Significant clinical benefit beyond current therapies.
The designation marks a major regulatory milestone for Hemispherian, recognizing both the urgent unmet medical need in glioma and the potential of GLIX1 to offer significant clinical benefit beyond current therapies.
“We are proud to have received this recommendation for an Orphan Drug Designation from the EMA Committee. This validates our scientific approach and supports our mission to transform treatment for patients with glioma, who currently face extremely limited and ineffective options,” said Zeno Albisser, CEO of Hemispherian.
About the Designation
Following a detailed review, the COMP determined that GLIX1 meets the criteria for orphan designation under Regulation (EC) No 141/2000. In particular:
- Glioma is a life-threatening and chronically debilitating disease affecting approximately 2.6 in 10,000 people in the EU.
- Existing therapies for Glioblastoma (a form of Glioma) offer only limited survival benefits, with median overall survival typically less than 15 months.
- Non-clinical studies with GLIX1 demonstrated significant tumor reduction and extended survival in validated animal models, including cases of complete tumor eradication.
These results suggest that GLIX1 offers a clinically relevant advantage over existing treatments, fulfilling the EMA’s criteria for “significant benefit.”
Benefits of Orphan Drug Designation- Faster market Access- 10 Years of market Exclusivity
Orphan Drug Designation by the EMA provides Hemispherian with a range of development and commercial incentives, including:
- 10 years of market exclusivity in the EU upon approval.
- Protocol assistance and regulatory guidance from EMA during clinical development.
- Eligibility for fee reductions for regulatory submissions, including marketing authorization.
These incentives are designed to encourage the development of innovative treatments for rare diseases with high unmet need.
About Hemispherian
Hemispherian is an Oslo-based pharmaceutical company focused on the development of a novel class of small-molecule drugs targeting glioblastoma and other aggressive cancers. The company’s proprietary GLIX platform is based on unique DNA-targeting technology aimed at improving patient survival and quality of life. So far, the treatment shows impressive effects, with limited to no side effects, and with no damage to healthy tissue.
Contact: Zeno Albisser, CEO – zeno@hemispherian.com