Business
Vertex Pharmaceuticals Initiates Phase I Development for VX-770 in Cystic Fibrosis
Vertex Pharmaceuticals Initiates Phase I Development for VX-770 in Cystic Fibrosis.
About this update from Vortex Energy Corp.
[{"type":"text","content":"\n\n\n\n\n FDA Grants Fast Track Designation to VX-770\n\nCAMBRIDGE, Mass., May 17 /CNW/ -- Vertex Pharmaceuticals\nIncorporated (Nasdaq: VRTX) today announced that it has initiated a Phase I\nclinical study for VX-770, a novel, oral drug candidate that specifically\ntargets a key mechanism underlying cystic fibrosis (CF). The study will\nevaluate the safety, tolerability and pharmacokinetics of escalating single\nand multiple doses of VX-770 in healthy volunteers, and also will evaluate\nsingle doses of VX-770 in patients with CF. The study is expected to enroll\nmore than 50 individuals. In March 2006, Vertex and Cystic Fibrosis\nFoundation Therapeutics Inc. (CFFT) entered into a collaboration to accelerate\nclinical development of VX-770. CFFT is the nonprofit drug discovery and\ndevelopment affiliate of the Cystic Fibrosis Foundation. Vertex retains\nworldwide rights to develop and commercialize VX-770.\n\"This first clinical study for VX-770 signifies an important milestone in\nthe productive collaborative history that we have shared with Vertex in the\ndiscovery of novel CF therapies,\" said Robert J. Beall, Ph.D., President and\nChief Executive Officer of the Cystic Fibrosis Foundation and CFFT. \"We\nbelieve that compounds such as VX-770 have great potential to change the\ncourse of CF, and we are pleased to support the accelerated development of\nVX-770 in early clinical studies.\"\n\"VX-770 is the first drug candidate to have emerged from our innovative CF\nresearch efforts, and the initiation of this Phase I study represents an\nexciting new stage in the development of this compound,\" said John Alam, M.D.,\nExecutive Vice President, Medicines Development, and Chief Medical Officer of\nVertex. \"Laboratory results for VX-770 have been highly encouraging and\nsupport the initiation of this first clinical study. We look forward to\nevaluating VX-770 in both healthy volunteers and patients with CF in the\ncoming months to determine the next steps for the VX-770 development program.\"\n\nStudy Design\nThe Phase I study for VX-770 announced today is expected to enroll more\nthan 50 individuals, including healthy volunteers and patients with CF.\nDosing has been initiated in the first cohort of healthy volunteers, and is\nexpected to progress to patients with CF later this year. Healthy volunteers\nin the Phase I study will...