Pixantrone Now Available in Europe on a Named-Patient Basis
May 05 2009 - 1:30AM
PR Newswire (US)
Cell Therapeutics and IDIS Partner to Accelerate Patient Access to
Pixantrone through Program SEATTLE, May 5 /PRNewswire-FirstCall/ --
Cell Therapeutics, Inc. (CTI) (Nasdaq and MTA: CTIC) today
announced that pixantrone is now available on a named-patient basis
in Europe. Pixantrone will be supplied by IDIS to healthcare
professionals for the treatment of individual patients with
aggressive non-Hodgkin's lymphoma (NHL) that has either relapsed
after standard therapies or is refractory to them. We know of no
therapy that has previously been shown to be effective treatment
for such patients. "CTI has worked hard to make pixantrone
available in Europe at the prescriber's request as it provides an
option for these difficult to treat aggressive NHL patients," noted
Craig Philips, President of CTI. "We continue to work toward
potential approval of pixantrone at the end of 2009 in the United
States and expect to complete the submission of the New Drug
Application to the Food & Drug Administration this quarter."
"Our experience with pixantrone has been positive with patients
achieving a complete response where such a result was not
achievable with other treatments," said Prof. Pier Luigi Zinzani,
M.D., Institute of Hematology and Oncology, University of Bologna.
"I am pleased that it is now available on a named-patient basis as
it has the potential to address a significant unmet need in this
heavily pretreated patient population." A named-patient program is
a compassionate use drug supply program under which physicians can
legally supply investigational drugs to qualifying patients. Under
a named-patient program, investigational drugs can be administered
to patients who are suffering from serious illnesses prior to the
drug being approved by the European Medicines Evaluation Agency.
"Named-patient" distribution refers to the distribution or sale of
a product to a specific healthcare professional for the treatment
of an individual patient. In Europe, under the named-patient
program the drug is most often purchased through the national
health system. Contact Information for Program: Licensed healthcare
professionals in Europe treating individual patients with relapsing
or refractory aggressive non-Hodgkin's lymphoma interested in
pixantrone should contact: IDIS Limited Tel: +44 (0) 1932 824 123
Fax: +44 (0) 1932 824 323 Email: Additionally, more information can
be found at http://www.celltherapeutics.com/pixantrone_europe About
Pixantrone Pixantrone (BBR 2778), is a novel major groove binder
with an aza-anthracenedione molecular structure that differentiates
it from the anthracyclines and other related chemotherapy agents.
Anthracyclines are the cornerstone therapeutic for the treatment of
lymphoma, leukemia, and breast cancer. Although they are
sufficiently effective to be used as first-line (initial)
treatment, they cause cumulative heart damage that may result in
congestive heart failure many years later. As a result, there is a
lifetime limit of anthracycline doses and most patients who
previously have been treated with an anthracycline are not able to
receive further anthracycline treatment if their disease returns.
Pixantrone has been designed to reduce the potential for these
severe cardiotoxicities without sacrificing anti-cancer activity.
It also can be administered through a peripheral vein rather than a
central implanted catheter as required for other drugs in this
class. About IDIS IDIS is the world leader in the development and
implementation of named-patient programs and has a proven track
record of working in strategic partnership with US-based companies
to bring new drugs to Europe for the first time. IDIS supports
customers in over 100 countries, supplying more than 400 different
medicines per month and responding to more than half a million
requests on a named-patient basis to medical professionals
worldwide. For more information on IDIS please visit their website
at http://www.idispharma.com/. About Cell Therapeutics, Inc.
Headquartered in Seattle, CTI is a biopharmaceutical company
committed to developing an integrated portfolio of oncology
products aimed at making cancer more treatable. For additional
information, please visit http://www.celltherapeutics.com/. This
press release includes forward-looking statements that involve a
number of risks and uncertainties, the outcome of which could
materially and/or adversely affect actual future results.
Specifically, the risks and uncertainties that could affect the
development of pixantrone include risks associated with preclinical
and clinical developments in the biopharmaceutical industry in
general and with pixantrone in particular including, without
limitation, the results of complete safety information, the failure
to receive anticipated number of requests for pixantrone to treat
specific patients, the potential failure of pixantrone to prove
safe and effective for treatment of relapsed aggressive NHL as
determined by the FDA, the possibility that the New Drug
Application submission will not be completed in the second quarter
of 2009, that priority review will not be granted by the FDA and
that a decision by the FDA is not rendered in late 2009, the
company's ability to continue to raise capital as needed to fund
its operations, competitive factors, technological developments,
costs of developing, producing and selling pixantrone, and the risk
factors listed or described from time to time in the Company's
filings with the Securities and Exchange Commission including,
without limitation, the Company's most recent filings on Forms
10-K, 8-K, and 10-Q. Except as may be required by law, CTI does not
intend to update or alter its forward-looking statements whether as
a result of new information, future events, or otherwise. Media
Contact: Dan Eramian T: 206.272.4343 C: 206.854.1200 E:
http://www.celltherapeutics.com/press_room Investors Contact: Ed
Bell T: 206.272.4345 Lindsey Jesch Logan T : 206.272.4347 F :
206.272.4434 E: http://www.celltherapeutics.com/investors
DATASOURCE: Cell Therapeutics, Inc. CONTACT: Media, Dan Eramian,
+1-206-272-4343, cell, +1-206-854-1200, , or Investors, Ed Bell,
+1-206-272-4345, or Lindsey Jesch Logan, +1-206-272-4347, fax,
+1-206-272-4434, , all of Cell Therapeutics, Inc. Web Site:
http://www.celltherapeutics.com/
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