Contacts
Chemin du Cyclotron, 6 | B-1348 Louvain-La-Neuve (Belgium)
Tel : +32 (0)2 764 52 81 info@promethera.com

Founded in 2009, Promethera Biosciences is a biopharmaceutical company that develops innovative treatments based on adult stem cell therapy.

Promethera Biosciences is a spin-off from the Catholic University of Louvain and the Pediatric Hepatology and Cell Therapy Laboratory directed by Professor Etienne Sokal a world-leading expert in hepatology and cell therapy.

Promethera Biosciences develops a unique cell therapy product HepaStem, to treat severe diseases of the liver affecting children and adults. HepaStem is based on a newly discovered and patented progenitor cell type: human Adult Liver-Derived Mesenchymal Stem Cells (hALDMSC).
The same cell line will be used for the development of HepaScreen, a cell model designed for the pharmaceutical and biotechnology industry for the discovery and pre-clinical evaluation of new chemical entities.

 

The company

About us

Promethera Biosciences' mission is to discover, develop and commercialize cell therapy products to treat liver diseases in an innovative way, using allogenic stem cells from healthy human livers.
Promethera Biosciences was founded in 2009 by Sopartec SA, the technology transfer company for the Catholic University of Louvain and Professor Etienne Sokal, a leading expert in hepatology and cell therapy.

Promethera Biosciences is completing a funding round of 6 million euros to achieve the following milestones:

1 To bring HepaStem to clinical phases in four indications; Crigler-Najjar deficiency, urea cycle defects, phenylketonuria and fulminant hepatitis.
2 To bring HepaScreen on the market

Achievements to date

A first clinical injection of HepaStem to patient was performed in May 2009 at Saint-Luc Hospital, under the responsibility of Prof. Etienne Sokal. The first patient is a 3-year old girl suffering from urea cycle deficiency. Safety of clinical injection of HepaStem has been demonstrated. Clinical follow-up of the patient will be performed over the next six months.

  		• Establishing program at UCL/St-Luc on mature liver cell transplantation for paediatric indications: 12 children have been successfully transplanted since 2001, proving efficacy of technique and validating route of administration.
  		• Recognition of Prof. Sokal’s team as scientific leaders in the filed of liver cell therapy as demonstrated by the high rate of top-rated peer-reviewed publications.
  		• Preclinical proof-of-concept studies undertaken in two different models of immunodeficient mice (SCID and uPA+/+-SCID) demonstrating that hALDMSC are able to engraft in the host
  		• First international patent application for hALDMSC submitted in December 2005 (Isolated liver stem cells).
  		• Achievements to datePositive evaluation by the EPO in January 2008 classifying majority of claims as
    innovative and inventive.
  		• Successfully completed a FTO study (Plasseraud, Paris) on patent showing freedom to operate to develop the HepaStem or HepaScreen products in Europe.
  		• Tissue bank agreement from the Belgian Ministry of Health, for liver stem cell production in view of clinical use (June 2008). Agreement received from Saint- Luc Ethical Committee for fist-in-man trial with liver stem cells (June 2008).
  		• Validated scaling up process to reach production of a clinical batch for the Firstin-man study.
  		• Regulatory advice from EMEA classifying the hALDMSC as Advanced Medicinal Product (July 2007) and clarifying the regulatory route for the product.
  		• Orphan drug designation by the European Community for the treatment of Crigler-Najjar syndrome (Oct 2007) and for the treatment of Urea Cycle diseases (ornithinine transcarbamylase deficiency -Feb 2008), leading to free of charge scientific advice from EMEA.
  		• Protocol assistance request form submitted to EMEA to validate preclinical development plan for HepaStem. Final recommendations received in April 2009 approving preclinical plan.
  		• File ‘avance récupérable’ agreed upon by the Wallonia Region covering 60% of preclinical study the costs for HepaStem, corresponding to 1.6 million €.
  		• HepaScreen development project, up to market release, financed at 80% (628.000€ over 4 years) within a collaborative project including UCB pharma.