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
About Celiac Disease
Celiac disease is a lifelong T-cell mediated auto-immune disorder, whichoccurs in individuals who are genetically susceptible and is characterized bysmall intestinal inflammation, injury and intolerance to gluten. CD is agrowing public health concern, affecting approximately 3 million people in theUnited States and over 6.5 million people worldwide. People with CD cannottolerate gluten proteins and have an inflammatory response to the gluten inwheat, barley and rye. This results in varying symptoms such as fatigue, skinrash, anemia, fertility issues, joint pain, weight loss, pale sores inside themouth, tooth discoloration or loss of enamel, depression, chronic diarrhea orconstipation, gas and abdominal pain. The immunology and nutritionalabnormalities in celiac disease can potentially result in long-termcomplications such as osteoporosis, refractory sprue, small intestinal cancer,and lymphoma. The only current treatment for CD is complete elimination ofgluten from the diet, which results in remission for most patients, but can bevery difficult to implement in practice. "However, the response to thegluten-free diet is poor in up to 30% of patients and dietary nonadherence isthe chief cause of persistent or recurrent symptoms."(1)
About "Larazotide Acetate"
Larazotide acetate is an experimental medicine and an inhibitor of barrierdysfunction that has been shown to block abnormally increased intestinalpermeability and the genesis of some autoimmune diseases, either as a resultof reduction of antigen presentation to the body's immune system, or throughinhibitory, 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 ofceliac disease, and is also being evaluated for the treatment of Crohn'sDisease. Results of the Company's first study in celiac patients are availableonline at:http://www.blackwell-synergy.com/doi/abs/10.1111/j.1365-2036.2007.03413.x
Alba Therapeutics Corporation is a privately held, clinical-stagebiopharmaceutical company focused on the discovery, development, andcommercialization of therapies to treat autoimmune and inflammatory diseasesand is located in Baltimore, Maryland. Alba's technology platform is basedupon a key pathway that regulates the assembly and disassembly of tightjunctions in cell barriers throughout the body. As a result of its uniquetechnology platform, Alba is a leader in mucosal bio
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