US FDA Grants Orphan Drug Designation For ONCOFID-P

Release Date: 14-Sep-2021

Fidia Farmaceutici receives Orphan Drug Designation from US FDA for ONCOFIDandreg;-P for the treatment of malignant mesothelioma (MM). ONCOFIDandreg;-P is an advanced anti-cancer drug, a conjugate of paclitaxel (taxol) with hyaluronic acid (HA). This conjugation brings numerous advantages, including the possibility of loco-regional administration. ONCOFIDandreg;-P, thanks to the HA component, exactly binds cancer cells expressing CD44, the HA receptor, significantly increasing the intracellular concentration of paclitaxel, and maintaining an excellent tolerability profile.


The characteristics of ONCOFIDandreg;-P makes it best also for the loco-regional treatment of some forms of mesothelioma, especially pleural mesothelioma, which represents about 83% of all types of mesotheliomas, a group of highly lethal neoplasms with an average survival of 10.6% at 5 years and 49.8% at 1 year from diagnosis.

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