Clinical Data from Studies of Bioenvision's Clofarabine to Be Presented at American Society of Hematology Meeting.Business Editors/Health/Medical Writers 45th Annual Meeting of the American Society of Hematology (ASH) NEW YORK--(BUSINESS WIRE)--Nov. 7, 2003 Bioenvision, Inc. (Amex:BIV BIV Bivouac BiV Biventricular BIV Bovine Immunodeficiency Virus BIV Built-in Variable (plumbing) ) today announced that three abstracts relating to its lead oncology product, clofarabine, have been accepted for presentation at the 45th Annual Meeting of the American Society of Hematology (ASH), to be held on December 5-9, 2003, in San Diego, CA. The abstracts are available on the ASH website at www.hematology.org. The three abstracts, entitled: "Clofarabine Is Active in Combination with Cytarabine (ara-C) in Adult Patients (pts) in First Relapsed and Primary Refractory Acute Leukemia acute leukemia Hematology A rapidly progressive malignancy of sudden onset, characterized by an uncontrolled 'clonal' proliferation of immature WBCs which replace BM and spill into the peripheral circulation; untreated AL may be fatal in wks to months. and High-Risk Myelodysplastic Syndrome (MDS MDS, n See temporomandibular pain-dysfunction syndrome. MDS 1 Maternal deprivation syndrome, see there 2 Myelodysplastic syndrome, see there )" (S. Faderl, V. Gandhi, et al.), "A Phase II, Open-Label Study of Clofarabine in Pediatric Patients with Refractory or Relapsed Acute Myelogenous Leukemia acute myelogenous leukemia n. Abbr. AML Myelogenous leukemia characterized by rapid abnormal increase in the number of myeloblasts and progression of symptoms. " (S. Jeha, P. Steinherz, et al.), and "A Phase II, Open-Label Study of Clofarabine in Pediatric Patients with Refractory or Relapsed 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. " (S. Jeha, P. Gaynon, et al.) are scheduled for presentation by clinical investigators. About Clofarabine Clofarabine is a second-generation purine nucleoside antimetabolite antimetabolite: see metabolite. antimetabolite Substance that competes with, replaces, or inhibits a specific compound within a cell, whose functioning is thereby disrupted. under development for the treatment of acute 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. and adult leukemias. Nucleoside analogues are antimetabolites that affect DNA synthesis. Clofarabine was rationally designed to combine many of the favorable properties of the two most commonly used nucleoside analogs, fludarabine and cladribine, but is reported to have greater potency at damaging the DNA DNA: see nucleic acid. DNA or deoxyribonucleic acid One of two types of nucleic acid (the other is RNA); a complex organic compound found in all living cells and many viruses. It is the chemical substance of genes. of Leukemia cells than these other agents. (Blood, "Mitochondrial Toxicity of Deoxyadenoside Analogs", November 15, 2000, Volume 96, Number 10). In a single center Phase II study of clofarabine in patients with refractory acute myelogenous leukemia (AML AML - A Manufacturing Language ), 42% of the patients had a complete response rate (CR) and a further 13% had a partial response (CRp). Bioenvision granted ILEX Ilex a bush bearing berries containing saponins; cause vomiting, diarrhea. Called also holly. the right to develop clofarabine in the United States and Canada. Bioenvision is entitled to milestone payments tied to the development of the compound and is entitled to royalties on North American sales. Bioenvision is developing clofarabine exclusively in the rest of the world. Bioenvision originally obtained clofarabine development and commercialization rights under patents held by Southern Research Institute. About Bioenvision Bioenvision's (Amex:BIV) primary focus is the acquisition, development and distribution of compounds and technologies for the treatment of cancer. Bioenvision has a broad pipeline of products for the treatment of cancer, including: clofarabine (in co-development with ILEX Oncology, Inc.), 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), and other products in clinical trials. Bioenvision is also developing anti-infective technologies, including the OLIGON 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. 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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