ROCKVILLE, Md., Jan. 25 /PRNewswire-FirstCall/ -- EntreMed, Inc. , a clinical-stage pharmaceutical company developing therapeutics for the treatment of cancer and inflammatory diseases, today announced that it has initiated Phase 2 studies with MKC-1. The single-arm, open-label study will be conducted at approximately 15 centers in the United States. Patients with advanced or metastatic breast cancer who have failed conventional therapies are expected to be enrolled. MKC-1 is a novel, orally- active, small molecule cell cycle inhibitor with a unique mechanism of action. Specifically, MKC-1 arrests cellular mitosis by inhibiting an intracellular target important in cellular trafficking that has been shown to be involved in cell division.
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MKC-1 belongs to a novel class of antimitotics and apoptosis-inducers with in vitro efficacy against a wide range of tumor cell lines, including those exhibiting multi-drug resistance, as well as in vivo activity against a number of multi-drug resistant cell lines. 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 in multiple cell lines, consistent with a mechanism in which MKC-1 blocks the nuclear uptake of proteins essential to cell replication.
MKC-1 has demonstrated broad-acting antitumor effects in multiple animal models, including paclitaxel-resistant models. MKC-1 was evaluated in several Phase 1 and 2 clinical studies prior to its acquision by Miikana. These studies resulted in extensive pharmacokinetic and safety data.
S. Gail Eckhardt, M.D., Professor of Medicine at the University of Colorado Heath Sciences Center and cofounder of Miikana Therapeutics commented on the initiation of the study, “The initiation of this trial represents an important milestone in the development of MKC-1. A careful review of previous clinical data in 269 patients who participated in earlier Phase 1 and 2 clinical studies led to the conclusion that the recommended Phase 2 dose of MKC-1 on a 14-day schedule could be administered safely to advanced cancer patients, in contrast to earlier studies that resulted in excessive toxicity (4-day schedule) and an a priori reduction of the dose in the phase 2 NSCLC and breast cancer studies. Even at a lower dose than that recommended in Phase 1, a prior Phase 2 study involving 35 advanced breast cancer patients showed evidence of antitumor activity on the 14-day schedule, including two partial responses (10 and 14 months), two minor responses, and four patients with stable disease for four or more cycles.”
Carolyn F. Sidor, M.D., M.B.A., EntreMed’s Vice President and Chief Medical Officer, said, “We are pleased to hit the ground running with the Miikana team. The addition of MKC-1 to EntreMed’s clinical pipeline is consistent with our expertise in cell cycle regulation and our continuing emphasis on anticancer agents with novel mechanisms of action.” According to Sidor, EntreMed, on a combined basis in 2006, will have two oncology product candidates in Phase 2 studies (currently MKC-1 in breast cancer and Panzem(R) NCD in glioblastoma with other indications planned for both compounds in 2006). In addition, EntreMed’s pipeline includes a Phase 1 oncology compound (ENMD-1198), together with a preclinical pipeline of novel compounds, including 2ME2 for the treatment of rheumatoid arthritis, an aurora kinase inhibitor in oncology, and an HDAC inhibitor in oncology.
James S. Burns, EntreMed President and Chief Executive Officer, concluded, “MKC-1 is our second product candidate to enter Phase 2 clinical trials this year. As a result, we have strengthened our clinical portfolio and repositioned EntreMed as a solid mid-stage clinical oncology company. Going forward, we will continue to maintain a lean infrastructure in support of our key clinical and preclinical programs, focusing internally where we can provide unique value and outsourcing what is readily available. On a consolidated basis, including taking the Miikana acquisition into account, we anticipate that our 2006 net operating expenses will be approximately $30 million which is an increase over 2005 and associated directly with advancing our clinical and preclinical programs.”
For information on this study, visit the Clinical Trials section of the Company’s web site at http://www.entremed.com.
About EntreMed
EntreMed, Inc. is a clinical-stage pharmaceutical company developing therapeutic candidates primarily for the treatment of cancer and inflammation. Panzem(R) NCD (2-methoxyestradiol or 2ME2), the Company’s lead drug candidate, is currently in clinical trials for cancer, as well as in preclinical development for rheumatoid arthritis. 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. Additional information about EntreMed is available on the Company’s website at http://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, 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; risks associated with the integration of Miikana and its 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).
CONTACT: James Moore EntreMed Communications (202) 258-0776
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CONTACT: James Moore of EntreMed Communications, +1-202-258-0776
Web site: http://www.entremed.com/
