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The collaborative clinical trials agreement, established in 1995 between the two organizations and Bristol-Myers Squibb Co. (NYSE:BMY), was designed to study the anticancer effects of thalidomide in breast, prostate and brain cancer as well as Kaposi's sarcoma.
The brain cancer trials began in March 1996 at Boston-based Dana-Farber Cancer Institute, MD Anderson in Houston, and Washington, D.C.'s Lombardi Cancer Center at Georgetown University with the intent to treat 15 progressive glioblastoma multiformae patients. Based on preliminary results to date, the enrollment was increased to 35 patients in October 1996.
Dr. Howard A. Fine, a leading neuro-oncologist based at the Dana-Farber Cancer Institute, serves as principal investigator of the trials. The decision to increase the number of patients was determined in part by assessing results of Magnetic Resonance Imaging (MRI) scans after finding a suggestion of reduction in tumor size in two of the 15 initial patients. Adverse neurological events, which could be attributed to either the progression of brain tumor growth or effects of the drug, have also been observed.
In preclinical animal studies, thalidomide was shown to inhibit new blood vessel growth. The growth of new blood vessels, or angiogenesis, plays a critical role in cancer, blindness and arthritis. In 1994, Drs. Robert D'Amato and M. Judah Folkman of Children's Hospital in Boston discovered the antiangiogenic properties of thalidomide. They demonstrated that thalidomide could prevent the formation of new blood vessels and starve tumors, suggesting it may block cancer growth in humans.
EntreMed is involved in an exclusive relationship with Dr. Folkman, a pioneer of angiogenesis research, and his team of scientists at Children's Hospital. In December 1995, EntreMed and Bristol-Myers Squibb announced a collaborative agreement in which Bristol-Myers Squibb obtained the exclusive worldwide licensing rights to certain antiangiogeneic compounds developed by EntreMed.
EntreMed Chairman and Chief Executive Officer Dr. John W. Holaday commented on the positive clinical results: "We are pleased to learn of the preliminary findings suggestive of positive results and the decision to expand these clinical trials. At present, there is no established therapeutic treatment for glioblastoma multiformae.
"The seamless, collaborative relationship among EntreMed, the National Cancer Institute and Bristol-Myers Squibb will help to define the therapeutic potential of thalidomide in treating a variety of cancer patients."
Rockville-based EntreMed, an innovative biopharmaceutical company, develops products that address the role of blood and blood vessels in health and disease.
The company's strategy is to accelerate development of its current core technologies, angiogenesis and cell permeation.
EntreMed also seeks to identify and acquire new technologies through sponsored research programs with university medical facilities, research companies and government laboratories. EntreMed anticipates commercialization of its products through strategic partnerships with major pharmaceutical companies. The company is a leader in the field of antiangiogenesis research, which involves the inhibition of blood vessel growth believed to be associated with cancer, blindness and arthritis.
Statements herein that are not descriptions of historical facts are forward-looking and subject to risk and uncertainties. Actual results could differ materially from those currently anticipated due to a number of factors, including those set forth in the company's Securities and Exchange Commission filings under "Risk Factors," including risks relating to 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).
CONTACT: EntreMed Inc. Susan J. Lewis, 301/738-2495 Dr. John W. Holaday, Chairman/CEO, 301/217/9858 or National Cancer Institute NCI Press Office, 301/496-6641
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