Study Shows Ambrilia's Therapeutic Peptide PCK3145 Has Clinical Activity In Metastatic Prostate Cancer Patients
MONTREAL, QUEBEC-- April 24, 2007) - Ambrilia Biopharma Inc. (TSX: AMB.TO), announced today that the findings of a Phase I/II clinical study conducted at the Memorial Sloan Kettering Cancer Centre (MSKCC) in New York City, indicate that the drug PCK3145 has shown evidence of clinical activity in metastatic prostate cancer patients. The therapeutic peptide drug PCK3145 was shown to increase PSA (Prostate Specific Antigen) doubling time (PSADT), suggesting clinical activity in such patients. The study also confirms down-regulation of MMP-9 (a matrix metalloproteinase enzyme involved in facilitating tumor metastasis), and disease stabilization as assessed by time to radiographic progression in several patients. The study of 28 metastatic hormone refractory patients was led by co-investigators Drs. Susan Slovin and Howard Scher.
"We are greatly encouraged by these recent findings on the potential clinical benefits of PCK3145 in late stage prostate cancer patients," said Stephen Sudovar, Executive Chairman and Interim CEO of Ambrilia. "The safety profile together with the quantitative results on PSADT, MMP-9 as well as stabilization of the metastatic process, we believe, warrant further development of this product. Ambrilia is currently evaluating various options on how to move forward with this exciting drug", he added.
"PCK3145 is a novel and unique drug in the armament of developing therapies for patients with prostate cancer who are progressing on hormones or hormone therapy", said Howard Scher of MSKCC. "The drug has shown sufficient activity in these early clinical trials to justify further development," he added
STUDY DESIGN AND RESULTS
In the first part of the study, 10 patients received 7.5 mg/m2 of the drug twice a week and 10 patients received 15 mg/m2 once a week, for a cycle of 4 weeks followed by a 2 week observation period. While the majority of the patients received one cycle of treatment, eight patients showed stable disease for two or more cycles, of which three patients (two at 15 mg/m2) have continued on for over 500 days of treatment and continue to show stable disease as assessed by radiographic progression of the cancer.
In the second part of the study, eight patients received 150 mg/m2 of the drug for a continuous treatment cycle of 16 weeks. Four of these patients have gone on to a second cycle and continue to remain on treatment as well as showing stable disease.
While the elevated MMP-9 plasma levels were reduced in most of the patients, 10 out of the 28 patients showed an increase in PSADT (PSA doubling time) from 1.5 fold to 5 fold. In retrospective studies it has been reported by investigators that a short PSADT was a significant predictor for fast tumor progression, while a longer PSADT was not.
As in the previous studies reported by Ambrilia, PCK3145 was found to be safe and well tolerated by all the patients at all the three dosage levels.
Prostate cancer is one of the most common cancers worldwide and the leading cancer in men in North America and Europe. According to the American Cancer Society, it is estimated that over 234,000 new cases will occur in the United States during 2007 and more than 27,000 men will die from prostate cancer in the same year.
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 an earlier trial conducted in the U.K. showed PCK3145 to be safe and well tolerated at all doses tested and further suggest that it also plays a role in preventing the metastatic process as measured by its effect on MMP-9 levels, a Gelatinase B enzyme involved in angiogenesis, tumor invasion and metastasis. 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.
CONFERENCE CALL INFORMATION
Ambrilia will be hosting a conference call and webcast on Tuesday, April 24th, at 9:00 AM ET, to discuss PCK3145's Phase I/II study findings. Interested parties may access the conference call by way of telephone or webcast. The numbers to access the conference call are 1(800) 595-8550 (toll free) or (416) 644-3421 (local). The webcast will be available at www.ambrilia.com, Investors section, Conference calls and webcasts. A replay of the call will be available at www.ambrilia.com, Investors section, Conference calls and webcasts, and the numbers to access the replay are (416) 640-1917 (local) and 1(877) 289-8525 (toll free) with access code 21228305.
Ambrilia's forward-looking statements
This press release contains forward-looking statements that reflect the Company's current expectation regarding future events. These 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. We refer you to the Risk Factors section of the Company's Management's Discussion & Analysis of Financial Condition and Results of Operations which contain a more exhaustive analysis of the risks and uncertainties that are generally connected to the business of the Company. Such statements are also based on various assumptions, including the successful and timely completion of clinical studies on Ambrilia's products demonstrating efficacy and safety for human use, their successful commercialization within the forecasted timelines and the attainment of the forecasted milestone payments and other revenues. While Ambrilia anticipates that subsequent events and developments may cause Ambrilia's views to change, Ambrilia specifically disclaims any obligation to update these forward looking statements.
ABOUT AMBRILIA BIOPHARMA
Ambrilia Biopharma Inc. (TSX: AMB.TO) is a biopharmaceutical company developing novel small molecules and peptides to treat infectious diseases and cancer. Ambrilia's product portfolio includes promising anti-HIV treatments (PPL-100 and an HIV Integrase Inhibitor Program), two new formulations of existing drugs developed with a patented technology (Octreotide and Goserelin), an anti-cancer therapeutic peptide (PCK3145), a tumor and tumor-vasculature targeting (TVT) technology platform, as well as other anti-virals and immunomodulators. Exclusive worldwide rights to PPL-100 and its related compounds have been granted to Merck & Co., Inc. in return for a $US 17 million upfront payment, potential milestones that could reach $US 212 million, and royalties. Ambrilia's head office, research and development and manufacturing facilities are located in Montreal with a regional office in France. For more information, please visit the Company's web site: www.ambrilia.com.