EntreMed, a clinical-stage pharmaceutical company, has initiated a single-center phase II study of oral ENMD-2076 in patients with advanced/metastatic soft tissue sarcoma at Princess Margaret Hospital where the study is led by Malcolm Moore, MD and Albiruni R.A. Razak, MD.

Currently, the median disease progression-free survival (PFS) for patients advanced/metastatic soft tissue sarcoma is less than two months without treatment or less than five months with treatment.

The primary objective of the phase II study is to evaluate the safety and efficacy of ENMD-2076 with the six month PFS rate as the end point of the study. EntreMed 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. EntreMed believes the co-inhibition of Aurora kinase A and angiogenesis would render ENMD-2076 an attractive and logical treatment for sarcoma.

“We believe ENMD-2076 has good potential in the treatment of sarcoma along with other oncology indications,” said Ken K. Ren, Ph.D., CEO of EntreMed. “In our phase I trial in solid tumors, 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."