BOSTON, May 23 /PRNewswire/ -- Surface Logix announced that Dr. Irwin Goldstein, a leading expert on sexual health and Editor-in-Chief, The Journal of Sexual Medicine, presented results from the first clinical study of SLx-2101 at the 2006 American Urological Association (AUA) meeting in Atlanta, GA. SLx-2101 is a novel, long acting PDE-5 inhibitor for the management of disorders associated with endothelial dysfunction, including erectile dysfunction.
The Phase I study demonstrated that SLx-2101 has a favorable safety, tolerability, pharmacokinetic and pharmacodynamic profile in healthy male volunteers. SLx-2101 is now completing a Phase IIa trial in patients with erectile dysfunction.
"I continue to be impressed with the data on SLx-2101 and was pleased to present the results at the AUA," notes Dr. Goldstein. "The preliminary Rigiscan data from the Phase IIa study shows that this drug is working at 48 hours after a single dose of 10mg and this is the first objective study of this type where I have seen confirmed efficacy for a PDE-5 inhibitor well beyond 36 hours."
Dr. Goldstein adds, "The developing profile of SLx-2101 with rapid onset and long duration suggests that it could well become the new gold standard for treating erectile dysfunction and other PDE-5 related disorders."
"We are extremely pleased with the progress of SLx-2101 in the clinic," comments Dr. William Prince, Chief Development Officer of Surface Logix, "The preliminary data from our Phase IIa study has surpassed our expectations and allows us to include other indications, outside of erectile dysfunction, in our development plans for SLx-2101. We plan to initiate additional Phase II studies by the end of this year and we look forward to reporting the results of these studies at the appropriate scientific forums next year."
About the Phase I Study
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(TM) Plus system and peripheral arterial tone was assessed using the Endo-PAT2000(TM) device.
About SLx-2101, Erectile and Endothelial Dysfunction
SLx-2101 is an oral phosphodiesterase-5 (PDE-5) inhibitor designed using Surface Logix' proprietary small molecule Pharmacomer(TM) 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 a major contributor to the development of several major diseases including atherosclerosis, pulmonary hypertension, 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 http://www.surfacelogix.com.
Contact: David H. Donabedian, Ph.D. Vice President, Business Development 617.746.8520 Media: Kari Watson MacDougall Biomedical Communications Inc. kwatson@macbiocom.com 508.647.0209
Surface Logix Inc.CONTACT: David H. Donabedian, Ph.D., Vice President, Business Developmentof Surface Logix, +1-617-746-8520; or Kari Watson of MacDougall BiomedicalCommunications Inc., +1-508-647-0209, kwatson@macbiocom.com
Web site: http://www.surfacelogix.com/
