Surface Logix Commences Phase 2a Clinical Trial of SLx-2101 in Raynaud's Disease

BOSTON, June 28 /PRNewswire/ -- Surface Logix Inc. today announced the initiation of a Phase 2a clinical trial for SLx-2101 in patients with secondary Raynaud's disease. SLx-2101 is a novel, long-acting PDE-5 inhibitor being developed for the management of diseases associated with vascular dysfunction such as Raynaud's, a vasospastic disorder of small blood vessels leading to a marked reduction of blood flow to areas such as the fingers and toes. Often triggered by exposure to cold, Raynaud's is associated with painful blue or white digits, and in severe cases, may lead to the development of digital ulcers.

"PDE-5 inhibition holds promise in several cardiovascular indications, though many disorders such as Raynaud's are currently not addressed by marketed PDE-5 inhibitors," commented Paul Sweetnam, Ph.D., Chief Scientific Officer of Surface Logix. "We used our novel chemistry platform to design SLx-2101 to have a profile that would deliver fast onset and long duration of therapeutic effects in difficult-to-treat conditions such as Raynaud's, potentially enabling quicker, longer-lasting relief to patients."

"The initiation of this trial is part of Surface Logix's multiple indication development plan for SLx-2101. We believe that it has applicability in cardiovascular indications beyond erectile dysfunction and are therefore pursuing its advancement in specialized indications, such as Raynaud's, as well as in larger cardiovascular markets," said Jim Mahoney, President and Chief Executive Officer of Surface Logix.

The Phase 2a trial is a single European center, randomized, double-blind, placebo-controlled, crossover pilot study that will enroll 20 patients with secondary Raynaud's disease. The trial is designed to examine the safety, tolerability and pharmacodynamic profile of repeat oral doses of SLx-2101 once daily for up to 14 days. The primary objective of this trial is to investigate the severity of secondary Raynaud's disease-related attacks during the dosing period. Secondary objectives include evaluating the frequency and total daily duration of disease-related attacks during the dosing period, the safety and tolerability of SLx-2101, and the effect of the drug on capillary blood flow velocity and vasospastic symptoms.

Surface Logix also initiated a Phase 2a clinical trial to test the safety, tolerability and pharmacodynamics of orally administered SLx-2101 in patients with hypertension in June 2007. Interim data from a Phase 2a study of SLx-2101 in erectile function confirmed its activity 48 hours after a single dose of 10mg, making it the first PDE-5 inhibitor to confirm such prolonged duration of activity using an objective measure. Phase 1 studies of SLx-2101 in healthy male volunteers demonstrated its favorable safety, tolerability, pharmacokinetics and pharmacodynamic activity. Additionally, in preclinical animal models, the candidate was highly potent and selective, induced rapid cellular and tissue response and provided an extended duration of action.

About SLx-2101 in Raynaud's Disease

SLx-2101 is an oral, potent, selective, fast-onset, long-acting (48 hour) PDE-5 inhibitor designed specifically to expand the therapeutic potential of PDE-5 inhibition beyond erectile dysfunction into larger cardiovascular (CV) markets. SLx-2101 was designed using Surface Logix's proprietary chemistry platform, the Pharmacomer Technology Platform, to have a combination of potency, selectivity, tissue distribution and half-life which optimizes its potential for once-daily utility in the vascular tissues involved in major cardiovascular diseases. The clinical experience of SLx-2101 to date establishes the PK range of the PDE-5 inhibitor, as well as demonstrates efficacy in established models of endothelial function (peripheral arterial tone and erectile function).

Raynaud's disease is a condition that classically affects the blood supply to the fingers and toes but may also involve the nose and ears. During a Raynaud's attack, or episode, the blood vessels constrict (narrow) and the blood supply to these areas is reduced. This results in skin color changes which are often accompanied by a throbbing or burning sensation, cold, and numbness. The exact cause of Raynaud's disease remains unknown. Raynaud's disease occurs more frequently in women than in men. Although it can occur at any age, it usually begins between the ages of 15 and 40. It is estimated that 4 - 5 percent of the United States population is affected. Secondary Raynaud's occurs when the Raynaud's episodes are associated with a number of underlying medical conditions such as rheumatoid arthritis and scleroderma.

About Surface Logix Inc.

Surface Logix Inc. uses its expertise in biophysical chemistry to create and develop novel small molecule drugs (NCE's) with superior intrinsic drug- like properties that are clearly differentiated from competitive products. The company is advancing multiple internal programs focused primarily on cardiovascular, metabolic, inflammatory and fibrotic diseases. For more information, please visit http://www.surfacelogix.com.

Contact: Warwick Tong MB ChB Surface Logix Inc. Senior Vice President, Commercial Development 617.746.8505 Media: Kari Watson MacDougall Biomedical Communications Inc. kwatson@macbiocom.com 508.647.0209

CONTACT: Warwick Tong MB ChB, Senior Vice President, CommercialDevelopment of Surface Logix Inc., +1-617-746-8505; or Media: Kari Watsonof MacDougall Biomedical Communications Inc. for Surface Logix Inc.,+1-508-647-0209, kwatson@macbiocom.com

Web site: http://www.surfacelogix.com/