Hemerion’s technology and therapeutic concept have undergone extensive preclinical and clinical validation studies.
The clinical development of Hemerion’s solutions continues at a rapid pace. Our goal is to bring our therapies to glioblastoma patients as soon as possible.
Investigator-Sponsored Studies (ISS) Program
Illuminating New Paths in Cancer Therapy
Open to surgeons and oncologists worldwide, Hemerion’s ISS program allows clinical teams to integrate Pentalafen® / Heliance® combination therapy and technologies into their clinical research and innovation programs.
Our goal: expand the boundaries of Photodynamic Therapy (PDT) and improve survival and quality of life for patients facing the most challenging diagnoses.
2024
HTX-GBM-01 : the in-progress phase 1 / 2 clinical trial
RECRUITING
Following an IND FDA clearance received April. 23, 2023, Hemerion currently sponsors an ambitious trial for its Pentalafen®/Heliance® drug-device combination against glioblastoma in partnership with the University of Pittsburgh Medical Centre and the Lille University Hospital.
This step is crucial to prepare an upcoming pivotal study to assess our treatment efficacy.
In detail
- Study Title: An Interventional, Multicenter, and International Phase 1/2, Light-dose-escalation Study to Investigate the Safety and Feasibility of Intraoperative Photodynamic Therapy (PDT) With Pentalafen® Drug and Heliance® Solution Device in Male and Female Patients 18 to 75 Years of Age With Grade IV Glioblastoma.
- Location: UPMC at Pittsburgh, PA, United States & Lille University Hospital at Lille, France
- Principal Investigators: Jan Drappatz, MD (UMPC) and Enora Vauleon, MD (Lille University Hospital)
- Summary: The primary objective of this clinical trial is to determine the safety and tolerability of two doses of light in intraoperative PDT added to standard of care; temozolomide-based chemotherapy in male and female patients aged 18 to 75 with newly diagnosed glioblastoma.
This treatment will be carried out in addition to the maximal surgical resection. Data collected during this trial will be used to design the upcoming pivotal study. The study will utilize an independent Data and Safety Monitoring Board (iDSMB) that will review safety data to allow dose escalation.
More information on ClinicalTrials.gov
Important information
If you are currently participating in this trial and wish to declare an adverse event you believe is related to Pentalafen® drug and/or the Heliance® Solution medical device, please contact your study doctor.
2021-2023
DOSINDYGO : a trial to evaluate increasing doses of light
Active, enrollment completed
The DOSINDYGO study originated after the successful INDYGO clinical trial demonstrating the feasibility and non-toxicity of the Hemerion technology.
DOSINDYGO aims to test increasing doses of light used by the Hemerion technology to eradicate cancer cells deep inside brain tissue while preventing harm to healthy tissue. The trial evaluated light doses up to four times higher than those previously administered during the INDYGO study (see below).
A total of 12 glioblastoma patients have been treated since the DOSINDYGO trial was launched in September 2021. An initial clinical evaluation was carried out 4 weeks after each treatment: no serious adverse events linked to this new treatment were observed. Treatment efficacy (extension of overall and progression-free survival) has yet to be assessed. It will be measured at the end of a 24-month follow-up for each patient after his or her operation.
More information on ClinicalTrials.gov
INDYGO : a worldwide clinical premiere with outstanding preliminary results
Completed
A first feasibility clinical study of the Hemerion drug-device therapy was sponsored by the University Hospital of Lille. 10 patients, enrolled from May 2017 to June 2018, have been treated.
This clinical world premiere, named INDYGO, was 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 2 clinical trials.
More information on ClinicalTrials.gov
2014
Our first 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.
Stay tuned to our clinical advances