OKLAHOMA CITY, OK, USA I December 19, 2011 I Selexys Pharmaceuticals announced today that it has completed a Phase I clinical study of its lead compound SelG1, an antibody specific for the pro-inflammatory cell adhesion molecule P-selectin.
The placebo-controlled, double-blind, ascending single dose and multiple dose study of SelG1 enrolled 27 healthy subjects. The study evaluated the safety and pharmacology of SelG1 to support its advancement into a Phase II clinical trial in patients with sickle cell disease.
SelG1 appeared to be safe and well tolerated, with no serious adverse events reported in any subjects. There was no observed immune response to SelG1 during the study. Analysis of SelG1 pharmacokinetic and pharmacodynamic data demonstrated a serum half–life of approximately two weeks and complete blockade of P-selectin activity in all patients for at least one month following a single intravenous dose.
"This Phase I study represents a major step in understanding the potential of SelG1 to address the unmet medical need in sickle cell disease and other indications," said Dr. Scott Rollins , Selexys president and CEO. "This trial completion marks a key milestone for Selexys as we prepare to initiate a large Phase II efficacy study of this novel compound in patients with sickle cell disease."
In 2008, Selexys received orphan-drug designation for SelG1 from the Food and Drug Administration Office of Orphan Products Development for the treatment of vasoocclusive crisis, a severe and painful complication of sickle cell disease. Orphan drug designation in the United States is awarded to therapeutics with the potential for safe and effective treatment, diagnosis or prevention of rare diseases and disorders that affect fewer than 200,000 people.
About SelG1
SelG1 is an investigational humanized monoclonal antibody directed against P-selectin, a key member of the adhesion molecule family known as the selectins. In preclinical studies, inhibition of P-selectin has been shown to effectively prevent vasoocclusion by blocking critical cell-cell interactions that drive this process. Therapeutic blockade of P-selectin may therefore reduce or prevent vasoocclusive crises in patients with sickle cell disease.
"SelG1 represents a first-in-class therapeutic approach for the treatment of sickle cell disease and potentially other proinflammatory and prothrombotic conditions," stated Dr. Russell Rother , Selexys executive vice-president and COO. "Based on preclinical studies we anticipate that by intervening in the vasoocclusive process, SelG1 may reduce or eliminate pain crises and ameliorate other serious and life-threatening complications that follow vasoocclusion."
The SelG1 program for sickle cell disease is supported by Small Business Innovation Research (SBIR) fast-track award #5R44HL093893-02 through the National Heart, Lung and Blood Institute.
About Selexys Pharmaceuticals
Selexys is a privately held biopharmaceutical company that is focused on development of therapeutics for the treatment of inflammation and thrombosis across a broad range of severe diseases. Selexys is also developing an antibody directed against PSGL-1 for the treatment of Crohn’s Disease and other inflammatory disorders. Selexys is headquartered in Oklahoma City , Oklahoma. For additional information please visit our website at www.selexys.com.
SOURCE: Selexys Pharmaceuticals
Post Views: 31
OKLAHOMA CITY, OK, USA I December 19, 2011 I Selexys Pharmaceuticals announced today that it has completed a Phase I clinical study of its lead compound SelG1, an antibody specific for the pro-inflammatory cell adhesion molecule P-selectin.
The placebo-controlled, double-blind, ascending single dose and multiple dose study of SelG1 enrolled 27 healthy subjects. The study evaluated the safety and pharmacology of SelG1 to support its advancement into a Phase II clinical trial in patients with sickle cell disease.
SelG1 appeared to be safe and well tolerated, with no serious adverse events reported in any subjects. There was no observed immune response to SelG1 during the study. Analysis of SelG1 pharmacokinetic and pharmacodynamic data demonstrated a serum half–life of approximately two weeks and complete blockade of P-selectin activity in all patients for at least one month following a single intravenous dose.
"This Phase I study represents a major step in understanding the potential of SelG1 to address the unmet medical need in sickle cell disease and other indications," said Dr. Scott Rollins , Selexys president and CEO. "This trial completion marks a key milestone for Selexys as we prepare to initiate a large Phase II efficacy study of this novel compound in patients with sickle cell disease."
In 2008, Selexys received orphan-drug designation for SelG1 from the Food and Drug Administration Office of Orphan Products Development for the treatment of vasoocclusive crisis, a severe and painful complication of sickle cell disease. Orphan drug designation in the United States is awarded to therapeutics with the potential for safe and effective treatment, diagnosis or prevention of rare diseases and disorders that affect fewer than 200,000 people.
About SelG1
SelG1 is an investigational humanized monoclonal antibody directed against P-selectin, a key member of the adhesion molecule family known as the selectins. In preclinical studies, inhibition of P-selectin has been shown to effectively prevent vasoocclusion by blocking critical cell-cell interactions that drive this process. Therapeutic blockade of P-selectin may therefore reduce or prevent vasoocclusive crises in patients with sickle cell disease.
"SelG1 represents a first-in-class therapeutic approach for the treatment of sickle cell disease and potentially other proinflammatory and prothrombotic conditions," stated Dr. Russell Rother , Selexys executive vice-president and COO. "Based on preclinical studies we anticipate that by intervening in the vasoocclusive process, SelG1 may reduce or eliminate pain crises and ameliorate other serious and life-threatening complications that follow vasoocclusion."
The SelG1 program for sickle cell disease is supported by Small Business Innovation Research (SBIR) fast-track award #5R44HL093893-02 through the National Heart, Lung and Blood Institute.
About Selexys Pharmaceuticals
Selexys is a privately held biopharmaceutical company that is focused on development of therapeutics for the treatment of inflammation and thrombosis across a broad range of severe diseases. Selexys is also developing an antibody directed against PSGL-1 for the treatment of Crohn’s Disease and other inflammatory disorders. Selexys is headquartered in Oklahoma City , Oklahoma. For additional information please visit our website at www.selexys.com.
SOURCE: Selexys Pharmaceuticals
Post Views: 31
