Saturday, August 29, 2009

Clinical trial results: Low-dose interferon alpha lozenges to treat Behcet's disease

Some Behcet's patients will probably remember the excitement several years ago about low-dose interferon alpha oral lozenges in the treatment of BD symptoms. The lozenges were created by Amarillo Biosciences in Texas (trade name Veldona), but the product needed to undergo clinical trials for use in treating BD. AmarBio already had good results in trials of treating COPD, idiopathic pulmonary fibrosis, and warts in HIV-positive patients, and are also banking on Veldona being very useful in treatment of flu epidemics.

Veldona modulates (evens out) immune system responses, instead of suppressing the immune system like a lot of other BD treatments.

Many BD patients in the U.S. have been able to get the lozenges through a "compassionate use" request, but it hasn't been easy -- especially once the manufacturing process settled in Canada, and U.S. patients faced the drugs being confiscated at customs during shipment if any part of the prescribing paperwork was left out (which happened enough to become an issue for some patients a while back).

People who have been helped by the lozenges swear by them (reducing oral/genital ulcers and other overall BD symptoms, with few to no side effects). Like all treatments, though, they haven't worked for everybody. Results are especially poor if people use the lozenges when they're already immunosuppressed by taking drugs like Imuran, methotrexate, etc., or if they're taking anti-TNF meds (Enbrel, Remicade), or using NSAIDS like ibuprofen or Naproxen. That knocks out a lot of BDers from the start. I've never personally used the lozenges, but might have tried harder to get them if prescriptions could be filled in the U.S. instead of Canada.

Regardless, results of the first clinical trial of the lozenges in the treatment of Behcet's were just published yesterday in the journal "Rheumatology."
[Low-dose natural human interferon-{alpha} lozenges in the treatment of Behçet's syndrome
Hasan Kiliç, Hasan E. Zeytin, Cengiz Korkmaz, Cem Mat, Ahmet Gül, Fulya Cosan, Ayhan Dinç, Ismail Simsek, Necdet Süt, and Hasan Yazici
Rheumatology. Published 28 August 2009, 10.1093/rheumatology/kep237]
The abstract can be viewed here:

The trial took place in Turkey, under the watchful eye of Hasan Yazici, MD. Unfortunately, BD patients who have been hoping for good results will be disappointed: There was no difference between using the lozenges and being given a placebo, in the number/size of oral ulcers in BD patients.

HOWEVER, the end of the article included a hopeful message for U.S. patients, suggesting that the lozenges may eventually be tested in a clinical trial at the NYC Behcet's Syndrome Center run by Dr. Yazici's son (Dr. Yusuf Yazici):

"Disease features of BS can show distinct geographical variation and there has been an indication that patients from New York with ethnic origins from non-endemic areas had milder disease [19]. We are aware that there are anectodal reports from patients from North America who claim benefit from off-label use of IL. Therefore, there might still be case for yet another controlled study with this agent limited to this region."

U.S. patients who'd like more information about getting prescription access to the lozenges should go here:
[If this link is not active, the ENTIRE link must be copied/pasted into your browser, from "http" at the start, through "firefox-a" at the end.)