Monday September 29, 7:01 am ET
The Company to present interim clinical data at BioContact in Quebec City and BioEurope in Frankfurt
MONTREAL, Sept. 29 /CNW Telbec/ - Procyon Biopharma Inc. (TSX: PBP - News) announced today positive interim results for PCK3145, Procyon's therapeutic drug indicated for hormone-refractory prostate cancer, a disease for which there is currently no effective therapy. The interim results from the first two cohorts of Procyon's Phase IIa clinical trial show no drug-related adverse effects, PSA reduction in some of the patients and significant decline in a tumor metastasis marker, MMP-9.
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The Company also announced that Mr. Hans J. Mader, President and Chief Executive Officer of Procyon along with Dr. Chandra J. Panchal, Senior Executive Vice-President, Oncology and New Technologies, will present this new clinical data at BioContact on Wednesday October 1st, at 3:30 p.m. in the Laval Room of the Chateau Frontenac Hotel, Quebec City, Canada. The Company will also present the new data at the BioEurope Annual Meeting to be held in Frankfurt, Germany, from November 17-19, 2003.
"These encouraging results clearly demonstrate that PCK3145 has the potential to significantly reduce tumor metastasis in hormone-refractory prostate cancer patients without safety concerns and adverse effects," said Hans J. Mader, President and Chief Executive Officer of Procyon. "Based on these interim clinical results, we are quite confident that PCK3145 will obtain positive results with the next cohorts as well as with the following studies in a larger patient population," he added.
"These clinical results are very interesting and suggest the potential role of PCK3145 in the intervention of the metastatic process, an effect that was alluded to by results of delay in the development of skeletal metastasis and reduction in malignancy-associated hypercalcemia in our syngeneic rat prostate cancer model, by PCK3145," said Dr Shafaat A. Rabbani of the McGill University Health Centre and a collaborator to Procyon. "The marked reduction in plasma MMP-9 levels of patients receiving PCK3145 treatment clearly indicates a biochemical effect, and provides a potentially novel mechanism of action of this small molecule in these patients", he added.
About the PCK3145 Phase IIa clinical trial
Procyon is currently conducting the multiple ascending dose open-label evaluation study. The study design includes 4 cohorts of 4 patients, each to receive respectively 5, 20, 40 and 80 mg/m2, intravenously, 3 times a week for 4 weeks followed by a 7-day observation period, for a total of 16 patients with an additional 6 patients allowable. Dosing regimens were based on efficacy observed in the Dunning rat MLL prostate cancer model.
The interim results here presented reflect the results obtained with eight patients of the first two cohorts (5 and 20 mg/m2). Some patients have received up to 5 cycles (6 months) of treatment, but the majority of patients are receiving two cycles. The third cohort enrolment is completed (including first cycle) and some patients are still receiving treatment. The enrolment of the first patient in the fourth cohort is planned for early October. Total recruitment of all patients is expected before the end of the fourth quarter.
The primary objective of this study is to evaluate the safety and the tolerability of PCK3145 administered intravenously for the therapeutic doses. The secondary objectives are to determine the pharmacokinetic profile of PCK3145 administered intravenously and to evaluate efficacy data, tumour response using CT scans / MRI and PSA, other tumour markers levels and hormone levels (testosterone, FSH and LH).
Two of the four patients in the first cohort showed a decline in PSA levels following treatment, one of them by almost 50%. Two patients in the second cohort also showed an initial response in PSA reduction. The time to PSA progression in these late-stage hormone-refractory patients ranged from about 30 days to over 160 days. The Karnofky Performance Status, indicating the general health of the patients, remained high (80-100), and CT scans showed disease stabilization during the treatment period. The PK (half-life) for peptide in the plasma was found to be 0.33 hr, comparable to similar peptide-based drugs.
The most dramatic and unexpected results were shown in the levels of MMP- 9 - Matrix Metalloproteinase-9 - a Gelatinase B enzyme involved in tumor invasion and metastasis. All four patients who had plasma MMP-9 levels over 100 ug/L before treatment had reductions ranging from 34% to 90% after two cycles of treatment. In the patient that received 5 cycles (approximately 6 months treatment), the MMP-9 level went down sequentially from 156 ug/L to 39 ug/L. In the other four patients that had low levels of MMP-9 prior to treatment (22 to 58 ug/L), they remained low and only increased in two cases when cancer relapse was deemed to have occurred.
A recent report (Reuters Health News, Sept. 18th, 2003 and Int.J.Cancer, 2003; 106:745-751) has suggested the utility of plasma levels of MMP-9 as a prognostic marker for the clinical status of patients with breast cancer. Patients responding to surgical intervention showed decline and maintenance of low levels of plasma MMP-9, while those that didn't respond to surgery had increasing MMP-9 levels. Similar results have also been reported previously with colon cancer, lung cancer and ovarian cancer patients.
"We are intrigued and encouraged by these interim clinical results. We have also seen that the drug is very well-tolerated in all of the patients," said Professor Robert Hawkins, Principal Investigator of the trial and Director, Cancer Research UK and Department of Medical Oncology at the Christie CRC Research Centre, Manchester, England. "These late-stage prostate cancer patients present us with very limited treatment options and hence we are very keen to be involved with new therapeutic approaches such as PCK3145. Since these patients have metastatic lesions to the bone and lymph nodes, the plasma MMP-9 profiles obtained with PCK3145 are very encouraging and will be immensely helpful in the design of the Phase IIb clinical trial," he added.
About PCK3145
PCK3145 is a synthetic 15-mer peptide that is derived from the natural sequence of amino acids of the prostate secretory protein (PSP94). PSP94 is one of three predominant proteins found in human seminal fluid along with PSA (prostate specific antigen) and prostate acid phosphatase (PAP). Several studies have been conducted to evaluate the activity of PCK3145 as a tumor suppressive agent of prostatic adenocarcinoma. PCK3145 shows activity in both in vitro and in vivo models using the androgen-resistant human prostate adenocarcinoma cell line, PC3 and the Dunning rat R-3327 MLL prostate cancer cell line, most likely acting through cell cycle arrest and induction of apoptosis.
Conference call
Procyon will host a conference call today, Monday, September 29, at 9:00 a.m. (EST) to discuss the PCK3145 interim results. To access the conference call, dial 1-800-814-4853 or 416-640-4127. Please connect approximately five minutes prior to the beginning of the call to ensure participation. To access the archived conference call, dial 1-800-289-8525 or 416-640-1917 and enter the reservation number 21019499(pound key). The conference call will be archived for replay until December 29, 2003, at midnight.
About Procyon Biopharma
Procyon Biopharma Inc. is a publicly traded, Montreal-based, Canadian biotechnology company actively engaged in the discovery and development of innovative therapeutics and diagnostics in the fields of oncology and infectious diseases. Procyon brings its products and technologies from the laboratory to phase II human clinical trials and licenses them to larger pharmaceutical partners for further development and commercialization. Procyon's pipeline comprises a healthy combination of early-stage anti-cancer platforms, PSP94 and ANsA, as well as anti-HIV/AIDS compounds, PL-100, a protease inhibitor, and PL-2500, a lead candidate integrase inhibitor. The Company also has two late-stage products: Fibrostat(R), licensed to Biovail Corporation, and Colopath(R)/ColorectAlert(TM), licensed to IMI International Medical Innovations Inc. Procyon shares are listed on the Toronto Stock Exchange (TSX) under the ticker symbol PBP. (www.procyonbiopharma.com) |
