By Colin Kellaher


Genenta Science SpA on Thursday said the U.S. Food and Drug Administration granted orphan-drug designation to Temferon, its lead product candidate, for the treatment of glioblastoma multiforme, the most aggressive malignant primary brain tumor.

The Milan, Italy, clinical-stage immuno-oncology company is testing the Temferon cell-therapy in a Phase 1/2a study in newly diagnosed patients with glioblastoma multiforme who have an unmethylated MGMT gene promoter.

Genenta said glioblastoma multiforme is the most common malignant primary brain tumor, with unmethylated MGMT promoter status identified in roughly 60% of the patient population.

The FDA's orphan-drug program gives special status to drugs and biologics for diseases and disorders that affect fewer than 200,000 people in the U.S., and provides for an extended marketing exclusivity period against competition.


Write to Colin Kellaher at colin.kellaher@wsj.com


(END) Dow Jones Newswires

03-02-23 0711ET