BALTIMORE, May 16 Alba Therapeutics Corporation announcedtoday that it has enrolled and randomized its first patient in a twelve-weekPhase IIb trial with oral larazotide acetate, an inhibitor of intestinalbarrier dysfunction, for the treatment of patients with active celiac disease(CD). The global multi-center, randomized, double-blind, placebo-controlledstudy will evaluate the clinical and histological efficacy, safety andtolerability of larazotide acetate in 106 active CD subjects adhering to agluten-free diet, while also testing components of a celiac disease activityrating index, a new patient reported outcomes instrument. "This is Alba'ssixth human trial with larazotide acetate and highlights our efforts toimprove the treatment of celiac disease and help the celiac community byraising the awareness of this important and neglected disease," stated Dr.Francisco Leon, Head of Clinical Research and Development at Alba. "Alba iscommitted to studying new treatment options for patients with celiac disease.By conducting this important pioneering clinical study we believe we can learnmore about celiac disease and provide insights for physicians and celiacpatients," stated Bruce Peacock, CEO of Alba. For more information aboutAlba's clinical trials, please visit the www.clinicaltrials.gov web site andsearch for Alba Therapeutics.
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