Diatech Inc. announced it completed Phase I/II trials of itsradiolabeled imaging agent, technetium-99m P280, for detecting bloodclots, and plans to start a pivotal Phase III study in September.The imaging agent is technetium-99m P280. P280 is a syntheticpeptide that Diatech said has an extremely high affinity for activatedplatelets that are present in blood clots."We saw [in previous trials] a very high sensitivity and specificity fordetecting thrombus in patients having previously documented deep-vein thrombosis," Richard Dean, president and CEO of theLondonberry, N.H., company, told BioWorld.The Phase III trial is expected to be done on about 200 patients,comparing the presence or absence of deep-vein thrombosis to resultsfrom existing technologies, contrast venography and ultrasound. Deansaid Tc-99m P280, given by intravenous injection, is most effective vs.competing products in detecting clots below the knees and inasymptomatic patients.He said the Phase III trial is expected to be completed in six to ninemonths, and a new drug application filed by the end of 1995. _ JimShrine

(c) 1997 American Health Consultants. All rights reserved.

No Comments