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


Hemerion addresses upfront management of newly diagnosed glioblastoma, during surgery, before any adjuvant treatment

Hemerion announces FDA clearance of IND application for its treatment of glioblastoma

Hemerion has received clearance from the US Food and Drug Administration (FDA) for the investigational new drug application (IND) for its Pentalafen® / Heliance® drug-device combination product for the treatment of glioblastoma (GBM). The decision enables Hemerion to proceed with a Phase I/II clinical study at University of Pittsburgh Medical Center (UPMC) by Q4 2023.

Glioblastoma is the most common and most aggressive primary brain tumor, with a median ove- rall survival (OS) of 15 months and a progression free survival (PFS) of 7 months only.

Current treatment options (surgery, followed by radiotherapy and chemotherapy) aim at removing or destroying tumor cells inside the brain. They slow the progression of the disease and reduce the symptoms but fail to offer genuine therapeutic solutions. As glioblastoma invades the brain deeply, the current standard of care fails to eradicate all tumor cells. Remaining tumor cells stay active and inevitably recur.

A technology designed to outperform the standard treatments

Hemerion’s technology brings a new option to kill these isolated tumor cells, without harming healthy tissue, within the frame of the current standard of care.

Hemerion’s drug-device technology combines a photosensitive drug (Pentalafen®) and an innovative laser based illumination platform (Heliance®). This combination product selectively destroys cancer cells without damaging healthy tissue. The Pentalafen® selectively accumulates in cancer cells before surgery. When photoactivated by the illumination platform Heliance®, the drug causes tumor cells death without harming healthy cells.

Tumor cells are eliminated wherever the light penetrates.

The best ever results achieved in a Phase I glioblastoma trial

The Pentalafen® / Heliance® combination has already passed several major clinical development milestones, including a Phase I trial concluded in 2021, the results of which have been published in the Journal of NeuroOncology. These results validate the feasibility and safety of the treatment and show spectacular preliminary efficacy results, with a more than doubled disease-free life expectancy compared to the current standard of care (17,1 vs.7 months).

Next clinical milestone: a phase I/II study in Pittsburgh

The FDA authorization enables Hemerion to commence a Phase I/II clinical study at University of Pittsburgh Medical Center by Q4 2023 to evaluate the upgraded Pentalafen® / Heliance® platform. The trial will be conducted under the clinical leadership of Dr Jan Drappatz, MD, neuro-oncologist (Principal Investigator) and Pr. Costas G. Hadjipanayis, MD, neurosurgeon (Co-Investigator).

Ideally positioned for the upcoming Series A financing round

Launched in 2020, Hemerion has successfully raised over €7 million in less than 3 years, enabling our team to implement the next Phase I/II study planned in Pittsburgh.

Hemerion actively prepares the next rounds of financing to fund the clinical phases required to obtain Marketing Authorization for its Pentalafen® / Heliance® combination product.