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Alba Therapeutics Announces the Enrollment and Randomization of the First Patient in the Phase IIb Clinical Trial for Larazotide Acetate (AT-1001) for the Treatment of Active Celiac Disease
Alba Therapeutics Announces the Enrollment and Randomization of the First Patient in the Phase IIb Clinical Trial for Larazotide Acetate (AT-1001) for the Treatment of Active Celiac Disease
BALTIMORE, May 16 /PRNewswire/ -- Alba Therapeutics Corporation announced
today that it has enrolled and randomized its first patient in a twelve-week
Phase IIb trial with oral larazotide acetate, an inhibitor of intestinal
barrier dysfunction, for the treatment of patients with active celiac disease
(CD). The global multi-center, randomized, double-blind, placebo-controlled
study will evaluate the clinical and histological efficacy, safety and
tolerability of larazotide acetate in 106 active CD subjects adhering to a
gluten-free diet, while also testing components of a celiac disease activity
rating index, a new patient reported outcomes instrument. "This is Alba's
sixth human trial with larazotide acetate and highlights our efforts to
improve the treatment of celiac disease and help the celiac community by
raising the awareness of this important and neglected disease," stated Dr.
Francisco Leon, Head of Clinical Research and Development at Alba. "Alba is
committed to studying new treatment options for patients with celiac disease.
By conducting this important pioneering clinical study we believe we can learn
more about celiac disease and provide insights for physicians and celiac
patients," stated Bruce Peacock, CEO of Alba. For more information about
Alba's clinical trials, please visit the www.clinicaltrials.gov web site and
search for Alba Therapeutics.
About Celiac Disease
Celiac disease is a lifelong T-cell mediated auto-immune disorder, which
occurs in individuals who are genetically susceptible and is characterized by
small intestinal inflammation, injury and intolerance to gluten. CD is a
growing public health concern, affecting approximately 3 million people inthe
United States and over 6.5 million people worldwide. People with CD cannot
tolerate gluten proteins and have an inflammatory response to the gluten in
wheat, barley and rye. This results in varying symptoms such as fatigue, skin
rash, anemia, fertility issues, joint pain, weight loss, pale sores inside the
mouth, tooth discoloration or loss of enamel, depression, chronic diarrhea or
constipation, gas and abdominal pain. The immunology and nutritional
abnormalities in celiac disease can potentially result in long-term
complications such as osteoporosis, refractory sprue, small intestinal cancer,
and lymphoma. The only current treatment for CD is complete elimination of
gluten from the diet, which results in remission for most patients, but can be
very difficult to implement in practice. "However, the response to the
gluten-free diet is poor in up to 30% of patients and dietary nonadherence is
the chief cause of persistent or recurrent symptoms."(1)
About "Larazotide Acetate"
Larazotide acetate is an experimental medicine and an inhibitor of barrier
dysfunction that has been shown to block abnormally increased intestinal
permeability and the genesis of some autoimmune diseases, either as a result
of reduction of antigen presentation to the body's immune system, or through
inhibitory, direct effects on gastrointestinal associated lymphoid tissue.
Larazotide acetate is orally formulated, has been granted "Fast Track"
designation by the U.S. Food and Drug Administration for the treatment of
celiac disease, and is also being evaluated for the treatment of Crohn's
Disease. Results of the Company's first study in celiac patients are available
online at:
http://www.blackwell-synergy.com/doi/abs/10.1111/j.1365-2036.2007.03413.x
About Alba
Alba Therapeutics Corporation is a privately held, clinical-stage
biopharmaceutical company focused on the discovery, development, and
commercialization of therapies to treat autoimmune and inflammatory diseases
and is located inBaltimore, Maryland. Alba's technology platform is based
upon a key pathway that regulates the assembly and disassembly of tight
junctions in cell barriers throughout the body. As a result of its unique
technology platform, Alba is a leader in mucosal biology and has developed a
pipeline of innovative therapeutic candidates that has the potential to modify
the course of disease and significantly improve upon existing treatments for a
wide range of diseases such as Celiac disease, Crohn's disease, and
Asthma/COPD or acute lung injury.
Contact: Wendy Perrow, MBA
Phone: 410-878-9850
E-mail: info@albatherapeutics.com
Web site: http://www.albatherapeutics.com
(1) Green, P, and Cellier, C, Review Article, Medical Progress, Celiac
Disease, N ENGL J MED 2007;357:1731-43
SOURCE Alba Therapeutics Corporation
Copyright © 2008, PRNewswire
Copyright © 2008, NewsBlaze,
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