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

Clinical Trials

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Hemerion’s technology and therapeutic concept have undergone extensive preclinical and clinical validation studies.

Preclinical results

In 2014, a first preclinical study proved the effectiveness of Hemerion therapeutic approach on glioblastoma (GBM) human cell lines. Several consecutive studies enabled our team to fine-tune the therapeutic procedure to improve efficacy and tolerance.

First clinical trials: a worldwide premiere with outstanding preliminary results

A first feasibility clinical study of the Hemerion drug-device innovation was sponsored by the University Hospital of Lille. 10 patients enrolled from may 2017 to June 2018 have been treated.

The clinical world premiere is highlighted in Nature’s 2018 september issue.

The preliminary results were published in the Journal of Neuro-Oncology in march 2021. These results demonstrate high tolerance of the treatment and are very encouraging in terms of efficacy. Indeed, outcomes were clearly improved with half of the patients treated having a progression-free survival beyond 17 months : a validation that paves the way for phase II clinical trials.

Next clinical steps

A second phase II study called DOSINDYGO is under way to evaluate a light dose escalation to fine-tune the optimal treatment parameters.

Hemerion received clearance from the U.S. Food & Drug Administration (FDA) for the investigational new drug application (IND) for its Pentalafen® / Heliance® drug-device combination product for the treatment of glioblastoma (GBM) in July. This decision enables Hemerion to proceed with a Phase 1/2 clinical study at University of Pittsburgh Medical Center (UPMC) by Q4 2023.

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