British Biotech plc - regulatory approval received to restart batimastat trials in cancer patients.OXFORD, England--(BUSINESS WIRE)--June 26, 1995--British Biotech plc announces that it has received approval from the Medicines Control Agency (MCA MCA in full Music Corporation of America Entertainment conglomerate. It was founded in Chicago in 1924 by Jules Stein as a talent agency. In the 1960s it bought Decca Records and Universal Pictures, and today it produces films, music, and television shows. ) in the United Kingdom to restart trials with batimastat, its injectable in·ject·a·ble adj. Capable of being injected. Used of a drug. n. A drug or medicine that can be injected. anti-cancer drug. This approval covers both the manufacture of batimastat and clinical trial protocols in malignant ascites malignant ascites Excess peritoneal fluid evoked by malignancy, which causes subdiaphragmatic lymphatic obstruction–eg, of the thoracic duct and ↑ intraperitoneal fluid production Etiology Ovarian, breast, gastric, pancreatic, hepatic, colorectal CA, and malignant pleural effusion Pleural Effusion Definition Pleural effusion occurs when too much fluid collects in the pleural space (the space between the two layers of the pleura). It is commonly known as "water on the lungs. . These protocols, which have also been agreed by clinical investigators, will now be submitted in the normal way to hospital ethics committees for approval. Subject only to these approvals, trials are expected to start this summer. Clinical trials British Biotech British Biotech was a British based biotech company. British Biotechnology Limited was founded in 1986 by former G D Searle managers Keith McCullagh and Brian Richards, [1] is investigating two potential indications for batimastat, malignant pleural effusion and malignant ascites. Pleural effusion is now considered to be the primary target for batimastat and two Phase II trials in patients with malignant pleural effusion will begin in the third quarter of 1995, one in the UK and a second, larger study in the USA. Positive results from the first study in pleural effusion patients were announced in April 1995 and these larger Phase II trials are intended to identify the ideal dose. In the second indication, malignant ascites, a Phase III trial was halted earlier in 1995 due to unexpected side-effects linked to changes made in the manufacturing process during scale-up for Phase III. The malignant ascites program will restart with a dose-ranging study. Newly manufactured material made on the basis of the process approved by the MCA will be available to supply all of these studies. Commenting on today's announcement, Dr. Keith McCullagh, British Biotech's chief executive said, "This regulatory approval is very good news for British Biotech. The excellent progress made by the company, particularly with its most important product, BB-2516, has recently been overshadowed by the difficulties with batimastat. This approval, achieved on schedule, means that batimastat's development can now recommence Re`com`mence´ v. i. 1. To commence or begin again. 2. To begin anew to be; to act again as. He seems desirous enough of recommencing courtier. - Johnson. v. t. 1. To commence again or anew. ." CONTACT: British Biotech plc Keith McCullagh or Katie Arber, 011-44-1865-748747 or British Biotech Inc. Peter P. McCann, 410/266-7909 or G.A. Kraut kraut n. 1. Sauerkraut. 2. often Kraut Offensive Slang Used as a disparaging term for a German. [German; see sauerkraut.] Noun 1. Co. Gerard Coffey, 212/696-5600 |
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