Collgard Biopharmaceuticals Announces Start of Phase II Trial of Tempostatin for the Treatment of Bladder Cancer.Business Editors & Health/Medical Writers BIOWIRE2K ATLANTA--(BUSINESS WIRE)--Dec. 10, 2002 Clinical Trial Commences in the U.K. and Israel Collgard Biopharmaceuticals (www.collgard.com), the tissue therapeutics company, announced today it is now enrolling patients in a Phase II clinical trial Noun 1. phase II clinical trial - a clinical trial on more persons than in phase I; intended to evaluate the efficacy of a treatment for the condition it is intended to treat; possible side effects are monitored phase II of Tempostatin(TM) (Halofuginone hydrobromide) for the treatment of intermediate and high-risk recurring bladder carcinoma. The objective of this trial is to assess the tolerability and safety of the oral administration of Tempostatin(TM) and to evaluate the ability of the agent to prevent the recurrence of bladder cancer bladder cancer Malignant tumour of the bladder. The most significant risk factor associated with bladder cancer is smoking. Exposure to chemicals called arylamines, which are used in the leather, rubber, printing, and textiles industries, is another risk factor. in high-risk patients. Bladder cancer is the 4th most common type of cancer in men and the 8th most common in women. 53,000 people in the U.S. and 12,500 in the U.K. are annually diagnosed with bladder cancer, a potentially fatal disease. Bladder cancer affects the inner lining of the bladder and develops slowly, possibly spreading to other organs near the bladder. At present, there is no effective non-invasive treatment for patients with recurrent bladder cancer who have already undergone surgical therapy. The Phase II trial will be conducted at four different clinics, two in the U.K. and two in Israel. Locations include Oxford (Principal Investigator Noun 1. principal investigator - the scientist in charge of an experiment or research project PI scientist - a person with advanced knowledge of one or more sciences : Professor Adrian Harris); Newcastle (Principal Investigators: Dr. Andrew Thorpe Andrew Thorpe (b.1962) is a British historian. He is Professor of Modern History and (from 2004-2007) was Head of History at the University of Exeter. He is a noted historian on the British Labour Party and the Communist Party of Great Britain particularly in the era of the and Dr. John Kelly John Kelly or Jack Kelly is the name of: People
Tempostatin(TM) has particular promise as a therapeutic agent for bladder cancer because of its ability to impact favorably on multiple aspects of disease progression including cancer cell division, cell migration and tumor blood vessel blood vessel n. An elastic tubular channel, such as an artery, a vein, a sinus, or a capillary, through which the blood circulates. blood vessel(s), n the network of muscular tubes that carry blood. formation (angiogenesis angiogenesis /an·gio·gen·e·sis/ (-jen´e-sis) vasculogenesis; development of blood vessels either in the embryo or in the form of neovascularization or revascularization. an·gi·o·gen·e·sis n. ). "There are 40 anti-angiogenesis agents currently in development by various companies. Of these agents, Tempostatin(TM) is unique: in pre-clinical and in vitro in vitro /in vi·tro/ (in ve´tro) [L.] within a glass; observable in a test tube; in an artificial environment. in vi·tro adj. In an artificial environment outside a living organism. studies, it has been shown to inhibit the production of extra cellular matrix proteins necessary for the growth of tumors, to suppress the growth of bladder cancer cells and to protect the bladder epithelial (lining) from developing carcinoma in response to cancer-causing chemicals. Tempostatin(TM) has positive pre-clinical actions, now it is time to apply the results to patients," said Professor Adrian Harris, Principal Investigator of the Collgard sponsored trial and head of the Cancer Research U.K. Medical Oncology Unit at the Churchill Hospital, Oxford University, U.K. The study will consist of a screening phase, a three-month treatment period and an additional three-month extension of treatment for responders (those patients with no recurrence on therapy). Up to 20 patients at risk for recurrence of TCC TCC The Car Connection (web site) TCC Tidewater Community College TCC Tallahassee Community College TCC Temporary Continuation of Coverage TCC Tucson Convention Center (Tucson, AZ, USA) (Transitional Cell Carcinoma tran·si·tion·al cell carcinoma n. A malignant neoplasm derived from transitional epithelium and occurring primarily in the urinary bladder, ureters, or renal pelvises. transitional cell carcinoma Bladder cancer, see there ) with Ta or T1 Grades I/II will receive oral outpatient therapy of Tempostatin(TM). Intermediate and high-risk patients are defined as those who had at least two prior events of recurrence, with the most recent within 12 months prior to inclusion in the trial. Patients admitted to the trial will have had surgical removal of their first tumor, with or without intravesical treatments with BCG BCG bacille Calmette-Guérin. BCG abbr. 1. bacillus Calmette-Guérin 2. ballistocardiogram BCG, n.pr See bacille Calmette-Guórin. and/or chemotherapy. The study is designed to evaluate the safety, tolerability, plasma levels and exposure profile of Tempostatin(TM). "There is a significant unmet clinical need for an effective treatment of bladder cancer. Tempostatin(TM) has the potential to make a significant contribution to the treatment of this disease, particularly as this is an oral agent in a field where the currently approved therapeutics all require invasive procedures. The present trial is designed to test Tempostatin(TM) as a therapeutic for patients that would have no other option than the surgical removal of the bladder. We are optimistic that this may be the beginning of a new way to treat patients who before had little hope of recovery," said Collgard CEO (1) (Chief Executive Officer) The highest individual in command of an organization. Typically the president of the company, the CEO reports to the Chairman of the Board. Dr. Bruce Bach. About Collgard Biopharmaceuticals Founded in 1996, Collgard Biopharmaceuticals is a clinical stage tissue therapeutics company, led by a global team of medical and drug development experts in Boston, Atlanta and Tel Aviv. The company is currently engaged in phase II clinical studies evaluating a novel approach to the prevention and treatment of organ failure, restenosis and specific cancers. Scientific and clinical collaborators include the Mayo Clinic, the U.S. National Cancer Institute, and the European Organization for Research and Treatment of Cancer (EORTC EORTC European Organization for Research and Treatment of Cancer ). About Tempostatin(TM) Tempostatin(TM) is a fully synthetic orally available small molecule, identified by Collgard as a "master switch" in the body's tissue repair process. Tempostatin(TM) works by influencing both the activation of tissue repair cells and the production and clearance of the extra cellular matrix protein. It has been shown to be a powerful inhibitor of tumor angiogenesis and tumor cell proliferation in pre-clinical studies. |
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