Posts Tagged ‘Treatment’

 

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PRESS RELEASE
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
Last update: 8:22 p.m. EST Nov. 11, 2008
BALTIMORE, Nov 11, 2008 /PRNewswire via COMTEX/ --

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 www.clinicaltrials.gov 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
    608-850-4745
    kemblem@aol.com 

    Corporate: Wendy Perrow, MBA
    Alba Therapeutics Corporation
    410-878-9850
    info@albatherapeutics.com
    http://www.albatherapeutics.com
----------------------
Author Information: John Libonati, Philadelphia, PA
Publisher, Glutenfreeworks.com.
Editor & Publisher, Recognizing Celiac Disease.
John can be reached by e-mail here.

The news release below is timely because anti-gliadin antibody blood tests are losing ground while the reality of gluten sensitivity looms far larger than is now appreciated by many doctors!  These blood tests are absolutely necessary to investigate health problems caused by gluten itself, yet they are being dismissed by doctors who look only to diagnosing celiac disease.

Positive anti-gliadin antibody tests show undigested gluten peptides in the bloodstream.  This abnormal finding tells the story that gluten has passed through the tight barrier defenses of the small intestinal lining into the body where it can wreak havoc, with or without celiac disease.  Gluten is a food protein in wheat, barley, rye and oats.

In screening for celiac disease, an inherited immune response to gluten entering the small intestinal lining, doctors rely on the celiac specific antibody tests, anti-endomysium and anti-tissue transglutaminase.  However, the investigation to find these auto-antibodies must not exclude the anti-gliadin antibodies. 

Doctors Slow To Recognise Gluten Harm.” Dr. Rodney Ford, Leading New Zealand Paediatrician And Allergist Challenges Medical Stalwarts With Revolutionary Gluten Thinking

There is more to gluten problems than just coeliac disease. Gluten sensitivity is ten times more prevalent than celiac disease in New Zealand and mostly undiagnosed. This is the message that Christchurch-based paediatrician, allergist and author, Doctor Rodney Ford wants to get across to the public and the ever conservative medical fraternity.

The practice of medicine is restricted to the knowledge, experience, attitudes and politics of the society it functions in. Medicine is an inexact but evolving science, thus current standard medical practices are often disproved. The validity of medical opinion, long held to be the gold standard of diagnosis and treatment, are constantly challenged. This is a healthy dynamic, one that enables the pursuit of excellence and the evolution of better forms of practice, resulting in better outcomes for patients. Why, then asks Dr Ford, is there such resistance to his new Gluten Syndrome hypothesis recently published in a book and supported by years of clinical experience and research.

In the absence of coeliac disease, his latest research shows that the simple gluten test (IgG-gliadin antibody) is a sensitive indicator to detect those people who get sick eating gluten but who have tested negative to Celiac Disease. However, this test is rarely ordered by general practitioners or specialists. He says “This is because of an illogical rejection of gluten sensitivity as a valid diagnosis. Ignoring gluten flies in the face of all of the evidence and is also alienating doctors from their patients.”

Picture this, if you will: a six year old girl, Elizabeth, small for her age, a distended stomach, gas and suffering from gastric reflux. Her teachers reported a lack of attention at school and early learning problems. Elizabeth had been thoroughly investigated by the medical profession: blood tests, bowel biopsies, colonoscopy, endoscopy. Celiac Disease had been ruled out, various medications had been tried and doctors had started to question her mother’s parenting skills. Elizabeth’s parents had gone beyond frustration and fear for their child, they were at the point of desperation.

This is a common story in Dr Ford’s practice. It is also one of the many success stories he has to share. After seeing Dr Ford, a positive IgG-gliadin antibody test and being put on a gluten free diet, Elizabeth improved within a few days. Within weeks she made a remarkable recovery and was in essence cured. Gluten was no longer a choice for her and accidental intake still causes her a reoccurrence of symptoms. Adhering to a gluten free diet has enabled Elizabeth to grow into the healthy, happy and successful young woman that she is today.

Common stories such as this, along with the increasing research and evidence of gluten based harm, should be enough to spur the medical profession into action in an effort to save the current generation of children from the long term health, social and financial consequences of what is an easily diagnosed and treatable condition.

The shocking truth is that this terrible scourge of gluten is being ignored by most medical practitioners. Even worse, the blood tests that can diagnose it are being abandoned by many medical laboratories. For instance, Medlab Diagnostics in Auckland no longer offers gliadin antibody tests.

The medical professions reluctance to act on the gluten problem is costing New Zealand billions of dollars each year with long term and far reaching consequences. From a dollars and cents point of view it makes no economic sense. From a patient care point of view it is bordering on negligence.

Source: Scoop Independent News, New Zealand, Thursday, 19 June 2008, 9:49 am You can find this news release at http://www.scoop.co.nz/stories/GE0806/S00059.htm

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