Orphan Drug Designation and Canadian CTA Accelerate ENMD-2076 Program Momentum
ROCKVILLE, Md., Feb. 9 /PRNewswire-FirstCall/ -- EntreMed, Inc. (Nasdaq: ENMD), a clinical-stage pharmaceutical company developing therapeutics for the treatment of cancer and inflammatory diseases, today announced recent developments in its program for ENMD-2076, an Aurora A/angiogenic kinase inhibitor. These developments include the presentation of initial results for a Phase 1 study in patients with refractory solid tumors as well as preclinical data showing significant potential for the use of ENMD-2076 in combination with platinum-based chemotherapy in breast cancer. In addition, EntreMed has received an Orphan Drug Designation from the FDA for the treatment of multiple myeloma using ENMD-2076. To further enhance its clinical development efforts for the drug candidate, a No Objection Letter was received by EntreMed from Health Canada permitting ENMD-2076 to be used in clinical trials within Canada. Data for the Phase 1 study in solid tumors, which is being conducted at the University of Colorado Cancer Center and the Dana-Farber Cancer Institute, were presented by Jennifer Diamond, M.D., during an oral presentation at the 11th International Symposium on Anti-Angiogenic Agents held last week in San Diego, California. Dr. Diamond is a Hematology/Oncology Fellow, working in the Developmental Therapeutics Program of the University of Colorado.
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Results from the ongoing Phase 1 study in patients with refractory solid tumors demonstrated that ENMD-2076 administered orally in 28-day cycles was well tolerated. Data show preliminary evidence of antitumor activity as determined by reduction in tumor markers in ovarian and colorectal cancer patients. Dose escalation continues to determine the primary endpoints of the study, safety, pharmacokinetics and a Phase 2 dose.
During the symposium, EntreMed's Senior Director, Translational Research, William E. Fogler, Ph.D., presented results from a preclinical evaluation of ENMD-2076 in combination with cisplatin in a multi-drug resistant, triple-negative human breast carcinoma model. Triple-negative breast cancer is a specific subtype of breast cancer that does not express estrogen receptor, progesterone receptor, or Her2 genes. This subtype is more aggressive and less responsive to standard treatment and is also associated with poorer patient prognosis. Data show the combination is well tolerated when using a maximally tolerated dose of cisplatin and a range of ENMD-2076 doses.
