ROCKVILLE, MD -- November 7, 2002-- EntreMed, Inc. (Nasdaq: ENMD), a biopharmaceutical leader in angiogenesis research and product development, announced today that its new derivative of thalidomide, ENMD 0995, received Orphan Drug designation from the Food and Drug Administration (FDA) for the treatment of patients with multiple myeloma. Multiple myeloma, the second most prevalent form of blood cancer among Americans, causes 11,000 deaths annually. FDA Orphan Drug designation encourages the development of therapeutics to treat diseases affecting fewer than 200,000 Americans by providing tax credits and marketing exclusivity incentives to companies.
In animal studies, ENMD 0995 exhibited significant activity in primary and in metastatic human tumor models of multiple myeloma and was more effective than thalidomide, a drug now widely used for the investigational treatment of multiple myeloma. Preclinical investigators reported that the progression of metastatic multiple myeloma disease was inhibited markedly in ENMD 0995- treated animals when compared with thalidomide-treated and control groups. Survival of the animals was significantly prolonged in the ENMD 0995 treated group. ENMD 0995's ability to inhibit angiogenesis and B-cell specific proliferation may be key to its success against multiple myeloma.
Dr. John Holaday, Chairman and Chief Scientific Officer, commented, "Building on our previous in-house research and development work with thalidomide as a possible cancer treatment, EntreMed scientists have successfully identified a new version of thalidomide that is more active and shows no signs of the toxic side effects associated with thalidomide in preclinical models. Receiving Orphan Drug status from the FDA reinforces he strength of EntreMed's scientific team and furthers our strategy of the successful and timely clinical development of ENMD 0995." Dr. Holaday continued, "This designation also increases our hope that ENMD 0995 will be a better treatment over therapies currently available to multiple myeloma patients." The Company will also develop other thalidomide analogs to treat
cancer and other diseases.
EntreMed has an orphan drug grant application pending with the Food and Drug Administration (FDA) to support the clinical costs associated with future ENMD 0995 clinical trials. In September, the FDA awarded EntreMed an orphan drug grant in the amount of $300,000 for three consecutive years to support the Company's Phase II Endostatin trial for neuroendocrine tumor patients. The FDA orphan drug grant program funds clinical research to accelerate the development of products that demonstrate promise to treat such rare diseases.
About ENMD 0995
ENMD 0995 is a small molecule analog of thalidomide with improved angiogenesis inhibitor activity that in animal models does not show evidence of the toxic side effects reported for thalidomide. ENMD 0995 is the 3-amino derivative of thalidomide with two mirror-image forms known as the S(-) enantiomer and the R(+) enantiomer. EntreMed scientists demonstrated in a number of animal models that the S(-) enantiomer form is more active than both the R(+) enantiomer form and the R,S mixture (racemate). Based on those data, EntreMed has chosen to move the S(-) enantiomer -- designated as ENMD 0995 -- towards the clinic. EntreMed scientists first identified that ENMD 0995 has not only angiogenesis-inhibitory activity, but also B-cell specific anti- proliferative activity. Therefore, ENMD 0995 may be an ideal candidate for the treatment of B-cell tumors such as multiple myeloma and some lymphomas, as well as some solid tumors.
About Multiple Myeloma
Multiple myeloma is the second most prevalent blood cancer and represents approximately 1% of all cancers and 2% of all cancer deaths. More than 40,000 Americans currently have multiple myeloma, including former Congresswoman Geraldine Ferraro. Over 14,000 new patients are diagnosed each year, with median survival ranging from 3 to 4.5 years. The cancer is twice as common in males as females. African Americans and Native Pacific Islanders have the highest reported incidence of this disease. Among African Americans, multiple myeloma is one of the top ten leading causes of cancer death. For further information regarding multiple myeloma, contact the Multiple Myeloma Research Foundation via Internet at http://www.multiplemyeloma.org or via phone at
203-972-1250.
About EntreMed
EntreMed, Inc., The Angiogenesis Company(R), is a clinical-stage biopharmaceutical company developing angiogenesis therapeutics that inhibit abnormal blood vessel growth associated with over 80 diseases such as cancer, blindness and atherosclerosis. Unlike other angiogenesis compounds, EntreMed's product candidates target disease-associated endothelial cells only and do not disrupt normal biological processes. As a result, our drug candidates have shown a strong safety profile with neither toxicity nor clinically significant side effects reported to date. EntreMed has three Phase II clinical drug candidates in oncology trials where doctors have reported some patients with tumor regression and disease stabilization. The Company also has a rich pipeline, consisting primarily of small molecules and peptides, under development and in preclinical studies. For further information, visit EntreMed's web site at http://www.entremed.com .
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 of products under development; uncertainties relating to clinical trials; 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).
SOURCE: EntreMed, Inc.
