Healthcare Industry News: estradiol
News Release - June 4, 2007
EntreMed Presents Phase 2 Results for Panzem(R) Capsules in Multiple MyelomaPatients Remain on Study for Over Four Years Without Disease Progression
ROCKVILLE, Md., June 4 (HSMN NewsFeed) -- EntreMed, Inc. (Nasdaq: ENMD ), a clinical-stage pharmaceutical company developing therapeutics for the treatment of cancer and inflammatory diseases, today announced the presentation of Phase 2 results for the capsule formulation of one of its lead oncology drug candidates, PanzemŽ (2-methoxyestradiol or 2ME2), in patients with relapsed and plateau phase multiple myeloma. The data were presented at the American Society of Clinical Oncology (ASCO) Annual Meeting being held this week in Chicago, Illinois. The study was conducted at the Mayo Clinic and the Dana-Farber Cancer Institute with Dr. Vincent Rajkumar and Dr. Paul Richardson as principal investigators, respectively.
Results of the Phase 2 study demonstrated prolonged stable disease and minor responses in patients receiving the original formulation of PanzemŽ Capsules. Sixty patients with relapsed or plateau phase multiple myeloma were enrolled in the study. PanzemŽ Capsules were well tolerated and did not cause significant neuropathy (peripheral nerve damage), myelosuppression (decreased bone marrow activity) or thromboembolic disease. Progression free survival (PFS) rates were 24%, 17% and 11% for all patients at 1, 2, and 3 years. Five patients continue to receive PanzemŽ Capsules, including three patients with plateau phase disease who have been on study for over four years without disease progression. EntreMed has also received orphan drug designation for 2ME2 in multiple myeloma from the FDA.
PanzemŽ is an orally-active small molecule that attacks tumor cells through multiple mechanisms of action and blocks the development of new blood vessels that feed tumor cells. One such mechanism is the upregulation of death receptor 5 (DR5) leading to apoptosis. PanzemŽ also reduces levels of IL-6, a known growth factor for myeloma cells. PanzemŽ Capsules continue to be used by the five patients remaining on the study. An improved oral liquid formulation, PanzemŽ NCD, is now being used in multiple Phase 1 and 2 clinical studies. PanzemŽ NCD has been shown to increase the exposure of 2ME2 in patients by 5 to 10 fold. Interim results from two additional clinical studies using PanzemŽ NCD are also being presented during the conference.
Carolyn F. Sidor, M.D., M.B.A, EntreMed Vice President and Chief Medical Officer, commented, "We are encouraged by these results as they demonstrate antitumor activity and represent a rationale for future studies with PanzemŽ NCD in multiple myeloma patients. This is especially true considering the higher drug levels possible with the NCD formulation. In addition, since several patients have received PanzemŽ for years, the data will help us build our safety profile to support additional oncology uses and for our planned program in rheumatoid arthritis."
To view the poster presentation, visit the Recent Presentations section of the Company's web site at www.entremed.com.
About Multiple Myeloma
Multiple myeloma is a type of cancer formed by cancerous plasma cells in the blood. When plasma cells grow uncontrollably, they can form a tumor, usually in the bone marrow. This tumor type is called myeloma, and if there are many tumors, it is called multiple myeloma. The exact cause of multiple myeloma is still unclear. Several risk factors associated with multiple myeloma include age and gender, race, radiation exposure, family history, and weight. The American Cancer Society estimates that approximately 19,000 new cases of multiple myeloma will be diagnosed in the United States in 2007, and approximately 11,000 deaths.
EntreMed, Inc. (Nasdaq: ENMD ) is a clinical-stage pharmaceutical company developing therapeutic candidates primarily for the treatment of cancer and inflammation. PanzemŽ (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 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.
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