Got this in an MS e-mail this morning.......More good news about Antegren.....Kim
Antegren Could Be Available in US as Early as 2005
Thought there were no new MS drugs on the horizon? Think again. In February, drug manufacturers Biogen and Elan jointly announced that they will file for FDA approval of Antegren (natalizumab) in mid-2004, a year earlier than scheduled. That means that the novel drug, if approved, could become available in the US as early as 2005.
Antegren is a humanized monoclonal antibody that is the first in a new class of drugs called selective adhesion molecule inhibitors, or SAMs. The mechanism of action is different from current ABCR drugs in that Antegren is designed to selectively inhibit immune cells from leaving the bloodstream and migrating into tissue. In MS, it is thought that the drug prevents white blood cells from entering and attacking the brain, causing lesions. Antegren is also being tested in other autoimmune disorders, including Crohn’s disease and rheumatoid arthritis.
Biogen and Elan garnered an accelerated FDA approval timeline for Antegren in MS based on the preliminary data from two Phase III clinical trials scheduled to conclude at the end of the 2004. Although the data from the first year results has not been released, industry analysts suggest that it must be strong to warrant the expedited schedule. Both trials are two-year, randomized, multi-center, placebo-controlled, double blind studies with the drug being administered by intravenous infusion once a month.
The AFFIRM (Antegren Safety and Efficacy in Relapsing-Remitting MS) trial is designed to determine whether Antegren slows the rate of relapses, while the SENTINEL trial (Safety and Efficacy of Antegren in Combination with Avonex) is investigating whether the combination of the two drugs is more effective than Avonex alone. Approximately 900 patients with relapsing-remitting multiple sclerosis (RRMS) are enrolled in the AFFIRM trial and approximately 1,200 in the SENTINEL trial.
Biogen and Elan’s announcement isn’t the only good news either. Excitement about Antegren’s potential efficacy in MS has been building since January, when a favorable six-month study from the UK was published in the New England Journal of Medicine. See our subsequent article, UK Study Finds Antegren Markedly Reduces Lesions in MS, for more details.
Back to the Top
UK Study Finds Antegren Markedly Reduces Lesions in MS
As previously described, the MS community is eagerly awaiting the results of the Phase III clinical trials of Antegren (natalizumab) in order to fully gauge the drug’s effectiveness. But in the interim, a small study published in the January 2nd issue of the New England Journal of Medicine has offered a vote of confidence for the drug, particularly its ability to reduce the development of new brain lesions. (1)
Researchers from the Institute of Neurology in London observed 213 patients with RRMS for six months in a randomized, double-blind trial. Patients were randomly assigned to receive an inactive placebo, 3 mg/kg of intravenous Antegren, or 6 mg/kg of intravenous Antegren every 28 days. The study’s primary endpoint was the number of new brain lesions as detected by monthly gadolinium-enhanced MRIs, although researchers also recorded the number of relapses during the study period and surveyed the patients as to their sense of well-being.
At the end of the six months, the investigators found a dramatic and statistically significant reduction in the mean number of new lesions in the two groups given Antegren (0.7 relapses per patient for 3 mg/kg, 1.1 relapses per patient for 6 mg/kg) as compared to the placebo group (9.6 relapses per patient). That means that for the groups given the active drug, approximately 65-75% of patients (depending on the dosage administered) had no new lesions develop during the study period.
The other study measurements reflected positively on Antegren as well. Patients receiving Antegren reported an improvement in well-being at the completion of the study, while those in the placebo group reported a slight worsening. The Antegren-treated patients also experienced fewer relapses than did the placebo group: 13 relapses and 14 relapses, respectively, among the two Antegren dosage groups, compared to 27 relapses in the placebo group.
Further research is needed to confirm the results of this trial as well as demonstrate continued benefit and safety during long-term use of the drug. But should the Phase III clinical trials return similar results in a larger number of patients over a longer period of time, Antegren could potentially prove more effective than any immunomodulator drug currently on the market.
(1) Miller DH, Khan OA, Sheremata WA, et al. A controlled trial of natalizumab for relapsing multiple sclerosis. N Engl J Med 2003 Jan 2; 348(1); 15-23.