OSLO, Norway, June 6, 2025 — Hemispherian AS, a forward-thinking biotech firm focused on creating next-generation treatments for aggressive cancers, has announced that the EMA’s COMP has given a favorable opinion recommending ODD for GLIX1, the company’s primary molecule, in the treatment of glioma, a particularly devastating and fatal form of brain cancer.
Significant clinical benefit beyond current therapies.
The designation is a significant regulatory achievement for Hemispherian, acknowledging the pressing unmet medical need for glioma treatment and GLIX1’s potential to provide substantial clinical advantages over existing treatments.
“We are pleased to have received this ODD recommendation from the EMA Committee. This supports our scientific strategy and strengthens our goal of changing the treatment landscape for glioma patients, who currently have very few effective options,” said Zeno Albisser, CEO of Hemispherian.
About the Designation
Following an in-depth assessment, the COMP concluded that GLIX1 satisfies the requirements for orphan designation as defined in Regulation (EC) No 141/2000. Specifically:
- Glioma is a life-threatening and chronically debilitating condition that affects approximately 2.6 out of 10,000 individuals in the EU.
- Current treatments for Glioblastoma (a type of Glioma) offer limited improvements in survival, with a median overall survival of typically less than 15 months.
- Preclinical studies of GLIX1 have shown considerable tumor reduction and increased survival rates in proven animal models, including instances of complete tumor elimination.
These findings indicate that GLIX1 provides a clinically significant advantage over existing therapies, meeting the EMA’s criteria for “significant benefit.”
Benefits of Orphan Drug Designation- Faster market Access- 10 Years of market Exclusivity
The EMA’s ODD provides Hemispherian with several development and commercial benefits, including:
- A decade of market exclusivity in the EU upon approval.
- Guidance and support from the EMA during clinical development through protocol assistance.
- Eligibility for reduced fees for regulatory submissions, including marketing authorization.
These incentives are designed to promote the development of innovative therapies for rare diseases that have a high unmet need.
About Hemispherian
Hemispherian, located in Oslo, is a pharmaceutical company dedicated to developing a new class of small-molecule drugs aimed at treating glioblastoma and other aggressive cancers. The company’s exclusive GLIX platform utilizes a unique DNA-targeting technology to improve patient survival rates and quality of life. Initial results have demonstrated significant effects with minimal to no side effects and without damage to healthy tissues.
Contact: Zeno Albisser, CEO – , +47 40603455
SOURCE Hemispherian AS
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