EDMONTON, July 28 /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
"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
"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
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:
For further information: Valens Pharma Ltd., Debbra DeMarco, Director of
Investor Relations, Phone: (780) 438-2818 ext. 223, Fax: (780) 438-2874,
E-mail: firstname.lastname@example.org, Internet: www.valenspharma.com; Investor
Relations, Ross Marshall, The Equicom Group Inc., Phone: (416) 815-0700 (Ext.
238), Fax: (416) 815-0080, E-mail: email@example.com