Navigation Links
EntreMed Announces FDA Acceptance of IND Application for Aurora Kinase/Angiogenesis Inhibitor, ENMD-2076
Date:1/3/2008

ROCKVILLE, Md., Jan. 3 /PRNewswire-FirstCall/ -- EntreMed, Inc. (Nasdaq: ENMD), a clinical-stage pharmaceutical company developing therapeutics for the treatment of cancer and inflammatory diseases, today announced that the U.S. Food and Drug Administration (FDA) has accepted its Investigational New Drug (IND) application for its aurora kinase/angiogenesis inhibitor, ENMD-2076.

(Logo: http://www.newscom.com/cgi-bin/prnh/20010620/ENMDLOGO )

ENMD-2076 is a novel, dual-acting, kinase inhibitor with potent activity against Aurora A and tyrosine kinases linked to promoting cancer and inflammatory diseases. ENMD-2076 acts through multiple pathways resulting in antiproliferative activity and the inhibition of angiogenesis. ENMD-2076 has demonstrated substantial, dose-dependent efficacy as a single agent in multiple xenograft models, including tumor regression in breast, colon, and leukemia models. Importantly, ENMD-2076 is an oral agent that has shown an acceptable toxicity profile in preclinical studies without cardiovascular effects.

Carolyn F. Sidor, MD, MBA, EntreMed Vice President and Chief Medical Officer commented on the IND, "Acceptance of the Investigational New Drug application for ENMD-2076 initiates the clinical program for our first compound that targets kinases. This is an exciting class of compounds with several recently approved in oncology indications. ENMD-2076 is unique in class because it not only inhibits Aurora A selectively over Aurora B, it also inhibits a number of other kinases important in the growth of tumors and, in particular, growth factor receptors critical to angiogenesis. ENMD-2076 has potent antitumor activity in multiple preclinical models including both solid tumors and hematological cancers. As such, we plan to initiate several clinical studies with ENMD-2076 that include Phase 1 trials in both solid and hematological cancers in 2008."

James S. Burns, EntreMed President & CEO commented, "The IND for ENMD-2076 represents an important milestone for EntreMed. This compound has shown significant single-agent activity, including tumor regression in multiple animal models. Moving ENMD-2076 forward into clinical development is consistent with our strategy of investing preferentially behind small molecule, orally-administered, multi-mechanism product candidates with potent single-agent antitumor activity and strong intellectual product coverage. Our goal is to commence clinical trials for ENMD-2076 and, in parallel, seek a development partner to help us accelerate the development of what I believe is an exciting oncology opportunity for EntreMed."

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) NCD is currently in multiple Phase 2 trials for cancer. Additionally, ENMD- 1198, a novel tubulin-binding agent, is in Phase 1 studies in advanced cancers. Panzem(R) (2-methoxyestradiol) is also in multiple Phase 2 studies in oncology patients. 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).

CONTACT:

Ginny Dunn

Associate Director, Corporate Communications & Investor Relations

EntreMed, Inc.

240.864.2643


'/>"/>
SOURCE EntreMed, Inc.
Copyright©2008 PR Newswire.
All rights reserved

Related biology technology :

1. EntreMed to Present at ThinkEquity Partners 5th Annual Growth Conference
2. EntreMed Appoints Senior Vice President of Research and Development
3. Dendreon Announces Publication of Phase 1 Study Highlighting Immunologic and Clinical Activity of Lapuleucel-T (Neuvenge(R)) in Advanced Breast Cancer Patients
4. YM BIOSCIENCES ANNOUNCES COMPLIANCE WITH AIM RULE 26
5. Emisphere Technologies, Inc. Announces Pricing of Registered Direct Offering
6. BioLife Solutions Announces Exclusive CryoStor(TM) Supply Agreement With the New England Cryogenic Center, Inc.
7. Carrington Announces Nasdaq Communication; Prepares for Shares to Be Quoted on the OTC Bulletin Board and Pink Sheets
8. China Kangtai Cactus Biotech Files 2nd Quarter 2007 10QSB and Announces Unaudited Quarterly Results
9. Cephalon Announces Positive Results from a Pivotal Study of FENTORA in Opioid-tolerant Patients with Non-cancer Breakthrough Pain
10. Advanced Life Sciences Announces Receipt of Nasdaq Staff Letter
11. ADVENTRX Announces Fast Track Designation Granted By the FDA For CoFactor For the Treatment of Metastatic Colorectal Cancer
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:6/23/2016)... -- The Biodesign Challenge (BDC), a university competition that asks ... systems and biotechnology, announced its winning teams at the ... York City . The teams, chosen ... MoMA,s Celeste Bartos Theater during the daylong summit. Keynote ... of architecture and design, and Suzanne Lee , ...
(Date:6/23/2016)... ... , ... In a new case report published today in STEM CELLS Translational ... lymphedema after being treated for breast cancer benefitted from an injection of stem cells ... this debilitating, frequent side effect of cancer treatment. , Lymphedema refers to ...
(Date:6/23/2016)... June 23, 2016 On Wednesday, June ... 4,833.32, down 0.22%; the Dow Jones Industrial Average edged 0.27% ... at 2,085.45, down 0.17%. Stock-Callers.com has initiated coverage on the ... Nektar Therapeutics (NASDAQ: NKTR ), Aralez Pharmaceuticals Inc. ... BIND ). Learn more about these stocks by ...
(Date:6/23/2016)... SAN FRANCISCO , June 22, 2016  Amgen ... platinum sponsorship of the QB3@953 life sciences ... improve human health. The shared laboratory space at QB3@953 ... startups overcome a key obstacle for many early stage ... As part of the sponsorship, Amgen launched two "Amgen ...
Breaking Biology Technology:
(Date:6/9/2016)... an innovation leader in attendance control systems is proud to announce the introduction of ... make sure the right employees are actually signing in, and to even control the ... ... ... ...
(Date:6/2/2016)... 2, 2016   The Weather Company , an IBM ... an industry-first capability in which consumers will be able to ... ask questions via voice or text and receive relevant information ... Marketers have long sought an advertising solution that ... be personal, relevant and valuable; and can scale across millions ...
(Date:5/16/2016)... YORK , May 16, 2016   EyeLock ... solutions, today announced the opening of an IoT Center ... to strengthen and expand the development of embedded iris ... an unprecedented level of convenience and security with unmatched ... authenticate one,s identity aside from DNA. EyeLock,s platform uses ...
Breaking Biology News(10 mins):