Bioenvision (NASDAQ:BIVN)
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Bioenvision (Nasdaq NM: BIVN) today announced that the
first seven patients had been enrolled in a Phase IV clinical study of
Modrenal(R) (trilostane) in post-menopausal women with advanced breast
cancer. The trial has been designed to evaluate the efficacy of
Modrenal(R) in patients who have failed prior endocrine therapy with
the new generation aromatase inhibitors. The study will be conducted
in nine leading UK centers and will enroll up to an additional 54
patients.
"We are delighted with the rapid recruitment we have seen in the
first month of the study and we expect to complete enrollment within a
year," said Hugh Griffith, Bioenvision's Chief Operating Officer.
Modrenal is licensed in the UK to treat post-menopausal advanced
breast cancer following relapse on prior therapy and has demonstrated
clinical benefit rates as high as 55%. The first patients have also
been enrolled in a Phase II trial, which evaluates the benefit of
Modrenal(R) for women with pre-menopausal advanced breast cancer, who
have relapsed or are refractory to prior therapies.
"These new, multi-center studies are an important step in the
commercial development of Modrenal(R), which has already demonstrated
significant efficacy in patients whose prior treatments have failed,"
commented Dr. Christopher Wood, Chairman and CEO of Bioenvision.
Initiation of the new clinical trial program follows the discovery
of new mechanisms of action for Modrenal, which is now known to be
effective in cases of acquired endocrine resistance.
About Modrenal(R)
Modrenal(R) is approved in the UK to treat post-menopausal
advanced breast cancer following relapse on prior endocrine therapy.
Over 800 patients with breast cancer have received Modrenal(R)
(trilostane) in clinical trials, and its anti-tumor activity has been
well documented; it is effective in a significant proportion of breast
cancer patients, particularly those with hormone-sensitive tumors.
New Mechanisms of Action
Two novel mechanisms of action for Modrenal(R) have been
discovered: The first unique mechanism of action, published in the
International Journal of Cancer in 2002, explained how Modrenal(R) can
uniquely effect the binding of the hormone estrogen to receptors in
cancer cells, and in particular to estrogen receptor beta (ER-beta).
ER-beta is now known to be important in controlling the proliferation
of breast cancer and is an influential predictor of survival.
Modrenal(R)'s effect on this receptor results in a reversal or
reduction in the growth of the cancerous breast tissue.
The second unique mechanism of action, presented at the American
Society of Clinical Oncology 2004 Annual Meeting in New Orleans,
outlined how Modrenal(R)'s ability to increase estrogen binding to
ER-beta and also decrease binding to ER-alpha, brings about a newly
discovered interaction at the binding site of a protein, AP1. AP1 is
known to be an important component in cell proliferation pathways that
become increasingly relevant as the cancer cells develop resistance to
endocrine therapies, such as tamoxifen and aromatase inhibitors.
Blocking the action of estrogen through the AP1 mechanism provides an
additional means to reduce the rate of cancer cell proliferation.
About Bioenvision
Bioenvision's primary focus is the acquisition, development and
distribution of compounds and technologies for the treatment of
cancer. Bioenvision has a broad pipeline of products for the treatment
of cancer, including: Clofarabine (in co-development with Genzyme
Corporation), 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 in clinical trials.
Bioenvision is also developing anti-infective technologies, including
an anti-viral agent (Virostat) and the OLIGON technology; an advanced
biomaterial that has been incorporated into various FDA approved
medical devices. 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.