Allon Therapeutics Inc., of Vancouver, B.C., said that it enrolled 75 percent of the planned 300 subjects in a pivotal study of its neuroprotective drug candidate davunetide for progressive supranuclear palsy. It is on schedule to complete enrollment by the end of 2011 and report data one year later. It also reported that MRI data from a previous Phase IIa trial of the drug in schizophrenia showed that davunetide may prevent cortical thinning.
AVI BioPharma Inc., of Bothell, Wash., began dosing in a Phase II study of eteplirsen, its lead exon-skipping therapeutic candidate, for the treatment of Duchenne muscular dystrophy. The 12-patient, placebo-controlled study will be conducted at Nationwide Children's Hospital in Columbus, Ohio. Endpoints include biochemical markers in muscle biopsies and clinical outcomes to measure muscle strength, function and degree of ambulation.
GlaxoSmithKline plc, of London, and Impax Pharmaceuticals, of Hayward, Calif., reported top-line results from the ASCEND-PD Phase III trial of IPX066 in patients with advanced Parkinson's disease. Compared to a regimen of carbidopa-levodopa plus entacapone (CLE) experienced motor symptoms (off time) just 24 percent of their waking hours, compared to 32.5 percent for those receiving CLE, and a 36.1 percent baseline before entering the trial. Full results of the trial will be presented at an upcoming scientific meeting.
ICo Therapeutics Inc., of Vancouver, British Columbia, said an investigator-sponsored Phase II trial of antisense drug iCo-007 for diabetic macular edema was initiated in the U.S. ICo-007, discovered by Isis Pharmaceuticals Inc., targets c-Raf kinase. (See BioWorld Today, Aug. 26, 2005.)
RegeneRx Biopharmaceuticals Inc., of Rockville, Md., began enrollment in a Phase II trial of RGN-259, a preservative-free eyedrop, in patients with dry eye syndrome. The company expects to enroll 72 subjects in the randomized, double-blinded, placebo-controlled trial by the end of the month, with the last patient completing the study the third week in September. Preliminary data should be available in October.
Starpharma Holdings Ltd., of Sydney, Australia, initiated a Phase II trial of VivaGel for the prevention of bacterial vaginosis in women with a prior history of recurrent disease. VivaGel is also being developed as a topical microbicide for the prevention of HIV and genital herpes and as a condom coating.
Ultragenyx Pharmaceutical Inc., of Novato, Calif., dosed its first patient in a Phase I trial of UX001 for hereditary inclusion body myopathy (HIBM). Ultragenyx is developing the product, an extended release formulation of sialic acid, as a replacement therapy for the disease. The study will evaluate pharmacokinetics and safety of the drug in 24 for patients with HIBM at four single dose levels, with repeat dosing at three dose levels after seven days. (See BioWorld Today, June 21, 2011.)