BOSTON, Nov. 18 /PRNewswire/ -- Surface Logix announced that Dr. Irwin Goldstein, a leading expert on sexual health and Editor-in-Chief, The Journal of Sexual Medicine, will present results from the first clinical study of SLx- 2101 today at the 2005 Sexual Medicine Society of North America, Inc. (SMSNA) meeting in New York City. SLx-2101 is a novel, long acting PDE-5 inhibitor for the management of disorders associated with endothelial dysfunction, including erectile dysfunction.
This Phase I study (first time in humans) demonstrated that SLx-2101 has favorable safety, tolerability, pharmacokinetics and pharmacodynamic activity in healthy male volunteers. Additional results for SLx-2101 from Surface Logix' preclinical program will be presented by Dr. Stewart Campbell, Vice President of Chemistry at Surface Logix, in a SMSNA poster session on Saturday, November 19. Surface Logix is planning to advance SLx-2101 into Phase IIa clinical studies in patients with erectile and endothelial dysfunction before the end of the year.
"The erectile dysfunction market is still grossly underserved. As much as 30-50% of the market still goes untreated due to limited efficacy and lack of consistent response to current therapies," notes Dr. Goldstein. "In SLx-2101, Surface Logix has developed a safe, well tolerated compound that exhibits a rapid onset as well as a duration of action in excess of 36 hours. I am extremely pleased and excited about presenting the Phase I results on SLx-2101 at the SMSNA."
In a double-blind, placebo controlled, randomized study, forty healthy male volunteers received single oral doses of SLx-2101 or placebo. Six subjects each received SLx-2101 at 5, 10, 20, 40 or 80 mg and ten subjects received placebo. No subjects withdrew from the study. 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.
Results of the Phase I study showed that there was clinically meaningful erectile activity as documented by RigiScan(R) plethysmography monitoring in these healthy adult males with or without visual sexual stimulation following single oral doses of SLx-2101 across the dose range of this study. In addition, there was evidence of improvement in endothelial function, based on RH-PAT index assessments, following single oral doses of SLx-2101 across the dose range at 9.5 hours and 24 hours post-dose compared with baseline. SLx- 2101 was safe and generally well tolerated at all doses in this study. Headache was the most frequently reported adverse event following administration of SLx-2101 or placebo. No back pain, myalgia, painful, prolonged erections nor priapism were reported.
"This Phase I study provided important validation for the clinical development of SLx-2101 because it not only confirmed a good safety and tolerability profile for the candidate, but it also demonstrated that SLx-2101 resulted in increased erectile activity across the dose range and improved endothelial function in this group of healthy, male volunteers," notes Dr. William Prince, Chief Development Officer. "We are extremely confident about the overall potential of SLx-2101 and therefore are planning to enter Phase II clinical trials for both endothelial dysfunction as well as erectile dysfunction before the end of this year, and in 2006, we plan to initiate additional Phase II clinical trials for SLx-2101 in pulmonary arterial hypertension and congestive heart failure."
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 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.
Contact: David H. Donabedian, Ph.D. Vice President, Business Development 617.746.8520 Media: Kari Watson MacDougall Biomedical Communications Inc. 508.647.0209
Surface Logix Inc.CONTACT: David H. Donabedian, Ph.D., Vice President of BusinessDevelopment at Surface Logix Inc., +1-617-746-8520; or Kari Watson ofMacDougall Biomedical Communications Inc., +1-508-647-0209
