#Norway #Oslo #Glioma #GLIX1 #Hemispherian

Hemispherian Achieves Milestone for GLIX1 in Glioma Treatment

Hemispherian AS, a forward-looking biotech firm based in Oslo, has reached a significant regulatory milestone with the European Medicines Agency (EMA). The EMA's Committee for Orphan Medicinal Products (COMP) has issued a positive opinion that recommends granting Orphan Drug Designation (ODD) for GLIX1, the company's leading therapeutic candidate, aimed at treating glioma, one of the deadliest forms of brain cancer.

Understanding the Implications of Orphan Drug Designation

The ODD designation is a critical achievement for Hemispherian. It not only signifies recognition of the critical medical needs among glioma patients but also emphasizes the potential of GLIX1 to deliver substantial clinical advantages over existing treatment options. Current therapies often rely on traditional techniques that yield limited survival benefits, with median overall survival for patients with Glioblastoma, a variant of glioma, remaining below 15 months.

Zeno Albisser, CEO of Hemispherian, expressed pride in receiving this recommendation which highlights the legitimacy of the company's scientific efforts and its commitment to altering treatment landscapes for glioma patients who have restricted and often ineffective options. “This validates our scientific approach and supports our mission to transform treatment for patients who currently face extremely limited options,” said Albisser.

GLIX1: A Promise for Glioma Patients

The COMP reviewed extensive data for GLIX1, concluding that it meets the necessary criteria for orphan designation under Regulation (EC) No 141/2000. Glioma affects approximately 2.6 in 10,000 people in the EU, creating a significant medical need for innovative therapies. Non-clinical studies have demonstrated that GLIX1 significantly reduces tumors, with some animal models showing complete tumor eradication.

These positive findings point to GLIX1 potentially offering higher survival rates and a clinically relevant advantage when compared to current drugs. The EMA acknowledges this as fulfilling the criteria for “significant benefit” necessary for orphan designation.

Advantages of Orphan Drug Designation

Receiving the Orphan Drug Designation carries numerous advantages for Hemispherian, facilitating the development and commercialization of GLIX1. Key benefits include:

• - Faster Market Access: Streamlining the approval process allows for quicker introduction of treatments to the market.
• - Ten Years of Market Exclusivity: Upon approval, Hemispherian will enjoy a decade of exclusivity within the EU market, protecting GLIX1 from generic competition.
• - Guidance and Assistance: The EMA will provide protocol assistance throughout the clinical development phase, enhancing the potential for successful outcomes.
• - Fee Reductions: Eligibility for reduced fees during the regulatory submission process eases financial burdens associated with bringing a new drug to market.

These incentives underscore the EMA’s commitment to encouraging the development of groundbreaking treatments for rare diseases, particularly those with significant unmet needs.

About Hemispherian

Founded in Oslo, Hemispherian is dedicated to the advancement of innovative therapies aimed at combating aggressive cancers. The company is focused on developing a novel class of small-molecule drugs that target glioblastoma and other hard-to-treat malignancies. At the core of Hemispherian’s research is its proprietary GLIX platform, which employs unique DNA-targeting technology designed to enhance survival chances and improve patients' quality of life. Early studies indicate that GLIX1 may offer effective solutions with minimal side effects, preserving healthy tissues throughout treatment.

Hemispherian continues its commitment to transforming cancer therapy, striving to bring hope and effective treatments to patients battling glioma.

For more information, please contact Zeno Albisser, CEO, at +47 40603455.