Prometic's PBI-4050 To Target Cystic Fibrosis As Its Next Orphan Indication

  • Majority of cystic fibrosis ("CF") patients develop diabetes and liver steatosis
  • PBI-4050 shown to reduce fibrosis in the lungs, pancreas and liver in preclinical models
  • PBI-4050 confirmed to reduce glycated hemoglobin in type 2 diabetes patients
  • Double-blind placebo-controlled phase II clinical trial to focus on pancreatic fibrosis, glucose intolerance and diabetes in CF patients

LAVAL, QC, Dec. 14, 2015 /CNW Telbec/ - ProMetic Life Sciences Inc. (TSX: PLI) (OTCQX: PFSCF) ("ProMetic" or the "Corporation") announced its plans today to initiate a double-blind placebo controlled phase II clinical trial in patients suffering from cystic fibrosis (CF) and related diabetes and liver steatosis. CF is a condition which affects approximately 70,000 individuals in North America and compromises their pulmonary, pancreatic and hepatic functions.

As a result of significantly improved standards of care over the past years, the average life expectancy for CF patients now surpasses 40 years. However, with a longer life expectancy, the genetic condition also generates serious pancreatic and hepatic complications.  In particular, 70% of CF patients will have an abnormal glucose tolerance and, 35-40% of adult CF patients will have developed a unique type diabetes, a condition known as cystic fibrosis-related diabetes (CFRD). CFRD is associated with all the complications typical of diabetes, leading to progressive eye, kidney, peripheral nerve, and gastrointestinal tract damage.

Dr John Moran, Chief Medical Officer of ProMetic commented: "CFRD is a devastating complication of CF which adds to the already heavy burden of treatment and leads to a more rapid decline in lung function and a higher mortality. This double blind placebo controlled phase II clinical trial will investigate whether PBI-4050 can reverse fibrosis in the pancreas and help manage the glucose intolerance and related diabetic complications experienced by the CF patients.  The clinical trial will also allow us to monitor the effects of PBI-4050 on other important parameters in CF patients, especially lung and liver function".

"PBI-4050 has been shown to significantly reduce fibrosis in several key organs in preclinical models and this, irrespective of how the injuries were induced or whether they were acute or chronic in nature", stated Dr Lyne Gagnon, VP of R&D preclinical at ProMetic. "For this reason and because of the positive effects recently observed in type 2 diabetic patients, we believe that PBI-4050 could provide significant clinical benefits to patients affected by this medical condition".

According to Ms. Norma Beauchamp, Chief Executive Officer of Cystic Fibrosis Canada: "Much progress has been accomplished in recent years in treating cystic fibrosis, yet, cystic fibrosis remains a devastating medical condition seriously affecting various key organs and quality of life for those who suffer from it. Innovative therapies such as the one put forward by ProMetic and its lead anti-fibrotic compound could play a key role in alleviating some of the associated medical complications while further improving quality of life of people living with cystic fibrosis in Canada and around the world".  

Information regarding the webcast

ProMetic will host a conference call at 11:30am (EST) on Monday, December 14, 2015 to discuss its clinical program for this new orphan disease indication. The telephone numbers to access the conference call are (647) 427-7450 (International) and 1-888-231-8191. A replay of the call will be available from Monday, December 14, 2015 at 2:00 p.m. until December 21, 2015. The numbers to access the replay are 1-416-849-0833 (passcode: 7026897) and 1-855-859-2056 (passcode: 7026897). A live audio webcast of the conference call will be available through the following: http://event.on24.com/r.htm?e=1108623&s=1&k=9C6F06CD7F1DFD10239E01ACABE4BF44

More on CF and CFRD

Cystic fibrosis (CF), also known as mucoviscidosis, is a life-threatening, genetic disease that affects especially the lungs but also the pancreas, liver, kidneys, and gut. Long-term issues include difficulty breathing and frequent lung infections, with long-term impairment of lung function.

In people with CF, a defective gene causes a buildup of thick mucus in the lungs, pancreas and other organs. In the lungs, the mucus clogs the airways and traps bacteria leading to infections, extensive lung damage and eventually, respiratory failure. In the pancreas, the mucus prevents the release of digestive enzymes that allow the body to break down food and absorb vital nutrients.

The pancreas contains the islets of Langerhans, which are responsible for making insulin, an anabolic hormone that regulates blood glucose. Damage to the pancreas can lead to loss of the islet cells, leading to a type of diabetes that is unique to those with the disease. This cystic fibrosis-related diabetes ("CFRD") shares characteristics that can be found in regular type 1 and type 2 diabetics, and is one of the principal non-pulmonary CF related complications.

CFRD  increases in prevalence with increasing age, and is becoming more common as the life expectancy of patients with CF improves, and is now the most common non-respiratory complication of CF. People with CFRD have lower lung function, worse nutrition, more frequent hospitalization, and worse mortality than CF people without diabetes.

More on 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.

                    

SOURCE ProMetic Life Sciences Inc.

For further information: Pierre Laurin, President and CEO, ProMetic Life Sciences Inc., p.laurin@prometic.com, +1.450.781.0115; Frédéric Dumais, Senior Director, Communications and Investor Relations, ProMetic Life Sciences Inc., f.dumais@prometic.com, +1.450.781.0115

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