CAMBRIDGE, Mass., Jan. 17 /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
patients with metastatic colorectal cancer who relapsed following prior
treatment with an Oxaliplatin and/or an Irinotecan regimen.
"Metastatic colorectal cancer remains an essentially incurable disease
that is characterized by serious morbidity. We believe there is still a great
need for additional effective second- and third-line novel agents with
different mechanisms of action that might complement existing therapies,"
stated Robert L. Capizzi, M.D., Senior Vice President and Chief Medical
Officer at Xanthus. "We believe that Symadex has particularly strong
potential in this cancer type given that the drug has demonstrated superior
anti-tumor activity in vitro when compared to three approved agents that are
widely used for treating human colorectal cancer."
"This study is Xanthus' third Phase 2 clinical trial initiated in the last
three months. These studies are important milestones for our company as our
clinical strategy is to rapidly advance multiple, well-characterized, small-
molecule oncology drug candidates that both meet unmet medical needs and
improve on existing therapies," noted Richard T. Dean, Ph.D., President and
CEO of Xanthus.
About the Phase 2 Metastatic Colorectal Cancer Trial
The trial is an open-label, multi-center European study of Symadex
expected to enroll approximately 49 patients with metastatic colorectal cancer
following Oxaliplatin and/or Irinotecan failure. Patients will receive weekly
intravenous infusions of Symadex for three weeks, followed by a week of rest
for a total of four cycles. Responding patients will continue for additional
cycles with regular tumor assessments 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 other non-hematological
toxicities as well as hemato-toxicities known to be associated with these
active drugs. Additionally, in previous Phase 1 and preclinical studies,
Symadex has shown evidence of oral activity. The Company intends to test
Symadex in multiple 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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