NEW YORK--()--Bioenvision, Inc. (NasdaqGM:BIVN) today announced that data from its pivotal Phase II clinical trial of Evoltra® (clofarabine) will be given in an oral presentation at the 48th Annual Meeting of the American Society of Hematology (ASH) in Orlando, Florida, December 8-12, 2006.
“A Phase II Study (BIOV-121) of Clofarabine Monotherapy First Line in Patients Aged 65 Years or Older with Acute Myeloid Leukemia for Whom Standard Intensive Chemotherapy Is Not Considered Suitable.”
The presentation is titled “A Phase II Study (BIOV-121) of Clofarabine Monotherapy First Line in Patients Aged 65 Years or Older with Acute Myeloid Leukemia for Whom Standard Intensive Chemotherapy Is Not Considered Suitable.” Professor Alan Burnett, M.D., the Chairman of the UK National Cancer Research Institute (NCRI) Hematological Oncology Study Group, will present the data on Monday, December 11th at 2:30pm.
In addition to the BIOV-121 oral presentation, Stefan Faderl, M.D., Assistant Professor, M.D. Anderson Cancer Center, Houston, Texas will provide an oral presentation titled “Clofarabine Plus Anthracycline Combinations in Acute Myeloid Leukemia” on Monday, December 11th at 8:00am.
A total of eleven abstracts on clofarabine were accepted for publication, including the two oral presentations and seven poster presentations. The data show the effect of clofarabine in patients with adult Acute Myeloid Leukemia (AML), Myelodysplastic Syndrome (MDS) and pediatric patients with Acute Lymphoblastic Leukemia (ALL).
“We are delighted that our pivotal data on Evoltra® will be featured prominently at such a prestigious, international forum,“said Christopher B. Wood, M.D., Chairman and Chief Executive Officer, Bioenvision.
Summary of Clofarabine Data Presentations
SUNDAY, DECEMBER 10TH, 2006, Poster Sessions 9:00am-8:00pm Hall E1: Abstract 1859 BIOV-111 a European Phase II Trial of Clofarabine (Evoltra(R)) in Refractory and Relapsed Childhood Acute Lymphoblastic Leukemia Poster Board #37-II Abstract 1950 The Feasibility of Combining Daunorubicin, Clofarabine and Gemtuzumab Ozogamicin Is Feasible and Effective. A Pilot Study Poster Board #128-II Abstract 1951 Phase II Study of Clofarabine and Cytosine Arabinoside in Adult Patients with Relapsed AML and in Elderly Patients with Untreated AML Who Are at High Risk of Anthracycline Toxicity Poster Board #129-II Abstract 1963 Phase I Clinical-Laboratory Trial of Clofarabine (CLO) Followed by Cyclophosphamide (CY) for Adults with Refractory Acute Leukemias: Evidence for Enhanced DNA Damage. Poster Board #141-II Abstract 1985 Effectiveness of Clofarabine in Elderly AML Patients with Adverse Cytogenetics Unfit for Intensive Chemotherapy Poster Board # 163-II Abstract 2582 A Role for DNA Double Strand Breaks in the Sensitivity of AML Cells to Clofarabine: Enhanced In Vitro Sensitivity in Primary AML Cells with FLT3 Mutations Poster Board #760-II Abstract 2660 Clofarabine Is Active in Myelodysplastic Syndrome (MDS) Poster Board #838-II MONDAY, DECEMBER 11TH, 2006, Oral Presentations Hall F5: Abstract 159 Simultaneous Session: Acute Myeloid Leukemia: Novel Therapies 8:00a.m. Presenter: Stefan Faderl, M.D. Clofarabine Plus Anthracycline Combinations in Acute Myeloid Leukemia Salvage Abstract 425 Simultaneous Session: Acute Myeloid Leukemia: Therapy in the Elderly 2:30p.m. Presenter: Professor Alan Burnet, M.D.
A Phase II Study (BIOV-121) of Clofarabine Monotherapy First Line in Patients Aged 65 Years or Older with Acute Myeloid Leukemia for Whom Standard Intensive Chemotherapy is Not Considered Suitable
Investor Conference Call
In conjunction with the release of the data at ASH, Bioenvision will host an investor conference call and webcast on Monday, December 11, 2006 at 7:15 p.m. ET.
Conference Call Information: Date: 12/11/06 Time: 7:15 p.m. ET Toll free: 866-585-6398 International: 416-849-9626 Web cast: www.bioenvision.com A replay of the call and web cast will be available for 14 days. Replay number toll free: 866-245-6755 Replay number international: 416-915-1035 Replay passcode: 780114 Web cast replay: www.bioenvision.com
About Evoltra® (clofarabine)
The European Marketing Authorization for Evoltra® (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 cancers and solid tumors. Bioenvision is also conducting Phase I studies of Evoltra® for the treatment of psoriasis and is planning further worldwide development of Evoltra® in autoimmune diseases.
Evoltra® (clofarabine) is a next generation purine nucleoside analog. Bioenvision holds an exclusive worldwide license (excluding U.S. and Canada) for the cancer applications of clofarabine and an exclusive worldwide license for all non-cancer indications. 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®. Bioenvision originally obtained clofarabine development and commercialization rights under patents held by Southern Research Institute.
Clofarabine has been granted orphan drug designation for the treatment of both ALL and AML 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®, Modrenal® (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. Bioenvision is also developing anti-infective technologies, including the OLIGON® technology; an advanced biomaterial that has been incorporated into various FDA approved medical devices and Suvus®, 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 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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