Positive Prostate Cancer Interim Results In Clinical Trials With Thalidomide
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Positive Prostate Cancer Interim Results In Clinical Trials With Thalidomide

ROCKVILLE and BETHESDA, Md. -- June 17, 1997-- EntreMed Inc. and the National Cancer Institute (NCI) Tuesday announced an increase in the number of prostate cancer patients in NCI-sponsored Phase II clinical trials using thalidomide treatment.

Recent findings showed positive results in Phase II trials using thalidomide in androgen-independent metastatic prostate cancer patients. The first 18 patients treated exhibited prostate-specific antigen (PSA) declines as well as disease stabilization.

These patients have been observed since the onset of trials in early 1996 at the National Institutes of Health (NIH) Clinical Center in Bethesda, Md. According to Dr. William D. Figg, who serves as principal investigator of the trial, the number of patients enrolled has been increased to 28, based on positive interim results.

The collaborative clinical trials agreement, established in 1995 between EntreMed and the NCI, was designed to study the anticancer effects of thalidomide in breast, prostate and brain cancer as well as Kaposi’s sarcoma.

Dr. Edward R. Gubish, senior vice president of Research and Development, who oversees the company's clinical efforts, stated: "The information obtained from thalidomide's use in this patient population will aid in determining the appropriate dosing schedule as we look ahead to the design of Phase III trials. Certainly, thalidomide continues to show promise as a leading antiangiogenic therapeutic and may help change the ways in which angiogenic diseases such as cancer, blindness and arthritis are treated in the future."

In other company news, a patent recently was issued by the U.S. Patent and Trademark Office with composition of matter claims directed to Angiostatin(TM) protein. This patent is for the treatment of angiogenic-mediated diseases with Angiostatin(TM) protein.

Patent applications for DNA sequences of Angiostatin(TM) and its use as a diagnostic agent are pending. The patent is owned by Children’s Hospital, a teaching affiliate of the Harvard Medical School in Boston, and is exclusively licensed to EntreMed. EntreMed has an exclusive research collaboration with Dr. Judah Folkman, a pioneer of angiogenesis research, and his team of scientists at Children’s Hospital. On June 11, 1997, Folkman was recognized for his notable scientific contributions when he received the 1997 General Motors Cancer Research Award.

"The early results demonstrating thalidomide's apparent benefit in prostate cancer are very exciting. These findings follow the recently reported interim results issued last month relating to thalidomide's success in Phase II trials for the treatment of brain tumors and Kaposi’s sarcoma. Our antiangiogenic technologies continue to show potential in the treatment of cancer as well as macular degeneration, the leading cause of blindness in the elderly. "

"Our work with Bristol-Myers Squibb Company relating to the further development of Angiostatin protein continues as we make progress in pilot-scale manufacturing for completion of preclinical studies. Therefore, the Angiostatin(TM) patent issuance is of a timely nature," added EntreMed Chairman and Chief Executive Officer Dr. John W. Holaday.

Rockville-based EntreMed Inc., an innovative biopharmaceutical company, develops products that address the role of blood and blood vessels in health and disease. The company is a leader in the field of antiangiogenesis research, which involves the inhibition of abnormal blood-vessel growth believed to be associated with a broad range of diseases.

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