EntreMed Commences Phase 2 Study With MKC-1 in Ovarian/Endometrial Cancers
Multi-Center Clinical Trial to be Conducted in Canada
ROCKVILLE, MD, January 23, 2008 â€“ EntreMed, Inc. (Nasdaq: ENMD), a clinical-stage pharmaceutical company developing therapeutics for the treatment of cancer and inflammatory diseases, today announced the commencement of a Phase 2 study with its novel cell cycle inhibitor, MKC-1, in recurrent or resistant epithelial ovarian cancer and advanced endometrial cancer patients. The study will be conducted at multiple sites in Canada with Dr. Amit Oza, Senior Staff Physician and Associate Professor of Medicine, Princess Margaret Hospital, University of Toronto, serving as the principal investigator.
The primary objective of this Phase 2 study will be to determine the antitumor activity of MKC-1 administered orally as a single agent in platinum or taxane refractory ovarian and endometrial cancer patients. In addition, safety, response duration in patients with an objective response, and progression free survival (PFS) will also be assessed. The study will be a two arm parallel group design with each group having two stages.
MKC-1 is a novel, orally-active cell cycle inhibitor with in vitro and in vivo efficacy against a broad range of human solid tumor cell lines, including multi-drug resistant cell lines. Data from previous studies with MKC-1 demonstrate broad-acting antitumor effects, showing tumor growth inhibition or regression in multiple preclinical models, including paclitaxel-resistant models.
MKC-1 has been shown to inhibit mitotic spindle formation, prevent chromosome segregation in the M-phase (mitosis) of the cell cycle, and induce apoptosis. Furthermore, MKC-1 inhibits the Akt-mTOR signaling pathways, which may occur through inhibition of the mTOR/rictor pathway. The Akt-mTOR pathway is the most frequently mutated pathway in human tumors and mutations have been shown to promote tumor progression and decrease survival in cancer patients.
â€œCommencement of this Phase 2 multi-center study represents the continuation of our focus on the development of MKC-1 in diseases where, based on its mechanism of action, we would expect activity,â€ commented Carolyn F. Sidor, M.D., M.B.A., EntreMedâ€™s Vice President and Chief Medical Officer. â€œWe now have five clinical trials underway to test the safety and efficacy of MKC-1 in solid and hematological cancers, including two clinical development programs in Canada. We expect to invest in further clinical trials during 2008 to test the extent of MKC-1â€™s clinical utility in multiple tumor types.â€
About Ovarian and Endometrial Cancers
Ovarian cancer accounts for 4% of all cancers among women in the United States, and ranks fifth as the cause of cancer deaths. The American Cancer Society estimates that there will be approximately 22,000 newly diagnosed cases of ovarian cancer in the U.S. in 2007 resulting in approximately 15,000 deaths. About half of all ovarian cancers occur in post-menopausal women. Ovarian cancer is frequently asymptomatic in the early stages. As a result, ovarian cancer is often not diagnosed until stage III or IV, where 5-year survival rates decline to 10-20%. Current drug therapy involves paclitaxel and carboplatin/cisplatin regimens. Many patients develop resistance to these drugs, so there is substantial need for innovative therapies that can overcome resistance, either as a single agent or in combination with approved chemotherapeutic agents.
Endometrial cancer, the most common cancer found in womenâ€™s reproductive organs, starts in the inner lining of the uterus (endometrium). The American Cancer Society estimates that there will be approximately 39,000 new cases of cancer of the uterine body diagnosed in the U.S. in 2007, resulting in approximately 7,400 deaths. There are currently four basic types of treatment for endometrial cancer including surgery, radiation, hormone therapy, and chemotherapy, of which surgery is the most common treatment.
EntreMed, Inc. is a clinical-stage pharmaceutical company developing therapeutic candidates primarily for the treatment of cancer and inflammation. MKC-1 is currently in multiple Phase 2 clinical trials for cancer. MKC-1 is an oral cell-cycle regulator with activity against the mTOR pathway. PanzemÂ® (2-methoxyestradiol) NCD is also in multiple Phase 2 studies in oncology patients. Additionally, ENMD-1198, a novel tubulin-binding agent, is in Phase 1 studies in advanced cancers. The Company has approved IND applications for PanzemÂ® in rheumatoid arthritis, and ENMD-2076, a dual-acting Aurora-angiogenesis inhibitor, for cancer. EntreMed’s goal is to develop and commercialize new compounds based on the Company’s expertise in angiogenesis, cell-cycle regulation and inflammation â€“ processes vital to the treatment of cancer and other diseases, such as rheumatoid arthritis. Additional information about EntreMed is available on the Companyâ€™s web site at www.entremed.com and in various filings with the Securities and Exchange Commission.
Forward Looking Statements
This release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act with respect to the outlook for expectations for future financial or business performance (including the timing of royalty revenues and future R&D expenditures), strategies, expectations and goals. Forward-looking statements are subject to numerous assumptions, risks and uncertainties, which change over time. Forward-looking statements speak only as of the date they are made, and no duty to update forward-looking statements is assumed. Actual results could differ materially from those currently anticipated due to a number of factors, including those set forth in Securities and Exchange Commission filings under “Risk Factors,” including risks relating to the need for additional capital and the uncertainty of additional funding; variations in actual sales of ThalomidÂ®, risks associated with the Companyâ€™s product candidates; the early-stage products under development; results in preclinical models are not necessarily indicative of clinical results, uncertainties relating to preclinical and clinical trials; success in the clinical development of any products; dependence on third parties; future capital needs; and risks relating to the commercialization, if any, of the Company’s proposed products (such as marketing, safety, regulatory, patent, product liability, supply, competition and other risks).
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