- Significant reduction of overproduction of collagen and fibrosis in a scleroderma preclinical model confirmed at Vanderbilt University
- Upcoming double-blind, placebo controlled phase 2 clinical trial to focus on fibrosis reduction in skin and affected organs
LAVAL, QUEBEC, CANADA – March 15, 2016 – ProMetic Life Sciences Inc. (TSX: PLI) (OTCQX: PFSCF) (“ProMetic” or the “Corporation”) today announced that it will be initiating a double-blind, placebo-controlled phase 2 clinical trial in patients suffering from scleroderma.
There is no cure for scleroderma, a chronic disorder characterized by an overproduction of collagen and abnormal growth of connective tissue. This collagen accumulation causes scarring (fibrosis) of the skin, and in the case of systemic scleroderma, also affects internal organs such as the lungs, the kidneys and gastrointestinal system. Scleroderma affects approximately 300,000 individuals in North America alone and varies in severity.
“PBI-4050 has been shown to significantly reduce fibrosis in several of the key organs in various preclinical models, irrespective of the cause of the injuries or whether acute or chronic in nature”, stated Dr. Lyne Gagnon, VP of R&D preclinical at ProMetic. “The most recent results have shown that even in mice genetically programmed to develop scleroderma, PBI-4050 prevented the over production of collagen and the formation of fibrotic scarring”, added Dr. Gagnon.
Dr. John Moran, Chief Medical Officer of ProMetic commented: “This accumulated data is very promising for patients affected by scleroderma in that, even though we do not understand the cause or causes of their condition, PBI-4050 addresses the underlying pathological process leading to the scarring of tissues and organs. This double-blind, placebo-controlled phase 2 clinical trial will investigate whether PBI-4050 can prevent or even reverse fibrosis in the skin and key target organs such as the lungs”.
“ProMetic is focused on and committed to targeting unmet medical needs where fibrosis is the underlying process leading to the medical complications”, stated Pierre Laurin, President and Chief Executive Officer of ProMetic who added, “We are merely leveraging PBI-4050’s proven ability to downregulate the excessive production of scarring tissue, which in the case of systemic scleroderma, is often life threatening”.
More about scleroderma (1):
Derived from the Greek words “sclerosis” meaning hardness and “derma” meaning skin, scleroderma literally means hard skin. Scleroderma, also known as systemic sclerosis, is a progressive and chronic connective tissue disorder. Some unknown factor triggers the over-production of collagen (body protein) causing thickening, hardening and scarring of the skin and internal organs. Normally collagen keeps the skin soft, but the overproduction makes the affected tissue thick and hard. This, in turn, affects the amount of blood the small vessels carry to many parts of the body.
The most characteristic feature of scleroderma is the presentation of hard, hide-bound thickening of the skin. Less visible but of major importance are the lesions that occur in small blood vessels (vascular lesions), which may involve major organs.
The natural history, or course of scleroderma, varies widely from that of a mild nuisance to a severe multi-system disease. Forms of the disease that primarily affect the skin without major organ involvement, have better long-term outlook. Those forms of scleroderma that involve major organs, such as the heart and kidney, are potentially more severe with possibly less desirable long-term outcomes.
(1): Scleroderma Society of Canada
MORE ABOUT PBI-4050
PBI-4050 is an orally active lead drug candidate with excellent safety and efficacy profiles confirmed in several in vivo experiments targeting fibrosis. Fibrosis is a very complex process by which continuing inflammation causes vital organs to lose their function as normal tissue is replaced by fibrotic scar tissue. The proof of concept data generated to date confirms our lead drug candidates’ anti-fibrotic activity in several key organs including the kidneys, the heart, the lungs and the liver. Twenty six million patients in the U.S. alone are diagnosed with chronic kidney diseases (“CKD”). Patients with severe CKD stages (3 and 4) suffer from a gradual and accelerated loss of their renal function (end-stage renal disease or ESRD) leading to the need for hemodialysis. Cardiovascular complications for ESRD patients on hemodialysis are a common cause of death.
About ProMetic Life Sciences Inc.
ProMetic Life Sciences Inc. (www.prometic.com) is a long established biopharmaceutical company with globally recognized expertise in bioseparations, plasma-derived therapeutics and small-molecule drug development. ProMetic offers its state of the art technologies for large-scale purification of biologics, drug development, proteomics and the elimination of pathogens to a growing base of industry leaders and uses its own affinity technology that provides for highly efficient extraction and purification of therapeutic proteins from human plasma in order to develop best-in-class therapeutics and orphan drugs. ProMetic is also active in developing its own novel small-molecule therapeutic products targeting unmet medical needs in the field of fibrosis, anemia, neutropenia, cancer and autoimmune diseases/inflammation as well as certain nephropathies. Headquartered in Laval (Canada), ProMetic has R&D facilities in the UK, the U.S. and Canada, manufacturing facilities in the UK and commercial activities in the U.S., Canada, Europe, Russia, Asia and Australia.
Forward Looking Statements
This press release contains forward-looking statements about ProMetic’s objectives, strategies and businesses that involve risks and uncertainties. These statements are “forward-looking” because they are based on our current expectations about the markets we operate in and on various estimates and assumptions. Actual events or results may differ materially from those anticipated in these forward-looking statements if known or unknown risks affect our business, or if our estimates or assumptions turn out to be inaccurate. Such risks and assumptions include, but are not limited to, ProMetic’s ability to develop, manufacture, and successfully commercialize value-added pharmaceutical products, the availability of funds and resources to pursue R&D projects, the successful and timely completion of clinical studies, the ability of ProMetic to take advantage of business opportunities in the pharmaceutical industry, uncertainties related to the regulatory process and general changes in economic conditions. You will find a more detailed assessment of the risks that could cause actual events or results to materially differ from our current expectations in ProMetic’s Annual Information Form for the year ended December 31, 2014, under the heading “Risk and Uncertainties related to ProMetic’s business”. As a result, we cannot guarantee that any forward-looking statement will materialize. We assume no obligation to update any forward-looking statement even if new information becomes available, as a result of future events or for any other reason, unless required by applicable securities laws and regulations. All amounts are in Canadian dollars unless indicated otherwise.