Navigation Links
Alba Therapeutics Announces Enrollment of Its First European Patient in Global Phase IIb Study of Larazotide Acetate for Treatment of Active Celiac Disease

- Milestone Marks the First Time a European Patient with Active Celiac Disease has Enrolled in a Clinical Trial for an Investigational Medication

from Alba Therapeutics -

BALTIMORE, Nov. 11 /PRNewswire/ -- Alba Therapeutics Corporation announced today that for the first time, a European patient with active celiac disease has been enrolled in its clinical trial to investigate a treatment for the disease. Alba has enrolled and randomized the newly diagnosed patient from Spain in an eight-week Phase IIb trial with oral larazotide acetate, a tight junction regulator, 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 assessing improvement in the clinical signs and symptoms of celiac disease.

"These are decisive times for our desire to one day be able to offer our celiac patients a treatment that allows them to live more normal lives," said Dr. Gemma Castillejo, MD, a pediatric gastroenterologist and principal investigator in the study. Dr. Castillejo, a leading European celiac expert from the Sant Joan de Reus University Hospital in Reus, Spain added, "I believe this clinical trial has the potential to be a turning point in the search for treatments for celiac disease."

"This is a major milestone for the celiac community in Europe," stated Francisco Leon, MD, PhD, Vice President, Clinical Development and Medical Affairs of Alba. "This is Alba's sixth human trial with larazotide acetate, and we are excited to be advancing our investigational program for larazotide acetate in this important region of the world."

About Celiac Disease

Celiac disease is an inherited autoimmune disorder where gluten has been identified as the environmental trigger of the disease. Gluten is an ingested protein found in wheat, barley and rye. Gluten is broken down into gliadin which can pass through the intestinal epithelial barrier during times of increased intestinal permeability. The ingestion of gluten causes an immune response which triggers an inflammatory reaction in the small intestine. This then causes damage to the villi in the small intestine and can lead to total villous atrophy in celiac disease. 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.

Celiac disease is a growing public health concern, affecting approximately 3 million people in the United States and over 6.5 million people worldwide. The only current management of celiac disease is complete elimination of gluten from the diet, which can be very difficult to implement in practice. Additionally, 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)

(1) Green, P, and Cellier, C, Review Article, Medical Progress, Celiac

Disease, N ENGL J MED 2007;357:1731-43

About "Larazotide Acetate"

Larazotide acetate is an experimental medicine and a tight junction regulator that acts locally by inhibiting the opening of tight junctions in epithelial cells lining the small intestine. In celiac disease, gluten crosses the epithelial barrier and stimulates the immune system, leading to cytokine release, gut inflammation, and opening of tight junctions. This leads to increased paracellular permeability, increased entry of gluten and the establishment of an intestinal permeability-inflammation loop. Larazotide acetate inhibits tight junction opening triggered by both gluten and inflammatory cytokines, thus reducing uptake of gluten. Larazotide acetate disrupts the intestinal permeability-inflammation loop, and reduces symptoms associated with celiac disease. 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. For more information about Alba's clinical trials, please visit the web site and search for Alba Therapeutics.

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.

Media: Mariesa Kemble

Sam Brown Communications


Corporate: Wendy Perrow, MBA

Alba Therapeutics Corporation


SOURCE Alba Therapeutics Corporation
Copyright©2008 PR Newswire.
All rights reserved

Related medicine technology :

1. Cell Therapeutics Pixantrone Phase III (EXTEND) Pivotal Trial Successful in Achieving Primary Endpoint
2. Cell Therapeutics Announces Study Data Set Cut-off for Phase III Pivotal Pixantrone (301) Trial
3. InteRNA Technologies and VU University Medical Center to Develop microRNA-Based Diagnostics and Therapeutics for Cancer
4. Sirion Therapeutics Announces Positive Pivotal Uveitis Data for Durezol(TM)
5. XTENT Announces Clinical Trial Data to be Presented at Annual Meeting of Transcatheter Cardiovascular Therapeutics Next Week
6. Alba Therapeutics Presents New Data for Larazotide Acetate at the 2008 American College of Gastroenterology Annual Scientific Meeting
7. In Vivo Data on Taligen Therapeutics Pipeline Candidates Presented at the XXII International Complement Workshop
8. BN ImmunoTherapeutics Announces Positive Mature Phase II Results From Newly Acquired Prostate Cancer Vaccine
9. Video: Sirion Therapeutics Launches Durezol for Postoperative Ocular Inflammation and Pain
10. Orexigen(R) Therapeutics Presents Data on Its Proprietary Formulation of Naltrexone Sustained Release (SR) Used in Contrave(R)
11. PTC Therapeutics Announces Data Showing Six-Minute Walk Test Consistently Measures Ambulatory Function in Patients With Duchenne Muscular Dystrophy
Post Your Comments:
(Date:12/1/2015)... 1, 2015 A federal court has denied the ... a lawsuit filed by the Pharmaceutical Care Management Association (PCMA) ... a new law that forces employers and consumers to pay ... Arkansas must now defend a law that raises ... and CEO Mark Merritt . --> ...
(Date:12/1/2015)... 2015 Pharma Tech Outlook recently conducted a ... Data Management Solution Providers - 2015 .  After careful ... CEOs, CIOs, VCs, analysts, and the Pharma Tech Outlook ... top 10 clinical data management solution providers (check out ... and 36 respectively). --> ...
(Date:12/1/2015)... Va. , Dec. 1, 2015  AccuTEC ... unveiled a new corporate logo and brand identity ... the design and engineering of bladed products where ... --> --> Serving manufacturers ... glass, and auto glass equipment, AccuTEC,s product lines ...
Breaking Medicine Technology:
(Date:12/1/2015)... ... December 01, 2015 , ... ... professionals who believe that with innovative technologies and under the right circumstances, these ... get the benefit of a dual-approach to his or her therapeutic sessions, as ...
(Date:12/1/2015)... ... 01, 2015 , ... CloudLIMS today announced that it is ... under the New Products and Services category for its innovative product offering, BioTracer. ... that helps labs organize data and track samples with storage inventories. BioTracer's ...
(Date:12/1/2015)... ... December 01, 2015 , ... ... of adjunctive imaging is the focus of numerous abstracts accepted for presentation here, ... 4, 2015. Nine abstracts highlight the use of Volpara Solutions’ quantitative breast ...
(Date:12/1/2015)... Francisco, CA (PRWEB) , ... December 01, 2015 ... ... Behavioral Health Center of Excellence (BHCOE) today announced that the organization has awarded ... in San Francisco, with a Distinguished Award. The award celebrates exceptional special needs ...
(Date:12/1/2015)... ... December 01, 2015 , ... TCS ... care management and population health arenas, is pleased to announce that VIP Care ... services, has successfully implemented the ACUITY Complete Care™ Management to back their collaborative ...
Breaking Medicine News(10 mins):