Navigation Links
Alba Therapeutics Corporation Reports Preliminary Phase IIa,Clinical Trial Results for AT-1001 for the Treatment of Celiac,Disease

Announces Plans for Advancing AT-1001 into Later Stage Clinical Trials

BALTIMORE, May 07, 2007 /PRNewswire/ -- Alba Therapeutics Corporation today announced preliminary results from its Phase IIa clinical trial for AT-1001 in subjects with Celiac Disease (CD), an autoimmune disease affecting over 3 million people in the United States. Alba's study, the first Phase IIa trial in CD and the first to assess dosing requirements for AT-1001 in CD, was designed to evaluate the safety, tolerability and efficacy of multiple doses of AT-1001 in CD subjects during a 2-week gluten challenge.

The randomized, double-blind, placebo-controlled clinical trial enrolled 86 patients who were confirmed biopsy positive for CD and in compliance with a gluten-free diet for at least six months prior to enrollment. Patients were randomized into seven drug-treated and placebo groups and challenged three times a day with gluten during a 14-day period. Four doses of the enteric coated oral formulation of AT-1001, all less than 10 mg, were given prior to each gluten challenge. Study endpoints included intestinal permeability (IP) -- a marker of disease state in CD -- as well as patient symptoms and outcomes, measured by two validated tests of gastrointestinal disease outcome: the Gastrointestinal Symptoms Rating Scale (GSRS) and the Psychological General Well-Being Index (PGWBI).

    Preliminary analysis revealed the following:


    -- At day 14, IP, as measured by the change in urinary lactulose-to-

       mannitol (LA/MA) ratio, exhibited a dose dependent response.   On day

       21, one week after the final drug dosing and gluten challenge, the dose

       dependent trend continued to statistically significant levels.


    -- The GSRS and PGWBI provided additional efficacy signals that further

       support the IP observations.   Patients on the AT-1001 drug arms

       performed better than those on the gluten/placebo arm.  Analyses

       demonstrated that seve
ral symptoms and outcomes improved at

       statistically significant levels.


    -- Safety and tolerability of multiple oral doses of AT-1001 in the

       patient population was demonstrated.  There were no Severe Adverse

       Events and all Adverse Events were reported as mild or moderate.

"We are very encouraged by the preliminary data and look forward to applying the extensive knowledge gained in this Phase IIa exploratory clinical trial to a larger, highly powered Phase IIb gluten challenge study later this year" said Blake Paterson, M.D., Chief Executive Officer of Alba Therapeutics. Using the highly complex and ambitious seven arm study design for the Phase IIa trial, we repeated the proof of concept from the Phase Ib study, showed a statistically significant effect across a variety of measures and are well prepared to move the celiac program forward."

Based on these results, Alba will advance AT-1001 into a Phase IIb clinical study in CD subjects during the third quarter of 2007. The Phase IIb study, to be performed in multiple centers in the United States and Canada, will assess the efficacy of AT-1001 utilizing multiple endpoints, including a composite index of disease activity. The first patient is expected to be enrolled into this study in the third quarter of 2007, and the study should conclude in early 2008.

About Celiac Disease

Celiac Disease is a T-cell mediated autoimmune disease that occurs in genetically susceptible individuals and is characterized by small intestinal inflammation, injury and intolerance to gluten. According to the National Institutes of Health, CD affects approximately 3 million Americans. The only current treatment for CD is complete elimination of gluten from the diet, which results in remission for some patients.

About Alba

Alba Therapeutics Corporation is a privately held biopharmaceutical company based in Baltimore, Ma ryland dedicated to the development and commercialization of disease modifying therapeutics to treat autoimmune and inflammatory diseases based upon the regulation of tight junctions. Alba's lead compound, AT-1001, is targeted towards the treatment of Celiac Disease, Inflammatory Bowel Disease and Type 1 Diabetes

    Contact:  Stuart Sedlack, SVP, Corporate Development

    Phone:    +1-410-319-0780

    E-mail:   

    Web site: http://www.albatherapeutics.com

info@albatherapeutics.com

CONTACT: Stuart Sedlack, SVP, Corporate Development, of Alba TherapeuticsCorporation, +1-410-319-0780, info@albatherapeutics.com

Web site: http://www.albatherapeutics.com//

Terms and conditions of use apply
Copyright © 2007 PR Newswire Association LLC. All rights reserved.
A United Business Media Company


'"/>




Related medicine technology :

1. Cell Therapeutics, Inc. Management to Discuss Todays Announcement of Interim Pixantrone Study Results
2. Halozyme Therapeutics Enhanze Technology Large Protein Molecule Therapeutic Clinical Trial Results Presented at the 34th Annual Meeting of the Controlled Release Society
3. CV Therapeutics Identifies Potential Anti-Diabetic Mechanism of Action for Ranexa
4. Fat Kills Cancer: Turning Stem Cells from Fat Tissue into Personalized, Cancer-Targeted Therapeutics
5. A 4-Week Therapy with Transition Therapeutics E1-I.N.T. Leads to Sustained Reductions in Blood Glucose Levels for 6 Months Post-treatment in Type 2 Diabetes Patients
6. Clinical Trial Suggests Bone Marrow Stem Cells Are Useful for Spinal Cord Injury; PrimeCell Therapeutics Provided Pre-Clinical Study
7. Opexa Therapeutics Reports Positive Top-line Data in Phase I/II Extension Trial with Tovaxin for Multiple Sclerosis
8. Orexigen Therapeutics to Present Data on Contrave Impact on Visceral Fat and Insulin Resistance at American Diabetes Association 67th Scientific Sessions in Chicago June 23
9. Allos Therapeutics Reports Results for Phase 3 Enrich Study of Efaproxyn in Women With Brain Metastases Originating From Breast Cancer
10. Trophos Publishes ALS Article in Journal of Pharmacology and Experimental Therapeutics
11. Novelos Therapeutics Announces Encouraging Results in Ongoing Phase 2 Ovarian Cancer Trial at Dana-Farber/Partners Cancer Care
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:10/4/2017)... 4, 2017 OBP Medical , ... medical devices, today announced regulatory approval from ... (or Agência Nacional de Vigilância Sanitária (ANVISA)) to ... surgical retractor with integrated LED light source and ... and exposure of a tissue pocket or cavity ...
(Date:10/2/2017)... The Rebound mobile app is poised to become ... tide of prescription drug addiction. The app empowers users to ... stepping down their dosage in a safe, controlled manner while ... the first 100,000 people to sign up will enjoy 3 ... ...
(Date:9/25/2017)... Sept. 25, 2017   Montrium , an ... solutions, today—from the IQPC Trial Master Files & ... NL)—announced that EastHORN Clinical Services has selected ... and TMF management. EastHORN, a leading European contract ... to increase transparency to enable greater collaboration with ...
Breaking Medicine Technology:
(Date:10/13/2017)... ... 13, 2017 , ... Lori R. Somekh, founder of the Law Office ... of elder law and special needs planning attorneys. “Membership in ElderCounsel helps our office ... forum to network with elder law attorneys nationwide,” said Somekh. , ElderCounsel ...
(Date:10/13/2017)... ... 13, 2017 , ... The Visiting Nurse Association (VNA) of Somerset Hills is ... vendors and unique items from across the nation, this holiday-themed event will raise funds ... by the VNA. The boutique will be open Saturday, November 4 (10:00 a.m. ...
(Date:10/13/2017)... Texas (PRWEB) , ... October 13, 2017 , ... Yisrayl ... this week that explains one of the most popular and least understood books in ... like cryptic and puzzling descriptions that have baffled scholars for centuries. Many have tossed ...
(Date:10/13/2017)... ... 13, 2017 , ... “The Journey: From the Mountains to the Mission Field”: ... souls in the Philippines. “The Journey: From the Mountains to the Mission Field” is ... Bible. She has taught all ages and currently teaches a class of ladies at ...
(Date:10/12/2017)... San Francisco, CA (PRWEB) , ... October 12, ... ... and Dr. Cheng, are now treating sleep apnea using cutting-edge Oventus ... sleep apnea, a serious sleep disorder characterized by frequent cessation in breathing. Oral ...
Breaking Medicine News(10 mins):