / (0)664 / 212 05 57
E: info(at)aposcience.com
http://www.aposcience.at/

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