British Biotech plc oral cancer drug, BB-2516, successfully completes Phase I studies: clinical trials in cancer patients to begin shortly.OXFORD, England--(BUSINESS WIRE)--March 21, 1995--British Biotech plc announces the results of the first studies of BB-2516, the oral anti-cancer drug, which have shown BB-2516 to be well tolerated and well absorbed by healthy volunteers. A presention of the results is being given today in Toronto, Canada, by British Biotech at the 86th Annual Meeting of the American Association for Cancer Research Wikipedia is not the place for advertisement or self-advertising. The American Association for Cancer Research (AACR) is an organization based in Philadelphia, Pennsylvania, that focuses on all aspects of cancer research including basic, clinical and translational (AACR AACR American Association for Cancer Research AACR Anglo-American Cataloging Rules AACR Australasian Association of Cancer Registries AACR African Armed Conflicts Resolved ). A series of studies of BB-2516 in cancer patients is due to start shortly in the United Kingdom and the United States. Aim of the Phase I study program BB-2516 is the first oral compound in an entirely new class of drugs, matrix metalloproteinase inhibitors (MMPIs), to be considered as a potential cancer treatment. The Phase I clinical trial Noun 1. phase I clinical trial - a clinical trial on a few persons to determine the safety of a new drug or invasive medical device; for drugs, dosage or toxicity limits should be obtained phase I program which was carried out in healthy volunteers, was designed to determine whether BB-2516 was absorbed well by mouth and thus had the potential to be tested in patients as a new chronic cancer treatment. These initial trials were used to assess the safety of BB-2516 and its ability to be absorbed into the bloodstream when administered as a capsule. Two studies have now been completed with BB-2516 in the UK. The first study involved administering single doses of BB-2516 to 13 healthy volunteers; doses of between 25mg and 800mg were tested in this rising dose study. The second study involved 18 further healthy volunteers being given the drug twice a day for one week at doses of 50mg, 100mg and 200mg, or placebo. Study results The results of the Phase I study program showed that: o BB-2516 was well tolerated; o BB-2516 achieved high blood levels after a single dose; o Good absorpotion and prolonged half life indicated that a potentially therapeutic drug level could be maintained by dosing with low doses of BB-2516 twice a day. BB-2516's favorable pharmacokinetic profile in man means that it is a suitable drug to investigate in cancer patients. Pilot efficacy studies in patients A series of studies of BB-2516 in patients with a variety of solid tumors are due to begin shortly. In the United States, an Investigational New Drug (IND) application has been approved and the first study will start imminently in ovarian cancer ovarian cancer Malignant tumour of the ovaries. Risk factors include early age of first menstruation (before age 12), late onset of menopause (after age 52), absence of pregnancy, presence of specific genetic mutations, use of fertility drugs, and personal history of breast patients. In the United Kingdom, Clinical Trial Exemption certificate (CTX CTX Context (Management; Tandem) CTX Centex Corporation (stock symbol) CTX Centrex CTX Cyclophosphamide CTX Corporate Trade Exchange CTX Cytoxan CTX Cholera Toxin CTX Clinical Trial Exemption ) applications have been submitted for studies to begin in ovarian and colorectal cancer colorectal cancer Malignant tumour of the large intestine (colon) or rectum. Risk factors include age (after age 50), family history of colorectal cancer, chronic inflammatory bowel diseases, benign polyps, physical inactivity, and a diet high in fat. patients. Subject to regulatory approval, UK Phase II studies with BB-2516 will start in the second quarter of 1995. British Biotech plans to carry out separate pilot efficacy studies in patients with ovarian, colorectal, prostrate pros·trate tr.v. pros·trat·ed, pros·trat·ing, pros·trates 1. To put or throw flat with the face down, as in submission or adoration: , pancreatic and lung cancer. These are all either rapidly progressing or common cancers. Up to 30 patients will be recruited into each study and parallel programs will be conducted in the UK and US. Doses of between 25mg and 100mg of BB-2516 will be administered to patients in these trials since these doses were sufficient to produce potentially therapeutic blood levels in the Phase I studies. Approxiamtely 25 US centers have agreed to participate in these trials in the USA. The centers participating in the ovarian cancer study are The Mayo Clinic, Albany Medical Center, University of Wisconsin, Georgetown University, Stanford University, Johns Hopkins Medical School, University of Arizona (body, education) University of Arizona - The University was founded in 1885 as a Land Grant institution with a three-fold mission of teaching, research and public service. and Indiana University. Background to BB-2516 and cancer therapy BB-2516 is believed to be the only oral MMPI MMPI abbr. Minnesota Multiphasic Personality Inventory MMPI Child psychiatry A personality assessment tool widely used in making psychologic evaluations, which is normally given at age 16 and older. Personality testing drug to have commenced clinical trials for cancer. MMPIs act by blocking the action of matrix metalloproteinases, enzymes that destroy connective material between cells and allow cancers to spread and grow. This mechanism is common to most solid tumors. Unlike traditional cancer treatments, MMPIs are not cytotoxic drugs and should be well tolerated by normal tissue. Batimastat and pleural effusion results announcement British Biotech also has under investigation an injectable MMPI, batimastat. The first clinical trial results in pleural effusion, a late stage complication of lung cancer, were due to be announced To be announced (TBA) A contract for the purchase or sale of an MBS to be delivered at an agreed-upon future date but does not include a specified pool number and number of pools or precise amount to be delivered. in May 1995. At the investigator's request, this announcement is being brought forward to April 4, 1995 when the results of the first 15 patients will be presented at the British Association for Cancer Research/Association of Cancer Physicians annual meeting in Nottingham, England. Background British Biotech plc, founded in 1986, combines approaches in molecular biology and synthetic chemistry to develop new therapeutic agents for the treatment of cancer. In addition the company is pursuing research in inflammatory, vascular and viral diseases. Neures Limited, a subsidiary investigating the role of metalloproteinase inhibitors in neuro-inflammatory diseases, was established in 1994. A US subsidiary, British Biotech Inc., was established in Annapolis, Md., in 1993. British Biotech, based in Oxford, England, is listed on the London Stock Exchange London Stock Exchange London marketplace for securities. It was formed in 1773 by a group of stockbrokers who had been doing business informally in local coffeehouses. and quoted on NASDAQ NASDAQ in full National Association of Securities Dealers Automated Quotations U.S. market for over-the-counter securities. Established in 1971 by the National Association of Securities Dealers (NASD), NASDAQ is an automated quotation system that reports on under the symbol BBIOY. CONTACT: British Biotech plc, 011-44-865-748747 Peter Lewis, Research & Development Director James Noble, Finance Director Katie Arber, Public Relations Manager or British Biotech Inc., 410-266-7909 Peter P. McCann, President 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. Company, 212/696-5600 Gerard Coffey, Vice President |
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