Marketwire
- PBI-4050 compares favorably to Pirfenidone, the only approved drug for IPF
- PBI-4050 combined with Pirfenidone further reduces fibrosis in lungs
- Data provides for regulatory pathway to address an orphan disease
- PBI-4050 on track to enter clinical stage
LAVAL, QUEBEC--(Marketwired - Sept. 9, 2013) - ProMetic Life Sciences Inc. (TSX:PLI)(OTCQX:PFSCF), ("ProMetic" or the "Corporation") presented new pre-clinical data at the 2013 European Respiratory Society ("ERS") annual congress held in Barcelona, Spain, suggesting that PBI-4050 offers a new therapeutic approach to IPF.
In a gold standard animal model proven to emulate pulmonary fibrosis in humans, PBI-4050 performed favorably compared to Pirfenidone, the only commercially approved product for such medical use. PBI-4050 significantly reduced the tissue scarring in the lungs otherwise observed in the lungs of non-treated animals. Moreover, the combination of PBI-4050 and Pirfenidone generated unprecedented reduction of fibrosis resulting in a significant improvement of organ function.
"These results clearly indicates that PBI-4050 alone and/or in combination with Pirfenidone offers a potential breakthrough therapy for IPF, a condition as deadly as many types of cancers", stated Mr. Pierre Laurin, President and Chief Executive Officer of ProMetic, who added "IPF qualifies as an orphan disease with unmet medical need, and this new data provides for a clear regulatory pathway. The Corporation is evaluating various non-dilutive funding avenues for its potential IPF program in addition to its other fibrosis programs".
Following the initial phase clinical program to confirm safety in humans to be performed in Q4 this year, the Corporation expect to start enrolling patients in early 2014 to demonstrate efficacy
The study results presented at the ERS annual conference demonstrated that the oral administration of PBI-4050 whether alone or in with Pirfenidone significantly reduced:
- Histological lesions and scars in the lungs
- Inflammatory/profibrotic cytokines (TGF-β1, CTGF, IL-23p 19 and IL-6)
- Fibrotic markers (collagen 1 and fibronectin)
- Remodeling markers (SPARC and MMP-2)
The posters presented at the ERS annual conference can be found on the ProMetic website at:
http://www.prometic.com/en/therapeutics/scientific-library.php.
More on Idiopathic Pulmonary Fibrosis
Idiopathic pulmonary fibrosis (IPF) is a chronic, devastating, and ultimately fatal disease characterized by a progressive decline in lung function. It is a specific type of interstitial lung disease in which the small air sacs of the lung, known as "alveoli," gradually become replaced by fibrotic (scar) tissue and is the cause of worsening dyspnea (shortness of breath). Fibrosis is usually associated with a poor prognosis. The term 'idiopathic' is used because the cause of pulmonary fibrosis is still unknown.
IPF usually occurs in adult individuals of between 50 and 70 years of age, particularly those with a history of cigarette smoking, and affects more men than women.
IPF affects about 130,000 people in the United States, with about 48,000 new cases diagnosed annually. Approximately 40,000 people die each year to IPF, the same as to breast cancer. The 5-year mortality rate for patients with IPF is estimated to range from 50% to 70%.
More on PBI-4050
PBI-4050 is one of ProMetic orally active lead drug candidates with efficacy and high safety profiles confirmed in several in vivo experiments targeting fibrosis. Fibrosis is a very complex process by which inflammation leads to the deposit of fibrous material to repair the damaged area and whereby vital organs gradually lose their functionality as normal and functional tissue is replaced by fibrotic scarring 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, cancer and autoimmune diseases/inflammation. Headquartered in Laval (Canada), ProMetic has R&D facilities in the UK, the U.S. and Canada, manufacturing facilities in the UK and business development activities in the U.S., Europe and Asia.
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 on page 26 of ProMetic's Annual Information Form for the year ended December 31, 2012, 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.