Orphan Drug Status for ALM201 for Ovarian Cancer

Over the last 10 years, Prof Tracy Robson has collaborated closely with Almac Discovery on the development of the therapeutic peptide, ALM201, based on her initial research into the anti-angiogenic properties of FKBPL.  ALM201 is part of the active anti-angiogenic domain of FKBPL and is a potent inhibitor of angiogenesis both in vitro and in vivo.  The technology was patented by Professor Robson and licensed to Almac Discovery.  Following collaborative pre-clinical work showing robust efficacy, this ‘first-in-class’ FKBPL-based antiangiogenic peptide has entered phase I/II clinical trials in the ovarian setting (EudraCT No: 2014-001175-31). Whilst the trial is ongoing, we have received exciting news that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation to the drug candidate ALM201 in the treatment of ovarian cancer. The FDA Office grants orphan drug designation to encourage the development of drugs for the prevention, or treatment of a medical condition affecting fewer than 200,000 people in the US and grants market exclusivity for a seven-year period if the sponsor complies with certain FDA specifications. Receiving Orphan Drug Designation for ovarian cancer underlines the fact that ALM201 may address a significant unmet medical need for this important disease.

Tracy Robson