Bioenvision's Evoltra(R) Data Selected for Oral Presentation at ASH 2006 Annual Meeting
December 04 2006 - 7:00AM
Business Wire
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. 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. Bioenvision,
Inc. (NasdaqGM:BIVN) today announced that data from its pivotal
Phase II clinical trial of Evoltra(R) (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. 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(R) 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 -0-
*T 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. *T -0- *T 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 *T 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. -0- *T 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 *T About Evoltra(R) (clofarabine) The
European Marketing Authorization 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 cancers and
solid tumors. Bioenvision is also conducting Phase I studies of
Evoltra(R) for the treatment of psoriasis and is planning further
worldwide development of Evoltra(R) in autoimmune diseases.
Evoltra(R) (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(R). 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(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), 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 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 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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