The following report features FDA Clinical Trial Updates for: QLT Inc. (NASDAQ:QLTI), Living Cell Technologies (ASX:LCT), BioMimetic Therapeutics (NASDAQ:BMTI), Array BioPharma (NASDAQ:ARRY)
QLTI: VISUDYNE (veteporfin), photodynamic or PDT light activated drug therapy, co-developed/marketed with Novartis, first approved treatment for certain forms for wet age related macular degeneration (AMD),combination studies with anti-VEGF (Lucentis) and steroid for wet AMD, expects to complete QLT sponsored RADICAL study mid-2010 for estimated results 3Q10. Updated 6/6/10.
LCT.AX: DIABACELL, encapsulated porcine islet, insulin-producing cell implants, next phase of trial with 4 new patients by July 2010 with interim results expected Oct 2010, final results at 1 year follow up, reported Phase 1/2a Russian study follow up results that met safety and proof of concept result that met safety and prro of concepts results for Type 1 diabetics, scheduled to present results at ADA meeting June 25-29,2010. Updated 6/6/10.
BMTI: Augment Bone Graft, a synthetic, off the shelf bone growth factor product, completed enrolment in EU pivotal study Nov 2008 for treatment of foot and ankle fusions with 108 patients, expects to report data mid-2010 and submit this data long with US pivotal stuffy data for regulatory approval in Europe during 3Q10. Updated 6/6/10.
ARRY: ARRY-520, a kinesin spindle protein or KSP inhibitor anti-cancer, presented on 6/5/10, Phase 1 results well tolerated with encouraging preliminary results for treatment of multiple myeloma (MM), advancing into Phase 2 portion as single-agent for MM during 3Q10, Phase ½ study for acute myeloid leukemia with estimated results during 3Q10. Updated 6/6/10.
