PROCYON BIOPHARMA INC ("PBP-T;PCYBF-0") - Financial Results for the Third Quarter of 2001
Procyon BioPharma announced its financial results for the third quarter of 2001.
The Company continued to make rapid progress during the quarter in the development of its Prostate Secretory Protein (PSP94) and Antinucleosomal Autoantibodies (ANA) technologies. "The peptide PCK3145, indicated for the treatment of prostate cancer, has been extensively tested in animal models and is on target to be tested in humans in early January 2002", stated Mr. Hans Mader, President and CEO of the Company. "We are on target to file an IND (Investigational New Drug submission) before the end of the year, to conduct Phase I/II human clinical trials in patients who have failed hormonal therapy for prostate cancer." The finalization of an agreement with Multiple Peptide Systems of California for the manufacture of cGMP grade PCK3145 to be used for the clinical trials was announced during the quarter.
"Together with our development partner Biovation Ltd (U.K.) and our research collaborators at Northeastern University (Boston), we have made substantial progress in the development of our second core technology platform ANA. The chimeric monoclonal antibody (c-2C5) as well as the de-immunized version of the same antibody, prepared by Biovation, are currently undergoing extensive testing in our laboratory, for safety and efficacy", added Mr. Mader. "Our manufacturing partner, Goodwin Biotechnology Inc. (Florida), has made progress in the plans to produce cGMP grade monoclonal c-2C5 and has completed the clone selection for large scale production."
Enrolment for the Canadian Phase II clinical studies for our lead product FIBROSTAT(R), for the treatment and prevention of hypertrophic scarring, was completed on October 25, 2001, with 132 patients on active treatment. We are on target to file the IND for clinical Phase III studies in Canada before the end of the year, in partnership with our licensee for Canada, Biovail Corporation. We are currently in advanced discussions for the licensing of FIBROSTAT(R) for the United States.
THIRD QUARTER RESULTS - ACCELERATION OF RESEARCH PROGRAMS CONTINUES |