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Press Release

EntreMed Commences Clinical Trials of Panzem(R) NCD in Patients With Advanced Cancer

January 05, 2005

ROCKVILLE, MD, Jan. 5—EntreMed, Inc. (Nasdaq: ENMD), a clinical-stage pharmaceutical company developing novel therapeutics for the treatment of cancer and inflammation, announced today that it has commenced Phase 1b clinical trials to evaluate the pharmacokinetic properties and safety of Panzem® NCD, its next generation formulation of its lead product candidate, Panzem® (2-methoxyestradiol or 2ME2). Advanced cancer patients whose disease has failed to respond to existing therapies or where no approved therapy is available are expected to be enrolled in the studies. The purpose of the dose escalation studies will be to evaluate the pharmacokinetics and safety of Panzem® NCD. George Wilding, M.D., Director, University of Wisconsin Comprehensive Cancer Center, and Christopher J. Sweeney, M.D., Co-Director, Experimental and Developmental Therapeutics Program, Indiana University Cancer Center, are the Principal Investigators of the studies.

2ME2 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. Panzem® Nanocrystal Colloidal Dispersion (Panzem® NCD), an oral liquid formulation, has been shown in pre-clinical studies to significantly increase the drug’s bioavailability, which is expected to result in enhanced drug levels of 2ME2 in patients.

“Given the results from previous clinical studies with Panzem®, we are excited to begin studies with Panzem® NCD,” stated Dr. Wilding. Dr. Wilding continued, “We believe that the reformulated drug candidate should yield greater bioavailability, as demonstrated in pre-clinical models, which will hopefully improve the clinical outcome for patients.”

Dr. Sweeney also commented on the study, “We are looking forward to participating again in the Panzem® clinical program and resuming trials in our patients along with Dr. Wilding at the University of Wisconsin. The goals of these trials are to evaluate pharmacokinetics and safety in cancer patients and, with these results, move into more focused efficacy trials.”

“EntreMed is fortunate to be working with exceptional investigators and cancer centers that have previously conducted clinical studies with 2ME2 and recognize its potential,” said Carolyn F. Sidor, M.D., EntreMed’s Vice President and Chief Medical Officer. “Valuable safety, pharmacokinetic and dosing information will be obtained from this study, which will enable us to move aggressively into the next stages of clinical testing focusing on specific tumor types and combinations with approved treatments. One of the key attributes of next generation cancer treatments will be drug candidates like Panzem® that affect multiple cellular pathways thereby limiting drug resistance. Panzem® is known to have direct anti-tumor activity in addition to anti-angiogenic activity while maintaining a strong safety profile,” Dr. Sidor concluded.

In previous Phase II studies in more than 165 cancer patients, Panzem® capsules showed evidence of clinical efficacy, including one partial response and several patients with stable disease. The drug was well tolerated with few side effects. Panzem® capsules were also tested clinically in combination with Taxotere in advanced breast cancer patients resulting in an objective response rate of 20 percent with no added toxicities.

For more information on this study, visit the Clinical Trials section of EntreMed’s web site at http://www.entremed.com

About EntreMed

EntreMed, Inc. (Nasdaq: ENMD) is a clinical-stage pharmaceutical company developing therapeutic candidates primarily for the treatment of cancer and inflammation. Panzem® (2-Methoxyestradiol or 2ME2), the Company’s lead drug candidate, is currently in clinical trials for cancer, as well as in preclinical development for indications outside of oncology. 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. The Company’s expertise has also led to the discovery of new molecules, including analogs of 2ME2, peptides of tissue factor pathway inhibitor (TFPI), and inhibitors of fibroblast growth factor-2 (FGF-2) and proteinase activated receptor-2 (PAR-2). EntreMed is developing these potential drug candidates for either in-house advancement or external partnering. Additional information about EntreMed is available on the Company’s website at http://www.entremed.com and in various filings with the Securities and Exchange Commission. Panzem® NCD is in clinical trials and has not been approved by the Food and Drug Administration.

Forward Looking Statements

This release contains, and other statements that EntreMed may make may contain, 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, strategies, expectations and goals. Forward-looking statements are typically identified by words or phrases such as “believe,” “feel,” “expect,” “anticipate,” “intend,” “outlook,” “estimate,” “target,” “assume,” “goal,” “objective,” “plan,” “remain,” “seek,” “trend,” and variations of such words and similar expressions, or future or conditional verbs such as “will,” “would,” “should,” “could,” “might,” “can,” “may,” or similar expressions. 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 EntreMed assumes no duty to update forward-looking statements. Actual results could differ materially from those currently anticipated due to a number of factors, including those set forth in EntreMed’s Securities and Exchange Commission filings under “Risk Factors,” including risks relating to EntreMed’s need for additional capital and the uncertainty of additional funding; the early-stage products under development; uncertainties relating to clinical trials (including the risk that clinical results will not be the same as those obtained in preclinical studies); our success in the further clinical development of Panzem®; 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).

COMPANY CONTACT:
CASI Pharmaceuticals, Inc.
Rui Zhang
240-864-2643
ir@casipharmaceuticals.com
INVESTOR CONTACT:
Solebury Trout
Xuan Yang
646-378-2975
xyang@troutgroup.com

About Us

CASI is a U.S. NASDAQ-listed biopharmaceutical company with a platform to develop and accelerate the launch of pharmaceutical products and innovative therapeutics in China, the U.S., and throughout the world. We have offices in Rockville, Maryland, and a wholly owned subsidiary in Beijing, China, through which substantially all of our operations are conducted.

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