Navigation Links
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
Date:5/16/2008

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 http://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 in the 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 in Baltimore, 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 PR Newswire.
All rights reserved

Related biology technology :

1. ImaRx Therapeutics Reports First Quarter Ended 2008 Financial Results
2. Cell Therapeutics, Inc. (CTI) to Present at Rodman & Renshaw 5th Annual Global Healthcare Conference
3. Nile Therapeutics Reports 2008 First Quarter Financial Results
4. Fate Therapeutics Taps Successful Biotech CEOs Paul Grayson and John Mendlein for Leadership Team
5. Vista Partners Initiates Coverage on Synvista Therapeutics, Inc. (AMEX: SYI)
6. Amicus Therapeutics Announces First Quarter 2008 Financial Results
7. Nile Therapeutics to Present at the Rodman & Renshaw 5th Annual Global Healthcare Conference
8. Synvista Therapeutics Announces Initiation of the BREAK Study of Alagebrium for Diastolic Heart Failure
9. Synvista Therapeutics to Present at Acumen BioFin Rodman & Renshaw 5th Annual Global Healthcare Conference
10. TorreyPines Therapeutics to Host First Quarter 2008 Results Conference Call and Webcast
11. Synvista Therapeutics Increases Commercial Focus by Appointing David C. Tantillo Senior Director of Marketing and Sales
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:6/23/2016)... (PRWEB) , ... June 23, 2016 , ... ... is pleased to announce the launch of their brand, UP4™ Probiotics, into Target ... over 35 years, is proud to add Target to its list of well-respected ...
(Date:6/23/2016)... 23, 2016 /PRNewswire/ - FACIT has announced the ... biotechnology company, Propellon Therapeutics Inc. ("Propellon" or ... of a portfolio of first-in-class WDR5 inhibitors for ... as WDR5 represent an exciting class of therapies, ... medicine for cancer patients. Substantial advances have been ...
(Date:6/23/2016)... HOUSTON , June 23, 2016 ... agreement with the Cy-Fair Sports Association to serve ... of the agreement, Houston Methodist Willowbrook will provide ... education and connectivity with association coaches, volunteers, athletes ... partner with the Cy-Fair Sports Association and to ...
(Date:6/23/2016)... , June 23, 2016  The Prostate Cancer Foundation (PCF) ... precise treatments and faster cures for prostate cancer. Members of the Class of ... 15 countries. Read More About the Class of 2016 ... ... ...
Breaking Biology Technology:
(Date:6/2/2016)... 2016 Perimeter Surveillance & Detection ... Physical Infrastructure, Support & Other Service  The ... offers comprehensive analysis of the global Border Security ... revenues of $17.98 billion in 2016. Now: ... leader in software and hardware technologies for advanced video ...
(Date:5/24/2016)... care by providing unparalleled technology to leaders of the medical imaging industry.  As such, ... to the range of products distributed by Ampronix. Photo - http://photos.prnewswire.com/prnh/20160524/371420 ... ... ... With ...
(Date:5/16/2016)... NEW YORK , May 16, 2016   ... authentication solutions, today announced the opening of an IoT ... to strengthen and expand the development of embedded ... provides an unprecedented level of convenience and security with ... to authenticate one,s identity aside from DNA. EyeLock,s platform ...
Breaking Biology News(10 mins):