REDHILL BIOPHARM - News -> RHB-104 - Possible Breakthrough Treatment for Crohn's Disease

I get so excited when I read about this possible treatment, RHB-104, for Crohn's!  I've been watching this drug for over a year now.  This is a  treatment that if approved by the FDA, I will be jumping on it as soon as it becomes available.  No doubt!  This is the kind of treatment we need.  Everything else just treats symptoms.
So, why is this so exciting?  If you read current research about what causes Crohn's disease, you will see that researchers are leaning away from considering Crohn's disease an autoimmune condition.  They have found that there is an underlying cause for the immune response to activate.  Crohn's is said to be caused by a combo of 3 factors - Immune system abnormalities, environmental influences and bacteria.  I just wiki'd Crohn's disease and this is what is said about what is believed to be the cause - "Crohn's disease is caused by interactions between environmental, immunological and bacterial factors in genetically susceptible individuals.[4][5][6] This results in a chronic inflammatory disorder, in which the body's immune system attacks the gastrointestinal tract possibly directed at microbial antigens.[5][7] While Crohn's is an immune related disease, it does not appear to be an autoimmune disease (in that the immune system is not being triggered by the body itself)."
What this means is that people that have Crohn's disease do not have the immune system capabilities to destroy a form of bacteria that have been introduced into the body at some point in time.  As research has indicated, a large number of people with Crohn's disease happen to have the MAP bacteria in their body somewhere.  The exact location of the bacteria is not known at this time.  Who cares where it is, as long as a treatment is available that will destroy it is my opinion.
See why this makes me super hopeful?  If Crohn's is caused by this MAP bacteria & if this new combination antibiotic eradicates the MAP bacteria from people with Crohn's disease, this could be the answer to the Crohn's disease epidemic!  Can someone say CURE :)
Wouldn't that be glorious?  

Clinical trial for a new antibiotic therapy for Crohn’s treatment started:

Crohn’s disease is an inflammatory bowel disease which may affect gastrointestinal tract from mouth to anus, and has a wide variety of symptoms. Mycobacterium avium subspecies paratuberculosis (MAP) is believed to be associated with Cronh’s disease. Professor Dr. Saleh Naser, UFC College of Medicine, believes that MAP is the cause of the disease. He said, "Crohn's disease affects more than 750,000 Americans, yet traditional treatments only address the symptoms of inflammation and not the cause." He further added, "I have seen case studies where patients' lives have been restored following treatment, which removes MAP. I have high hopes that this clinical trial may lead to finding a cure." Dr. Saleh Naser will soon conduct clinical trials on a new antibiotic therapy acquired by RedHill Biopharma for curing the disease. 240 participants will be recruited for this double blind clinical trial.

http://health-beauty-2468.blogspot.com/2013/09/clinical-trial-for-new-antibiotic.html



RedHill Biopharma to initiate phase III trial of RHB 104 in Crohn's disease patients

UCF College of Medicine professor Dr. Saleh Naser soon will participate in a clinical trial to test whether a new antibiotic therapy acquired by RedHill Biopharma can be used to treat Crohn's disease patients.

The FDA-approved phase III trial is expected to commence within weeks by RedHill Biopharma, which licensed Naser's DNA technology for detecting Mycobacterium aviumsubspecies paratuberculosis, known as MAP. It is believed to be associated with Crohn's disease. RedHill Biopharma developed the anti-MAP antibiotic regimen known as RHB 104. Crohn's disease is a chronic inflammatory disease of the gastrointestinal tract characterized by cramping and diarrhea.

Naser developed and patented a way to detect MAP from milk, blood and tissue clinical samples. The bacterium is known to cause inflammation in the intestines of cows. It is also linked to Crohn's disease, although its role has been debated for more than a century. Naser believes MAP is an underlying cause of the disease.

"Crohn's disease affects more than 750,000 Americans, yet traditional treatments only address the symptoms of inflammation and not the cause," Naser said. "I have seen case studies where patients' lives have been restored following treatment, which removes MAP. I have high hopes that this clinical trial may lead to finding a cure."

RedHill will be enrolling 240 subjects from the United States, Canada and Israel in this double blind clinical trial in which blood and intestinal biopsy specimens from Crohn's patients will be tested for MAP before, during and following the one-year treatment with the antibiotic RHB 104.

"Since we acquired the license to Dr. Saleh Naser's MAP detection technique in 2011, we have had an excellent collaboration with UCF," said RedHill's CEO Dror Ben-Asher. "The UCF team of researchers- is at the forefront of global academic research on MAP and its detection."

Naser is looking forward to the trial and hopes this will end the academic debate regarding MAP and Crohn's disease.

"I am ecstatic to be part of a team, which will help determine whether or not MAP is associated with Crohn's disease; certainly a final answer to a one hundred-year old controversy," Naser said.

Source: University of Central Florida

http://www.news-medical.net/news/20130918/RedHill-Biopharma-to-initiate-phase-III-trial-of-RHB-104-in-Crohns-disease-patients.aspx

RedHill Readying Phase III Trials In Crohn's

With a PDUFA target date of Feb. 3, 2014 for its migraine drug, RHB-103, and NDA filing planned for the first quarter of 2014 for the anti-emetic drug, RHB-102, RedHill Biopharma (RDHL) is now focusing its efforts on its flagship programs: RHB-104 for Crohn's disease and RHB-105 for Helicobacter pylori (H. pylori).

RedHill is preparing to begin a potential groundbreaking Phase III study in the current quarter in North America and Israel (the MAP U.S. Study) of Crohn's disease, using a novel patent-protected formulation that combines three antibiotic ingredients in a single capsule, and is planning and preparing a parallel Phase III study in Europe (the MAP Europe Study).

"Following the discovery of the link between H. pylori bacterium and peptic ulcers, there is a growing body of evidence supporting the proposition that Crohn's disease and other so-called autoimmune diseases, such as multiple sclerosis, are linked to infections," chief business officer Guy Goldberg says in an interview with BioTuesdays.com, referring to emerging scientific evidence that the microbiome, or the trillions of intestinal microbes, plays a major role in health and disease.

"There's a paradigm shift of viewing the body not as a single organism but as a collection of organisms, with the microbiome as the habitat within the body," he adds.

In 2005, researchers in Australia won the Nobel Prize for identifying H. pylori bacterium and the role it plays in causing peptic ulcers. Stress and lifestyle were long believed to be the primary cause of intestinal ulcers. Fellow Australian, Prof. Thomas Borody, who is now a member of RedHill's advisory board, developed the first antibiotic treatment for ulcers.

RedHill's two lead drug candidates - RHB-104, for Crohn's disease and multiple sclerosis (MS), and RHB-105, forH. pylori - were built on the success of Prof. Borody's approaches to gastrointestinal tract diseases and infections.

"RHB-104 is the biggest program in our pipeline," Mr. Goldberg says. "To the best of our knowledge, we are the only company with a Phase III combination antibiotic approach for treating Crohn's disease, even though there is a lot of academic research connecting Crohn's to a bacterial infection."

RedHill is currently advancing six clinical programs; two of which are expected to be reviewed by the FDA during 2014, and three that are entering pivotal clinical studies.

In a research report last month, Bioassociate Innovative Consulting reiterated its "buy" rating and price target of $14.91 per RedHill American Depositary Share, "given the multiple milestones approaching and the company being on-track with the clinical programs' timelines."

Crohn's is a severe inflammatory disease in the GI tract. Existing drugs, such as Remicade, treat the inflammatory symptoms of the disease by suppressing the immune system. However, they are widely considered to have a poor safety profile and limited long-term efficacy. "There clearly is a strong unmet medical need for a better alternative for Crohn's patients," Mr. Goldberg contends. The global market to treat Crohn's exceeded $3.5-billion in 2012.

(Click to enlarge)

Phase II Study Pictures in Crohn's Patients (Borody et al (2002), Digest Liver Dis 34:29-38)

He explains that RHB-104 is a novel and proprietary combination of three approved antibiotic ingredients - clarithromycin, clofazimine and rifabutin - targeting Mycobacterium Avium Paratuberculosis (MAP). Crohn's patients are believed to have seven times greater likelihood of being MAP-positive than non-Crohn's patients.

The MAP U.S. Study will enroll 240 moderately-to-severely active Crohn's patients at 50 sites in North America and Israel. The primary endpoint is the state of remission at week 26. The study will also examine safety, the maintenance of remission through week 52, efficacy outcome measures in relation to the presence of MAP infection and other secondary endpoints.

If the study is successful, RedHill may submit a new drug application to the FDA in 2015. RHB-104 previously received orphan drug status from the FDA for pediatric use. Mr. Goldberg says discussions are underway with European regulators to begin a second Phase III study with RBH-104 in Europe - the MAP Europe Study.

RedHill also is developing RHB-104 to treat patients with relapsing remitting MS. In June, the company commenced a Phase IIa proof-of-concept trial in Israel. "This is the first time that this type of antibiotic therapy will be tested on MS patients in a Phase II clinical trial," Mr. Goldberg contends.

RedHill's second lead program is RHB-105 in development to treat H. pylori bacteria, which plays an important role in gastritis, peptic ulcers and gastric cancer. Mr. Goldberg points out that H. pylori is increasingly developing resistance to treatment with clarithromycin and metronidazole, and that standard therapy fails in up to 30% to 40% of patients who continue to remain H. pylori-positive.

A Phase IIa study in 2005 by Prof. Borody in Australia demonstrated over 90% eradication of the bacteria in 130 patients who had previously failed standard therapy with clarithromycin. Approximately three millionH. pylori-infected patients are treated annually in the U.S. market, resulting in a potential market estimated at $1-billion to $1.5-billion.

Mr. Goldberg explains that RHB-105 is a novel all-in-one combination of two antibiotics - rifabutin and amoxicillin - and a proton pump inhibitor, omeprazole. RedHill plans to begin a Phase II/3 clinical trial with RHB-105 during the quarter, he says, adding that a successful study could lead to an NDA filing in 2014.

http://seekingalpha.com/article/1645962-redhill-readying-phase-iii-trials-in-crohns?source=yahoo

Another Study Reveals Benefits of Medicinal Marijuana -Crohn's Remission

I have read dozens of articles, studies, reports, etc. that read similar to this article!  How many more studies are necessary for people to realize pot is not harmful and isn't going to kill anyone? It's actually almost funny that this herb is still looked at as a dangerous drug.  It's a plant... and it's shown to provide more benefits than harm.   The research always results in a significant benefit when studies are conducted.  I don't ever remember reading anything negative about marijuana, or it causing serious problems for the people that smoke it.  We would definitely know by now if weed were harmful.  Even if there were terrible outcomes from smoking pot, we do not hear these reports because of all the legality issues surrounding the word "marijuana".  It's ridiculous that the plant is still illegal and considered harmful here in the US!  Wake Up America!

Eventually, pot will be legal in all US states, but it's going to take a long time for all of them to adopt legislation (NY will probably be one of the last states to legalize it).  Turtle pace.... because that's how the US of A rolls.  Nice and s loooooooooooowwww. 

Medical Marijuana Causes 'Complete Remission' In Crohn's Disease Patients Without Side Effects, Study Finds : Latin Times:

Crohn's Disease has long been a fickle illness that requires meticulous attention to treat and live with. Researchers at the Department of Gastroenterology and Hepatology, Meir Medical Center in Israel, however, may have found relief for patients of the disease in medical marijuana. The study split 21 patients who received a high Crohn's disease activity index and were not responding to other treatments into two groups. One group was given a joint to smoke twice a day while the other group were given placebos lacking cannabinoids for the duration of eight weeks.

The study found complete remission for 45 percent of the group that smoked cannabis, or 5 out of 11 patients, as compared to the control group, which only experienced a 1 in 10 remission rate, the Huffington Post reported. It is speculated that cannabinoids with their anti-inflammatory properties are likely the cause of relief for the disease, which causes inflamation of the bowels. This inflammation can lead to extreme discomfort, diarhrea that may contain blood, weight loss, vomiting, rashes, inflammation of other parts of the body and tiredness among other symptoms, SF Gate reported. Others in the cannabis group reported lessened strength in their usual symptoms without the side effects caused by steroids often used to treat the illness.

"THC-rich cannabis produced significant clinical, steroid-free benefits to 11 patients with active Crohn's disease, compared with placebo, without side effects," the researchers wrote in the study. "Subjects receiving cannabis reported improved appetite and sleep, with no significant side effects."

The study, the authors conceded, was not a complete success as it was hypothesized that induced remission would occur for all or most of the patients. Still, researchers say that the relative success of this study is worth noting. The results have indeed produced a need for further investigation, the study says.

RELATED: Marijuana Diabetes: Pot Smokers Have Lower Diabetes Risk; Are Pot Smokers Skinnier? 

Crohn's disease is highly prevalent for whites, with 43.6 percent of every 100,000 being affected by the disease, one study by the Department of Family Medicine in San Bernardino, Calif. found. Latinos, by contrast, have the lowest rate of the disease with only 4.1 percent in every group of 100,000 being affected. Latinos, especially immigrants to the U.S., however, have notably higher rates of ulcerative colitis than most whites, VOXXI reported. A study in the American Journal of Gastroenterology, the urgency of treatment also contrasted non-Hispanics. Whites needed surgery at a much higher rate than Hispanics. Access to care may influence how often the disease is actually diagnosed, but researchers said that it does not explain the difference between U.S.-born and foreign-born Hispanics in terms of the prevalence of the disease.

"It is unclear what is responsible for this observation, but possibilities include changes in the environment with migration, diet and other factors related to acculturation," Daniel Sussman, assistant professor of clinical medicine in the Division of Gastroenterology, Jackson Memorial Hospital and University of Miami, said. "Our research did not measure the incidence or prevalence of IBD in Hispanics. Available population-based studies show that the incidence of IBD in some Latin American countries is higher than anticipated; this may be a result of the "westernization" of many Latin-American countries. As the Hispanic population continues to grow in the U.S., we expect that the number of Hispanic patients with IBD will also rise."

Researchers Report - 200 Genes Have a Connection to Crohn's Disease

Wish there was more to be said about these 200 genes they found that point to Crohn's.  Nice to know.  

Crohn's Disease, from what I read on a regular basis, is one of the most complex diseases to understand.  Scientists seem to always discover a relationship with "A" ("A" could be any of the following, I'm only listing a few:  impaired  immune response, an increased level of a serine protease, an antigen/toxin, introduced into the body,  a pathogen {a bacteria(especially MAP), virus, fungus} are associated with Crohn's, genetic factors... 200 of them apparently, drugs ( Accutane is the one I hear about the most), environmental factors such as hormonal therapy, ex. birth control.  Not enough exposure to parasites, microorganisms and infectious agents in early childhood- See: Hygiene Hypothesis.     OK that's enough.    You get the point.  

Crohn's can be associated with so many factors, but the progression to determine more components about that factor "A", may lead to other discoveries that bring understanding about how "A" and "B", but not enough to progress with more research studies. 

Then ... That's it!  Scientists reach dead ends. It seems as if the findings discovered do not provide enough concrete information to bring more understanding about the disease which halts additional  research You never hear  much more about the relationship between A & B again. This happens so much with so many of the studies that seek to understand the disease and they all seem to reach a dead end at some point during the research.  There's  a few factors that have a pretty good progression that continue to lead to more connections; & its MAP.  It is the only information that I have read  and continue to read that discover  new findings and links to Crohn's.  Scientists are able to get somewhere with their findings that allow them to be able to do more studies and they gain more  understanding about the disease. 

The other factor that stands out is the Hygiene Hypothesis.  Read about it, it makes sense. 

Of all the conditions we would have to have is one as complicated as the Crohn.    I associate the Crohn's with a nightmare person that is sorta like a stalker/rude/unpredictable/enjoys messing up my day(s) and overstays their welcome ... but they were never welocome to begin with ... The nightmare just comes right in and makes itself at home.   

Anyway... enough of my babble.  Feel free to comment on your thoughts on what research seems to stand and  make progress toward an effective treatment and maybe even a cure.  I'd love to hear what you've found .

Scientists Now See 200 Genes Linked to Crohn's Disease: MedlinePlus:

WEDNESDAY, Dec. 19 (HealthDay News) -- Using a new technique, researchers have pinpointed a large number of additional genes associated with Crohn's disease, bringing the total to 200.

The scientists at University College London, in England, created a new method to identify and map the locations of genes associated with complex inherited diseases such as Crohn's.

Crohn's disease, a type of inflammatory bowel disease, affects about 100 to 150 people out of every 100,000. Understanding more about the genes associated with the disease may lead to improved treatments, the researchers said.

The 200 genes so far linked to Crohn's are more than have been found for any other disease, according to the researchers. For example, just 66 gene regions are known for type 2 diabetes.

"The discovery of so many gene locations for Crohn's disease is an important step forward in understanding the disease, which has a very complicated genetic basis," study senior author Dr. Nikolas Maniatis said in a university news release. "We hope that the method we have used here can be used to identify the genes involved in other diseases which are similarly complex -- for example different cancers and diabetes."

The new research was published Dec. 13 in the American Journal of Human Genetics.

SOURCE: University College London, news release, Dec. 13, 2012

HealthDay

Copyright (c) 2012 HealthDay. All rights reserved.

*ViDEO*Semi-Vegetarian Diet & Effects On Reaching Remission in Crohn's Disease -

"Meat (including fish),  cheese, and animal protein intake in general have been associated with an increased risk of inflammatory bowel disease (IBD). In the meantime, plant-based diets may not only help prevent such conditions, but treat them as well, resulting in the longest recorded remission rates for Crohn’s disease."

Dietary Treatment of Crohn's Disease | NutritionFacts.org:

'via Blog this'

MARCH is NATIONAL AUTOIMMUNE DISEASE AWARENESS MONTH

AARDA hopes to educate public on autoimmune diseases during March

March is National Autoimmune Diseases Awareness Month, and the American Autoimmune Related Diseases Association (AARDA) is working to educate the public on risk factors, prevalence, and the severe lack of awareness surrounding autoimmune diseases. During March, AARDA hopes to educate the public on the top five things everyone should know about autoimmune disease: (1) 50 Million Americans have an autoimmune disease, comprising a major U.S. health crisis. (2) There are 100+ autoimmune diseases including Crohn's disease, celiac disease, rheumatoid arthritis(RA), vasculitis, and Addison's disease. (3) Autoimmune diseases "cluster" in families; for example, if your grandmother had lupus, you could be at greater risk for developing an autoimmune disease. (4) Fewer than 13 percent of Americans can name an autoimmune disease. (5) Autoimmune diseases target women 75 percent more often than men; and combined, autoimmune diseases are one of the top ten killers of women under the age of 65.
Increased levels of awareness amongst the general public is more important now than ever before according to AARDA's President and Executive Director Virginia T. Ladd. She says, "Autoimmune diseases such as multiple sclerosis (MS), type 1 diabetes, and celiac disease have all been shown to be on the rise, but answers as to why these increases are occurring are yet unknown. However, it is imperative that the public be more aware of their own risk factors for developing autoimmune diseases so that, as symptoms occur, they can seek a diagnosis and begin a treatment regimen. Early diagnosis and onset of treatment can make a significant difference in someone's chances of becoming disabled or suffering organ damage."

AARDA will sponsor several events this March in honor of National Autoimmune Diseases Awareness Month, including a free public forum, "What Every American Needs to Know About Autoimmune Disease," which will be held in partnership with the University of Colorado Anschutz Medical Campus, in Denver, CO, March 3. Additionally, to increase awareness in Congress and advocate for autoimmune diseases becoming a national health priority, AARDA will host a Congressional Briefing in collaboration with the National Coalition of Autoimmune Patient Groups, on March 28. March will also bring the launch of AARDA's Autoimmune Walk Campaign led by Actress Kellie Martin who serves as the campaign's Ambassador. The campaign will lead the way to AARDA's inaugural awareness and fundraising walk which will take place in Chicago, IL on June 2.
Source: American Autoimmune Related Diseases Association (AARDA)