MONTREAL, Dec. 8 /PRNewswire-FirstCall/ - Procyon Biopharma Inc. , a biotechnology company developing innovative therapeutics in the fields of cancer and HIV/AIDS, announced today that it has received regulatory approval from the Therapeutic Products Directorate of Health Canada to initiate the first-in-man Phase I clinical trial for its lead protease inhibitor PPL-100 for the treatment of drug resistant HIV. As reported by the Company on November 16, 2005, the data from the in vitro resistance study indicated the high genetic barrier of PPL-100 confirming the potential utility of the drug for first-line treatment of resistant HIV patients. New antiviral drugs with a high genetic barrier (making it more difficult for the virus to develop resistance) are needed to fight the emergence of resistant HIV viruses.
The first-in-man Phase I study, which will be initiated by the end of December 2005, will be an escalating dose, placebo-controlled study conducted with 40 healthy male subjects, 30 receiving the active medication and 10 receiving placebo. Five doses of PPL-100 (300, 600, 1200, 1800 and 2400mg) will be administered in order to determine the maximum tolerated dose. Results from this study, including safety, tolerability and single-dose pharmacokinetics, will be used to finalize the protocol of the subsequent multi-dose study which is expected to be completed in the second quarter of fiscal 2006. The first-in-man Phase I study is to be conducted in a U.S. Food and Drug Administration-approved contract research organization in Canada.
"We are very happy to have met this important milestone in our lead HIV protease inhibitor PPL-100 development program, as this allows us to advance this promising drug candidate to the clinical stage. As well, we expect to have results available within the next 4 to 5 months", said Hans J. Mader, president and chief executive officer of Procyon Biopharma.
PPL-100, is a phosphorylated Pro-drug of Procyon's PL-100 protease inhibitor. PL-100 is the active antiviral agent that is potent, specific and non-cytotoxic with a high genetic barrier and favorable cross-resistance profile in drug and multi-drug resistant strains of HIV-1. PL-100 is active against several HIV-1 strains specifically selected for key mutations that render these strains resistant to currently marketed protease inhibitors. Preclinical safety studies as well as animal pharmacokinetic studies have recently been completed and human clinical studies expected to commence by the end of the year.
ABOUT PROCYON BIOPHARMA INC.
Procyon Biopharma Inc. is a biotechnology company actively engaged in the discovery and development of innovative therapeutics in the fields of cancer and HIV/AIDS. The Company leverages its strengths in research and clinical development, bringing products through late-stage clinical trials and then evaluating the best options for further development, such as co-development and licensing. Procyon's pipeline includes: PCK3145, a non-toxic peptide soon to enter a Phase II North American trial for the treatment of advanced metastatic prostate cancer; TVT-Dox, a tumor vasculature targeting technology for the treatment of solid tumors for which an IND filing is expected within 12 months; and, PPL-100, a protease inhibitor for the treatment of drug- resistant HIV/AIDS soon to enter the clinic. Procyon has won the 2005 Frost & Sullivan Award for Excellence in Technology for its overall scientific and technological contributions towards the advancement of cancer therapy. Headquartered in Montreal, Procyon shares are listed on the Toronto Stock Exchange (TSX) under the ticker symbol PBP. For more information, visit www.procyonbiopharma.com.
This release contains forward-looking statements that reflect the company's current expectation regarding future events. The forward-looking statements involve risks and uncertainties. Actual events could differ materially from those projected herein and depend on a number of factors including, but not limited to, changing market conditions, successful and timely completion of clinical studies, uncertainties related to the regulatory approval process, establishment of corporate alliances and other risks detailed from time to time in the company's filings.
PROCYON BIOPHARMA INC.
CONTACT: Procyon Biopharma Inc., Julie M. Thibodeau, Director,Communications, firstname.lastname@example.org, (514) 685- 2000 ext 118,email@example.com