Pharmacy

Selexys Pharmaceuticals has initiated enrollment in a phase I clinical study of its lead compound, SelGl, a humanized anti-P-selectin   antibody   for   sickle cell disease.

This placebo-controlled, double-blind, first-in-human, ascending single dose and multiple dose study of SelGl will enroll approximately 30 healthy subjects. This study will evaluate the safety and pharmacology of SelGl prior to advancement into a phase II trial in patients with sickle cell disease.

Dr Scott Rollins, Selexys President and CEO, said, "This phase study represents the first step in understanding the potential of SelGl to address the unmet medical need  sickle cell disease and we are excited to initiate the clinical development of this novel compound. 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 SelGl from the FDA Office of Orphan Products Development (OOPD) 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.