Illuminating New Paths in Cancer Therapy
The mission to defeat glioblastoma and find new therapies against aggressive solid tumors extends well beyond our own programs. We recognize that breakthrough insights often originate from the clinical frontlines—from the surgeons and researchers interacting directly with patients.
Through our Investigator-Sponsored Study (ISS) program, we invite the European and American medical community to propose innovative research concepts that leverage our proprietary Pentalafen®/Heliance® technology.
Together, we can expand the boundaries of Photodynamic Therapy (PDT) and improve survival and quality of life for patients facing the most challenging diagnoses.
What is an ISS?
An Investigator-Sponsored Study (also known as an Investigator-Initiated Trial/IIT) is a research study where the concept, design, and operational execution originate from an independent investigator or academic institution. In this model, Hemerion acts as a supporter, but the investigator retains full responsibility as the regulatory sponsor.
Why partner with Hemerion?
We are committed to supporting scientifically sound research that advances medical knowledge. Our support is grounded in a transparent collaboration aimed at:
- Exploring new therapeutic indications for Pentalafen®
- Optimizing the intraoperative use of the Heliance®
- Generating Evidence to complement our corporate-sponsored clinical trials
- Improving patient outcomes in areas of high unmet medical need
What are our strategic research priorities?
While Hemerion welcomes unsolicited proposals across various domains, we have identified key scientific gaps where we believe our technology could have the most significant impact. We encourage investigators to consider the following areas when developing their concepts:
| Research Domain | Key Areas of Interest |
|---|---|
| Clinical Neuro-Oncology | Other rare CNS conditions or metastatic disease |
| Translational Science | Biomarker analysis for tumor selectivity (fluorescence-guided resection utility) Histopathological analysis of PDT effects on the tumor microenvironment (TME) |
| Pipeline Expansion | Feasibility studies in Non-CNS tumors |
Note: Proposals are evaluated on their scientific merit and feasibility. Research outside these priority areas will be considered if a strong clinical rationale is provided.
These priorities were established in January 2026 and may evolve as our work progresses.
What resources are available to support your research?
Hemerion Therapeutics may provide the following forms of support, subject to internal review and execution of a written agreement:
Drug Supply
Provision of GMP-grade Pentalafen® (investigational product).
Device Access & Training
Loan of the Heliance® controller and provision of sterile diffusers. Crucially, this includes comprehensive technical training for the neurosurgical and OR teams to ensure safe and effective system operation.
Research Funding
Where applicable and subject to Fair Market Value (FMV) assessments, financial grants might be provided to cover study-specific costs (e.g., data management, ethics committee fees, patient screening).
Scientific Expertise
Access to investigator brochures (IB), preclinical data, and consultation with our teams.
What is The Role of the Sponsor-Investigator?
As the Regulatory Sponsor, the investigator (or their institution) assumes all statutory responsibilities, including but not limited to:
Regulatory Compliance
Holding the IND (US FDA 21 CFR 312), IDE (US FDA 21 CFR 812), CTA (EU Regulation 536/2014), or ensuring compliance with the Medical Device Regulation (EU MDR 2017/745) as applicable.
Study Conduct
Ensuring the study is conducted in accordance with the Protocol, Good Clinical Practice (GCP), and the Declaration of Helsinki.
Safety Reporting
Managing all pharmacovigilance activities, including the timely reporting of Serious Adverse Events (SAEs) to Health Authorities and to Hemerion’s Safety Department.
Approvals
Obtaining and maintaining Institutional Review Board (IRB) / Ethics Committee (EC) approvals.
Data & Publication
Managing data integrity and committing to the publication of results in peer-reviewed journals, regardless of the study outcome.
Hemerion does not act as the sponsor for these studies and cannot provide monitoring or CRO services.
How to Submit a Proposal
We utilize a streamlined, staged review process to ensure efficiency and transparency.
Step 1: Concept Submission
To minimize the workload for investigators, we first request a Study Synopsis.
What to include
Rationale, primary objectives, estimated sample size, timeline, and high-level budget request.
Action
Submit via email to clinical@hemerion.com.
Step 2: Scientific Review
Your concept will be evaluated by Hemerion’s cross-functional ISS Review Committee.
Criteria
Scientific merit, alignment with safety standards, investigator qualifications, and facility suitability.
Step 3: Full Protocol & Contract
If the concept is endorsed, you will be invited to sign an NDA to enable the sharing of confidential data. You’ll be asked to submit a full protocol. Upon final approval, the parties will execute a Grant Agreement and/or Supply Agreement.
Note
Device loan agreements may require specific clauses regarding equipment maintenance and return.
Step 4: Study Initiation
Release of funding and drug/device shipment occurs only after receipt of all regulatory and ethics approvals (IRB/EC/Competent Authority).
Start the Conversation
Are you a physician, surgeon or researcher interested in collaborating?
Contact our Clinical Affairs Team:
Downloadable Resources:
Hemerion Therapeutics supports Investigator-Sponsored Studies based strictly on scientific and medical merit. Support is not contingent upon, nor intended to induce, the prescription, supply, administration, or promotion of any Hemerion product. All interactions with Healthcare Professionals are conducted in compliance with applicable laws, including the U.S. Physician Payments Sunshine Act, the French “Loi Bertrand,” and other global transparency regulations.