A drug that is claimed to reverse fibrosis/cirrhosis.
I don't remember seeing anything about this Company/drug which is now in phase II trials. It claims to reverse fibrosis and cirrhosis in NASH and NAFDL but I see no reason why it wouldn't be beneficial in HCV and HBV patients as well as liver diseases in general. I've been watching Galectin since June 2013.
Sept. 10, 2013, 8:00 a.m. EDT
Galectin Therapeutics Receives US Patent for Potential Ground-Breaking Treatment for Fatty Liver Disease
NORCROSS, Ga., Sep 10, 2013 (GLOBE NEWSWIRE via COMTEX) -- Galectin Therapeutics GALT +4.37% , the leading developer of therapeutics that target galectin proteins to treat fibrosis and cancer, today announced that it has received a notice of issuance from the U.S. Patent and Trademark Office for Patent Application Number 13/573,454 titled "Galacto-rhamnogalacturonate compositions for the treatment of non-alcoholic steatohepatitis and non-alcoholic fatty liver disease." The patent covers the Company's carbohydrate-based galectin inhibitor compound GR-MD-02 for use in patients with fatty liver disease with or without fibrosis or cirrhosis. Fatty liver disease affects as many as 15 million Americans, results in severe scarring of the liver (cirrhosis), and there are no currently approved pharmaceutical therapies.
The U.S. Food and Drug Administration (FDA) recently granted GR-MD-02 Fast Track designation for non-alcoholic steatohepatitis (NASH) with hepatic fibrosis, commonly known as fatty liver disease with advanced fibrosis. Galectin Therapeutics is currently conducting a Phase 1 clinical trial to evaluate the safety, tolerability and exploratory biomarkers for efficacy for single and multiple doses of GR-MD-02 over four weekly doses of GR-MD-02 treatment in patients with fatty liver disease with advanced fibrosis.
"The issuance of this patent provides broad coverage in the U.S. for the use of GR-MD-02 in fatty liver disease through September 2031 and international patent coverage is pending for the same intellectual property," said Peter G. Traber, MD, President, CEO and CMO of Galectin Therapeutics. "There is a truly vast unmet medical need for the treatment of fatty liver disease with fibrosis, as the most prevalent liver disease in the U.S. We are hopeful that our development program for GR-MD-02 will lead to the first therapy for this unmet medical need."
The patent inventors include Peter Traber, Eliezer Zomer and Anatole Klyosov with assignment to Galectin Therapeutics. The major claims are for methods of obtaining galectin inhibitor compounds, obtaining a composition for parenteral or enteral administration in an acceptable pharmaceutical carrier and administering to a subject having at least one of the following: fatty liver, non-alcoholic fatty liver disease, non-alcoholic steatohepatitis, non-alcoholic hepatitis with liver fibrosis, non-alcoholic steatohepatitis with cirrhosis, or non-alcoholic steatohepatitis with cirrhosis and hepatocellular carcinoma. The use covers reversing or slowing the progression of disease activity or medical consequences of the disease. Moreover, additional claims cover the use of the galectin inhibitor compounds in combination with multiple other agents that may have potential activity in the disease that are under investigation elsewhere.
About Fatty Liver Disease with Advanced Fibrosis
Non-alcoholic steatohepatitis (NASH), also known as fatty liver disease, has become a common disease of the liver with the rise in obesity rates, estimated to affect nine to 15 million people, including children, in the U.S. Fatty liver disease is characterized by the presence of fat in the liver along with inflammation and damage in people who drink little or no alcohol. Over time, patients with fatty liver disease can develop fibrosis, or scarring of the liver, and it is estimated that as many as three million individuals will develop cirrhosis, a severe liver disease where liver transplantation is the only current treatment available. Approximately 6,300 liver transplants are done on an annual basis in the U.S. There are no drug therapies approved for the treatment of liver fibrosis. FDA and AASLD (American Association for the Study of Liver Disease) recently held a 2-day workshop with leading scientific experts in NASH and key FDA officials to discuss acceptable regulatory endpoints for approval of drugs to treat NASH (http://www.aasld.org/additionalmeetings/Pages/aasldfdanash.aspx).
About Galectin Therapeutics
Galectin Therapeutics GALT +4.37% is developing promising carbohydrate-based therapies for the treatment of fibrotic liver disease and cancer based on the Company's unique understanding of galectin proteins, key mediators of biologic function. We are leveraging extensive scientific and development expertise as well as established relationships with external sources to achieve cost effective and efficient development. We are pursuing a clear development pathway to clinical enhancement and commercialization for our lead compounds in liver fibrosis and cancer. Additional information is available at www.galectintherapeutics.com.
Thanks Mike I have never heard of this company and I follow the pharma's closely. I didn't even know what a galectin protein was. I found this on their website.
Science of Galectin Proteins
Galectins are important therapeutic targets because they are the mediators of fundamental biologic mechanisms in pathological processes. Galectic Science PublicationThere are nearly 3500 scientific publications with “galectin” in the title. Additionally, our company has edited two peer-reviewed books that bring together authoritative articles on the function of galectin proteins in disease.
The latest book includes proceedings from a galectin-focused symposium hosted by Galectin Therapeutics in September 2012, Galectins and Disease Implications for Targeted Therapeutics. The book is edited by Dr. Anatole Klyosov, Chief Scientist at Galectin, and Dr. Peter G. Traber, Chief Executive Officer and Chief Medical Officer of Galectin. These symposium proceedings are currently available here. Print copies of the book are available from Oxford University Press under ISBN: 978-0-8412-2880-1.
There are 15 galectin protein subtypes with the common characteristic of a carbohydrate recognition domain that binds to galactose-containing carbohydrates and glycoproteins. A good review article on the structure and function of galectin proteins is Di Lella 2011. A key factor that differentiates galectin protein subtypes is their oligomerization domains that allow the galectin protein to bind with another protein of the same family, creating a dimer (See the figure below). Secreted galectins have been shown to bind with high affinity to galactose-containing glycoproteins on the cell surface and in the extracellular matrix. Their ability to dimerize creates the opportunity for galectins to link glycoproteins and form a lattice structure on the cellular surface and to promote cell-cell and cell-matrix interactions. The associations between glycoproteins created by galectins can trigger intracellular signaling and potentiate or modulate certain biologic and pathologic effects. Galectin proteins also have intracellular functions, but we are focused on the extracellular functions which are accessible to targeting with our drugs.
Model of Galectins
While galectins are normally expressed in small amounts in many different cell types, they are most highly expressed in macrophages of the immune system. Secreted galectins are markedly increased and have important roles in a wide variety of pathological processes involved in immune regulation, inflammation, fibrogenesis and tumor cell biology. Our drug compounds are designed to bind to and inhibit the function of secreted galectins. With these characteristics, our drugs have the potential to modulate and treat diseases where increased galectins promote or potentiate the pathological situation.
I rarely give investment advice but I really like this stock. I think the potential market is huge. They are also suggesting that it can also treat lung fibrosis which is a bigger problem than some people realize. The way I see this stock is that it will either be huge or it will go bust and it depends on the trials. If people start getting sick or if the endpoints are not realized the stock will fall like a stone. If it works without serious side effects then the sky is the limit.
This is really great news! Thanks so much for sharing. A friend of mine was asked to joint this trial but as a level 2 she was afraid to try, she has NALFD I think that is it.
I will let her know.
Thanks so much for sharing this.
The only other thing I heard about was the PPC that HepatitisResearcher used to talk about. It is an older post which to my surprise has gotten over 130 responses
my understanding is that the exclusion of hcv-antibody-positive applicants was done (along with other exclusions) to yield as homogenous-as-possible cohort of subjects for this clinical trial. beyond that, nothing should be read into the exclusion.
as we're often reminded, "cirrhosis is cirrhosis - regardless of the cause." and no doubt the same can be said for (its precursor) fibrosis. therefore it's reasonable to expect that an effective antifibrotic would work 'across the board' - regardless of what had actually caused the fibrosis...whether diet, hepatitis, alcohol, whatever.
"therefore it's reasonable to expect that an effective antifibrotic would work 'across the board' - regardless of what had actually caused the fibrosis...whether diet, hepatitis, alcohol, whatever...."
....this is assuming that the cause has been removed. if the underlying cause (such as hcv) has not been - or cannot be - removed, then the effectiveness of any antifibrotic would likely be diminished. .perhaps in such a case the disease progression could at least be slowed down...but these are all things that remain to be seen. meanwhile we can at least hope for progress to be made -
"as we're often reminded, "cirrhosis is cirrhosis - regardless of the cause." and no doubt the same can be said for (its precursor) fibrosis. therefore it's reasonable to expect that an effective antifibrotic would work 'across the board' - regardless of what had actually caused the fibrosis...whether diet, hepatitis, alcohol, whatever".
i dont know iam wrong but i read and heard that an alcohol,or hep-b caused cirrhosis has better chances to improve as an hep-c caused cirrhosis.
altough for me its not logigcal nor understandable,because i thought/think also cirrhosis is cirrhosis no matter what has caused it.
i hope there are some poeple who could explain this,would be interesting to know.
rexx, you are correct. and that is exactly the point made in my addendum when I wrote the following:
"...this is assuming that the cause has been removed. if the underlying cause (such as hcv) has not been - or cannot be - removed, then the effectiveness of any antifibrotic would likely be diminished. "
in cirrhosis caused solely by alcohol the cause can always be removed.
in cirrhosis caused by a hepatitis virus the cause can sometimes be removed (...an example is successful treatment of HCV, attaining SVR status).
One thing's for certain: SOMETHING is driving this company Galectin Therapeutics' stock, which has more than tripled in value since the Nov 2013 date of the last post in this discussion. I'm keeping my fingers crossed - in anticipation of the first human clinical trial results...to be released in April, only a few weeks away! A possible breakthrough treatment for fibrotic liver diseases!!.
Big news last week - the release of preliminary results of first HUMAN clinical trial: this Galectin antifibrotic drug DOES work!! This could well mark the beginning of a cure for liver fibrosis and cirrhosis!! Even with its FDA 'fast track' designation, it will take awhile to cycle through the FDA approval process. You can read all about it here:
Thank you, Spent about 5 mins checking into it. For me the following info is enough for now. Hopefully we will hear more positive info and trials a year or two for HCV SVR with Advanced Fibrosis if applicable.
Phase 1 Study to Evaluate Safety of GR-MD-02 in Subjects With Non-Alcoholic Steatohepatitis (NASH) and Advanced Fibrosis
This study is enrolling participants by invitation only.
Non-Alcoholic Steatohepatitis (NASH)
Exclusion Criteria: #11 of 20
Subject has a history of hepatitis C. Patients found on screening to have hepatitis C antibody, even if PCR negative for HCV RNA, are excluded from this study.
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