Celluminova receives Orphan Drug Designation in the EU for p-HTMI in malignant glioma
June 17, 2024
- p-HTMI is intended to support neurosurgeons to visualize and remove glioma stem cells, cells considered to be a major contributing factor to the short patient survival.
- An Orphan Drug Designation (ODD) is a special status accorded to drug candidates considered potential treatments for rare (´orphan´) and life-threatening diseases.
- The compound receives 10 years of market exclusivity upon market approval.
- ODD brings numerous financial advantages.
Celluminova, a privately owned Life Science company specialized in identification of cancer stem cells, announces that the European Commission has granted Orphan Drug Designation for p-HTMI. Celluminova’s patented compound p-HTMI is the first molecule of its kind to enable detection of glioma stem cells by fluorescence during surgery for patients with malignant gliomas, including the most aggressive form called glioblastoma. By targeting these tumor-driving cells, p-HTMI may have the potential to slow the progression of the disease and increase patient survival.
“The combination of Orphan Drug and SME1 status granted by EMA2 puts us in a very favorable situation as a company, with significantly reduced fees and continuous advice during the development of p-HTMI”, says Shirin Ilkhanizadeh, Ph.D., cofounder, and CEO of Celluminova. “This eases our path to market approval and enables us to reach the seriously ill patients more quickly. We are pleased that EMA shares our view of the promise of our data and recognizes the significant value of our compound.”
Today´s treatment for glioblastoma combine surgery followed by radiation and chemotherapy. Despite treatment, half of the patients die within 15 months of diagnosis. The scientific community today agrees that this dismal prognosis is due to the glioma stem cells’ ability to escape existing treatments, thereby giving rise to relapse.
In Sweden, approximately 400 patients per year are diagnosed with glioblastoma. In Europe, it amounts to 15,000 and in the United States 13,000 patients. p-HTMI is in preclinical stage, expected to reach the first clinical study in humans during 2026.
For further information, please contact
Shirin Ilkhanizadeh, CEO
shirin@celluminova.se
About p-HTMI
p-HTMI is a patented small molecule that enables detection of glioma stem cells by fluorescence. p-HTMI is currently included in an ex vivo study (NCT05556486) for mapping of glioma stem cells in the resection margin of malignant glioma.
About malignant gliomas
Malignant gliomas are a type of aggressive brain tumors consisting of astrocytoma, oligodendroglioma and glioblastoma, where the latter is the most common and deadly form. For a deeper description of glioma classification, see “The fifth edition of the WHO Classification of Tumors of the Central Nervous System (CNS)”, published 2021.
About Celluminova
Celluminova is a privately owned Swedish Life Science company specialized in identification of cancer stem cells. The company was established after a successful collaboration between researchers at Linköping University and Karolinska Institute. For further information about Celluminova and their technology, please visit www.celluminova.se
1 Small or medium-sized enterprise (SME): businesses whose personnel and revenue numbers fall below certain limits. The definition of an SME is important for access to financing and EU support programs. EMA provides incentives for SMEs with the aim of promoting innovation and development of new medicines.
2 European Medicines Agency (EMA): EMA’s main task is to approve and monitor medicines in the EU.
Image assets
Photo: Jens Tärning.