New Evoltra(R) Data Shows Impressive Response and Survival Rates
December 11 2006 - 1:59PM
Business Wire
Bioenvision, Inc. (NasdaqGM:BIVN) today announced new efficacy,
survival and safety data on Evoltra� from its pivotal Phase II
study BIOV-121 at the 48th Annual Meeting of the American Society
of Hematology (ASH) in Orlando, Florida. These detailed data
demonstrate significantly higher response rates and improved
survival compared to the current standard of care, especially in
high risk sub groups. These data were reported in several
presentations given by Prof. Alan Burnett, M.D., Chairman of the
U.K. National Cancer Research Institute (NCRI) Hematological
Oncology Study Group and the Chief Investigator of study BIOV-121.
These new data included: -- The demographics of the study
population, who were considered unsuitable for intensive
chemotherapy, were: median age 71 years; 29% had adverse
cytogenetics (no patients had favorable cytogenetics); 24%
secondary AML; 74% of patients had greater than or equal to 1
co-morbidities -- The overall response rate achieved with
clofarabine (30mg/m2) was substantially higher than expected at 48%
for the full analysis set (FAS) and 55% for the per protocol set
(PPS). The complete response rate (CR + CRi) was 44% for the FAS
and 50% for the PPS. -- Complete response rates for the poor
prognosis groups were: adverse cytogenetics 47%; secondary AML 31%;
patients greater than or equal to 70 years 49%. -- A pooled
analysis was performed on study BIOV-121 and the NCRI AML 14 trial
in the elderly AML population unsuitable for intensive
chemotherapy. The median overall survival for all patients was 152
days for clofarabine, 105 days for LDAC, and 69 days for HU. The
overall survival at 12 months for the poor prognosis groups were:
-- Adverse Cytogenetics - clofarabine 28% compared with 0% for LDAC
and 5% for HU; -- Secondary AML - clofarabine 50% compared with 18%
for LDAC and 0% for HU; -- Wheatley Poor Risk Index - clofarabine
36% compared with 16% for LDAC and 4% for HU. -- In the pooled
analysis the early death rate (within 30 days) was 21% for
clofarabine and 26% for both LDAC and HU. Of the 14 patients with
early deaths on clofarabine, 3 had neutropenic sepsis, 3 had
infection, 3 had infection and acute renal failure, 2 had
hemorrhage, and 1 died with disease progression. -- The most
frequent treatment-related adverse events were nausea, vomiting,
diarrhoea, and constipation which occurred in 42 (64%), 31 (47%),
26 (39%) and 10 (15%) patients respectively. Treatment-related
thrombocytopenia, anemia and neutropenia occurred in 29 (44%), 18
(27%) and 19 (29%) patients respectively. -- In study BIOV-121 the
median time to ANC recovery to greater than 1.0 x 10(9)/L and
platelet recovery to greater than 100 x 10(9)/L was 24 and 38 days
respectively. �Clearly, clofarabine is active as a single agent in
adult patients with acute myeloid leukemia and who are not
candidates for intensive therapy, and has a favorable risk/benefit
profile,� said Professor Alan Burnett, M.D. �As with all active
anticancer agents, the patients need to be carefully monitored,
however clofarabine achieves a high response rate and improved
survival in these elderly patients. �These data from the pivotal
study BIOV-121 and the pooled analysis from other studies will form
the basis of Bioenvision�s filing with the European Medicines
Agency (EMeA) for the use of clofarabine in adult AML patients over
65 years and who are considered unsuitable for intensive therapy.
The data from this press release and the presentations at ASH
relating to BIOV-121 reflect important results from the full data
set which will form the basis for the European filing. 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 has conducted nonclinical 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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