MONTREAL, Oct. 25 /PRNewswire-FirstCall/ - Procyon Biopharma Inc. announced today progress for the U.S. dose finding study for PCK3145, its
non-toxic therapeutic peptide for the treatment of advanced prostate cancer, and indicated that the study is on track for completion by year end. With four patients remaining to be enrolled in the study, PCK3145 is found to be very well tolerated in all patients treated so far. No side effects have been noted and the data suggests that there is again an impact on the metastatic enzyme, MMP-9 (Matrix Metalloproteinase-9), plasma levels.
“We are very pleased with our experience with PCK3145 to date, a novel drug in our hands showing a rapid onset of action,” said Dr. Susan Slovin, principal investigator for the study at the Memorial Sloan Kettering Cancer Center, New-York. “Our ‘star’ patient who enrolled into the study with metastatic prostate cancer to the bone and lymph nodes is undergoing his 4th cycle of treatment and continues to show both a stable PSA (Prostate-Specific Antigen) and scans, a very encouraging result” she added.
“I am delighted that we are showing equally promising observations for PCK3145 in two different studies conducted at two independent sites, this strengthens our confidence in the potential of PCK3145 to treat advanced prostate cancer patients,” said Hans J. Mader, president and chief executive officer of Procyon Biopharma.
ABOUT PCK3145 U.S. DOSE FINDING STUDY
The objective of the study is to assess optimal dose/schedule showing an effect on MMP-9 regulation in asymptomatic, metastatic, castrated patients. Two cohorts of ten patients each are receiving 7.5mg/m2 two times per week and 15mg/m2 once a week, respectively. Patients are treated for 4 weeks followed by a 2 week non treatment period. MMP-9, PSA, pharmacokinetic parameters and radiographic/CT/MRI assessments are made at screening, at week 2, at completion of the treatment period (week 4) and at completion of the non-treatment period (week 6).
ABOUT PCK3145 THERAPEUTIC PEPTIDE
PCK3145 is a synthetic 15-mer peptide that is derived from the natural sequence of amino acids of the prostate secretory protein (PSP94), one of three predominant proteins found in human seminal fluid. PSP94 expression in the prostate is down regulated in patients with advanced prostate cancer, and believed to be a survival mechanism for the cancer cells. Results from the Phase IIa trial confirmed PCK3145 to be safe and well tolerated at all doses tested further suggesting that it also plays a role in preventing the metastatic process as measured by its effect on Matrix Metalloproteinase-9 (MMP-9) levels, a Gelatinase B enzyme involved in angiogenesis, tumor invasion and metastasis. Procyon has filed an Investigational New Drug (IND) application with the FDA. A dose finding study as a lead-in to a North American Phase II study is underway. The mechanism of action and receptor for PCK3145 suggests PCK3145 to be a signal transduction inhibitor with multiple ways (apoptosis, anti-angiogenesis and anti-metastasis) to restrict disease development.
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 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: Julie M. Thibodeau, Procyon Biopharma Inc.,jthibodeau@procyonbiopharma.com , ir@procyonbiopharma.com , (514) 685-2000ext 118; Christine Labaree, The Trout Group, clabaree@troutgroup.com ,(781) 685-2934; Marcy Strickler, The Trout Group, mstrickler@troutgroup.com, (212) 477-9007 ext. 27; Dominic Sicotte, Echoes Financial Network Inc.,dsicotte@roadshows.tv , (866) 633-9551; Martin Lavoie, Echoes FinancialNetwork Inc., mlavoie@roadshows.tv , (866) 633-9551
