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Teva sclerosis drug shows positive data

JERUSALEM (AP) - Israeli drug maker Teva Pharmaceutical Industries (NASDAQ:TEVA) Inc. said Thursday a three-year study of its multiple sclerosis drug showed slower disease progression and fewer relapses in patients who did not respond to other treatments.

The three-year study showed patients who switched to Teva's Copaxone after failing treatment with a standard interferon drug experienced 77 percent fewer relapses of their disease. Patients switched among different interferon drugs also had fewer relapses, but patients who switched to Teva's drug also showed slowed disability progression.

Teva added the proportion of patients who didn't experience a relapse over the three-year period of the study increased to 68% from 16% after switching to Copaxone.

Response to Rainer: From what I hear from a friend who has MS and from the posts, the TEVA press release on Copaxone appears unduly optimistic, especially re side effects.
As a chemist with a strong interest in alternative medicine and supplements, I believe that ROS (reactive oxygen species) are one cause of MS (Chl pneum another ?) and a host of other inflammatory diseases and that ROS inhibitors like NAC (N-acetyl cysteine) have a place in prevention and treatment of these diseases.

Indeed Teva has a pending patent application, WO2006/029036, which essentially discloses the heretofore unpublished results of a clinical study of a combination therapy of Copax and NAC, commonly available at healthfood stores. According to their claims, the optimal dose appears to be 2.5 g NAC taken twice daily. Note this is an application or disclosure and it may not be issued as a formal patent. And even if it does, it would not prevent MS patients from buying their own NAC.
A competing Israeli company, Yissum, had filed an earlier application (WO2004/012652) which covers a broad range of NAC substances (but not NAC itself) acting like pro-drugs that more readily pass through the blood brain barrier (BBB) before conversion to NAC in the brain. Such patented pro-drugs may be more effective than NAC at lower doses. If this patent issues, it would allow Yissum to exclusively sell or license the NAC pro-drugs as independent or combination MS therapies.
Another patent application (WO2006/032053) claims effectiveness of calciferol or calcitriol Vitamin D substances in reducing fatigue and relapses when taken by itself or in combination with Copax. Vita D dose range is 0.003 to 80 mg per week (IV or oral?)
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hrfjc, nice find! (hrfjc is so long, mind if I just call you "h"?) I've been wondering about that study. The full results don't appear to be available, but this is more than I've seen anywhere else.


STUDY MEDICATION
Subjects are treated with a daily dose of copaxone in combination with a twice daily dose of 2.5 g of NAC.

RESULTS
Patients treated with COPAXONE and N-acetylcysteine or a pharmaceutically acceptable salt thereof exhibit a reduction in the total number of T1 Gd-enhancing lesions well as a reduction of new T2 lesions. Relapsing remitting multiple sclerosis patients also exhibit a reduction in the progression of brain atrophy.

http://www.wipo.int/pctdb/en/wo.jsp?wo= ... SPLAY=DESC

Interesting stuff. This study: http://www.ncbi.nlm.nih.gov/pubmed/17786245 is listed in the wiki article on NAC as being evidence for adverse reactions. Any idea how high the dosage was there?

Copaxone ®
(glatiramer acetate)

MS Drugs - Copaxone ® Efficacy
(Effectiveness of Copaxone ®)

How effective is Copaxone ®?
% of patients relapse free at 2 years

Placebo 27%

Copaxone ® 34%



Number of patients progression free† completing 2 years of Copaxone ®

% of patients progression free at 2 years

Placebo 75%

Copaxone ® 78%



Mean relapse rate

Mean relapse rate over 2 years

Placebo 1.68

Copaxone ® 1.19


Average time to first relapse

Average number of days till first relapse

Placebo 198 days Copaxone ® 287 days


† Progression is defined as an increase in at least 1 point in the DSS (Kurtzke Expanded Disability Scale) for at least 3 consecutive months


Ref: Copaxone® prescribing information


Reviewed July 2004