MN-166
Posted: Wed Apr 02, 2008 4:44 am
Good news, it looks like MN-166 successfully completed its phase 2 trial and will move to phase 3. I like that one of the measures they used was disability progression. Interesting that there isn't even a mention of relapses in this press release. I assume that means it had no effect.
MN-166 Slows Disability Progression; Significant Neuroprotective Effects Observed by MRI
April 7, 2008 - MediciNova today announced positive clinical findings from the completed two-year Phase II clinical trial of orally administered MN-166 for the treatment of multiple sclerosis (MS). The second year findings expand upon the results from the first year of this study reported previously.
MN-166 treatment resulted in positive findings on three independent measures indicative of a potential disease-progression modifying effect. The findings include:
* Sustained disability progression was significantly less
likely (by approximately 50 percent) in those patients
receiving MN-166 at either 30 or 60 mg per day for 24 months
than in those patients receiving the drug for 12 months
(p=0.026). Sustained disability progression was measured
as a greater than or equal to 1.0 point increase from
baseline in the Expanded Disability Status Scale (EDSS)
score for four consecutive months. This positive clinical
finding was corroborated by positive findings on two separate
radiologic measures.
* The clinical trial demonstrated that the significant reduction
in brain volume loss (p=0.035), as measured by cranial magnetic
resonance imaging (MRI) scans, observed after 12 months in
patients treated with 60 mg per day of MN-166 compared to
placebo was again demonstrated in year two of the study. Brain
volume loss was significantly less (p=0.030) in patients
receiving 60 mg per day of MN-166 for 24 months compared to
the other treatment groups (for more information on Percent
Brain Volume loss for each of the treatment groups in year
two of the study, see
http://media.primezone.com/cache/7767/file/5480.jpg
* MN-166 treatment at 60 mg per day significantly reduced the
relative risk for conversion of new inflammatory lesions
identified at month two to Persistent Black Holes (PBH), an
MRI indicator of neuronal loss, eight months later at month
ten by 37 percent (p=0.011); such lesions that remain
unchanged for eight months are considered PBHs as compared
to transient inflammatory lesions that are more closely
associated with relapses. MN-166 treatment at 30 mg per day
resulted in a trend toward reducing evolution to PBH (p=0.074).
Loss of brain volume and development of PBHs on MRI have been
shown to correlate with clinical progression and disability
in MS patients.
MN-166 was well tolerated at all doses over the 24 months of this clinical trial. Of the 297 patients enrolled in the study, 82.5 percent, or 245 patients, completed the full 24 months of the study. The most common adverse events possibly related to MN-166 included mild, transient gastrointestinal disturbances and depression.
"After an extensive review of these data our Scientific Advisory Board recommended that MN-166 be advanced into pivotal-design studies with clinical and MRI evaluations of MS progression as the primary objectives," said Yuichi Iwaki, M.D., Ph.D., President and Chief Executive Officer of MediciNova, Inc. "The significant favorable effects on measures of disability progression and reduced neuronal damage observed in this study are quite exciting and representative of the type of new treatment being sought by the MS scientific community according to our advisors. We are excited to be part of advancing MS treatment in a new direction and look forward to confirming these findings in future clinical trials with the assistance of a corporate partner."
The two-year randomized, double-blind, placebo-controlled Phase II clinical trial included 297 patients with relapsing MS. In the second year of the study, all patients were on drug. Patients who received 30 or 60 mg of MN-166 per day during the first 12 months of the study remained on the assigned dose for the second 12 months of the study; patients who received placebo during the first 12 months of the study were randomized to receive either 30 or 60 mg of MN-166 per day (double-blind maintained) during the second 12 months of the study. Clinical and radiological outcomes were evaluated.
http://www.primenewswire.com/newsroom/n ... l?d=139633
