- Follows positive review of PBI-4050 data by external IPF panel of experts
- IPF clinical program to commence in Q4 2014
LAVAL, QUEBEC, CANADA – October 15, 2014 – ProMetic Life Sciences Inc. (TSX: PLI) (OTCQX: PFSCF) ("ProMetic" or the "Corporation") announced today that it will be pursuing IPF as one of its PBI-4050 orphan indications. This decision follows the completion of a favorable external review of the extensive anti-fibrotic preclinical data generated to date by an independent panel of world experts on idiopathic
pulmonary fibrosis and the analysis of the current market landscape.
"Our preclinical data has demonstrated robust improvements in pathology and breadth of response in key bio-markers implicated in the progression of this deadly disease. After thoroughly reviewing both the pre-clinical and phase I safety data, our scientific advisers strongly recommended to advance the investigation
of PBI-4050 for IPF", stated Mr. Pierre Laurin, President and Chief Executive Officer of ProMetic. "We are very enthusiastic about the potential of PBI-4050 to offer breakthrough therapy clinical benefits to patients suffering from this deadly medical condition", added Mr. Laurin.
ProMetic is first initiating its IPF clinical program this quarter in Canada and intends to include other already identified sites in the United Kingdom and US shortly thereafter. ProMetic is currently preparing a request for an IPF Orphan Drug Designation ("ODD") to be filed with the US Food and Drug Administration ("FDA").
"The ability of PBI-4050 to reduce or improve some of the most recognized inflammatory and fibrotic indicators, typically representative of lesions and scars in the lungs, provides a compelling case to aggressively investigate the use of this oral therapy to treat IPF patients", said Dr. John Moran,
ProMetic's Chief Medical officer.
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 tissue scarring in the lungs otherwise observed in non-treated animals. Moreover, the combination of PBI-4050 and Pirfenidone generated unprecedented reduction of fibrotic markers, indicating the potential for clinically significant improvement and stabilization in lung function. ProMetic has also successfully completed its PBI-4050 Phase I clinical trial in 40 healthy volunteers where it was found to
be safe and very well tolerated without any serious adverse events reported.
About Idiopathic Pulmonary Fibrosis ("IPF")
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, the "alveoli," gradually become replaced by fibrotic (scar) tissue and is the cause of worsening dyspnea (shortness of breath). IPF 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 men more often 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 with IPF, a similar number of deaths to those due to breast cancer. The 5-year mortality rate for patients with IPF is estimated to range from 50% to 70%.
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.
About ProMetic Life Sciences Inc.
ProMetic Life Sciences Inc. (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. 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 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 in ProMetic's Annual Information Form for the year ended December 31, 2013, 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.