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Anyone following PLTN? Palatin recently moved from the BB to the NASDAQ Small Cap. Palatin Submits IND With The FDA For Kit-Packaged Radioimaging Diagnostic System IND Filed With FDA PRINCETON, N.J.--(BW HealthWire)--Oct. 15, 1997--Palatin Technologies Inc. (NASDAQ:PLTN) Wednesday announced it has submitted an Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA) for company sponsored clinical trials of LeuTech, Palatin's kit packaged radiolabeled infection imaging system. This submission follows Palatin's pre-IND meeting with the FDA's Bureau of Biologics, and incorporates a number of changes suggested by the FDA to strengthen the company's application. The company sponsored trials will build on the success of previous physician-sponsored clinical trials at the UCLA/Harbour Medical Center in Los Angeles. Investigators in these trials found that LeuTech demonstrated rapid imaging of infection sites and high overall diagnostic accuracy. LeuTech, injected intraveneously, binds with white blood cells specifically and quickly at the infection sites within the body. The infection site can then be imaged, sometimes within minutes of injection, using conventional gamma camera, planar imaging techniques. Palatin Executive Vice President Charles Putnam commented, ''The filing of the LeuTech IND is a critical milestone for the product and the company, and we are pleased to have accomplished it as planned.'' ''Assuming a successful FDA review, we remain on track to complete LeuTech clinical studies by late-summer 1998. We expect to file a Biologic License Application (BLA) shortly thereafter.'' Palatin Technologies is a development-stage medical technology company involved in developing and commercializing products and technologies for diagnostic imaging, cancer therapy and ethical drug development based on its proprietary monoclonal antibody, radiolabeling and enabling peptide platform technologies. NOTE: Statements about the company's future expectations, including development and regulatory plans, and all other statements in this document other than historical facts are ''forward-looking statements'' within the meaning of Section 27A of the Securities Act of 1933, Section 21E of the Securities Exchange Act of 1934, and as that term is defined in the Private Securities Litigation Reform Act of 1995. The company intends that such forward-looking statements be subject to the safe harbors created thereby. Since these statements involve risks and uncertainties and are subject to change at any time, the company's actual results could differ materially from expected results. | ||||||||||||||
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