Bioenvision (NASDAQ:BIVN)
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Bioenvision, Inc. (NasdaqGM:BIVN) today announced the
latest results from the ongoing European study (BIOV-111) of
Evoltra(R) (clofarabine) in pediatric acute lymphoblastic leukemia
(ALL) - presented for the first time this week - have confirmed
Bioenvision's recently approved drug, Evoltra(R), delivers a
significant response rate in a difficult to treat patient population.
In addition, updated results from the pivotal clinical study CLO-212*
showed that response to clofarabine provides the opportunity for
patients to proceed to stem cell transplant, which offers them the
best chance for long term survival.
The data was presented this week at the 38th Congress of the
International Society of Pediatric Oncology (SIOP) in Geneva,
Switzerland, which is one of the largest gatherings of pediatric
cancer specialists in the world and this year has attracted over 1700
delegates.
Although the first-line treatment of children with leukemia is
generally successful, patients with multiple relapsed or refractory
leukemia have a low response rate to existing treatment options and a
very poor prognosis, with a median survival of approximately 9-10
weeks.
Study BIOV-111 - response rate and survival benefits
Interim results from Study BIOV-111 - the ongoing European phase
II study of Evoltra(R) in refractory and relapsed childhood acute
lymphoblastic leukemia (ALL) - showed, in the evaluable patients, a
complete response rate (CR + CRp) of 28%. In addition, Evoltra(R)
achieved a notable survival advantage, with a current median survival
of 37.4 weeks in responding patients compared to 9.4 weeks in
non-responding patients. Dr Pamela Kearns, Senior Lecturer in
Pediatric Oncology, Bristol University and Bristol Royal Hospital for
Children, who presented the data commented, "The overall remission
rate seen in this study is exceptional in such a difficult to treat
group of patients who have failed other currently available
treatments. Evoltra achieves durable responses with a notable survival
advantage for the responders".
Study CLO-212* - latest update
Updated results from pivotal clincial study CLO-212* were
presented at SIOP. Dr Sima Jeha, St. Jude Children's Hospital,
Memphis, reported that a 30% response rate was achieved in heavily
pre-treated patients with multiple relapsed/refractory ALL with a
median survival at the latest data cut-off is 66.6 weeks compared with
just 7.6 weeks for the non responders. "Although the original aim of
this phase II study was not to follow patients indefinitely, due to
the very favorable results and the number of patients proceeding to
transplant, the protocol was amended and we continued to follow them,"
said Dr. Jeha.
Dr Rupert Handgretinger, Tubingen, Germany one of the transplant
specialists in the study also presented updated information on those
children who received a stem cell transplant following response to
Evoltra(R). Dr Handgretinger commented, "The majority of patients who
received a transplant after responding to Evoltra(R) are still alive,
one is alive three years post transplant".
Evoltra(R) was granted European Marketing Authorization by the
European Commission on 29th May 2006 and is available in all 25 member
states of the European Union. Bioenvision chose the SIOP 2006 meeting
as the ideal forum to officially launch Evoltra(R) in Europe. The
formal launch meeting was attended by approximately 200 of the worlds
leading pediatric hematologists and oncologists. In addition study
results were presented at the plenary sessions of SIOP and at a
dedicated Evoltra satellite symposium.
*clinical study CLO-212 was conducted by Genzyme Corporation in
the U.S.
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
late-stage preclinical development 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:
http://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.