ROCKVILLE, MD, September 26, 2006 -- EntreMed, Inc. (NASDAQ: ENMD), a clinical-stage pharmaceutical company developing therapeutics for the treatment of cancer and inflammatory diseases, today announced commencement of a Phase 1 study with its clinical-stage drug candidate, MKC-1, in patients with hematological (blood) malignancies. The study will be conducted at the University of Texas MD Anderson Cancer Center in Houston, Texas. Francis J. Giles, M.D., Professor, Department of Leukemia at the MD Anderson Cancer Center, will serve as Principal Investigator. MKC-1 is also being evaluated currently in a Phase 2 clinical study in patients with metastatic breast cancer.
Patients with relapsed or refractory leukemias will be enrolled. At the present time, there is a need for more effective therapies for patients with relapsed or refractory leukemias. MKC-1 has shown good activity against a variety of hematological cell lines leading to interest in a clinical trial in patients with leukemias.
MKC-1 is a novel, orally active cell cycle inhibitor with in vitro and in vivo efficacy against a wide range of human solid tumor cell lines, including multi-drug resistant cell lines. MKC-1 has demonstrated broad-acting antitumor effects, showing tumor growth inhibition or regression in multiple animal models, including paclitaxel-resistant models. In addition to the strong preclinical activity of MKC-1 towards solid tumor lines, the lack of neuropathy and cardiotoxicity seen in clinical trials suggests that MKC-1 may also be valuable in the treatment of hematological cancers.
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. These effects are consistent with a mechanism resulting from MKC-1 binding to its intracellular targets, tubulin and the importin β proteins. The importin β family of proteins plays a critical role in nuclear transport and cell division.
Carolyn F. Sidor, M.D., M.B.A., EntreMed’s Vice President and Chief Medical Officer, commented, “Initiation of this clinical trial represents continued progress on our clinical development plan for MKC-1. This is the first clinical study where MKC-1 will be given to patients with hematological cancers. These patients may be particularly suited for MKC-1 treatment based on MKC-1’s mechanisms of action. MD Anderson is well-known for its expertise in hematological cancers and Dr. Giles has substantial experience in evaluating new therapies in this patient population.”
For information on this study, visit the Clinical Trials section of the Company’s web site at www.entremed.com.
About Hematological Malignancies
Hematological malignancies are cancers that affect blood, bone marrow and lymph nodes. As the blood, bone marrow and lymph nodes are intimately connected through the immune system, a disease affecting one of the three will often affect the other. Chromosomal translocations are a common cause of these diseases, which leads to a different approach in diagnosis and treatment. Diseases characterized as hematological malignancies include leukemia, lymphoma and multiple myeloma.
EntreMed, Inc. (NASDAQ: ENMD) 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 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. Additional information about EntreMed is available on the Company’s website at www.entremed.com and in various filings with the Securities and Exchange Commission.
Forward Looking Statements
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