Array BioPharma Inc., of Boulder, Colo., filed an investigational new drug application for ARRY-520, a kinesin spindle protein inhibitor that demonstrated tumor regression in preclinical models of human solid tumors and leukemias...The six-month study will enroll about 360 surgically menopausal women and will be conducted under a Phase III protocol and investigational new drug application reviewed by the FDA
Panacos Pharmaceuticals Inc., of Watertown, Mass., filed an investigational new drug application for its second-generation HIV maturation inhibitor, PA-1050040, and intends to begin Phase I trials in the first quarter of next year
Exelixis Inc., of South San Francisco, submitted an investigational new drug application to the FDA for XL518, a specific inhibitor of MEK, a key component of the RAS/RAF/MEK/ERK pathway...ISTA Pharmaceuticals Inc., of Irvine, Calif., filed an investigational new drug application with the FDA for its eye-drop formulation of bepotastine for allergic conjunctivitis
Jenken Biosciences Inc., of Research Triangle Park, N.C., said the FDA cleared its investigational new drug application for JKB-122, an off-patent drug for which Jenken has discovered a potential use against liver damage associated with hepatitis C and other diseases associated with organ inflammation...Based on those results, the companies plan to submit a supplemental new drug application during the first half of 2007
Memory Pharmaceuticals Corp., of Montvale, N.J., said the FDA completed its review of the investigational new drug application for MEM 3454 and released the clinical hold
Samaritan Pharmaceuticals Inc., of Las Vegas, said the FDA requested additional information on the company's investigational new drug application for Caprospinol prior to Phase I testing
Lexicon Genetics Inc., of The Woodlands, Texas, submitted an investigational new drug application to the FDA for LX1031, an internally developed small-molecule compound for gastrointestinal disorders such as irritable bowel syndrome
Based on the results from both trials, the company plans to submit a new drug application in mid-2007...Janus intends to launch a Phase II/III trial in the first quarter of 2007, with a new drug application targeted for early 2009
Lux Biosciences Inc., of Jersey City, N.J., said the 30-day waiting period for its investigational new drug application for the development of LX211 in uveitis has elapsed, paving the way for initiation of pivotal clinical trials in early 2007
MannKind Corp., of Valencia, Calif., said the FDA cleared its investigational new drug application for its cancer immunotherapy program, and the company expects to begin a Phase I trial to test the immune response, safety and tolerability of a DNA vector with two synthetic peptides in subjects with solid malignancies, in a plasmid prime-peptide boost treatment...The product is in Phase II and Phase III trials, and Pharmaxis anticipates completing a new drug application in 2008
The company anticipates using the pooled data from both trials to file a new drug application for Xcytrin by the end of the year. (See BioWorld Today, Dec. 17, 2001, and Dec. 20, 2005...Somaxon expects results from its final Phase III trial in December, with a new drug application anticipated in the third quarter of 2007
Evotec AG, of Hamburg, Germany, initiated a second Phase II study of EVT 201 under an investigational new drug application...Virax Holdings Ltd., of Melbourne, Australia, said the FDA has allowed an investigational new drug application for Phase II testing of the company's VIR201 vaccine for treatment of HIV/AIDS
The 380-patient trial is being conducted under a special protocol assessment, and pending positive results, is expected to be one of the pivotal trials that form the basis for a new drug application
Advanced Viral Research Corp., of Yonkers, N.Y., filed an amendment with the FDA to its existing investigational new drug application to expand the use of its product, AVR118, to include topical and intralesional therapy, which could be used in treating dermatologic conditions
ThromboGenics NV, of Leuven, Belgium, said the FDA completed its review of the company's investigational new drug application for microplasmin for intraocular injection
Protalex plans to conduct additional analyses of the data, but said the planned investigational new drug application in idiopathic thrombocytopenia purpura, initially expected in the fourth quarter, will be delayed
Array BioPharma Inc., of Boulder, Colo., filed an investigational new drug application for ARRY-520, a kinesin spindle protein inhibitor that demonstrated tumor regression in preclinical models of human solid tumors and leukemias...The six-month study will enroll about 360 surgically menopausal women and will be conducted under a Phase III protocol and investigational new drug application reviewed by the FDA