Phase 2 Results for EntreMed's Panzem NCD Brain Cancer Study Presented at ASCOSafety and Single-Agent Activity Support Development of Panzem(R) NCD as a Combination Therapy for Glioblastoma Multiforme
ROCKVILLE, Md., June 05, 2007 /PRNewswire-FirstCall/ -- EntreMed, Inc. , a clinical-stage pharmaceutical company developing therapeutics for the treatment of cancer and inflammatory diseases, announces the presentation of results of a single-agent Phase 2 study for Panzem(R) NCD (2ME2) in patients with glioblastoma multiforme (GBM). The data were presented by David A. Reardon, M.D., Associate Deputy Director at The Preston Robert Tisch Brain Tumor Center, Duke University Medical Center and principal investigator for the study, at the American Society of Clinical Oncology (ASCO) Annual Meeting underway in Chicago.
The single-agent, open-label study, conducted at Duke University, was designed to assess the safety, pharmacokinetics and efficacy of Panzem(R) NCD in patients with recurrent GBM who have failed initial therapies. Of the 27 patients enrolled in this study, 78% had received two or more prior cancer agents. Results from this Phase 2 study included one partial response and seven stable diseases. Panzem(R) NCD was well-tolerated with reversible transaminase elevations as the only grade 3 toxicity in more than one patient, and no grade 4 toxicities.
Commenting on the results of the study, Dr. Reardon said, "Panzem(R) NCD was generally well-tolerated and showed modest activity as a single agent. This study and prior preclinical studies support the hypothesis that Panzem(R) NCD could be used in combination with an approved chemotherapeutic agent such as temozolomide (Temodar(R)) in GBM patients to potentially improve outcome further. The Duke University Brain Tumor Center has recently initiated a Phase 2 study of the Panzem(R) NCD/Temodar(R) combination."
Carolyn F. Sidor, M.D., MBA, EntreMed Vice President and Chief Medical Officer, commented, "Our clinical development plan for Panzem(R) NCD in GBM is based on its use in combination with Temodar(R). However, since glioblastoma patients had never been treated previously with Panzem(R) NCD, this single- agent trial was designed to determine safety and activity in a recurrent GBM patient population. The results of the study are consistent with the safety data obtained in our other clinical studies and showed single-agent activity of Panzem(R) NCD, further supporting our rationale for combining Panzem(R) NCD with an approved chemotherapeutic agent. Also, results from in vivo preclinical glioblastoma studies combining Panzem(R) NCD with Temodar(R) demonstrated tumor regression compared with either agent alone. Positive results from the Panzem(R) NCD/Temodar(R) clinical study currently underway at Duke would allow us to evaluate this combination in a larger randomized clinical study as a potential first-line therapy."
Panzem(R) NCD is an orally-administered anticancer agent that attacks tumor cells through multiple mechanisms of action (MOA) and blocks the development of new blood vessels that feed tumor cells. Panzem's MOAs include apoptosis (programmed cell death), tumor cell cycle inhibition at the G2/M phase of mitosis, and disruption of angiogenesis through the inhibition of hypoxia inducible factor-1 alpha (HIF-1alpha), a protein required for angiogenesis and cell survival under stress. By these mechanisms, Panzem(R) has the potential to attack cancer cells through multiple pathways that affect the formation and replication of tumor cells, and can interrupt the formation of blood vessels that nourish tumor cells and sustain tumor growth.
To view the poster presentation of this Phase 2 trial, visit the Recent Presentations section of the Company's web site at www.entremed.com. Temodar(R) is a registered trademark of its owner and Panzem(R) is a registered trademark of EntreMed, Inc.
EntreMed, Inc. is a clinical-stage pharmaceutical company developing therapeutic candidates primarily for the treatment of cancer and inflammation. Panzem(R) (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 various Phase 2 studies for cancer. ENMD-1198, a novel tubulin-binding agent, is 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 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 Thalomid(R), risks associated with the Company'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).
CONTACT: Ginny Dunn EntreMed, Inc. Associate Director Corporate Communications & Investor Relations 240-864-2643
CONTACT: Ginny Dunn, Associate Director Corporate Communications &Investor Relations, EntreMed, Inc., +1-240-864-2643
Web site: http://www.entremed.com/
Ticker Symbol: (NASDAQ-NMS:ENMD)
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Posted: June 2007