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ARES-SERONO'S INTERLEUKIN-6 GRANTED EUROPEAN PATENT; WORLDWIDE CLINICAL TRIALS ONGOING

 BOSTON and GENEVA, SWITZERLAND, July 13 /PRNewswire/ -- The Ares- Serono Group today announced the approval of European patent No. 220,574 for production of the company's recombinant Interleukin-6 (IL-6). The mention of grant was published on July 7, 1993, in the European Patent Bulletin 93/27 by the European patent office based in Munich, Germany.
 The patent claims provide full coverage of any recombinant IL-6, whether it is produced in eukaryotic (mammalian) or prokaryotic (Escherichia coli - bacterial) cells.
 A genetically engineered molecule developed by Ares-Serono, IL-6 is showing promise in the treatment of blood platelet deficiency (thrombocytopenia), a condition frequently resulting from chemotherapy and radiotherapy in cancer treatment. IL-6 is also under investigation for treating certain types of cancer.
 "We are pleased that this European patent has been granted and remain confident that this new drug will provide significant benefit to patients suffering from various cancers," said Fabio Bertarelli, chief executive officer of The Ares-Serono Group. "In fact, the Expert Committee on Biological Standardization of the World Health Organization recently adopted the Ares-Serono Glycosylated form of IL-6 as the international standard."
 Phase I/II clinical trials of IL-6 began in Europe and the United States in 1992 following regulatory approvals. Clinical trials were initiated earlier this year in Japan.
 In the United States alone, nearly 900,000 new cases of cancer are diagnosed each year. At least 25 percent of these patients are treated by one or more courses of chemotherapy and/or radiotherapy.
 A major problem of these cancer treatments is the suppression of bone marrow activity. The bone marrow produces red and white cells and also platelets, a vital component in blood clotting. Platelet deficiency (thrombocytopenia) may result in hemorrhage.
 Patients with a low peripheral blood platelet count generally require transfusions of blood platelets, which are not only costly procedures, but also carry the risk of transmission of viral contaminants such as HIV, cytomegalovirus and hepatitis.
 Interleukin-6 has proven in experimental studies to be the most potent treatment for blood platelet deficiency. This could mean that, for thousands of cancer patients suffering from thrombocytopenia, transfusions may no longer be necessary (a). In the United States, Ares-Serono has filed an Investigational New Drug (IND) amendment with the Food and Drug Administration (FDA) for the additional indication of autologous bone marrow transplant (ABMT).
 Interleukins are 'immunomodulators', also known as cytokines, substances which play a key role in the body's immune response. Evidence, produced in experimental models, indicates that IL-6 has a wide range of activities in the immune response.
 Equally important is the activity of IL-6 in inhibiting tumor growth, particularly for certain cancers (breast cancer, melanoma and colon carcinoma). IL-6, in combination with other cytokines, could have an even more potent antiproliferative activity on cancer cells, thus improving the outcome of anti-cancer treatments.
 NOTE: (a) Herodin F. et al: Recombinant glycosylated human Interleukin-6 accelerates blood platelet count recovery in radiation- induced bone marrow depression in baboons. "Blood," 1992; pp 688-695.
 -0- 7/13/93
 /CONTACT: Gina Cella of Ares-Serono, 617-982-9000/


CO: Ares-Serono ST: Massachusetts IN: MTC SU: PDT

SJ -- NE009 -- 1064 07/13/93 17:09 EDT
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Date:Jul 13, 1993
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