Biopharmaceutics announces Orphan Drug Filing.BELLPORT, N.Y.--(BUSINESS WIRE)--May 1, 1995--Biopharmaceutics Inc. (ASE (Adaptive Server Enterprise) A relational DBMS from Sybase that runs on Windows NT/2000, Linux and a variety of Unix platforms. ASE is a comprehensive and robust data management product with a long history dating back to the late 1980s. :BPH BPH abbr. benign prostatic hyperplasia BPH Benign prostatic hypertrophy, a very common noncancerous cause of prostatic enlargement in older men. ) announced today that it has filed for Orphan Drug Status for its chemotherapeutic agent, dibromodulcitol (Mitolactol; DBD), for an indication for brain cancer. The company's filing refers to the recently completed Phase III test results of the European Organization for the Research and Treatment of Cancer (EORTC EORTC European Organization for Research and Treatment of Cancer ). Those results demonstrate that DBD increases both the survival time and the time to disease progression in patients with grades III and IV astrocytoma astrocytoma /as·tro·cy·to·ma/ (as?tro-si-to´mah) a tumor composed of astrocytes; the most common type of primary brain tumor and also found throughout the central nervous system, classified on the basis of histology or in order of compared to standard therapy. The percentage of survivors at 18 months and 24 months using DBD, was 62% and 75% higher than when DBD was not used. The percentage of patients without signs of recurrence at 18 and 24 months, with the use of DBD, was 144% and 220% higher than when radiation only was used. The American Brain Tumor Association The American Brain Tumor Association (ABTA), founded in 1973, is a not-for-profit organization that "exists to eliminate brain tumors and to meet the needs of brain tumor patients and their families". The organization is headquartered in Des Plaines, Illinois. (ABTA ABTA n abbr (= Association of British Travel Agents) → Verband der Reiseveranstalter ) estimated that 20,500 new cases of primary brain tumors were diagnosed in 1990 and at least 20,700 new cases of metastatic brain tumors, a combined total of 41,200 new cases. Company spokesperson, Stuart Fine said, "The Company is pleased with the results of the EORTC study. We feel this orphan filing if granted, will enhance DBD's profile when our New Drug Application is ready to be filed. Biopharm currently holds Orphan Drug Status for DBD for cervical cancer. The National Cancer Institute has conducted Phase II and Phase III trials with DBD in women with cervical cancer. The company anticipates filing its New Drug Application for DBD in 1996." CONTACT: Biopharmaceutics, Inc., Bellport Stuart Fine, 516/286-5800 |
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