MEDCO COMMENCES IPPA CLINICAL TRIAL
MEDCO COMMENCES IPPA CLINICAL TRIAL LOS ANGELES, Sept. 14 /PRNewswire/ -- Medco Research, Inc.
(AMEX: MRE) reported today that the Food and Drug Administration (FDA) approved the Investigational New Drug (IND) application for its nuclear cardiac diagnostic, IPPA, and that doctors at Albert Einstein Medical Center in Philadelphia have begun enrolling patients to start Phase II trials.
IPPA (iodophenylpentadecanoic acid) is a synthetic fatty acid coupled to a radioisotope, iodine-123. An earlier limited independent clinical study reported in the recent July issue of The Journal of Nuclear Medicine concluded that certain patients may benefit from coronary bypass surgery or balloon angioplasty as a result of IPPA's identification of minimally active ("hibernating") heart muscle. The objective of the current study, to be conducted at several medical centers, is to accumulate data on appropriate dosage and imaging parameters. Assuming successful completion of this study, the company plans to move rapidly to a larger, multi-center Phase III clinical trial. Common diagnostic techniques identify as dead or nonviable heart muscle which may be only "hibernating." In many cases, "hibernating" tissue can be restored to normal function through coronary bypass surgery or balloon angioplasty. Currently, the most accurate method of selecting patients who may benefit from balloon angioplasty or bypass surgery has been positron emission tomography (PET). However, PET is an expensive procedure, and is available in fewer than 100 specialty centers in the United States. Utilizing IPPA and a standard nuclear camera commonly available in most U.S. hospitals, patients with "hibernating" heart muscle may be selected for angioplasty or bypass surgery at a far lower cost. Medco is collaborating in the clinical program with BioImaging Technologies, of West Trenton, N.J., a company with expertise in imaging software, to develop image acquisition and processing capabilities. In April 1992, Medco licensed U.S. rights to IPPA from Canadian-based Nordion International, which also is the manufacturer of IPPA. "If, as we anticipate, the clinical program corroborates the original study, we believe that use of IPPA could benefit an estimated 300,000 of the 1.5 million patients who each year undergo thallium imaging in the U.S.," said Archie W. Prestayko, Ph.D., president and chief executive officer of Medco Research. "IPPA holds the potential of providing an effective and less expensive alternative to PET scanning." Medco Research is a pharmaceutical company engaged in the acquisition, research and development of new prescription drugs for the diagnosis or treatment of certain cardiovascular diseases and cancer. -0- 9/14/92 /CONTACT: Archie W. Prestayko, president and CEO of Medco, 213-966-4148; or Fredric Spar of Kekst and Company, 212-593-2655, for Medco/ (MRE) CO: Medco Research, Inc.; BioImaging Technologies ST: California, Pennsylvania, New Jersey IN: MTC SU:
GK-OS -- NY024 -- 9030 09/14/92 10:19 EDT
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|Date:||Sep 14, 1992|
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