MB07133 is in clinical development for the treatment of primary liver cancer, a deadly disease for which
there are currently no FDA-approved drug therapies. MB07133 uses our HepDirect technology to target
an activated form of the leukemia drug, cytarabine, to the liver, while decreasing levels in tissues outside of
the liver. We believe that by directly delivering an activated form of cytarabine to the liver, we can effectively
target the tumor cells while potentially reducing or avoiding extra-hepatic side effects such as bone marrow
suppression and gastrointestinal side effects.
We completed a Phase 1/2 dose escalation clinical trial for MB07133 in 28 patients by the end of the year
and preliminary results were presented at the 2006 American Society of Clinical Oncology meeting. Results
of the clinical trial indicated that MB07133 at doses up to 2400 mg/m2/day IV infusion was well tolerated
in patients with primary liver cancer and that there were no clinically significant dose-limiting toxicities
associated with MB07133. Although this Phase 1/2 clinical trial was not designed to demonstrate the efficacy
of MB07133, encouraging signs of drug activity were observed, including evidence of disease stabilization
and tumor shrinkage in some patients who received multiple cycles of the product candidate. These results
are considered promising, given the usual deadly progression of primary liver cancer. The next clinical trial
for MB07133 is expected to start after discussions with the FDA regarding the future development of the
product candidate, likely later in 2007.