Bioenvision Establishes Corporate Headquarters in New York City.Business & Health Editors NEW YORK--(BUSINESS WIRE)--Sept. 17, 2002 Bioenvision, Inc. (OTC OTC See: Over-the-counter. OTC See over-the-counter market (OTC). BB: BIOV) today announced that it has established its corporate headquarters in midtown Manhattan. With offices now in London and Manhattan, the Company is better positioned to develop new corporate relationships and to further expand ongoing clinical programs. "Having a presence both in the U.K. and the U.S. will enable us to take full advantage of the research and partnership opportunities as well as allow us greater exposure to the capital markets in both countries," said Dr. Christopher Wood, President and 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. of Bioenvision. Background on the Company's programs: The Company's lead product, clofarabine, is currently being tested clinically in a variety of hematological malignancies as well as solid tumors. Clofarabine is currently being studied in Phase II clinical trials in children with 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. (ALL), children with 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. (AML AML - A Manufacturing Language ), and adults with acute myelogenous leukemia (AML). Preliminary clinical data in these indications has looked very promising. Phase I/II trials are planned to begin this year in Non-Hodgkins Lymphoma and Chronic Lymphocytic Leukemia chronic lymphocytic leukemia n. Abbr. CLL Lymphocytic leukemia occurring mainly in older adults, characterized by slow onset and gradual progression of symptoms. . Additionally, Phase I clinical testing of clofarabine in patients with solid tumors is set to begin later this year. Clofarabine is a novel investigational therapeutic designed as a second-generation nucleoside analogue to overcome the limitations of current analogues, such as fludarabine and cladrabine. Clofarabine exhibits the mechanistically favorable properties of both fludarabine and cladrabine in terms of 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. chain termination and inhibition of ribonucleotide reductase, respectively. In several preclinical models, when compared to Fludara, clofarabine has shown several-fold greater lymphocytic potency. It also appears to work through a unique additional mechanism, whereby it directly damages the mitochondria in cancer cells and induces apoptosis (Blood 2000 96: 3537). Bioenvision is co-developing clofarabine with ILEX Ilex a bush bearing berries containing saponins; cause vomiting, diarrhea. Called also holly. Oncology, Inc. (ILXO). Bioenvision is also developing Modrenal, a compound already approved in the U.K. for the treatment of advanced post-menopausal breast cancer. Clinical trials have shown the compound is effective in breast cancer patients, particularly after treatments with hormonal therapy, for example with tamoxifen tamoxifen (təmŏk`sĭfĕn'), synthetic hormone used in the treatment of breast cancer. Introduced in 1978, tamoxifen is used to prevent recurrences of cancer in women who have already undergone surgery to remove their tumors. , are no longer effective. Data recently published in the International Journal of Cancer suggest that Modrenal, in addition to inhibiting production of estrogen, also has a novel second mode of action that could explain the drug's broad clinical activity (Puddlefoot J.R. et al Int. J. of Cancer 101; 17-22 2002). Currently available anti-estrogens, such as tamoxifen, are competitive inhibitors that bind to the ligand binding sites of estrogen receptors (ER). Modrenal does not bind to the receptors but inhibits the receptors from binding to estrogen response elements in DNA and stops estrogen- stimulated gene transcription. Thus, the drug works in the cancer cell at a site different than most other breast cancer drugs and could therefore potentially be used when the other agents have failed. Also, of particular interest is the way in which Modrenal acts on the "second" estrogen receptor, ER beta. Recently published data suggest that ER beta may play an important role in the development of hormone sensitive cancers, such as breast and prostate cancer, and this recently-described receptor has become a prime target for new forms of treatment. A part of Modrenal's action is directed specifically at ER beta. Bioenvision's OLIGON technology, licensed to a leader in the treatment of cardiovascular disease, utilizes a proprietary process that creates an electrochemical electrochemical /elec·tro·chem·i·cal/ (-kem´i-k'l) pertaining to interaction or interconversion of chemical and electrical energies. e·lec·tro·chem·i·cal adj. reaction between dissimilar metals (silver and platinum). The OLIGON technology involves the impregnation impregnation /im·preg·na·tion/ (im?preg-na´shun) 1. fertilization. 2. saturation (1). impregnation 1. the act of fertilizing or rendering pregnant. 2. saturation. of a polymer material with silver, platinum and carbon particles. Upon contact with an ionic solution such as saline, medications or body fluids, an electrochemical reaction between the silver and platinum particles is activated, and silver ions are actively released to the surface of the polymer and then into its immediate surrounding environment, a process known as Oligodynamic Iontophoresis iontophoresis /ion·to·pho·re·sis/ (i-on?to-fah-re´sis) the introduction of ions of soluble salts into the body by means of electric current.iontophoret´ic i·on·to·pho·re·sis n. . The OLIGON antimicrobial material can be customized to help prevent infection for any number of devices, including over-the-counter and consumer products, where markets are estimated to be billions of dollars. Bioenvision plans to establish OLIGON as a broadly effective, safe and superior technology. In vitro and animal testing and human clinical trials have shown OLIGON to be superior to antibiotic, antiseptic and other silver technologies in reducing device-related infections. The first commercial sales of a product using OLIGON, a central venous catheter central venous catheter n. A catheter passed through a peripheral vein and ending in the thoracic vena cava; it is used to measure venous pressure or to infuse concentrated solutions. (CVC See CSC. ) was rolled out in June 2000. The product is the first CVC made of a biocompatible biocompatible /bio·com·pat·i·ble/ (-kom-pat´i-b'l) being harmonious with life; not having toxic or injurious effects on biological function. and antimicrobial material, and the Company is currently generating revenues from its sale. Recently, the Company received 510K approval for a pulmonary artery catheter In medicine pulmonary artery catheterization is the insertion of a catheter into a pulmonary artery. Its purpose is diagnostic; it is used to detect heart failure or sepsis, monitor therapy, and evaluate the effects of drugs. and expects to begin marketing the product soon. About Bioenvision Bioenvision's (OTC BB: BIOV) 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); and other products in clinical trials. Bioenvision is also developing anti-infective technologies, including the OLIGON technology, an advanced biomaterial that has been approved for certain indications by the 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. in the U.S. 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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