Palatin Technologies Initiates Phase 3 LeuTechClinicals at Ten Sites in U.S.A.; Infection...

PRINCETON, N.J.--(BW HealthWire)--Oct. 1, 1998--Palatin Technologies Inc. (Nasdaq:PLTN) Thursday reported that it has initiated Phase 3 clinical trials of its LeuTech infection imaging agent for use in the diagnosis of equivocal (difficult to diagnose) appendicitis at 10 major medical centers around

The trials, which are expected to enroll approximately 200 patients by January 1999, will be pivotal, according to Chairman, President & Chief Executive Officer Edward J. Quilty, and the company plans to submit a marketing application to the FDA following completion of the studies, expected in the first calendar quarter of 1999.

Quilty commented, "Prior clinical trials have indicated that directly-injected LeuTech involves no blood handling, acts quickly and provides gamma-camera scans of high quality and clarity. We hope to confirm those results in Phase 3 studies."

Mathew L. Thakur, Ph.D., professor of Diagnostic Radiology and director of Radiopharmaceutical Research at Thomas Jefferson University in Philadelphia two decades ago pioneered the concept of neutrophil (white blood cell) radiolabeling. Immediately thereafter, he turned his attention to developing superior and more specific methods of infection imaging, leading to the LeuTech antibody. Thakur said that LeuTech "has the potential to be an excellent clinical tool for nuclear imaging of infectious lesions because of the accuracy, handling ease, clear 'hot spot' images and high white cell binding that it has demonstrated in clinical trials to date. For the next-generation direct injectable white cell imaging agents like LeuTech, I believe that the most critical characteristic will be white cell binding ability. To the best of my knowledge LeuTech has the highest binding ability ever reported in the scientific literature for an agent of this kind. We look forward to confirming the clinical impact of this unique agent in the ongoing Phase 3 trials."

Eric B. Rypins, M.D., F.A.C.S., chief of General Surgery at Tri-City Hospital in Oceanside, Calif. and clinical associate professor at the University of California, Irvine, has monitored and analyzed LeuTech clinical trials to date. He commented, "Because of the large volume of emergency patients from three surrounding cities and our experience with white blood cell scanning, our radioimaging facility probably handles more equivocal appendicitis cases than any other hospital in the country. In Phase 2 clinical studies here at Tri-City, LeuTech has demonstrated several desirable features -- rapid diagnosis with 100 percent sensitivity, excellent image quality, elimination of blood handling and lab workups.

"In the 49 patients we studied, we observed changes in two-thirds of original treatment plans as a result of LeuTech imaging. Instead of being admitted and observed, patients with confirmed appendicitis were sent sooner to the operating room and patients without appendicitis could be sent home, avoiding an unnecessary admission. We've also observed savings in hospital stay and related facility-based expenses.

"If this performance continues in Phase 3," Rypins said, "LeuTech has the potential to significantly reduce the costs and patient risks of managing appendicitis."

The Phase 2 clinical trial at Tri-City showed that the correct ultimate treatment decision whether or not to operate was made in 95 percent of LeuTech-aided diagnoses. In addition, an analysis of patient billing records showed a net savings per patient for facilities charges alone of $380; physician and other professional fees saved were not factored in, but at Tri-City would typically represent substantial billings.

Rypins said that trials at his institution have been based specifically on equivocal appendicitis, but the system may possess even broader clinical applicability. Palatin intends to continue the study of LeuTech for the imaging of osteomyelitis, fevers of unknown origin and other hidden infections with the initiation of Phase 2 trials during the fourth quarter of this year.

Bruce Barron, M.D., associate professor of Radiology at the University of Texas-Houston Medical School, summarized the reactions of professionals who will be involved in the Phase 3 clinical trials: "LeuTech has shown a number of diagnostic advantages throughout the first two phases. Our staff is eager to begin Phase 3 to validate what we've seen so far."

In addition to Tri-City Hospital and The University of Texas Houston Medical School, Phase 3 clinical tests will be conducted at eight other major medical institutions located in California, Oregon, New York and Illinois. Patients with equivocal appendicitis are being enrolled at the time of initial surgical evaluation, typically in the hospital's emergency room.

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.

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.