Questions raised by the FDA about Glycomed Inc.'scompound Astenose will delay Phase I testing of the productat least three months, company President Brian Atwood toldBioWorld on Monday.Astenose is a form of heparin that has been chemicallymodified to lessen the anti-coagulant effects. Glycomed nowhopes to begin Phase I testing of Astenose in July (rather thanApril) for vascular restenosis following angioplasty.The Alameda, Calif., company filed an investigational newdrug (IND) application with the FDA in February, but theagency informed Glycomed last week that more informationrelated to toxicology and chemistry of the compound isneeded before the IND can be granted.The FDA wants a better characterization of the chemicaldifferences between Astenose and heparin, which Atwoodsaid will be addressed quickly and easily. He added that thecompany believes it has already addressed the agency'squestions about toxicity in its 12-volume IND."We want to go into a discussion with the FDA to understandwhat they understood," Atwood said. "Asking anybody toassimilate that much information in a 30-day period is reallyexpecting a lot."He said at least several weeks of communication by mail withthe agency will be necessary before the matter is resolved.Glycomed reported in January that Astenose reducedrestenosis (narrowing of the arteries) by 50 percent to 70percent in baboons treated with the drug for 30 days. It wasthe first drug for restenosis to show efficacy in baboons, withthe exception of high-dose fish oil, said Sam Teichman,Glycomed's assistant vice president of medical affairs.Teichman said the drug seems to work by inhibiting smoothmuscle cell growth and potentially by affecting the vascularremodeling that occurs during the healing process afterballoon angioplasty.Several other companies have compounds in preclinicaldevelopment for treatment of restenosis. They include GentaInc., which is collaborating with CV Therapeutics and aStanford researcher, Prizm Pharmaceuticals Inc., SeragenInc., Cor Therapeutics Inc. and NeoRx Corp.
-- Jim Shrine
(c) 1997 American Health Consultants. All rights reserved.