Weekday Links Part 1: Low Dose Naltrexone for Chronic Pain, Traveling Increasing Risk of Crohn's, Patent for Oral Anti-TNF, Qu Biologics Trial

I got a little carried away and found many links in the past couple of weeks and found some great links. So enjoy!

LDN for Anti-inflammatory treatment chronic pain
     For a while now I have been blogging about low dose naltrexone (LDN) and how it really has shown benefits for Crohn's patients here, Originally approved for alcoholics in the late 1980's the drug has shown promise for people with Crohn's disease and other chronic illnesses. Since 2007 Dr. Jill Smith of Penn State has shown that LDN has helped Crohn's patients with very limited side effects. The only problem is the trials for LDN are small (< 50 patients). For major drugs you generally needed hundreds of patients.

This article talks about how low dose naltrexone is low cost and well tolerated. However, the article points out that the sample sizes are low and replications of studies have not occurred. The article does finally conclude that LDN may possibly be used for management of chronic pain disorders

Traveling Increased Risk of Crohn's 
This is probably a favorite study of mine and something I have been wondering about for a while. It seems as if traveling in an airplane could induce some inflammation. An even better study would be to take a c-reactive test while in the air and then when people land to see if it changes. The thinking is that hypoxia can lead to inflammation in the gastrointestinal track. The patients who frequently traveled and go to places above 2,000 meters had more flare ups when compared to patients in remission.

Patients Benefit From Second Treatment of Remicade (Infliximab)
In a study where 29 patients who had Crohn's disease who took Remicade (infliximab) and Humira (adalimumab) restarted Remicade. The conclusion was that a second treatment of Remicade after Remicade or Humira don't work could help.

Patent Awarded to Avaxia for Oral Anti-TNF for Inflammatory Bowel Disease
Drug company Avaxia Biologics filed a patent (AVX-470) in order to deliver anti-TNF (Remicade and Humira) to patients. I had read before that creating an oral anti-TNF would be difficult because of the way the digestive track broke down the medicine. The drug it looks like the Phase 1b clinical trials are for ulcerative colitis.

Qu Biologics Opens Crohn's Trial to U.S. Participants
I have been following Qu Biologics for a while. The company is a small Canadian company that has probably come up with the most novel therapy to treat Crohn's. The company uses Site Specifics Immunomodulators (SSI) which are used in order to reboot the immune system. 60 patients are being used in the drug trial. 10 patients have already been treated and the results are pretty good. 70% of patients showed a full resolution of clinical symptoms after 3 months or more. 40% of the 70% or (28% of the overall patients) had sustained clinical remission after discontinuing all medications (including the SSI treatment)! This is pretty amazing that patients were able to not only stop the actual treatment but all other treatments. Hopefully SSIs can be used to help people with Crohn's in the near future.

Low Dose Naltrexone for Crohn's: The No-Brainer Case For The FDA

         
           (This picture is of a colonscopy of a before and after of a Crohn's patient who took LDN)

So in a prior post I discussed low dose naltrexone (LDN). LDN was first introduced in 1984 for people with alcohol dependence. The drug has been shown to reduce the relapse rates. What inspired me to write this post was I saw this recent story that talked about how drug company TNI BioTech met with the FDA and Phase III trials may start as early as first quarter in 2014.

The evidence for low dose naltrexone is pretty convincing in terms of being both effective and safer than the current alternativies of Humira, Remicade, and other drugs. This land mark study from Dr. Jill Smith at Penn State University showed that 67% of people went into remission. 89% of patients showed a clinical response which is similar to the rates of Humira and Remicade (however the only real side effects with LDN is vivid dreams and fatigue). In 2011, this study was done by Smith and her colleagues which found that 78% of patients showed an endoscopic response. 88% of patients who took the LDN showed a 70 point decline in their CDAI score (which is a significant decrease). The only side effect was fatigue.

A recent study from April 2013 in children showed that low dose naltrexone was safe and showed reduced activity for Crohn’s patients. However, only 25% of children (between 8-17 years of age) went into remission, however 67% showed improvement. Here is a case study of a 14 year old girl who had Crohn's and pain for 3 years. After a month of taking 4.5 mg of low dose naltrexone she improved. An EGD (esophagogastroduodenoscopy) showed complete muscoal healing and normal biopsies which is quite impressive.

LDN has been shown to be useful in other treatments like multiple sclerosis, prolonging the live of pancreatic cancer patients, and may even help people with HIV and AIDS. There is no question some more studies have to be done on what LDN can exactly help.

Why on earth is this drug still not approved for Crohn's? I would suggest the FDA talk to patients with Crohn's and see how they currently feel given the current state of options in the Crohn's world. Low dose naltrexone seems to show help patients with minimal side effects compared to Humira, Remicade, Enbrel, 6-MP and any other drugs you want to compare it to. The initial study for LDN on Crohn's was done in 2007. So why is it taking 7 years to now just get around to a Phase III trial? 

Crohn’s Weekend Links: Enterovirus, Red Meat & Colon Cancer, LDN for Crohn’s, Vitamin D and Crohn’s

Crohn’s and Enterovirus

                Apparently in children there may be a link between Crohn’s and enterovirus within the intestinal area. The enterovirus could be seen in deeper parts of the intestinal wall. The enterovirus is stored in the nerve cells of the intestine and can spread by other nerve fibers within the intestine.  Hopefully a study on adults can be done.

Red Meat and Colon Cancer

                This really isn’t news in a way. I did blog here about the medical literature on reducing colon cancer (one was to avoid red meat). This study just further confirms that avoiding foods like roast beef (which I love), hot dogs, and sausage can contribute to colon cancer.  Since 1991 colon cancer has declined by 30% for colon cancer which is good but colon cancer can be fatal if not caught early enough.

Low Dose Naltrexone FDA Meeting

                It is good news that TNI BioTech company is having a Type C meeting with the FDA to look over the Phase III trial for Naltrexone HCL. Research from Dr. Jill Smith shows that LDN helped 67% of patients achieve remission (this was back in 2007) and the drug is still not on the market.  LDN really doesn’t have any adverse side effects other than vivid dreams which sounds interesting.

Vitamin D Helps Crohn’s

                This study found that 5,000 IU/d reduced CDAI scores for Crohn’s disease which suggests that Vitamin D might be useful for people with mild-moderate Crohn’s disease.