Cerimon Pharmaceuticals,
Inc., announced it has initiated a Phase II proof-of-concept study of
Simulect(R) (basiliximab) for the treatment of noninfectious uveitis, a
chronic and potentially sight-threatening inflammation of the eye. The
randomized, double-masked, placebo-controlled study will evaluate the
safety and efficacy of Simulect as maintenance therapy in 56 patients.
During the study, patients will undergo tapering of concomitant
immunosuppressive medications, the mainstay of treatments for noninfectious
uveitis. This is the second mid-stage trial for basiliximab run by Cerimon,
which began a Phase IIb study for patients with moderate-to-severe,
steroid-refractory ulcerative colitis (UC) in April 2007.
“The initiation of this proof-of-concept study is part of our overall
strategy to seek additional indications for already marketed drugs in areas
with significant unmet medical needs,” stated Paul Sekhri, President and
CEO of Cerimon Pharmaceuticals. “In noninfectious uveitis, we believe
Simulect has the potential to significantly improve the quality of life for
patients by reducing adverse events often associated with oral or topical
corticosteroids while maintaining effective control of their inflammation.”
Basiliximab is a monoclonal antibody that selectively blocks the
interleukin-2 (IL-2) receptor. This mechanism of action provides highly
targeted inhibition of the T-lymphocyte activation that is involved in
serious immune-related diseases including noninfectious uveitis. In
February 2006, the Company licensed basiliximab from Novartis Pharma AG for
the treatment of Inflammatory Bowel Disease (IBD) and initiated a Phase IIb
clinical study for the treatment of moderate-to-severe, steroid-refractory
ulcerative colitis the following year. In December 2007, Cerimon entered
into an agreement with Novartis to conduct a proof-of-concept study for
basiliximab for the treatment of noninfectious uveitis.
About Noninfectious Uveitis
Uveitis is an inflammation of the internal structures of the eye.
Uveitis can be described by the underlying condition that causes it:
autoimmune (noninfectious), bacterial, viral, parasitic and eye trauma, and
by the part of the eye that it affects: anterior, intermediate, posterior
and panuveitis. Noninfectious uveitis affects approximately two hundred
forty thousand people worldwide and can lead to complications, such as
glaucoma, cataract and total vision loss. Current treatments include
topical and oral corticosteroids, steroidal implants and immunosuppressive
drugs; however, these generally have limited success and can lead to
adverse events.
About Cerimon Pharmaceuticals
Cerimon Pharmaceuticals, Inc., is a biopharmaceutical company dedicated
to developing and commercializing therapeutic products for autoimmune
diseases, inflammation and pain. Cerimon believes these new treatment
options will enable physicians to further improve the lives of their
patients.
Cerimon currently has two drugs in clinical development. The Company’s
autoimmune program has two development programs. The lead program is a
Phase IIb study in which Simulect(R) (basiliximab) is being assessed as a
treatment for moderate-to-severe, steroid-refractory ulcerative colitis
(UC). The second program is studying Simulect as a treatment for
noninfectious uveitis in a Phase II study. Cerimon’s lead asset in its pain
portfolio is the Company’s topical formulations of diclofenac. The Company
is in mid-stage clinical testing with its topical diclofenac products.
The Company continues to seek additional assets to add to its
development pipeline and is financed by the premier investors MPM, Nomura
Phase4 Ventures and OrbiMed Advisors.
For more information on Cerimon, please visit the Company’s website at
cerimon.
Cerimon Pharmaceuticals, Inc.
cerimon
View drug information on Simulect.