Valens Pharma Announces Next Steps
EDMONTON, Aug. 5 /CNW/ - Valens Pharma Ltd. (Valens, formerly known as "CardioMetabolics Inc."), today announced that the Company has suspended work on its DCA i.v program, a proprietary intravenous formulation of dichloroacetate pending further review by its Scientific Advisory Board. Based
on the analysis of the voluntary Phase II "Mini-Metrxics" clinical trial by the Company's Scientific Advisory Board to date, it is clear that Valens does
not have sufficient evidence to quickly move into its planned Phase III METRxICS Trial as had been anticipated. As previously announced, while data
from the Phase II trial met certain biochemical endpoints, the anticipated clinical signals of a reduction in time spent in the intensive care unit
(ICU), a reduction in ventilator times and a reduction in hospital times were not present. While there were no deaths during the actual trial in this high
risk geriatric population, there were more adverse events in the group that received DCA compared to the control group. Requests for further information
may be directed to the Company.
The Company's Board of Directors has established a Special Committee of independent directors to assess the full range of strategic options available
to the corporation. To assist in this matter, Deloitte Touch has been retained to report directly to the Board on a limited non-exclusive basis. The Special
Committee will make a report to the Board by the end of August. After that time, the Company expects to announce the next steps from this process. In the
interim period, Valens has taken immediate steps to reduce its burn rate to one-third of the previous rate by cutting all non-vital expenditures.
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.
About Valens Pharma Ltd.
Edmonton-based Valens Pharma Ltd., is a privately held, biopharmaceutical company focused on commercializing drug product candidates in the novel class of energy metabolism agents. 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.: Kimmo Lucas, President &
CEO, Phone: (780) 438-2813, Fax: (780) 438-2874, Investor Relations:
Ross Marshall, The Equicom Group Inc., Phone: (416) 815-0700 (Ext. 238), Fax:
(416) 815-0080, E-mail: email@example.com/
Posted: August 2008
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