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Celluminova receives Orphan Drug Designation in the EU

Celluminova has announced 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.”

“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.”

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Photo: iStock

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