Bioenvision to Formally Launch Evoltra(R) Throughout Europe; Bioenvision To Showcase Leukemia Drug At International Pediatric Oncology Conference.NEW YORK New York, state, United States New York, Middle Atlantic state of the United States. It is bordered by Vermont, Massachusetts, Connecticut, and the Atlantic Ocean (E), New Jersey and Pennsylvania (S), Lakes Erie and Ontario and the Canadian province of -- Bioenvision, Inc. (NasdaqGM: BIVN) today announced the Company will be formally launching Evoltra(R) throughout Europe at the 38th Congress of the International Society of Pediatric pediatric /pe·di·at·ric/ (pe?de-at´rik) pertaining to the health of children. pe·di·at·ric adj. Of or relating to pediatrics. Oncology (SIOP SIOP Single Integrated Operational Plan (US military) SIOP Sheltered Instruction Observation Protocol SIOP Société Internationale d'Oncologie Pédiatrique (International Society of Pediatric Oncology) ) in Geneva Geneva, canton and city, Switzerland Geneva (jənē`və), Fr. Genève, canton (1990 pop. 373,019), 109 sq mi (282 sq km), SW Switzerland, surrounding the southwest tip of the Lake of Geneva. , Switzerland from September 17th-21st. "This conference is the perfect platform for Bioenvision to share data on our new, innovative cancer drug Evoltra(R) (clofarabine) with hundreds of oncologists, pediatricians, hematologists, surgeons and nurses who treat pediatric patients all over the globe," said Dr. Christopher B. Wood, Chairman and Chief Executive Officer of Bioenvision. The annual scientific conference of SIOP is the major international meeting for all healthcare professionals who treat children with cancer. 1700 specialists are expected to attend. Interim results from the Bioenvision European pediatric acute lymphoblastic leukemia acute lymphoblastic leukemia n. Abbr. ALL Lymphoblastic leukemia occurring mainly in older adults, characterized by rapid onset and progression of symptoms. Also called acute lymphocytic leukemia. study have been selected for oral presentation in the plenary scientific session on Tuesday, September 19th 2006. Dr Pamela Kearns, one of the Chief Investigators for this important study, will be making the presentation. Three additional abstracts have also been selected for poster presentations and focus on the most recent data from the pivotal study conducted in the US which led to both US and EU marketing approval. Bioenvision is also sponsoring a dedicated satellite symposium entitled "New treatment options in pediatric acute leukemias Leukemias, Acute Definition Leukemia is a cancer that starts in the organs that make blood, namely the bone marrow and the lymph system. Depending on their characteristics, leukemias can be divided into two broad types. " which will include presentations relating to Evoltra from Professor Rob Pieters, Dr Sima Jeha, Professor Vaskar Saha and Professor Andre Baruchel. "The 38th Congress of SIOP is the most appropriate forum for our formal launch of Evoltra(R) throughout Europe. It provides an excellent stage to further communicate the benefits associated with Evoltra to the world's leading paediatric Adj. 1. paediatric - of or relating to the medical care of children; "pediatric dentist" pediatric haematologists and oncologists," said Hugh S. Griffith, Chief Operating Officer Chief Operating Officer (COO) The officer of a firm responsible for day-to-day management, usually the president or an executive vice-president. of Bioenvision. Evoltra(R) received marketing approval from the European Commission this summer for the treatment of relapsed and refractory acute lymphoblastic leukemia in children. About Evoltra(R) (clofarabine) The European Marketing Authorisation for Evoltra(R) (clofarabine) is for "the treatment of acute lymphoblastic leukemia (ALL) in pediatric patients who have relapsed or are refractory to at least two prior regimens and where there is no other treatment option anticipated to result in a durable response. Safety and efficacy have been assessed in studies of patients less than or equal to 21 years old at initial diagnosis." Clofarabine is in clinical development for the treatment of other hematological hematological, hematologic pertaining to or emanating from blood cells. hematological tests total and differential white cell counts, hematocrit estimation, erythrocyte count. cancers and solid tumors. Bioenvision is also conducting late-stage preclinical development of Evoltra(R) for the treatment of psoriasis and is planning further worldwide development of Evoltra(R) in autoimmune diseases Autoimmune diseases A group of diseases, like rheumatoid arthritis and systemic lupus erythematosus, in which immune cells turn on the body, attacking various tissues and organs. Mentioned in: Complement Deficiencies, Premature Menopause . Evoltra(R) (clofarabine) is a next generation purine nucleoside analog. Bioenvision holds an exclusive worldwide license for clofarabine (outside Japan and Southeast Asia) and an exclusive, irrevocable option to develop, market and distribute clofarabine for all human applications in Japan and Southeast Asia. Bioenvision granted an exclusive sublicense to Genzyme Corporation to develop and commercialize clofarabine for certain cancer indications in the U.S. and Canada, which Genzyme markets under the name of Clolar(R). Bioenvision holds an exclusive license in the U.S. and Canada for all non-cancer indications. Bioenvision originally obtained clofarabine development and commercialization rights under patents held by Southern Research Institute. Clofarabine has been granted orphan drug orphan drug, drug developed under the U.S. Orphan Drug Act (1983) to treat a disease that affects fewer than 200,000 people in the United States. The orphan drug law offers tax breaks and a seven-year monopoly on drug sales to induce companies to undertake the designation for the treatment of both ALL and AML AML - A Manufacturing Language in the U.S. and Europe. In Europe, the designation provides marketing exclusivity for 10 years following Marketing Authorization. About Bioenvision Bioenvision's primary focus is the acquisition, development, distribution and marketing of compounds and technologies for the treatment of cancer. Bioenvision has a broad pipeline of products for the treatment of cancer, including: Evoltra(R), Modrenal(R) (for which Bioenvision has obtained regulatory approval for marketing in the United Kingdom for the treatment of post-menopausal breast cancer following relapse to initial hormone therapy Hormone therapy Treating cancers by changing the hormone balance of the body, instead of by using cell-killing drugs. Mentioned in: Breast Cancer, Thyroid Cancer hormone therapy ), and other products. Bioenvision is also developing anti-infective technologies, including the OLIGON(R) technology, an advanced biomaterial that has been incorporated into various FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. approved medical devices and Suvus(R), an antimicrobial agent currently in clinical development for refractory chronic hepatitis C infection. For more information on Bioenvision please visit our Web site at www.bioenvision.com. Certain statements contained herein are "forward-looking" statements (as such term is defined in the Private Securities Litigation Reform Act The Private Securities Litigation Reform Act of 1995 (PSLRA) implemented several significant substantive changes affecting certain cases brought under the federal securities laws, including changes related to pleading, discovery, liability, class representation and awards fees and of 1995). Because these statements include risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. Specifically, factors that could cause actual results to differ materially from those expressed or implied by such forward-looking statements include, but are not limited to: risks associated with preclinical and clinical developments in the biopharmaceutical industry in general and in Bioenvision's compounds under development in particular; the potential failure of Bioenvision's compounds under development to prove safe and effective for treatment of disease; uncertainties inherent in the early stage of Bioenvision's compounds under development; failure to successfully implement or complete clinical trials; failure to receive marketing clearance from regulatory agencies for our compounds under development; acquisitions, divestitures, mergers, licenses or strategic initiatives that change Bioenvision's business, structure or projections; the development of competing products; uncertainties related to Bioenvision's dependence on third parties and partners; and those risks described in Bioenvision's filings with the SEC. Bioenvision disclaims any obligation to update these forward-looking statements. |
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