CAMBRIDGE, Mass., Oct. 20 /PRNewswire/ -- Xanthus Life Sciences today
announced the commencement of a Phase 2 study of Xanafide(TM) (amonafide
malate) in combination with cytosine arabinoside (ara-C) for the treatment of
patients with secondary acute myeloid leukemia (AML).
"Currently, there are no approved therapies specifically indicated for
secondary AML, a disease that responds infrequently and only briefly to
standard therapies," said Robert L. Capizzi, M.D., Xanthus' Chief Medical
Officer. "We are extremely encouraged by the 46% response rate achieved in
the Phase 1 trial of amonafide and ara-C in patients with AML, together with
the acceptable safety profile, given that the vast majority of enrollees in
this phase 2 trial are likely to be elderly, with high-risk AML."
About the Phase 2 study
The Phase 2 study will be conducted at multiple centers in North America
and is expected to enroll up to 60 patients with secondary AML (patients with
antecedent myelodysplastic syndrome or prior exposure to leukemogenic
therapy). Patients will receive a daily dose of Xanafide for five days in
combination with a standard dose of ara-C as a continuous infusion for 7 days.
The primary endpoint of the study is the rate of complete remission, and
secondary endpoints include duration of remission and overall survival.
About Xanafide(TM)
Xanafide (amonafide malate) is an ATP-independent topoisomerase 2
inhibitor. In a Phase 1 study, amonafide and ara-C in patients with poor-risk
AML demonstrated a clinical response rate of 46% (12/26), with 38% (10/26)
achieving complete remission and two patients achieving near-complete
remission. The median duration of remission was five months, with two patients
remaining disease-free for over two years and over 5 years following post
remission therapy. Results of this Phase 1 study were presented at the 2005
ASCO annual meeting.
About Xanthus
Xanthus is an oncology drug development company. Xanthus' small molecule
candidates are Xanafide(TM), Symadex(TM) and Clomet(TM) which are advancing in
clinical and preclinical development for multiple cancer indications. Each of
these product candidates was in-licensed based on significant clinical and/ or
preclinical data supporting safety and activity. Xanthus also has proprietary
technology to individualize patient dosing, which it believes may help improve
the performance of certain drugs in development, and facilitate the life cycle
management of certain marketed products, without limiting patient populations
or markets.
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.
SOURCE Xanthus Life Sciences
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Related links:
http://www.xanthus.com
CONTACT:
Richard T. Dean, Ph.D., Chief Executive
Officer of Xanthus Life Sciences, +1-617-225-0522; or Kari Watson
of MacDougall Biomedical Communications, Inc., for Xanthus Life
Sciences, +1-508-647-0209, kwatson@macbiocom.com
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