CAMBRIDGE, Mass., Jan. 3 /PRNewswire/ -- Xanthus Life Sciences, Inc., a
privately-held oncology drug development company, today announced that it has
begun dosing patients in a Phase 2 clinical trial with Symadex(TM) (C-1311) in
women with metastatic breast cancer following anthracycline and taxane
failure.
"Even though significant advances have been made in the treatment of early
breast cancer, treatment options for advanced breast cancer are still limited
and metastatic breast cancer is almost always fatal," stated Robert L.
Capizzi, M.D., Senior Vice President and Chief Medical Officer at Xanthus.
"We are particularly enthusiastic about Symadex in the treatment of metastatic
breast cancer because prior studies suggest that its activity will not be
affected by acquired resistance to the commonly-used first-line therapies. We
also believe that the potential reduction in cardio- and hemato-toxicities
associated with Symadex will be beneficial to this very sick patient
population."
"The initiation of this study is an important milestone for our Company as
it marks Xanthus' second oncology candidate to enter Phase 2 clinical trials
this year. In 2006, we plan to initiate a second Phase 2 study with Symadex
in patients with metastatic colorectal cancer, and expect to broaden our
clinical pipeline by entering the clinic with our third oncology candidate,
Clomet(TM)," noted Richard T. Dean, Ph.D., President and CEO of Xanthus.
About the Phase 2 Metastatic Breast Cancer Trial
The trial is an open-label, multi-center European study of Symadex
expected to enroll 49 patients with metastatic breast cancer who relapsed
following prior treatment with an anthracycline and taxane regimen. Patients
will be treated with Symadex via intravenous administration weekly for three
weeks followed by a week of rest for a minimum of two four-week cycles. After
completing two cycles, patients with stable disease will continue for two
further cycles. Responding patients will continue for additional cycles with
tumor assessments every eight weeks until progressive disease or death. The
primary objective of the study is overall response rate (including patients
with complete responses and partial responses). Secondary objectives of the
study include, time-to-progression, duration-of-response and overall survival,
as well as determination of toxicity and pharmacokinetic characteristics for
Symadex.
About Symadex(TM)
Symadex (formerly C-1311) is a next-generation investigational anticancer
drug that has shown a potentially novel, targeted mechanism of action in
preclinical studies. Symadex was developed to deliver efficacy comparable to
anthracyclines (e.g., doxorubicin) and anthracenediones (e.g., Novantrone(R)
(mitoxantrone)), but with reduced cardio- and hemato-toxicities known to be
associated with these active drugs. Additionally, in previous preclinical
studies, Symadex has shown early evidence of both oral activity and efficacy
in various models of acquired drug resistance. The Company intends to develop
Symadex in several tumor indications. Xanthus is also exploring the use of
Symadex for the treatment of a number of autoimmune diseases, such as Multiple
Sclerosis, where early preclinical data has shown encouraging signs of
activity. Xanthus licensed intellectual property related to Symadex from BTG
International, Ltd.
About Xanthus Life Sciences, Inc.
Xanthus Life Sciences, Inc. is developing a portfolio of novel, clinical-
stage, small-molecule oncology drugs through a management team whose
accomplished track record encompasses all aspects of drug development, from
discovery through regulatory approval and commercialization. The Company is
applying its expertise both to advance its current pipeline and expand it into
indications of unmet medical need beyond oncology.
Xanthus is headquartered in Cambridge, Massachusetts with an additional
facility in Montreal, Quebec. More information is available at
http://www.xanthus.com.
This press release contains forward-looking statements concerning Xanthus
that involve a number of risks and uncertainties. For this purpose, any
statements contained herein that are not statements of historical fact may be
deemed to be forward-looking statements. Without limiting the foregoing, the
words, "believes," "anticipates," "plans," "expects," "estimates," "intends,"
"should," "could," "will," "may," and similar expressions are intended to
identify forward-looking statements. There are a number of important factors
that could cause Xanthus' actual results to differ materially from those
indicated by such forward-looking statements, including risks as to whether
results obtained in early clinical studies or in preclinical studies such as
the studies referred to above will be indicative of results obtained in future
clinical trials or warrant additional trials; whether products based on
Xanthus' technology will advance through the clinical trial process and
receive approval from the United States Food and Drug Administration or
equivalent foreign regulatory agencies; whether the company will have the cash
resources to develop and commercialize its products; and whether the patent
and patent applications owned or licensed by Xanthus will protect the
Company's technology and prevent others from infringing it. Xanthus disclaims
any intention or obligation to update any forward-looking statements.
Contacts:
Kari Watson, MacDougall Biomedical Communications, Inc. -
kwatson@macbiocom.com or (508) 647-0209
John A. McCarthy, Jr., Senior Vice President & CFO, Xanthus Life Sciences,
Inc. - john.mccarthy@xanthus.com or (617) 225-0522, x 125
SOURCE Xanthus Life Sciences, Inc.
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Related links:
http://www.xanthus.com
CONTACT:
Kari Watson of MacDougall Biomedical
Communications, Inc., +1- 508-647-0209, kwatson@macbiocom.com; or
John A. McCarthy, Jr., Senior Vice President & CFO of Xanthus
Life Sciences, Inc., +1-617-225-0522, ext. 125,
john.mccarthy@xanthus.com
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