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New data confirms potential novel therapy for diabetic kidney diseases (DKD), chronic kidney diseases (CKD) and pulmonary fibrosis.
LAVAL, Canada I- July 11, 2013 I ProMetic Life Sciences Inc. (TSX: PLI) (OTCQX: PFSCF), (“ProMetic” or the “Corporation”)announced today that its lead drug candidate PBI-4050, is on track to enter the clinical trial program starting in September 2013. During the first half of 2013, the Corporation has systematically executed on all key activities required to enable the initiation of the clinical trials.
The manufacturing process for its orally active anti-fibrotic lead drug candidate has been successfully scaled up in an FDA and EMA approved facility. The required GMP material has been delivered to advance the toxicology program necessary to enable the commencement of the clinical trials. Throughout the preclinical program, PBI-4050 has demonstrated efficacy with a remarkable safety profile. This is expected to be further confirmed in the on-going toxicology studies being performed by a certified contract research organisation (“CRO”).
“The recently presented data on PBI-4050 confirms its potential as a novel therapy to inhibit inflammation and fibrosis which underlies most progressive chronic renal diseases” stated Dr Raymond Hakim, MD, PhD, a kidney specialist who until recently was the Chief Medical Officer of one of the largest provider of renal services in the US and a new member of ProMetic’s Board of Directors. “Diabetes further accelerate the loss of kidney function in patients with CKD, and the extensive PBI-4050 preclinical data generated suggest that this patient population would greatly benefit from this therapeutic approach” added Dr Hakim.
In a well-recognized animal model designed to study the long term effect of diabetes on organs, PBI-4050 reduced kidney hyperfiltration, proteinuria, and the expression of inflammatory/fibrotic markers in kidney.
These results and new data that further confirms PBI-4050’s ability to reduce fibrosis in kidney were recently presented at the European Renal Association in Istanbul ( http://www.prometic.com/en/therapeutics/scientific-library.php)
and at the world congress in nephrology in Hong Kong (http://www.prometic.com/en/therapeutics/scientific-library.php).
New results demonstrating the efficacy of PBI-4050 in a challenging pulmonary fibrosis model will be presented at the forthcoming European Respiratory Society 2013 Meeting to be held in Barcelona in September.
“Following the initial phase clinical program to confirm safety in humans to be performed in Q4 this year, we expect to start enrolling patients in early 2014 to demonstrate efficacy” commented Dr John Moran, also a member of ProMetic’s Board of Directors “Patients affected by CKD cost Medicare nearly 75 billion dollars a year. Needless to say an effective therapy would greatly benefit patients and reduce the ever-growing
costs to the healthcare system” added Dr Moran.
“While renal indications may represent the highest value on a long term basis, the development strategy
pursued may also target other fibrotic indications as point of initial commercial entry” mentioned Pierre Laurin, CEO of ProMetic, who added “Pulmonary fibrosis for instance, is a good example of an interesting target indication for which PBI-4050 has demonstrated superior efficacy compared to the only other
commercially available therapy”.
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.
- The positive effects of PBI-4050 observed in several different animal models designed to reproduce
chronic kidney diseases can be summarized as follows:
- Increase in GFR (improvement of the renal function)
- Decrease in Proteinuria (reduction of protein found in urine)
- Decrease in Serum creatinine (reduction of creatinine in blood)
- Decrease in Serum urea (reduction of urea in blood)
- Decrease in Histological lesions (reduction of fibrosis & lesions, leading to a more functional and normal renal tissue)
- Decrease of collagen deposition in the tissue
- Decrease in several biomarkers confirming the reduction of inflammation and fibrosis
SOURCE: ProMetic Life Sciences
Post Views: 81
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New data confirms potential novel therapy for diabetic kidney diseases (DKD), chronic kidney diseases (CKD) and pulmonary fibrosis.
LAVAL, Canada I- July 11, 2013 I ProMetic Life Sciences Inc. (TSX: PLI) (OTCQX: PFSCF), (“ProMetic” or the “Corporation”)announced today that its lead drug candidate PBI-4050, is on track to enter the clinical trial program starting in September 2013. During the first half of 2013, the Corporation has systematically executed on all key activities required to enable the initiation of the clinical trials.
The manufacturing process for its orally active anti-fibrotic lead drug candidate has been successfully scaled up in an FDA and EMA approved facility. The required GMP material has been delivered to advance the toxicology program necessary to enable the commencement of the clinical trials. Throughout the preclinical program, PBI-4050 has demonstrated efficacy with a remarkable safety profile. This is expected to be further confirmed in the on-going toxicology studies being performed by a certified contract research organisation (“CRO”).
“The recently presented data on PBI-4050 confirms its potential as a novel therapy to inhibit inflammation and fibrosis which underlies most progressive chronic renal diseases” stated Dr Raymond Hakim, MD, PhD, a kidney specialist who until recently was the Chief Medical Officer of one of the largest provider of renal services in the US and a new member of ProMetic’s Board of Directors. “Diabetes further accelerate the loss of kidney function in patients with CKD, and the extensive PBI-4050 preclinical data generated suggest that this patient population would greatly benefit from this therapeutic approach” added Dr Hakim.
In a well-recognized animal model designed to study the long term effect of diabetes on organs, PBI-4050 reduced kidney hyperfiltration, proteinuria, and the expression of inflammatory/fibrotic markers in kidney.
These results and new data that further confirms PBI-4050’s ability to reduce fibrosis in kidney were recently presented at the European Renal Association in Istanbul ( http://www.prometic.com/en/therapeutics/scientific-library.php)
and at the world congress in nephrology in Hong Kong (http://www.prometic.com/en/therapeutics/scientific-library.php).
New results demonstrating the efficacy of PBI-4050 in a challenging pulmonary fibrosis model will be presented at the forthcoming European Respiratory Society 2013 Meeting to be held in Barcelona in September.
“Following the initial phase clinical program to confirm safety in humans to be performed in Q4 this year, we expect to start enrolling patients in early 2014 to demonstrate efficacy” commented Dr John Moran, also a member of ProMetic’s Board of Directors “Patients affected by CKD cost Medicare nearly 75 billion dollars a year. Needless to say an effective therapy would greatly benefit patients and reduce the ever-growing
costs to the healthcare system” added Dr Moran.
“While renal indications may represent the highest value on a long term basis, the development strategy
pursued may also target other fibrotic indications as point of initial commercial entry” mentioned Pierre Laurin, CEO of ProMetic, who added “Pulmonary fibrosis for instance, is a good example of an interesting target indication for which PBI-4050 has demonstrated superior efficacy compared to the only other
commercially available therapy”.
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.
- The positive effects of PBI-4050 observed in several different animal models designed to reproduce
chronic kidney diseases can be summarized as follows:
- Increase in GFR (improvement of the renal function)
- Decrease in Proteinuria (reduction of protein found in urine)
- Decrease in Serum creatinine (reduction of creatinine in blood)
- Decrease in Serum urea (reduction of urea in blood)
- Decrease in Histological lesions (reduction of fibrosis & lesions, leading to a more functional and normal renal tissue)
- Decrease of collagen deposition in the tissue
- Decrease in several biomarkers confirming the reduction of inflammation and fibrosis
SOURCE: ProMetic Life Sciences
Post Views: 81
