EntreMed, Inc., a clinical-stage pharmaceutical company, has started a single-centre phase II study entitled “A phase II study of oral ENMD-2076 administered to patients with advanced/metastatic soft tissue sarcoma” at Princess Margaret Hospital where the study is led by Malcolm Moore, MD and Albiruni RA Razak, MD. The study is sponsored by Princess Margaret Cancer Centre.

Albiruni RA Razak, MD, commented on the study, “Soft tissue sarcomas (STS) are diverse mesenchymal tumors that commonly affect patients in the prime of life. The prognosis for patients with advanced/metastatic sarcoma remains poor and there are limited options for their treatment. The median disease progression-free survival (PFS) for those patients is less than two months without treatment or less than five months with treatments currently available. This is certainly an area of unmet medical need. The primary objective of this phase II study is to evaluate the safety and efficacy of ENMD-2076 in advanced/metastatic STS patients with the six month PFS rate as the end point of the study. We will also perform biomarker correlative studies that may define patients with a superior/inferior progression free survival. A number of pre-clinical and clinical investigations have provided encouraging results for the use of ENMD-2076 in the treatment of various types of cancer, including sarcoma. We believe the co-inhibition of Aurora kinase A and angiogenesis would render ENMD-2076 an attractive and logical treatment for sarcoma.”

Ken K Ren, Ph.D., EntreMed’s chief executive officer commented, “We are excited about the initiation of this trial. We believe ENMD-2076 has good potential in the treatment of sarcoma along with other oncology indications. In our phase I trial in solid tumours, we had one patient with advanced/metastatic sarcoma relapse after multiple lines of previous therapies, however after being treated with ENMD-2076, the patient had prolonged disease PFS for 21 months. This phase II trial will enable us to explore the potential of ENMD-2076 for this indication further. We look forward to our continued advancement and development of ENMD-2076 as an oncology platform.”

ENMD-2076 is an orally-active, Aurora A/angiogenic kinase inhibitor with a unique kinase selectivity profile and multiple mechanisms of action. 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. ENMD-2076 has shown promising activity in phase I clinical trials in solid tumour cancers, leukaemia, and multiple myeloma. ENMD-2076 is currently completing a phase II trial for ovarian cancer. EntreMed, Inc. recently initiated a dual-institutional phase II study of ENMD-2076 in triple-negative breast cancer.