Celiac Disease Support Group
Celiac disease is an auto-immune disorder of the digestive system that occurs in genetically-predisposed individuals. It is characterised by damage or flattening to all or part of the villi lining the small intestine, which interferes with the absorption of nutrients. This damage is caused by eating anything with gluten (gliadin), a protein found in wheat, rye, and barley...
Looks like they are moving right along with this! Let's keep our fingers crossed :)
1. News: FIRST PATIENT ENROLLED IN 12 WEEK TRIAL OF LARAZOTIDE ACETATE FOR THE TREATMENT OF PATIENTS WITH ACTIVE CELIAC DISEASE
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 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 THERAPEUTICS CORPORATION: 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.
1. News: FIRST PATIENT ENROLLED IN 12 WEEK TRIAL OF LARAZOTIDE ACETATE FOR THE TREATMENT OF PATIENTS WITH ACTIVE CELIAC DISEASE
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 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 THERAPEUTICS CORPORATION: 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.
The way they are testing this pill is dangerous. They are giving Celiac's pills filled with gluten. It is a double blind study so there is no way to know who is getting the gluten. Then they are doing repeated biospies of the small bowel of these folks. How much damage can one bowel take?
The pill is planned for daily adminstration to help with ACCIDENTIAL ingestion of gluten. It will not let us return to normal diets! All of this is just to have a daily pill that might prevent problems in case of cross contamination. What use is that? I certainly won't take a pill for that!
What will resturants do for us if there is a pill like this? They will expect us to take this pill and then they don't have to be at all careful about how they handle our food. This is just going to make our lives worse than they already are! I have a resturant near me that provides totally GF food. They are super careful about handling and even have a fryer that is used only for GF foods. Why would the corporation continue this if this pill is released?
Those who enroll are being told that the side effects are minor, diahrrea, stomach problems. They are ignoring the long term damage to the body from being deprived of nutrition.
I can't see anything good coming from this except the drug companies will make more money off of us.
Sorry this is not sugary sweet but I am really upset by this study. WE should all boycott this. How can the FDA allow people to be harmed this way?
I came as close as you can to dying from this disease. This pill will not be one I trust. Unless you've been there you can't imagine what it is like to be nearly dead and have no one believe that you are sick. There is no pill that will heal the damage done to my body. I am afraid that this pill will just allow Celiac's to take longer to reach the point of death.
How will doctor's treat CD if there is a pill? Will they just prescribe the pill and then put us off if we continue to have problems? Again, I can't see any positives coming from this. There is already enough hostility toward Celiac's in the world. We don't need a pill that "seems" to the world to be a cure. If they don't understand now, they will not have reason to try if this pill is released.