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developed by Roche; EntreMed has an exclusive worldwide license to
develop and commercialize the drug.
-- MKC-1 is currently in multiple Phase 1 and Phase 2 clinical trials,
including metastatic breast cancer (MBC), non-small cell lung cancer
(NSCLC), hematological cancers, ovarian and endometrial cancer, and
pancreatic cancer. Milestones for MKC-1 in 2008 include reporting
results for the single agent MKC-1 MBC study (2Q08); presentation of
interim data for MKC-1/Alimta combination study in NSCLC (2Q08);
presentation of Phase 1 data for MKC-1 in hematological cancers (2H08);
initiation of a Phase 1 MKC-1 continuous dosing study (2Q08); and
presentation of interim data for a Phase 2 study in pancreatic cancer
(4Q08).
-- ENMD-1198 is a potent, orally-active, antimitotic agent discovered at
EntreMed that causes cell cycle arrest and apoptosis in tumor cells.
ENMD-1198 has shown pronounced antitumor activity and survival
increases in multiple preclinical models, including a substantial
decrease in tumor cell proliferation and angiogenesis in a breast
cancer model; synergistic effects in combination with vincristine that
prolonged survival in preclinical leukemia models; and a three-fold
increase in survival compared to standard-of-care Cisplatin in a
preclinical NSCLC model.
-- A Phase 1b dose-escalation clinical trial is currently underway to
evaluate ENMD-1198 in patients with refractory solid tumors. Completion
of the study is expected around mid-2008 with a further trial expected
in the second half of 2008. ENMD-1198 milestones for 2008 include
completion of Phase 1b enrollment (2Q/3Q08); initiation of an expanded
Phase 1 or Phase 2 trial (3Q/4Q08); and the reporting of data for the
Phase 1b clinical
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