Bioenvision Announces Latest Data on Evoltra(R) in Pediatric and Adult Leukemias
11 December 2006 - 5:44AM
Business Wire
Bioenvision, Inc. (NasdaqGM:BIVN) announced the latest results from
clinical studies of clofarabine (Evoltra�) were presented in seven
posters today at the 48th Annual Meeting of the American Society of
Hematology (ASH) in Orlando, Florida. The posters featured data on
the efficacy and safety of clofarabine in Acute Lymphoblastic
Leukemia (ALL), Acute Myeloid Leukemia (AML) and Myelodysplastic
Syndrome (MDS). Of the data presented, Bioenvision's data included:
A pooled analysis of three studies, BIOV-121, UWCM-0001 and AML-14,
showed a 46% complete response rate (CR/CRi) in elderly AML
patients with adverse cytogenetics who were unsuitable for standard
intensive treatment. The current standard of care low dose Ara-C
(LDAC) had a 0% complete response rate. The one-year survival rate
for Evoltra was 21%, compared with 0% for LDAC. (Abstract 1985;
Poster 163) A dose-ranging study assessing the combination of
Evoltra� and daunorubicin showed an overall response rate of 65%.
In the 20mg cohort the response rate was 100%. The overall survival
at 1 year for the full cohort of 37 patients was 62%. The
combination of clofarabine 20mg/m2 plus daunorubacin 50mg/m2 was
well tolerated with acceptable toxicity. This combination has been
chosen for the NCRI Phase III AML-16 Intensive Study which is now
enrolling patients. (Abstract 1950; Poster 128) The latest update
from study BIOV-111 showed a complete response rate (CR + CRp) of
31% in heavily pre-treated pediatric patients with
relapsed/refractory ALL. These data confirm the results of the
pivotal US CLO-212* study and further establish Evoltra� as the
standard of care for pediatric patients with relapsed/refractory
ALL . (Abstract 1859; Poster 37) �We are very encouraged about the
potential these new data show for Evoltra� to be used alone or in
combination with other therapies to treat acute leukemia in
children and adults,� said Professor Christopher Wood, M.D., Chief
Executive Officer and Chairman, Bioenvision. �Based on these
results, we are moving ahead with new clinical studies of Evoltra�
in other disease areas, such as MDS, chronic leukemias and solid
tumors.� �Evoltra� provides elderly patients with AML who are
unsuitable for intensive chemotherapy a much higher response rate
and a real survival advantage, especially in those patients with
additional poor prognostic factors,� said Hugh Griffith, Chief
Operating Officer, Bioenvision. �These data, along with data to be
presented tomorrow, will form the basis for our marketing
authorization application to the European Medicines Agency (EMeA)
for a label extension of Evoltra� for adults with AML who are
unsuitable for intensive chemotherapy.� On Monday at 2:30 p.m.,
data from Bioenvision�s pivotal Phase II trial of Evoltra� in adult
AML will be featured in an oral presentation entitled �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.� Alan
Burnett, M.D., Chairman of the UK National Cancer Research
Institute (NCRI) Hematological Oncology Study Group, will present
these data in Hall F5. Investor Conference Call and Meeting at ASH
In conjunction with the release of the data at ASH, Bioenvision
will host an investor meeting, 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 pre-clinical 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. *
CLO-212 was conducted by Genzyme Corporation. 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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