FDA Clears Hybridon's IND For GEM 132

The US Food and Drug Administration has approved Hybridon'sInvestigational New Drug application for the antisense oligonucleotide GEM 132, used in the treatment of cytomegalovirus retinitis, a disease which results in blindness in around 40% of late-stage AIDS patients.

Hybridon is to commence the enrollment of 14 patients with relapsing CMV retinitis for the Phase I/II open-label, dose-ranging trial, to be conducted at three separate sites in the USA. A similar trial will also be initiated in France, says the company. The compound will be administered intravitreally to patients; in preclinical trials GEM 132 remained in the retina for up to 16 weeks following a single injection.

The company also presented data from its Phase I European trial at the 4th Conference on Retroviruses and Opportunistic Infections, held in Washington, USA on January 23. The trial involved 18 healthy volunteers who each received an intravenous infusion of GEM 132 in increasing doses up to 0.5mg/kg. It was shown to be well-tolerated with no dose-limiting side effects. A Phase I/II trial for the IV formulation is due to begin this month in Paris, France.