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
SOURCE Surface Logix Inc.
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Related links:
http://www.surfacelogix.com
CONTACT:
Warwick Tong MB ChB, Senior Vice President,
Commercial Development of Surface Logix Inc., +1-617-746-8505; or
Media: Kari Watson of MacDougall Biomedical Communications Inc.
for Surface Logix Inc., +1-508-647-0209, kwatson@macbiocom.com
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