Latest news with #ZenoAlbisser
Yahoo
01-07-2025
- Business
- Yahoo
Hemispherian Receives U.S. FDA Orphan Drug Designation for GLIX1 for the Treatment of Malignant Glioma
OSLO, Norway, July 1, 2025 /PRNewswire/ -- Hemispherian AS, a pioneering biotech company developing next-generation therapeutics for aggressive cancers, announced today that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) for GLIX1 for the treatment of malignant glioma, a category of devastating brain cancers that includes glioblastoma. 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. "This designation from the FDA further validates our scientific approach and mission to address high unmet needs in oncology," said Zeno Albisser, CEO of Hemispherian. "GLIX1 is a first-in-class small molecule with a unique mechanism of action, and we are encouraged by the recognition from both U.S. and EU regulators of its potential to offer meaningful benefit to patients with malignant glioma." About the Designation The FDA's Office of Orphan Products Development granted ODD under section 526 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360bb). The designation is based on GLIX1's potential to treat a rare and life-threatening disease affecting fewer than 200,000 people in the United States. GLIX1 demonstrated substantial preclinical efficacy, including tumor regression and survival benefit in validated models of glioma. Benefits of Orphan Drug Designation The Orphan Drug Designation from the FDA provides several benefits intended to support and accelerate the development of promising therapies for rare diseases, including: 7 years of market exclusivity in the U.S. upon FDA approval Tax credits for qualified clinical trial expenses Exemption from FDA application fees Eligibility for accelerated regulatory pathways About GLIX1 and Hemispherian GLIX1 is a first-in-class small-molecule therapeutic targeting DNA repair vulnerabilities in cancer cells. Hemispherian's proprietary GLIX platform enables the selective elimination of cancer cells with minimal impact on healthy tissue. In preclinical studies, GLIX1 has shown the ability to eradicate tumors in validated animal models with limited side effects, making it a highly promising candidate for the treatment of glioma and other aggressive cancers. Hemispherian is an Oslo-based pharmaceutical company focused on developing breakthrough cancer therapies. The company is supported by a growing global network of academic and clinical partners. Contact: Zeno Albisser, CEO – zeno@ - +47 40603455 Logo - View original content to download multimedia: SOURCE Hemispherian AS Sign in to access your portfolio
Yahoo
06-06-2025
- Business
- Yahoo
Hemispherian receives positive opinion for Orphan Medicinal Product Designation in the EU for GLIX1 in glioma
OSLO, Norway, June 6, 2025 /PRNewswire/ -- Hemispherian AS, a pioneering biotech company developing next-generation therapeutics for aggressive cancers, announced today that the European Medicines Agency's (EMA) Committee for Orphan Medicinal Products (COMP) has issued a positive opinion recommending Orphan Drug Designation (ODD) for GLIX1, the company's lead molecule, for the treatment of glioma, one of the most devastating and lethal brain cancers. 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@ +47 40603455 View original content: SOURCE Hemispherian AS Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
Yahoo
06-06-2025
- Business
- Yahoo
Hemispherian receives positive opinion for Orphan Medicinal Product Designation in the EU for GLIX1 in glioma
OSLO, Norway, June 6, 2025 /PRNewswire/ -- Hemispherian AS, a pioneering biotech company developing next-generation therapeutics for aggressive cancers, announced today that the European Medicines Agency's (EMA) Committee for Orphan Medicinal Products (COMP) has issued a positive opinion recommending Orphan Drug Designation (ODD) for GLIX1, the company's lead molecule, for the treatment of glioma, one of the most devastating and lethal brain cancers. 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@ +47 40603455 View original content: SOURCE Hemispherian AS
