[BREAKING] Hemerion obtains the FDA clearance for its next US clinical trial

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First ever patient treated with Hemerion technology

May 12. 2017: the first ever patient treated with Hemerion technology

Five years ago, on May, 12th 2017, Pr. Nicolas Reyns delivered, for the first time ever, the therapy currently being developed by Hemerion. It was the first time that this approach was evaluated, in a frontline setup, for a patient harboring newly diagnosed glioblastoma (GBM). 

The technology proposed for the treatment of GBM was based on the unprecedented combination of a photosensitizing drug and an innovative photonic device: dedicated laser light and illumination equipment suitable for brain surgery.

After years of hard work in the lab, developing the idea, designing the proof of concept, experimenting the drug/device combination, evaluating the effect in vivo, we were finally ready to go for a phase I clinical trial. All the team was already committed to deliver a solution that best fits the standard of care.

A first-in-human Phase I clinical trial that shows promising results

The French Health Agency and Ethics Committee authorized this first-in-human Phase I clinical trial, entitled INDYGO (intraoperative photodynamic therapy for glioblastomas). The trial was sponsored by the University Hospital of Lille to assess our treatment feasibility and toxicity.

That achievement was made possible thanks to the motivating and dynamic environment offered by several academic institutions: University Hospital of Lille, University of Lille and Inserm (National Institute of Health and Medical Research). Within OncoThAI Lab headed by Pr. S. Mordon.

The Journal of Neuro-Oncology published the INDYGO trial results in 2021. These results demonstrate high tolerance of the treatment and are very encouraging in terms of efficacy: a validation that paved the way for phase II clinical trials.

Almost 2 years ago, we eventually established Hemerion, to push forward the development of this approach with the ambition to make this treatment available for GBM patients worldwide.

Hemerion initiates Phase II clinical trials in France and the USA

Now, five years after the first patient, a phase II study is opened thanks to a partnership between Hemerion, SATT nord and CHU de Lille and currently enrolling patients. Whereas in the USA, Hemerion and Mount Sinai Health System (NYC) are collaborating to launch an ambitious clinical trial. This collaboration has won the “Best Collaboration in the MedTech and Digital Health” award of the 2021 Galien Medstartup Prize

Recently, Hemerion Therapeutics successfully completed a €3.55 million seed round combining investment funds, business angels and a loan from Bpifrance. This high level of seed funding will directly contribute to our international clinical development and open a new chapter of our history.

  • First ever patient treated with Hemerion technology
  • First ever patient treated with Hemerion technology
  • First ever patient treated with Hemerion technology
  • First ever patient treated with Hemerion technology
  • First ever patient treated with Hemerion technology
  • First ever patient treated with Hemerion technology