Formulation patent issues for 2ME2 covering diseases characterized by abnormal cell division.

EntreMed, Inc. (Rockville, MD), a clinical-stage pharmaceutical company developing therapeutics for the treatment of cancer and inflammatory diseases, said the issuance of a United States patent covering methods of treatment and formulations for its lead clinical-stage compound, 2-methoxyestradiol (2ME2). Panzem NCD, an oral formulation of 2ME2, is currently in Phase 2 clinical trials for cancer. Panzem is also in preclinical development for rheumatoid arthritis.

Patent No 7,081,477, entitled "Estrogenic Compounds as Anti-Mitotic Agents," contains claims granted by the United States Patent and Trademark Office covering methods of using 2ME2 to treat diseases that are characterized by abnormal cell division (mitosis), including cancer and non-oncology diseases. The claims are independent of mechanism and cover various cancers, tumor metastases, vascular abnormalities, inflammatory and immune disorders, and abnormal angiogenesis that accompanies diseases such as rheumatoid arthritis. The patent also covers multiple formulations for 2ME2. The inventors are Drs. Robert D'Amato and Judah Folkman from Children's Hospital (Boston, MA). Children's Hospital has licensed 2ME2 exclusively to EntreMed.

Panzem (2ME2) is a novel anticancer agent that binds tubulin and works through multiple cellular pathways by disrupting microtubules necessary for rapid cancer cell division (mitosis), inducing programmed cell death (apoptosis), and blocking blood vessels that support tumor growth (angiogenesis inhibition). Results from preclinical studies also support the potential for Panzem as a disease modifying anti-rheumatic drug (DMARD) for the treatment of rheumatoid arthritis (RA). A marked inhibition of tissue and joint damage has been shown following treatment with 2ME2 in preclinical models of established rheumatoid arthritis.

James S. Burns, EntreMed President & CEO, commented, "This patent further expands the intellectual property coverage for Panzem, our lead multi- mechanism drug candidate. We have increasing evidence that 2ME2 has both antitumor and antiinflammatory properties, providing us with potential opportunities to treat diseases such as cancer and rheumatoid arthritis. Since the role of different mechanisms may vary by indication, it is important to have patent coverage that is mechanism-independent. This newly issued patent gives us those mechanism-independent claims. EntreMed's 2ME2 patent estate now covers composition, method, use and formulation patents through 2022."

EntreMed is a clinical-stage pharmaceutical company developing therapeutic candidates primarily for the treatment of cancer and inflammation. Panzem (2-methoxyestradiol or 2ME2), the company's lead drug candidate, is currently in multiple Phase 2 clinical trials for cancer, as well as in preclinical development for rheumatoid arthritis. MKC-1, an oral cell cycle regulator, is in Phase 2 studies for metastatic breast cancer. ENMD-1198, a novel tubulin binding agent, is also in Phase 1 studies in advanced cancers. EntreMed's goal is to develop and commercialize new compounds based on the company's expertise in angiogenesis, cell cycle regulation and inflammation - processes vital to the treatment of cancer and other diseases, such as rheumatoid arthritis.

EntreMed, Inc.

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