Draft:Aposcience
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Last edited by JJMC89 bot (talk | contribs) 2 seconds ago. (Update) |
| Company type | Private |
|---|---|
| Industry | Biopharmaceutical |
| Founded | 2008 |
| Founder | Hendrik Jan Ankersmit |
| Headquarters | Dresdner Straße 87/21, 1200 Vienna, Austria |
| Products | APOSEC™ |
| Website | aposcience.com |
Aposcience
[edit]Aposcience is a clinical-stage biopharmaceutical company based in Vienna, Austria. Founded in 2008 as a spin-off from the Medical University of Vienna, the company focuses on regenerative medicine through the development of "cell-free" secretome therapies, primarily its lead product line branded APOSEC™.[1] [2]
History
[edit]- Established in 2008 by Hendrik Jan Ankersmit from the Medical University of Vienna’s Thoracic Surgery Clinic, Surgical Research Laboratories and the General Hospital of Vienna.
- Developed as part of a public‑private partnership with support from the Christian Doppler Society, Austrian Research Promotion Agency (FFG) and Vienna Business Agency.[3]
Technology
[edit]Aposcience leverages secretomes (proteins, lipids, exosomes) derived from cultured stressed apoptotic/necroptotic peripheral blood mononuclear cells (PBMCs) in combination with culture medium containing medical grade albumin and insulin. These therapeutic secretomes are produced under strict Good Manufacturing Practice (GMP) conditions at the Red Cross Blood Donation Service in Linz, Austria.[4] [3]
Unlike stem cell therapies and other ATMPs, APOSEC™ works via paracrine signaling and is a "cell-free" product. APOSEC™ is an allogeneic "off the shelf" investigational medicinal product (IMP) and is developed as a biological medicinal product (Directive 2001/83/EC). Non-clinical safety assessment thus falls under the scope of International Commission of Harmonisation (ICH) S6. The IMP is produced with a validated quality management system and all tests are documented according to standard operating procedures (SOPs).[5]
Products in Development
[edit]APO‑1 (APOSEC™ – intra-venous use)
[edit]An injectable formulation aimed at treating internal ischemic and inflamatory diseases such as acute myocardial ischemia (AMI)[6], spinal cord injury[7] and myocarditis[8].[9]
A topical formulation designed to improve the healing of chronic wounds, especially diabetic foot ulcers (DFU).[4] The clinical program included:
- MARSYAS I (Phase I) - Prospective, randomized, double-blinded, placebo-controlled, dose-finding study in healthy volunteers with induced wounds utilizing autologous APOSEC™ (NCT02284360)
- MARSYAS II (Phase I/II) - A multicenter, randomized, double-blinded, placebo-controlled, dose-ranging study in 122 patients with diabetic foot ulcers with allogeneic APOSECTM (NCT04277598).[10] [11] [12]
Key Publications & References
[edit]Key Publications
[edit]- Peripheral blood mononuclear cell secretome for tissue repair[13]
- Therapeutic application of cell secretomes in cutaneous wound healing[14]
- Marsyas I results published in Scientific Reports (2017)[15]
- Official study protocol for MARSYAS II published in Trials (2021)[5]
- Marsyas II results were published as Synopsis (2024)[16]
References
[edit]
- ^ "Aposcience AG – the secretome company". www.aposcience.at. Retrieved 2025-06-27.
- ^ "Life Sciences Directory: Aposcience AG". www.lifesciencesdirectory.at. Retrieved 2025-06-27.
- ^ a b "APOSCIENCE AG completes secretome-based Phase I trial in diabetic foot ulcer (DFU) - DSMB recommends initiation of multinational Phase II trial of MARSYAS II". LISAvienna - life science austria. 2021-10-15. Retrieved 2025-06-27.
- ^ a b Angerer, Johannes; Vienna, Medical University of. "Safe and effective wound healing preparation reaches Clinical Phase II". medicalxpress.com. Retrieved 2025-06-27.
- ^ a b Gugerell, Alfred; Sorgenfrey, Dirk; Laggner, Maria; Raimann, Jürgen; Peterbauer, Anja; Bormann, Daniel; Suessner, Susanne; Gabriel, Christian; Moser, Bernhard; Ostler, Tobias; Mildner, Michael; Ankersmit, Hendrik J. (2020). "Viral safety of APOSECTM: a novel peripheral blood mononuclear cell derived-biological for regenerative medicine". Blood Transfusion. 18 (Blood Transfusion - 1 2020 (January-February)): 30–39. doi:10.2450/2019.0249-18. ISSN 1723-2007. PMC 7053523. PMID 30865581.
- ^ Lichtenauer, Michael; Mildner, Michael; Hoetzenecker, Konrad; Zimmermann, Matthias; Podesser, Bruno Karl; Sipos, Wolfgang; Berényi, Ervin; Dworschak, Martin; Tschachler, Erwin; Gyöngyösi, Mariann; Ankersmit, Hendrik Jan (2011-11-01). "Secretome of apoptotic peripheral blood cells (APOSEC) confers cytoprotection to cardiomyocytes and inhibits tissue remodelling after acute myocardial infarction: a preclinical study". Basic Research in Cardiology. 106 (6): 1283–1297. doi:10.1007/s00395-011-0224-6. ISSN 1435-1803. PMC 3228946. PMID 21952733.
- ^ Haider, Thomas; Höftberger, Romana; Rüger, Beate; Mildner, Michael; Blumer, Roland; Mitterbauer, Andreas; Buchacher, Tanja; Sherif, Camillo; Altmann, Patrick; Redl, Heinz; Gabriel, Christian; Gyöngyösi, Mariann; Fischer, Michael B.; Lubec, Gert; Ankersmit, Hendrik Jan (2015-05-01). "The secretome of apoptotic human peripheral blood mononuclear cells attenuates secondary damage following spinal cord injury in rats". Experimental Neurology. 267: 230–242. doi:10.1016/j.expneurol.2015.03.013. ISSN 0014-4886. PMID 25797576.
- ^ Hoetzenecker, Konrad; Zimmermann, Matthias; Hoetzenecker, Wolfram; Schweiger, Thomas; Kollmann, Dagmar; Mildner, Michael; Hegedus, Balazs; Mitterbauer, Andreas; Hacker, Stefan; Birner, Peter; Gabriel, Christian; Gyöngyösi, Mariann; Blyszczuk, Przemyslaw; Eriksson, Urs; Ankersmit, Hendrik Jan (2015-03-14). "Mononuclear cell secretome protects from experimental autoimmune myocarditis". European Heart Journal. 36 (11): 676–685. doi:10.1093/eurheartj/ehs459. ISSN 1522-9645. PMC 4359357. PMID 23321350.
- ^ "Focus Myocardial Infarction – Aposcience AG". www.aposcience.at. Retrieved 2025-07-03.
- ^ "Clinical – Aposcience AG". www.aposcience.at. Retrieved 2025-07-03.
- ^ Gugerell, Alfred; Gouya-Lechner, Ghazaleh; Hofbauer, Helmut; Laggner, Maria; Trautinger, Franz; Almer, Gabriele; Peterbauer-Scherb, Anja; Seibold, Marcus; Hoetzenecker, Wolfram; Dreschl, Christiane; Mildner, Michael; Ankersmit, Hendrik Jan (2021-01-06). "Safety and clinical efficacy of the secretome of stressed peripheral blood mononuclear cells in patients with diabetic foot ulcer—study protocol of the randomized, placebo-controlled, double-blind, multicenter, international phase II clinical trial MARSYAS II". Trials. 22 (1): 10. doi:10.1186/s13063-020-04948-1. ISSN 1745-6215. PMC 7789696. PMID 33407796.
- ^ "APO-2 in Diabetic Foot Ulcer (DFU) - Clinical Trials Registry - ICH GCP". ichgcp.net. Retrieved 2025-06-27.
- ^ Beer, Lucian; Mildner, Michael; Gyöngyösi, Mariann; Ankersmit, Hendrik Jan (2016-12-01). "Peripheral blood mononuclear cell secretome for tissue repair". Apoptosis. 21 (12): 1336–1353. doi:10.1007/s10495-016-1292-8. ISSN 1573-675X. PMC 5082595. PMID 27696124.
- ^ Bormann, Daniel; Gugerell, Alfred; Ankersmit, Hendrik Jan; Mildner, Michael (2023-06-01). "Therapeutic Application of Cell Secretomes in Cutaneous Wound Healing". Journal of Investigative Dermatology. 143 (6): 893–912. doi:10.1016/j.jid.2023.02.019. ISSN 0022-202X. PMID 37211377.
- ^ Simader, Elisabeth; Traxler, Denise; Kasiri, Mohammad Mahdi; Hofbauer, Helmut; Wolzt, Michael; Glogner, Christoph; Storka, Angela; Mildner, Michael; Gouya, Ghazaleh; Geusau, Alexandra; Fuchs, Carola; Eder, Claudia; Graf, Alexandra; Schaden, Michaela; Golabi, Bahar (2017-07-24). "Safety and tolerability of topically administered autologous, apoptotic PBMC secretome (APOSEC) in dermal wounds: a randomized Phase 1 trial (MARSYAS I )". Scientific Reports. 7 (1): 6216. Bibcode:2017NatSR...7.6216S. doi:10.1038/s41598-017-06223-x. ISSN 2045-2322. PMC 5524970. PMID 28740204.
- ^ "MARSYAS II Synopsis of Clinical Study Report – Aposcience AG". www.aposcience.at. Retrieved 2025-07-03.