Almac Discovery, has announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation to its drug candidate ALM201 in the treatment of ovarian cancer.
ALM201 is a therapeutic peptide developed to mimic some of the properties of the naturally occurring protein FKBPL. The development of ALM201 by Almac Discovery builds upon initial research work by Professor Tracy Robson who has shown that FKBPL is a naturally secreted protein with effects on a number of important tumour biology processes including cancer stem cells and angiogenesis.
Ovarian cancer ranks among the top ten diagnosed and top five deadliest cancers in most countries. Unfortunately, approximately 80% of patients present with advanced disease, therefore it is critical that clinicians are provided with as many treatment options as possible which can target this disease, either as a monotherapy or in combination with other treatments.
Dr Stephen Barr, Managing Director & President, Almac Discovery commented “The FDA’s Orphan Drug Designation of ALM201 in the treatment of ovarian cancer will allow for valuable assistance from the FDA during clinical development for either ourselves or our partners for this difficult to treat patient population.”
The FDA Office grants orphan drug designation to novel drugs and biologics that are intended for the safe and effective treatment, diagnosis or prevention of rare diseases or disorders that affect fewer than 200,000 people in the United States.