CAMBRIDGE, Mass., June 5 /PRNewswire/ -- Xanthus Pharmaceuticals, Inc.,
a privately-held oncology drug development company, today announced the
presentation of data from a Phase 1 clinical trial of Symadex(TM) (C-1311)
at the 42nd Annual Meeting of the American Society of Clinical Oncology
(ASCO). Symadex is currently being studied in two Phase 2 trials in
patients with metastatic colorectal cancer and metastatic breast cancer.
The Phase 1 results were presented by study investigator Dr. Nicolas
Isambert, of the Centre G-F Leclerc, Dijon, France in a poster titled,
"Evaluation of the safety of C-1311 administered in a Phase 1 dose
escalation trial as a weekly infusion for three consecutive weeks in
patients with advanced solid tumors" (abstract number 6029). In the Phase 1
study, Symadex was well tolerated in patients with advanced solid tumors
and the recommended dose of 480 mg/m2 yielded a predictable safety profile.
"Meeting our Phase 1 safety endpoint is an important milestone that
supports our continued advancement of Symadex in clinical trials for
patients with advanced malignancies," stated Richard T. Dean, Ph.D., Chief
Executive Officer at Xanthus.
"In our ongoing studies, Symadex continues to be a promising candidate
for both cancer and autoimmune disease," stated Robert L. Capizzi, M.D.,
Chief Medical Officer at Xanthus. "Bioavailability merits further
investigation as oral delivery could greatly improve dosing convenience for
patients." Dr. Capizzi continued by stating that, "More recently, our
research on Symadex has yielded new evidence suggesting that Symadex may be
a targeted kinase inhibitor, a very exciting finding that we are
investigating preclinically."
About the Phase 1 Trial
The Phase 1 trial was a dose escalation study that enrolled 22 patients
with advanced solid tumors. The primary goal of the study was to determine
the optimal dosing schedule to be used in Phase 2. Patients received weekly
intravenous infusions of Symadex for three weeks, followed by a week of
rest. The dose increased as each patient was added until dose limiting
toxicity was reached (640 mg/m2/week) at which point additional patients
were treated at the recommended dose of 480 mg/m2/week. Six patients were
treated at 480 mg/m2/week in an extension study in which one of the first
two doses was given orally.
Symadex exhibited a predictable tolerability profile, with reported
adverse events including transient neutropenia, nausea, asthenia, vomiting
and diarrhea. Two serious adverse events were reported, both consisting of
post-infusion fever without evidence of infection, resolving within 24
hours. No cardiac events were reported.
Researchers published the results from a second Phase 1 study with
Symadex in the ASCO 2006 Book of Abstracts that support the safety and
tolerability of Symadex when dosed as a one hour infusion, every three
weeks. The lead investigator on the study was Dr. Anne Thomas, and the
abstract titled, "Evaluation of the safety of C-1311 administered in a
Phase 1 dose-escalation trial as a 1-hour infusion once every 3 weeks in
patients with advanced solid tumors" is referenced as number 12005.
About Symadex(TM)
Symadex (formerly C-1311) is a next-generation investigational
anticancer compound that is part of a new series of agents, the
imidazoacridinones, which have shown a potentially novel, targeted
mechanism of action in preclinical studies. Additionally, in 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 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.
Contacts:
Kari Watson, MacDougall Biomedical Communications, Inc. -
kwatson@macbiocom.com or (508) 647-0209
Lisa Terry, Xanthus Pharmaceuticals, Inc. - lisa.terry@xanthus.com or
(617) 225-0522, x 105
SOURCE Xanthus Pharmaceuticals, Inc.
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Related links:
http://www.xanthus.com
CONTACT:
Lisa Terry of Xanthus Pharmaceuticals, Inc.,
+1-617-225-0522, ext. 105, lisa.terry@xanthus.com; or Kari Watson
of MacDougall Biomedical Communications, Inc., +1-508-647-0209,
kwatson@macbiocom.com
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