Hologic receives FDA approval for hydroxyprogesterone caproate injection

January 09, 2016

Dr. Mark Bray, Vice President Research at EntreMed, commented on the publications, "It is extremely gratifying to have the early preclinical data for ENMD-2076 in print concurrently with the exciting results from the Phase 1 clinical trials that have been presented and published. The Molecular Cancer Therapeutics manuscript is the culmination of several intensive years of work by a dedicated team, who were able to show through a series of rigorous experiments that ENMD-2076 is a highly active, well-tolerated compound with a novel mechanism of action involving both antiangiogenic and antiproliferative components.  Information obtained through the course of this research has been invaluable in designing and interpreting correlative studies within our ongoing clinical trials."

EntreMed initiated a multi-center Phase 2 study for ENMD-2076 in ovarian cancer patients in 2010.  Ovarian cancer was selected as the initial Phase 2 indication based on results from the Phase 1 study in patients with solid tumors in which the clinical benefit of ENMD-2076 was observed in this patient population. Recently, the Company completed enrollment for the Phase 2 study in ovarian cancer patients and, once the data have been analyzed, intends to present results of the study at an upcoming scientific meeting.

As previously announced, data from the Phase 1 studies in multiple myeloma and leukemia were presented during the American Society of Hematology meeting in December 2010.  Of nine evaluable patients who participated in the Phase 1 study with ENMD-2076 in multiple myeloma, three patients had stable disease and one patient achieved a partial response. The study continues to enroll patients.  In the Phase 1 study in patients with relapsed or refractory leukemia, results for 20 evaluable patients showed that ENMD-2076 was associated with anti-leukemia activity.  One patient achieved a durable CRi (complete remission with incomplete hematological recovery) and three patients achieved a morphologic leukemia-free state (MLFS).  An additional 4 patients had reductions in bone marrow blast counts of 11%, 14%, 23%, and 65%.  

SOURCE EntreMed, Inc