Clofarabine's Excellent Results Confirmed at 6th International Symposium on Leukemia and Lymphoma; Latest Results from Adult and Pediatric Acute Leukemia Studies.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 (Nasdaq: BIVN) today announced interim results from the ongoing clinical studies of clofarabine in 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 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. trials which confirm clofarabine's outstanding profile observed in previous studies. Clofarabine has recently been approved 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 the treatment of relapsed/refractory pediatric Acute Lymphocytic Leukemia acute lymphocytic leukemia n. See acute lymphoblastic leukemia. acute lymphocytic leukemia Acute lymphoblastic leukemia, ALL A malignant lymphoproliferative process that commonly affects children and young adults (ALL). Professors Alan K. Burnett and Varsha Ghandhi, world-renowned leukaemia experts, presented data from clofarabine's ongoing clinical development program at the 6th International Symposium and Expert Workshops on Leukemia and Lymphoma in Amsterdam, Netherlands, March 17-19, 2005. Professor Burnett, Chairman of the U.K. National Cancer Research Institute Hematological hematological, hematologic pertaining to or emanating from blood cells. hematological tests total and differential white cell counts, hematocrit estimation, erythrocyte count. Oncology Study Group, presented the first interim analysis of the Phase II multi-center, international study designed to further evaluate clofarabine in older adult patients with Acute Myeloid Leukemia myeloid leukemia n. See myelogenous leukemia. (AML AML - A Manufacturing Language ) who are unsuitable for intensive chemotherapy. To date, a total of 23 patients have been enrolled in the study and, of the 12 evaluable patients, a complete response rate of 58% (6 CR and 1 CRp) has been observed by the investigators. An additional 3 patients achieved a partial response giving a combined response rate of 83%. "These data further confirm the 60% complete response rate we achieved in the pilot study of 30 patients conducted last year and validated by an independent response panel," commented Professor Burnett. The initial patients were enrolled mainly in the United Kingdom, but new centers have now been initiated in Ireland, Italy and France and enrollment is expected to increase rapidly. Professor Ghandhi of the M.D. Anderson Cancer Center, in Houston, Texas, shared the interim results from the European pediatric relapsed/refractory 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) multi-center study. A total of 23 patients have been enrolled and, of the 12 evaluable patients, 42% achieved a complete response (2 CR and 3 CRp), as determined by the investigators. "This is exciting news for clofarabine and for Bioenvision," said Christopher Wood M.D., Chairman 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. Dr. Wood added, "These clinical results will form an important part of our regulatory strategy in Europe." Conference Call Information Bioenvision will host an investor conference call today, March 21st, 2005 at 8:30AM Eastern Time to discuss the subject of this press release. Those parties interested in participating via telephone may join by dialing (877) 825-5811 or (973) 582-2767 for calls outside of Canada and the United States The United States and Canada share a unique legal relationship. U.S. law looks northward with a mixture of optimism and cooperation, viewing Canada as an integral part of U.S. economic and environmental policy. . A telephone replay of the conference call will be available one hour following the conclusion of the call and will be available for replay until March 28, 2005 at midnight Eastern Time. To access the telephone replay, dial (877) 519-4471 domestically, or (973) 341-3080 for calls outside of Canada and the United States, and enter pin number 5854514. The conference call will also be webcast live and may be accessed by visiting Bioenvision's website at www.bioenvision.com. A replay of the audio webcast will be available on the Company's website one hour following the conclusion of the call on March 21st, 2005 and will be available for replay until March 28, 2005 at midnight Eastern Time. About Clofarabine The FDA granted marketing approval for clofarabine for the treatment of patients ages 1 to 21 with refractory or relapsed ALL after at least two prior conventional regimens. It is the first new pediatric cancer drug to be introduced in over 10 years. Clofarabine is a next generation of the drug class, purine nucleoside nucleoside Any of a class of organic compounds, including structural subunits of nucleic acids. Each consists of a molecule of a five-carbon sugar (ribose in RNA, deoxyribose in DNA) and a nitrogen-containing base, either a purine or a pyrimidine. analogs that inhibit 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. production necessary for cancer cell growth. Bioenvision and Genzyme (Nasdaq: GENZ) are co-developing clofarabine. Bioenvision holds an exclusive worldwide license to clofarabine (outside Japan and Southeast Asia). Bioenvision granted an exclusive sublicense for the US and Canadian cancer markets to Genzyme. Bioenvision holds an exclusive license in the US and Canada to all non-cancer indications and an exclusive, irrevocable option to develop and market clofarabine for all human applications in Japan and Southeast Asia. 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 adult and pediatric ALL and AML in the U.S. and Europe. In the U.S., orphan drug status extends market exclusivity for seven years. The FDA also recently granted an additional six months market exclusivity to clofarabine under the Best Pharmaceuticals for Children Act. In Europe, the designation provides marketing exclusivity for 10 years. About Bioenvision Bioenvision's 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 Genzyme Corporation), 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 in clinical trials. Bioenvision is also developing anti-infective technologies, including the OLIGON technology; an advanced biomaterial biomaterial /bio·ma·te·ri·al/ (bi?o-mah-ter´e-al) a synthetic dressing with selective barrier properties, used in the treatment of burns; it consists of a liquid solvent (polyethylene glycol-400) and a powdered polymer. that has been incorporated into various FDA 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. |
|

Printer friendly
Cite/link
Email
Feedback
Reader Opinion