Palatin Receives FDA Go-Ahead for Clinical Tests of LeuTech,
Kit-Packaged Radioimaging Diagnostic System
This is some excellent progress eh Bev?
Phase I, II Trials to Begin in Tandem Immediately
PRINCETON, N.J.--(BW HealthWire)--Nov. 20, 1997--Palatin Technologies Inc. (NASDAQ:PLTN -news) Thursday announced it has received clearance from the U.S. Food & Drug Administration (FDA) to initiate company-sponsored Phase I and II clinical trials of LeuTech, Palatin's kit-packaged radiolabeled infection imaging system.
Both trials will begin immediately and are expected to be completed in early 1998. Phase I is an overall safety study; Phase II will investigate the safety and efficacy of LeuTech for the detection of equivocal appendicitis.
Previously, Palatin had reported positive results from physician-sponsored clinical trials of LeuTech at the UCLA/Harbor Medical Center in Los Angeles. Investigators reported LeuTech's ability to afford, without recourse to laboratory blood cell separation and radiolabeling, rapid infection site imaging and high overall diagnostic accuracy.
LeuTech can be injected intravenously at bedside; it then seeks out and binds with white blood cells at infection sites within the body. Diagnostic imaging can be quickly achieved, sometimes within minutes,
with conventional planar gamma camera techniques. The UCLA/Harbor research team report said, in part, that the LeuTech technique ''will decrease cost and increase speed and safety for this procedure.''
Palatin Executive Vice President Charles Putnam said that the FDA go-ahead ''means that we are on target with our stated plan and timetable and should be able to remain on schedule to complete all clinical studies
ON TARGET
chris
and file a Biologic License Application (BLA) by the end of 1998.'' |
