First Patients Enrolled in Three Breast Cancer Studies for Bioenvision's Modrenal(R)
November 17 2005 - 7:00AM
Business Wire
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.
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