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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.