Clinical Trial Results News

Many companies have been releasing news about the results of the clinical trials they have been conducting on various new therapies for Crohn's disease and ulcerative colitis. Here are some of the latest trial results.

ALICAFORSEN (ISIS 2302) 

Results of the trials for alicaforsen (also known as ISIS 2302) have been released by Isis Pharmaceuticals. The drug shows definite promise in ulcerative colitis. Three separate Phase II studies were done to measure activity and duration of response, and to determine the appropriate dose for a larger, Phase III trial. The studies — one a placebo-controlled study, one to test how the drug performs in the body, and one to compare it to the effects of mesalamine — found that patients who received an alicaforsen enema each night for six weeks and responded to the initial treatment were able to keep that response for up to six months. Also, the alicaforsen enema treated patients had improved mucosal healing, decreased rectal bleeding and decreased stool frequency. In the trial where alicaforsen was compared to a mesalamine enema, it was found to achieve improvements in the disease equal to or better than mesalamine for a longer period of time. A recent small open-label trial also showed that alicaforsen enema improved clinical symptoms and pouchoscopy appearance among patienst with chronic, unremitting, pouchitis. The drug was found to be well-tolerated in all the trials. Alicaforsen belongs to a new class of antisense drugs which act by being mirror images of the messenger RNA or building blocks which the body uses to produce various inflammatory proteins or molecules. This drug inhibits a molecule known as ICAM-1 that plays a key role in intestinal inflammation. Unfortunately, alicaforsen was shown not to induce remission in Crohn's disease, but Isis is committed to developing the drug for ulcerative colitis. Remember — keep visiting the CCFA Clinical Trials section for the latest information on the Phase III ulcerative colitis trial.

NATALIZUMAB (FORMERLY ANTEGREN)

The FDA recently approved natalizumab (formerly known as Antegren) for the treatment of multiple sclerosis. Natalizumab is now known as Tysabri,® and is currently undergoing Phase III trials in Crohn's disease. In September of 2004, Elan Pharmaceuticals filed for approval of natalizumab with the European equivalent of the FDA for use in Crohn's disease, based on a completed Phase III study for induction and maintenance of remission. The large initial induction study known as ENACT-1, which enrolled 905 patients with Crohn's disease, did not show significant benefit over placebo, possibly due to a higher than expected response rate among those patients assigned placebo. However, the subsequent maintenance study known as ENACT-2 showed significant benefits among patients who received 300mg infusions every 4 weeks in terms of clinical remission, response and ability to stop steroids. A second Phase III study is ongoing, and once those results are available, natalizumab may undergo FDA review and approval. This drug is an antibody that inhibits a specific 'adhesion' molecule on certain immune cells, preventing them from migrating from the blood stream into the intestines and adhering to the intestinal lining, which is a major cause of inflammation in Crohn's disease.

MESALAMINE (High Dose Asacol)

Results of the first trial confirming that larger doses of mesalamine would be effective for patients with moderate ulcerative colitis was reported at the American College of Gastroenterology Annual Meeting held in early November. A new tablet formulation of mesalamine (Asacol®) 800 mg, instead of 400 mg, will allow patients to take only six tablets a day instead of 12, once it is approved by the FDA. "This was really the last phase of data needed to move forward with a higher and more convenient dose for the patient," says Dr. William Sandborn, one of the investigators of the study. The study, sponsored by Procter & Gamble Pharmaceuticals, was a multicenter clinical trial of 268 patients with moderately active ulcerative colitis.

ADHESION BARRIER  (Seprafilm)

Patients who undergo abdominal surgeries run the risk of having adhesions. Adhesions are basically scar tissue that sticks to another organ or other tissues. For IBD patients, these adhesions can lead to small bowel obstructions after colorectal surgery. Genzyme manufactures a bioabsorbable membrane known as Seprafilm® to be used in abdominal surgeries, and recently concluded a trial to determine whether or not the use of Seprafilm® could reduce the risk of complications from adhesions. The study found that by using this membrane during an initial surgery, the relative risk of small bowel obstruction due to adhesion could by reduced by 47 percent.


Some of the trials listed here were featured in CCFA's Clinical Trials section. More than 80 new therapies are being developed in the pipeline for inflammatory bowel disease. Click here to check the trials section frequently to keep up to date. Although it can sometimes take a long while before trial results can be accurately reported, only your participation can help develop these new therapies!