LONDON ¿ Pharming Group NV, of Leiden, the Nether lands, said it expects to start pivotal Phase III trials of alpha glucosidase in the treatment of the glyco-lipid storage disorder, Pompe¿s disease, in the third quarter.
The company made the announcement as it presented details of the Phase II trials. All the infants enrolled in the trial are alive today, and Pharming, which specializes in the production of human proteins in the milk of transgenic animals, said the trial is well on the way to meeting its objectives with respect to patient survival, target tissue enzyme levels, and the observed safety profile.
The U.S. and European Phase III trial in infants will be followed by trials in juveniles. That is in line with Pharming¿s aim of launching human alpha glucosidase in mid-2000.
The company also is awaiting the birth this month of 10 female transgenic calves that have been generated via nuclear transfer. The calves, to be born in Wisconsin, have been generated in collaboration with collaborative partner Infigen Inc., of DeForest, Wis. ¿ Nuala Moran