EntreMed, Inc. (Nasdaq: ENMD), today announced the presentation of data for its Phase 2 oncology drug candidate, ENMD-2076 an Aurora A/angiogenic kinase inhibitor. Data from the Phase 1 studies with ENMD-2076 in patients with multiple myeloma and relapsed or refractory leukemia were presented by EntreMed investigators during poster sessions at the 2010 American Society of Hematology (ASH) Annual Meeting being held December 4-7 in Orlando, Florida. The ongoing multi-center Phase 2 study with ENMD-2076 in ovarian cancer patients is progressing as planned.
Interim results from the Phase 1 study with ENMD-2076 in relapsed or refractory multiple myeloma (MM) patients were presented by principal investigator, Dr. Sherif Farag, Indiana University Simon Cancer Center. Data showed that daily oral administration of ENMD-2076 was well tolerated. No dose limiting toxicities (DLT) were observed in this heavily pre-treated patient population. Of the nine evaluable patients, three patients had stable disease and one patient achieved a partial response. Pharmacodynamic studies in this trial are ongoing and include examination of the effects of ENMD-2076 on markers of angiogenesis as well as on key survival pathways important in MM progression such as the PI3 kinase pathway.
Results for the ENMD-2076 Phase 1 study in patients with relapsed or refractory leukemia were presented by principal investigator, Dr. Karen Yee, Princess Margaret Hospital, Toronto. Data for 20 evaluable patients demonstrated that daily oral administration of ENMD-2076 was associated with reductions in bone marrow blast counts of 11%, 14%, 23%, and 65%. One patient achieved a CRi (complete remission with incomplete hematological recovery) and three patients achieved a morphologic leukemia-free state (MLFS). Analysis of signaling pathways in residual blast cells of the patient exhibiting a CRi indicate a striking inhibition of constitutive pSTAT5, consistent with inhibition of mutant FLT3 signaling, as well as significant inhibition of stem cell factor-activated kinase S6, ERK, and Akt, all of which are consistent with c-Kit inhibition during treatment with ENMD-2076.
“These data will be instrumental in evaluating additional indications for Phase 2 trials beyond our ongoing Phase 2 study in ovarian cancer patients,” commented Dr. Carolyn F. Sidor, EntreMed’s Vice President and Chief Medical Officer. “The Phase 1 data in both our hematological and solid tumor studies demonstrate ENMD-2076’s potential therapeutic value in a variety of tumor types. In the Phase 1 studies, ENMD-2076 has shown responses in patients with AML, multiple myeloma, and ovarian cancer. Other patients have had tumor reductions or prolonged stable disease with a variety of cancers including hepatocellular, renal cell, neuroendocrine, breast, melanoma and colorectal cancer supporting the activity of ENMD-2076 in treating many types of cancer.”
SOURCE EntreMed, Inc.