Phase 1 Study to be Conducted in Advanced Cancer Patients
ROCKVILLE, Md., April 2, 2008 /PRNewswire-FirstCall/ -- EntreMed, Inc. (Nasdaq: ENMD), a clinical-stage pharmaceutical company developing therapeutics for the treatment of cancer and inflammatory diseases, today announced that it has commenced a Phase 1, open-label, continuous dosing study with its oral cell cycle inhibitor, MKC-1, in patients with advanced or metastatic solid tumors. The clinical trial will be conducted at the University of Wisconsin, Paul P. Carbone Comprehensive Cancer Center. Dr. Glenn Liu, Assistant Professor of Medicine, University of Wisconsin, will serve as principal investigator.
The purpose of the dose-escalation trial is to determine the maximum tolerated dose (MTD) of MKC-1 administered orally twice a day continuously in advanced or refractory solid tumor patients. Response and/or tumor marker improvement will also be evaluated. Up to 24 patients with metastatic or unresectable solid tumors for which standard curative measures do not exist or are no longer effective will be enrolled.
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. To date, MKC-1 has been evaluated in over 400 patients in multiple Phase 1 and 2 clinical trials.
MKC-1 has been shown to induce apoptosis, inhibit mitotic spindle formation, and prevent chromosome segregation in the M-phase (mitosis) of the cell cycle. Furthermore, MKC-1 inhibits the PI3K-Akt-mTOR signaling pathways, which may occur through inhibition of the mTOR/rictor pathway. The PI3K-Akt- mTOR pathway is the most frequently mutated pathway in human tumors. Mutations in this pathway have been shown to promote tumor progression and decrease survival in cancer patients.
"The potential of increasing drug activity by exploiting its inhibitory effects on the PI3K-Akt-mTOR pathway is exciting and we hope to define this effect with novel molecular imaging techniques," commented Dr. Glenn Liu.
EntreMed Vice President and Chief Medical Officer, Carolyn F. Sidor, M.D., M.B.A., commented on the study, "This will be our first continuous dosing study for MKC-1 in patients with solid tumors. We believe that a continuous dosing schedule has the potential to improve tolerability and enhance MKC-1 activity in cancer patients, similar to increased antitumor activity that sustained exposure has demonstrated in preclinical studies. Through this Phase 1 study, we expect to determine not only the maximum tolerated dose of MKC-1 when administered orally twice a day on a continuous basis, but the pharmacodynamic changes using imaging techniques as proof of drug effect and assessment of toxicity."
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. ENMD-1198, a novel antimitotic agent, is in a Phase 1 study in advanced cancer patients and ENMD-2076, a selective kinase inhibitor, is expected to begin a Phase 1 study in 2Q08. The Company also has an approved IND application for Panzem(R) in 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 web site at http://www.entremed.com and in various filings with the Securities and Exchange Commission.
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Associate Director, Corporate Communications & Investor Relations
|SOURCE EntreMed, Inc.|
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