Bioenvision (NASDAQ:BIVN)
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Bioenvision (Nasdaq:BIVN) today announced that the first
patients have been enrolled and commenced treatment in three separate,
clinical studies of Modrenal(R) (trilostane). These studies are
investigating the efficacy of Modrenal in three distinct settings: (1)
a Phase IV trial in advanced, post-menopausal breast cancer, (2) a
Phase II trial in pre-menopausal breast cancer; and (3) a Phase II
trial utilizing Modrenal(R) as a neo-adjuvant (pre-operative)
treatment in post-menopausal breast cancer.
The Phase IV study will evaluate the efficacy of Modrenal(R) in
post-menopausal women who have failed prior aromatase inhibitor
therapy. The study is being conducted in nine leading UK centers and
the first 18 patients have been recruited, with a target of 61
evaluable patients. The primary objective of the Phase IV study is to
determine the clinical benefit rate associated with Modrenal(R)
treatment, and the trial is expected to be completed Q4, calendar
2006. The study will add to the existing database for Modrenal(R) in
over 700 patients with advanced post-menopausal breast cancer.
The Phase II sponsored clinical study will focus on pre-menopausal
women with advanced breast cancer who have relapsed or are refractory
to first line treatment. The study is being conducted at eight leading
UK centers and will recruit up to 41 evaluable patients. The primary
objective of the Phase II study is to determine the clinical benefit
rate associated with Modrenal(R) treatment and this trial is also
expected to be completed Q4, calendar 2006.
A Phase II, investigator sponsored study will examine the role of
Modrenal(R) as first line treatment for post-menopausal patients with
the objective of decreasing the breast cancer tumor mass prior to
surgery. The first 12 patients have been recruited with a target of 30
evaluable patients in total. This study is expected to complete
enrollment in Q2, calendar 2006.
"These multi-center studies are an important step in the
development of Modrenal(R)," commented Dr. Christopher Wood, CEO and
Chairman of Bioenvision. "There is an enormous need for new drugs that
offer alternative treatment options, especially for patients who have
developed resistance to existing therapies," added Dr. Wood.
Modrenal(R) is licensed and marketed in the UK to treat
post-menopausal advanced breast cancer following relapse on initial
hormone therapy and has demonstrated clinical benefit rates as high as
55%.
Instigation of this new clinical trial program follows the
discovery of new mechanisms of action for Modrenal(R), 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 initial hormone 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 recently 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 on
the surface of 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
Virostat for hepatitis-C 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.