CIMZIA submitted for US FDA approval

UCB put out a press release announcing their submission for approval of a new anti-TNF drug. They note that:

If approved, CIMZIA would be the first-ever biologic utilizing subcutaneous injection for the treatment of Crohn's disease.

To lightly paraphrase their results, data from PRECiSE 2 (the second of four studies) demonstrated that within six weeks of initiating CIMZIA, 64.1 percent of patients achieved a clinical response.

At the end of 26 weeks, significantly more patients, 62.8 percent on CIMZIA vs. 36.2 percent on placebo, maintained an overall clinical response. Additionally, at 26 weeks, significantly more of CIMZIA patients were in clinical remission compared to placebo patients. CIMZIA was generally well tolerated with an adverse event profile similar to other anti-TNF agents.

Reuters adds:

Cimzia will compete against Johnson & Johnson's Remicade in the Crohn's market and against Amgen's Enbrel and Abbott Laboratories' Humira -- as well as Remicade -- in arthritis.

Teduglutide trial promising

Yahoo has a press release about a small study into an interesting experimental drug Teduglutide:

Overall, the study results showed a positive and consistent trend toward efficacy and a dose response favoring the highest dose group: 36.8% of patients receiving the highest dose of teduglutide reached clinical remission (Crohn's disease activity index (CDAI) score of less than 150 points) at week two versus 16.7% of the placebo group, while 55.6% of patients in the highest dose group reached clinical remission by week eight compared to 33.3% of the placebo group. Teduglutide was well tolerated with no serious adverse events related to the drug.

...

Teduglutide is a proprietary analog of glucagon-like peptide 2 (GLP-2), a naturally occurring hormone that regulates the growth, proliferation and maintenance of cells lining the gastrointestinal tract. A previous Phase 2 clinical study in patients with Short Bowel Syndrome showed that daily subcutaneous injections of teduglutide resulted in significant growth of the intestinal lining and improved dietary absorption of nutrients and fluids.

Crohn's due to weakened immune system

The BBC reports on a Lancet study that indicates that Crohn's may be due to a "weakened immune system failing to destroy bacteria".

The UCL team compared the immune system response of Crohn's patients and healthy individuals to minor injuries, such as skin abrasions.

They found the Crohn's patients produced much lower numbers of infection-fighting white blood cells called neutrophils, and lower quantities of chemicals involved in the inflammatory process.

...

The researchers believe that, because Crohn's patients have weakened immune systems, they are unable to destroy bacteria that penetrate the intestinal wall.

Thus the bacteria are left to build up in the tissue, stimulating the secretion of inflammatory chemicals that trigger the symptoms of Crohn's.

Forbes has further specific information:

Segal and his colleagues measured the number of neutrophils (white blood cells) produced by Crohn's patients in response to trauma in the bowel and on the surface of the skin.

Surprisingly, these patients produced 79 percent fewer neutrophils and inflammatory mediators compared with healthy individuals subjected to the same trauma.

When a harmless form of bacteria was injected under the skin, blood flow in healthy volunteers increased tenfold over 24 hours. But in people with Crohn's disease, blood flow increased only fourfold.

...

But others feel that the work does not really break new ground. "There have been other studies in the last year or two that Crohn's disease is really a problem dealing with bacteria in the colon and the inflammation is set up because there's more of a defective immune response to the bacteria in the gut," said Dr. John Thompson, director of the division of pediatric gastroenterology and nutrition at the University of Miami's Miller School of Medicine.

The link between Crohn's and MAP

The Saturday Evening Post has an in-depth interview with leading researcher and advocate on the link between Crohn's and MAP, Dr. John Hermon-Taylor.

He explains why he believes there is a link between Crohn's and MAP and describes the success he has had in treating Crohn's patients.

Using the polymerase chain reaction (PCR) technique, you can show that virtually everyone with chronic inflammation of the Crohn's disease type is infected with the MAP bug. MAP is an organism that is a specific cause of chronic inflammation of the intestine in many different species of animals, including primates.

...

There are now four open-label clinical studies carried out independently ... which essentially all say the same thing. That is, that somewhere between 50 to 75 percent of people with active Crohn's disease who can take rifabutin and clarithromycin treatment will get better and heal--sometimes like magic.

COX-2 inhibitors for pain-relief?

EurekAlert has a release about the results of two research programs into the use of COX-2 inhibitors by people with IBD:

Both studies examined the benefits of non-steroidal anti-inflammatory drugs (NSAIDs), including COX-2 inhibitors, in a patient population with ulcerative colitis and/or Crohn's disease. Study findings show that NSAIDs were well-tolerated, with COX-2 inhibitors offering the most effective pain relief in this group.

MedPage Today has another summary:

... these studies imply that NSAIDs -- long thought to be absolutely contraindicated for patients with inflammatory bowel disease -- can be used safely in some circumstances

Sargramostim trial

Australia's ABC News is reporting that use of cancer therapy drug Sargramostim in trials for Crohn's disease is showing good signs:

... Dr Graham Radford-Smith from the Royal Brisbane Hospital says the outlook is positive.

'The important things are that this drug is very safe, it's got a long track record, it's been around for a long time, there have not been any major safety issues,' he said.

'We're yet to see what happens in terms of efficacy and that's obviously critical in the drug being successful in the treatment of Crohn's disease.'

According to the Yahoo Health Drug Guide:

Sargramostim is used to increase white blood cells and decrease the risk of infection in conditions such as cancer, bone marrow transplant, and pre-chemotherapy blood cell collection.

The New England Journal of Medicine has the full report of another trial of Sargramostim for Crohn's disease. Though the report costs money to view, the quite detailed abstract is free to read. Its conclusion was interesting:

This study was negative for the primary end point, but findings for the secondary end points suggest that sargramostim therapy decreased disease severity and improved the quality of life in patients with active Crohn's disease.