EntreMed Initiates Phase 2 Study for ENMD-2076 in Ovarian Cancer
No Objection Letter Received from Health Canada
ROCKVILLE, Md., April 13, 2010 - EntreMed, Inc. (Nasdaq:ENMD - News) today announced the initiation of a multi-center Phase 2 study with its lead oncology product candidate, ENMD-2076, in patients with platinum resistant ovarian cancer. The study will be conducted at up to six sites in the United States and Canada. In addition, EntreMed received a No Objection Letter (NOL) from the Therapeutic Products Directorate of Health Canada on its Clinical Trial Application to conduct the Phase 2 clinical trial in ovarian cancer patients. The first study site initiated is Princess Margaret Hospital, University of Toronto, and Dr. Amit Oza, Senior Staff Physician and Professor of Medicine, will serve as principal investigator. Additional sites are expected to join the study during the second quarter.
In this Phase 2 study, patients with platinum resistant ovarian, fallopian or peritoneal cancer will receive ENMD-2076 administered orally as a single agent once a day. The primary objective of the study will be to determine the progression-free survival (PFS) rate of patients at six months. A total of 60 patients are expected to be enrolled in the study. Additional endpoints will include response rate and overall survival.
Ovarian cancer was chosen as the initial indication for a Phase 2 study based on Phase 1 results. In Phase 1, patients (n = 20) with resistant and refractory ovarian cancer treated with single agent, daily, oral ENMD-2076 had a median PFS of 16 weeks. In addition, the combined response rate (using RECIST and CA-125 criteria) is 40% (8/20) with an objective response rate using RECIST of 10% (2/20) and confirmed CA-125 response rate of 30% (6/20). The median number of prior chemotherapy regimens for these patients was 5. Response to ENMD-2076 was independent of prior therapies including prior bevacizumab therapy.
These results compare favorably with agents currently on the market for the treatment of platinum refractory/resistant ovarian cancer such as liposomal doxirubicin and topotecan that have reported a median PFS of 9.1 and 13.6 weeks respectively. Single agent bevacizumab in a less heavily treated group of ovarian cancer patients was associated with a median PFS of between 4.4 and 4.7 months.
Dr. Oza commented, “We are looking forward to participation in this Phase 2 study with EntreMed and colleagues from sites in the U.S. Research from EntreMed laboratories here in Toronto led to the discovery of ENMD-2076. As such, it is particularly rewarding to be involved in the clinical development of ENMD-2076 and we are encouraged by the data from the Phase 1 patients and its potential to add to treatment options for ovarian cancer patients.”
Carolyn F. Sidor, MD, MBA, EntreMed Vice President and Chief Medical Officer commented on the study, “Initiation of this first Phase 2 study represents a significant achievement in the clinical development strategy for ENMD-2076. We are pleased with the Phase 1 results for ENMD-2076 in patients with ovarian cancer and are encouraged by the overall PFS rate of ENMD-2076 when compared to the current options for this patient population. Additional cancer centers in the U.S. are expected to join Princess Margaret during this quarter. The Phase 1 data also support the fact that ENMD-2076 has activity against several types of cancer and we look forward to expanding its development with additional clinical studies.”
ENMD-2076 is currently in three Phase 1 studies in solid tumors, multiple myeloma, and leukemia. As previously announced, the Company has been granted orphan drug designation for ENMD-2076 in the treatment of ovarian cancer as well as multiple myeloma and leukemia.
ENMD-2076 is an orally-active, Aurora A/angiogenic kinase inhibitor with a unique kinase selectivity profile and multiple mechanisms of action. Preclinical studies with ENMD-2076 demonstrated significant antitumor activity, including tumor regression, in multiple solid and hematological malignancies. ENMD-2076 has been shown to inhibit a distinct profile of angiogenic tyrosine kinase targets in addition to the Aurora A kinase. Aurora kinases are key regulators of mitosis (cell division), and are often over-expressed in human cancers. ENMD-2076 also targets the VEGFR, Flt-3 and FGFR3 kinases which have been shown to play important roles in the pathology of several cancers.
EntreMed, Inc. is a clinical-stage pharmaceutical company committed to developing primarily ENMD-2076, a selective angiogenic kinase inhibitor, for the treatment of cancer. ENMD-2076 is currently in Phase 1 studies in advanced cancers, multiple myeloma, and leukemia. Additional information about EntreMed is available on the Company’s web site at www.entremed.com and in various filings with the Securities and Exchange Commission.
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