SURFACE LOGIX PHASE 1 CLINICAL TRIAL ACHIEVES TARGET PROFILE
SLx-2101, A Novel Long Acting PDE-5 Inhibitor for Disorders Related to Endothelial Dysfunction
BOSTON , Mass. ( October 11, 2005 ) – Surface Logix today announced the successful completion of the first clinical trial for SLx-2101. The Phase 1 study was designed to assess the safety and tolerability of SLx-2101, establish the pharmacokinetic (PK) profile and to provide evidence of activity in two pharmacodynamic (PD) models. The results of this study will be presented by noted urologist and recognized expert on sexual health, Dr. Irwin Goldstein, at the upcoming Sexual Medicine Society of North America, Inc. (SMSNA) meeting in New York City from November 17-20.
“The initial Phase 1 trial indicated that SLx-2101 was safe, well tolerated and pharmacodynamicaly active,” notes Dr. William Prince , Chief Development Officer. “We were particularly pleased to find that the PK profile more than met our expectations for SLx-2101 and we look forward to sharing these results with our peers in November.”
In a double-blind, placebo controlled, randomized study, healthy male volunteers received single oral doses of SLx-2101 or placebo. Five dose levels were included and subjects were monitored for adverse events and pharmacokinetic sampling was performed out to 48 hours post dose. Two methods of assessing pharmacodynamic activity were included in the study. Erectile response was assessed over 24 hours using the Rigiscan™ Plus system and peripheral arterial tone was assessed using the Endo-PAT2000™ device.
The results from the trial confirm the ability of the Pharmacomer™ Technology Platform to design specific pharmacokinetic performance into a molecule while optimizing potency and selectivity. The design of SLx-2101 and its preclinical program was directed to differentiate SLx-2101 from other PDE5 inhibitors based on the combined features of potency and duration of action in excess of 24 hours. The development plan for SLx-2101 includes a number of conditions related to endothelial dysfunction including male erectile dysfunction (MED), pulmonary arterial hypertension (PAH), and congestive heart failure (CHF).
About SLx-2101 and Endothelial Dysfunction
SLx-2101 is an oral phosphodiesterase-5 (PDE-5) inhibitor designed using Surface Logix’ proprietary small molecule Pharmacomer™ Technology. SLx-2101 is being developed to treat endothelial dysfunction, a physiological disability of endothelial cells, the cells that line the inner surface of all blood vessels, arteries and veins, that prevents them from carrying out their normal biochemical functions. Normal endothelial cells are involved in mediating the processes of coagulation, platelet adhesion, immune function, control of volume and electrolyte content of the intravascular and extravascular spaces. Endothelial dysfunction is believed to be the underlying cause for several major diseases including atherosclerosis, congestive heart failure, hypertension and erectile dysfunction.
About Surface Logix Inc.
Surface Logix Inc uses its expertise in biophysical chemistry to create new small molecule drugs that are optimized to meet the challenges of human physiology. The Company is advancing multiple internal programs focused primarily on cardiovascular disease, oncology and metabolic disorders and works with strategic partners to create differentiated new chemical entities. For more information, please visit www.surfacelogix.com.
Contact:
David H. Donabedian, Ph.D.
Surface Logix Inc.
Vice President, Business Development
617.746.8520
Media:
Kari Lampka
MacDougall Biomedical Communications, Inc.
508.647.0209 |
