Valens Pharma Reports Top-Line Results from Voluntary Phase II Trial
EDMONTON, July 28, 2008 /CNW/ - Valens Pharma Ltd. (Valens, formerly known as "CardioMetabolics Inc."), today announced preliminary results from its voluntary Phase II "Mini-Metr*ics" clinical trial evaluating its proprietary intravenous formulation of dichloroacetate (DCA i.v.) in high risk, geriatric patients undergoing open heart surgical procedures. A primary objective of this exploratory Phase II study was to collect key information to help design further trials.
A secondary objective was to determine if there was evidence of clinical efficacy for endpoints that included reduced time in the Intensive Care Unit for this patient group. Evidence of efficacy for those endpoints was not revealed in this pilot study. However, as expected, the biochemical benefits of DCA shown in earlier trials, such as lower plasma lactate levels and lower, more stable levels of glucose, were confirmed among treated patients.
"A thorough analysis of the data from this trial, when received, is expected to provide key knowledge required for further clinical development of DCA i.v., including information regarding the dosage regimen for high risk geriatric patients and other measures of successful outcomes," commented Dr. Ruth Collins-Nakai, Chief Medical Officer for the Company.
The Phase II trial encompassing 83 patients, was a randomized, double blind, placebo controlled trial, conducted at the University of Alberta, in Edmonton. Patients in the study group received a bolus infusion of DCA i.v. immediately post surgery followed by a continuous infusion of DCA i.v. for a 24 hour period. DCA i.v., had been evaluated in three previous clinical trials involving 109 cardiac patients, but this was the first time the drug had been tested under this dose regimen in an elderly population with a higher risk profile.
"Our stated goals leading in to this trial were to learn more about our study population and clinical endpoints in order to advance our clinical program. We achieved our goal of gaining essential data from the trial," said Kimmo Lucas, President and CEO. "Although we had approval from Health Canada and the FDA to conduct a Phase III trial, we chose to undertake a much smaller, less expensive voluntary Phase II trial to assess select clinical endpoints in the same high risk geriatric population as the Phase III protocol. While the trial did not achieve all of the clinical endpoints, which is common in a phase II powered to this level, Valens is now better positioned to move forward as full analysis of data becomes available."
About Valens Pharma Ltd.
Edmonton-based Valens Pharma Ltd., is a privately held, late-stage, biopharmaceutical company focused on commercializing drug product candidates in the novel class of energy metabolism agents, referred to as PDK blockers. The Company's technology is focused on metabolic modulation, through the use of dichloroacetate (DCA) and related compounds, which improve energy production by favouring glucose metabolism. In addition to "DCA i.v." the Company has exciting earlier stage compounds intended to target the treatment of cardiovascular disease, and related metabolic conditions (e.g., diabetes). Cardiovascular disease is the "number one" cause of death in North America, and each year in the United States alone, over 650,000 open heart surgeries are conducted.
This news release may contain forward-looking statements, including statements regarding the business and anticipated financial performance of Valens Pharma Ltd. Forward looking statements involve risks and uncertainties related to our business and the general economic environment, many beyond our control. These risks, uncertainties and other factors could cause our actual results to be materially different. Some of the factors that could cause such differences include exchange rate fluctuations, market demand for our products and services, the general state of the economy, our ability to execute projects and deliver solutions, our ability to retain and attract qualified employees and contain payroll expenses, the availability of credit lines and future financing, legal claims, the results of our scientific research, in particular the results of clinical trials, our ability to obtain necessary regulatory approvals to continue or initiate further or future clinical trials, and other factors.
For further information: Valens Pharma Ltd., Debbra DeMarco, Director of Investor Relations, Phone: (780) 438-2818 ext. 223, Fax: (780) 438-2874, E-mail: ddemarco@valenspharma.com
Posted: July 2008
