To print: Select File and then Print from your browser's menu --------------------------------------------------------------------------------------- Title: FDA Grants Orphan Drug Status to Endostatin and Panzem for Neuroendocrine Tumors and Multiple Myeloma URL: http://www.pslgroup.com/dg/20398A.htm Doctor's Guide August 15, 2001
ROCKVILLE, MD -- August 15, 2001 -- EntreMed, Inc. announced today that Endostatin and Panzem™ received orphan drug status, a Food and Drug Administration (FDA) designation to provide exclusivity for new drugs that target diseases affecting smaller patient populations. Endostatin, a protein drug candidate, and Panzem, an orally available small molecule drug candidate, are antiangiogenesis agents that inhibit the abnormal blood vessel growth associated with cancer and other diseases.
EntreMed received orphan drug status for Endostatin in neuroendocrine tumors. Specifically, the FDA accepted EntreMed's application upon review of data that demonstrated an absence of dose-limiting toxicities and some clinical benefit in Phase I trials. Although the on-going Phase I studies were designed to investigate safety, some patients with neuroendocrine tumors of the pancreas at Dana-Farber Partner's Cancer Consortium demonstrated tumor stabilization or tumor regression during treatment with Endostatin. Based on these Phase I results, a focused Phase II study is planned for later this year.
EntreMed also received orphan drug status from the FDA for Panzem in multiple myeloma, a blood cancer that causes bone loss and is often fatal. Panzem is currently in Phase II clinical studies for multiple myeloma. These studies are being sponsored by EntreMed at the Mayo Clinic in Rochester, Minnesota, and at the Dana Farber Partner's Cancer Consortium in Boston, Massachusetts.
"This is an important step in advancing Endostatin and Panzem," said Dr. Edward Gubish, EntreMed's President and Chief Operating Officer. "EntreMed's progress to date reflects favorable results from our Phase I studies with both drug candidates where clinical benefit was observed without dose-limiting toxicities."
EntreMed continues to move forward in several clinical trials with Endostatin, Panzem and Angiostatin. These studies are being conducted in cancer patients with advanced tumors that are unresponsive to traditional therapies.
In addition to the multiple myeloma trial, Panzem is under clinical investigation for two additional indications -- breast cancer, and hormone refractory prostate cancer -- at the University of Indiana Cancer Center and the University of Wisconsin. These Phase I and Phase II studies are investigating the effects of Panzem as a single agent, as well as in combination with Taxotere® in collaboration with Aventis.
Endostatin, in addition to the aforementioned neuroendocrine study, is also under clinical investigation for solid tumors, including melanoma and sarcoma, where it is being administered by continuous infusion or by subcutaneous injections. These Phase I and Phase I/II studies are underway at the MD Anderson Cancer Research Center in Houston, the Dana-Farber Partner's Cancer Consortium in Boston, and at the Free University Academic Hospital in Amsterdam, the Netherlands.
Phase I trials are underway at Thomas Jefferson University Hospital in Philadelphia for Angiostatin as a single agent and in combination with radiation therapy.
SOURCE: EntreMed, Inc.
Related Link: EntreMed, Inc. --------------------------------------------------------------------------------------------- Copyright © 1999 P\S\L Consulting Group Inc. All rights reserved. Republication or redistribution of P\S\L content is expressly prohibited without the prior written consent of P\S\L. P\S\L shall not be liable for any errors, omissions or delays in this content or any other content on its sites, newsletters or other publications, nor for any decisions or actions taken in reliance on such content. --------------------------------------------------------------------------------------------- This news story was printed from *Doctor's Guide to the Internet* located at http://www.docguide.com --------------------------------------------------------------------------------------- Return to News Story Page This site is maintained by webmaster@pslgroup.com Please contact us with any comments, problems or bugs. All contents Copyright (c) 1998 P\S\L Consulting Group Inc. All rights reserved.