OKLAHOMA CITY, May 4, 2011 /PRNewswire/ -- Selexys Pharmaceuticals announced today that it has initiated enrollment in a Phase I clinical study of its lead compound, SelG1, a humanized anti-P-selectin antibody.
The placebo-controlled, double-blind, first-in-human, ascending single dose and multiple dose study of SelG1 will enroll approximately 30 healthy subjects. This study will evaluate the safety and pharmacology of SelG1 prior to advancement into a Phase II trial in patients with sickle cell disease.
"This Phase I study represents the first step in understanding the potential of SelG1 to address the unmet medical need in sickle cell disease and we are excited to initiate the clinical development of this novel compound," said Dr. Scott Rollins, Selexys President and CEO. "This Phase I trial represents a key milestone for Selexys as we transition from a preclinical to a clinical development stage biopharmaceutical company."
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 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.
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 vasoocclusion and subsequent 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, who heads the clinical development program for Selexys. "Effective therapies that target vasoocclusion are needed to address the serious complications in patients with this life-threatening disease."
The SelG1 program for sickle cell disease is supported by a 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 SelK1, a fully human monoclonal antibody directed against PSGL-1 for the treatment of Crohn's Disease and other inflammatory disorders. Selexys is headquartered in Oklahoma City, OK. For additional information please visit our website at www.selexys.com.
SOURCE Selexys Pharmaceuticals