CAMBRIDGE, Mass., June 5 /PRNewswire/ -- Xanthus Pharmaceuticals, Inc.,
a privately-held oncology drug development company, today announced the
completion of a planned interim analysis of its Phase 2 study of
Xanafide(TM) (amonafide malate) for the treatment of patients with
secondary acute myeloid leukemia (AML).
The planned interim efficacy analysis was conducted on data from the
first 26 patients enrolled in the trial. In addition, an independent Data
Safety Monitoring Board (DSMB) has reviewed the current safety and efficacy
data and has recommended continuation of the trial under the current
protocol.
"The completion of this planned interim efficacy analysis and the DSMB
review are an important milestone in our Xanafide development program, as
we continue enrolling patients and move forward to complete this Phase 2
study. While it is too early to draw any firm conclusions, we were pleased
with the interim results of this Phase 2 study, both in terms of safety as
well as the clinical response rate," said Richard T. Dean, Ph.D., Chief
Executive Officer at Xanthus.
About the Xanafide(TM) Phase 2 study
The Phase 2 study is being conducted at multiple centers in North
America and is expected to enroll up to 80 patients with secondary AML
(patients with antecedent myelodysplastic syndrome or prior exposure to
leukemogenic therapy). In this study, patients 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.
Xanthus also announced today that data from Phase 1 studies of Xanafide
were presented at the 42nd Annual Meeting of the American Society of
Clinical Oncology (ASCO). The data were from a retrospective review of the
activity of Xanafide, both as a monotherapy and in combination with ara-C,
specifically in patients with secondary AML in the Phase 1 studies. In both
the monotherapy and combination regimens Xanafide was found to be active.
These results formed the basis of Xanthus' ongoing Phase 2 trial. The
details of the data can be found in ASCO abstract # 6584 titled, "Clinical
and Cytogenetic Responses to Amonafide in Secondary Acute Myeloid Leukemia
(AML)".
About Xanafide(TM) and Secondary AML
Xanafide (amonafide malate) is an ATP-independent topoisomerase 2
inhibitor that the Company is developing for the treatment of secondary
acute myeloid leukemia (AML) and related disorders. Secondary AML patients
have had either antecedent myelodysplastic syndrome or prior exposure to
leukemogenic therapy and represent a poor prognosis population. While de
novo AML is currently treated by approved drugs for this first-line
indication, no effective therapies are approved specifically for patients
with secondary AML. In a Phase 1 study conducted in patients with poor-risk
AML, amonafide and ara-C exhibited particularly promising clinical activity
in patients with secondary AML and in some cases, resulted in complete or
near-complete remissions.
About Xanthus Pharmaceuticals, Inc.
Xanthus Pharmaceuticals, Inc. is developing a portfolio of novel,
clinical-stage, small-molecule oncology candidates 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.
SOURCE Xanthus Pharmaceuticals, 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
Lisa Terry of Xanthus Pharmaceuticals, Inc., +1-617- 225-0522,
ext. 105, lisa.terry@xanthus.com
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