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
SOURCE Surface Logix Inc.
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CONTACT: David H. Donabedian, Ph.D., Vice President of Business Development at Surface Logix Inc., +1-617-746-8520; or Kari Watson of MacDougall Biomedical Communications Inc., +1-508-647-0209
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