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EntreMed Commences Phase 2 Study With MKC-1 In Ovarian/Endometrial Cancers
EntreMed, Inc.
(Nasdaq: ENMD), a clinical-stage pharmaceutical company developing
therapeutics for the treatment of cancer and inflammatory diseases,
announced the commencement of a Phase 2 study with its novel cell cycle
inhibitor, MKC-1, in recurrent or resistant epithelial ovarian cancer and
advanced endometrial cancer patients. The study will be conducted at
multiple sites in Canada with Dr. Amit Oza, Senior Staff Physician and
Associate Professor of Medicine, Princess Margaret Hospital, University of
Toronto, serving as the principal investigator.
The primary objective of this Phase 2 study will be to determine the
antitumor activity of MKC-1 administered orally as a single agent in
platinum or taxane refractory ovarian and endometrial cancer patients. In
addition, safety, response duration in patients with an objective response,
and progression free survival (PFS) will also be assessed. The study will
be a two arm parallel group design with each group having two stages.
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.
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. Furthermore, MKC-1 inhibits the Akt-mTOR signaling
pathways, which may occur through inhibition of the mTOR/rictor pathway.
The Akt-mTOR pathway is the most frequently mutated pathway in human tumors
and mutations have been shown to promote tumor progression and decrease
survival in cancer patients."
Commencement of this Phase 2 multi-center study represents the
continuation of our focus on the development of MKC-1 in diseases where,
based on its mechanism of action, we would expect activity," commented
Carolyn F. Sidor, M.D., M.B.A., EntreMed's Vice President and Chief Medical
Officer. "We now have five clinical trials underway to test the safety and
efficacy of MKC- 1 in solid and hematological cancers, including two
clinical development programs in Canada. We expect to invest in further
clinical trials during 2008 to test the extent of MKC-1's clinical utility
in multiple tumor types."
About Ovarian and Endometrial Cancers
Ovarian cancer accounts for 4% of all cancers among women in the United
States, and ranks fifth as the cause of cancer deaths. The American Cancer
Society estimates that there will be approximately 22,000 newly diagnosed
cases of ovarian cancer in the U.S. in 2007 resulting in approximately
15,000 deaths. About half of all ovarian cancers occur in post-menopausal
women. Ovarian cancer is frequently asymptomatic in the early stages. As a
result, ovarian cancer is often not diagnosed until stage III or IV, where
5-year survival rates decline to 10-20%. Current drug therapy involves
paclitaxel and carboplatin/cisplatin regimens. Many patients develop
resistance to these drugs, so there is substantial need for innovative
therapies that can overcome resistance, either as a single agent or in
combination with approved chemotherapeutic agents.
Endometrial cancer, the most common cancer found in women's
reproductive organs, starts in the inner lining of the uterus
(endometrium). The American Cancer Society estimates that there will be
approximately 39,000 new cases of cancer of the uterine body diagnosed in
the U.S. in 2007, resulting in approximately 7,400 deaths. There are
currently four basic types of treatment for endometrial cancer including
surgery, radiation, hormone therapy, and chemotherapy, of which surgery is
the most common treatment.
About EntreMed
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. Panzem(R) (2-methoxyestradiol) NCD is also in multiple Phase
2 studies in oncology patients. Additionally, ENMD-1198, a novel
tubulin-binding agent, is in Phase 1 studies in advanced cancers. The
Company has approved IND applications for Panzem(R) in rheumatoid
arthritis, and ENMD-2076, a dual-acting Aurora- angiogenesis inhibitor, for
cancer. 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.
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).
EntreMed, Inc.
http://www.entremed.com
EntreMed începe studiu de fazã 2 cu MKC-1 în ovarian / endometrului tipuri de cancer - EntreMed Commences Phase 2 Study With MKC-1 In Ovarian/Endometrial Cancers - articole medicale engleza - startsanatate