(MBP8298) on an un-blinded basis. To date, approximately 95% of
patients enrolled in MAESTRO-01 have proceeded to MAESTRO-02.
- MAESTRO-03: A U.S. pivotal phase III trial evaluating dirucotide
(MBP8298) for the treatment of SPMS. Enrollment for the randomized,
double-blind study was initiated in June, 2007 and to date there have
been in excess of 375 patients enrolled. The trial will include
approximately 510 patients at approximately 68 sites across the U.S.
To date, the DSMB has conducted two reviews of the data from this
trial and has recommended it continue. The trial is expected to
complete enrollment in mid-2008.
- MINDSET-01: A phase II clinical trial evaluating dirucotide (MBP8298)
for the treatment of relapsing-remitting MS (RRMS). The randomized,
double-blind study has completed recruitment with 218 patients
enrolled at 24 trial sites in 6 countries across Europe. The DSMB has
completed three safety analyses to date and recommended that the
trial continue as per the protocol. Completion of the trial is
expected at the end of 2008 with results anticipated in the first
half of 2009.
Licensing and Development Agreement
On December 17, 2007, BioMS entered into a licensing and development
agreement granting Eli Lilly and Company exclusive worldwide rights to
dirucotide (MBP8298). Under the terms of the agreement, Lilly and BioMS
will collaborate on the development of dirucotide (MBP8298) and will also
share in certain development costs with Lilly being responsible for future
research and development, manufacturing and marketing activities. The
transaction closed on January 25, 2008 with the receipt of an upfront
payment of US$87 million. BioMS has the potential to receive additional
development and sales milestones of up to US $410
|SOURCE BioMS Medical Corp.|
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