Surface Logix Commences Phase IIa Trial for Novel PDE5 Inhibitor SLx-2101 in Patients with Endothelial Dysfunction
BOSTON, Nov. 30 /PRNewswire/ -- Surface Logix today announced the commencement of a company-sponsored Phase IIa clinical trial for SLx-2101, a new potent and selective long-acting, oral PDE5 inhibitor.
SLx-2101 is being evaluated for the treatment of vascular and cardiovascular disease where endothelial dysfunction is a significant component of the pathogenesis of the
disease.
This study will assess the safety, tolerability and efficacy of different single doses of SLx-2101 in patients with erectile dysfunction who are known to respond to the marketed PDE5 inhibitors.
Efficacy will be determined using the Rigiscan(TM) technique that is well established as a valid measure in studies of this kind. The study was designed to establish the dose response and the duration of action of SLx-2101 in patients as suggested by the Phase I study which demonstrated that SLx-2101 has an extended half-life and pharmacodynamic activity in healthy subjects.
"This first study in patients will build on the excellent data from the Phase I study to provide important information about the dose response in patients. This will direct the design and dosage choices for studies in other vascular and cardiovascular indications as we continue the clinical
development of SLx-2101.
There is significant overlap between the daily doses of the marketed PDE5 inhibitor for pulmonary hypertension and the dosages used for erectile dysfunction, supporting our confidence that dosage information gained from this study with SLx-2101 will help guide our decisions for a range
of Phase IIa and IIb studies," notes Dr. William Prince, Chief Development
Officer of Surface Logix.
"The further progression of SLx-2101 into studies in patients is another important milestone for Surface Logix. The data from our Phase I study exceeded our expectations and gave us the confidence to quickly advance SLx- 2101 into a patient population," said Jim Mahoney, Chief Executive Officer of Surface Logix. "We expect to build a significant body of data for SLx-2101 through the initiation of additional Phase II studies in 2006, and we look
forward to reporting the results of these studies at appropriate scientific forums next year."
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.
More information about Surface Logix is available on the Net:
surfacelogix.com.
Contact:
David H. Donabedian, Ph.D.
Vice President, Business Development
617.746.8520
Media:
Kari Watson
MacDougall Biomedical Communications Inc.
508.647.0209
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