Cell Therapeutics Announces Results from Preclinical Study of Pixantrone
(PIXUVRI®) Presented at the AACR-NCI-EORTC Meeting
-- Findings Suggest New Class of Anti-Cancer Agents with Novel Mechanism for
Tumor Cell Killing --
SEATTLE, Oct. 21, 2013
SEATTLE, Oct. 21, 2013 /PRNewswire/ -- Cell Therapeutics, Inc. (CTI) (NASDAQ
and MTA: CTIC) today announced the presentation of findings from a preclinical
study of PIXUVRI^® (pixantrone) that suggest its mechanism of inducing tumor
cell death is novel and distinct from that of anthracyclines such as
doxorubicin. PIXUVRI is a first-in-class aza-anthracenedione with unique
structural and physiochemical properties that is currently approved in the
European Union for use as a monotherapy for the treatment of adult patients
with multiply relapsed or refractory aggressiveB-cell non-Hodgkin lymphoma.
The study results were presented by Neil Beeharry, Ph.D., at the Fox Chase
Cancer Center during a poster session at the AACR-NCI-EORTC International
Conference on Molecular Targets and Cancer Therapeutics held October 19-23,
2013 in Boston, MA.
"The study results suggest that PIXUVRI is unique in its mechanism for
inducing tumor cell death, thereby supporting the thesis that it is the first
approved drug in a new class of anti-cancer agents. PIXUVRI's mechanism of
action is differentiated from the cytotoxic action induced by anthracyclines
and could be the basis for the efficacy and safety profile of the drug,"
stated Dr. Beeharry.
The study assessed the mechanism of tumor cell killing induced by PIXUVRI in a
variety of cancer cell lines. Specifically, the study assessed the impact
PIXUVRI had on cell proliferation and time to cell death, the cell cycle, DNA
damage response and longer term effects on cell division. Unlike
anthracyclines -- which kill both normal and cancer cells with short-term
exposure -- PIXUVRI had minimal short-term effects on cell survival, but
probably through formation of stable DNA adducts, caused delayed but efficient
tumor cell death. This effect was not dependent on the presence of the p53
gene, a gene associated with recognition of chromosomal damage and apoptosis.
Loss of p53 was only associated with a further delay in cell death with longer
exposure to PIXUVRI. The authors concluded that PIXUVRI appears to be
impairing chromosomal segregation during mitosis, thereby generating loss of
genetic material in daughter cells, an abnormality, which is ultimately
lethal, and that PIXUVRI would likely be effective in cells resistant to other
cytotoxic agents such as doxorubicin. The authors are pursuing leads to
further understand the exact mechanism of action.
The full poster presentation is available online at
About PIXUVRI (pixantrone)
PIXUVRI is a novel aza-anthracenedione with unique structural and
physiochemical properties. Unlike related compounds,PIXUVRI forms stable DNA
adducts and in preclinical models has superior anti-lymphoma activity compared
to related compounds. PIXUVRI was structurally designed so that it cannot
bind iron and perpetuate oxygen radical production or form a long-lived
hydroxyl metabolite -- both of which are the putative mechanisms for
anthracycline induced acute and chronic cardiotoxicity. These novel
pharmacologic properties allow PIXUVRI to be administered to patients with
near maximal lifetime exposure to anthracyclines without unacceptable rates of
InMay 2012, theEuropean Commission(EC) granted conditional marketing
authorization for PIXUVRI as a monotherapy for the treatment of adult patients
with multiply relapsed or refractory aggressiveNHL. The benefit of PIXUVRI
treatment has not been established in patients when used as fifth line or
greater chemotherapy in patients who are refractory to last therapy. The
Summary of Product Characteristics (SmPC) has the full prescribing
information, including the safety and efficacy profile of PIXUVRI in the
approved indication. TheSmPCis available atwww.pixuvri.eu.
CTI is currently accruing patients into a Phase 3 trial comparing PIXUVRI and
rituximab with gemcitabine and rituximab in the setting of aggressive B-cell
NHL. PIXUVRI does not have marketing approval intheUnited States.
About Cell Therapeutics, Inc.
CTI (NASDAQ and MTA: CTIC) is a biopharmaceutical company committed to the
development and commercialization of an integrated portfolio of oncology
products aimed at making cancer more treatable. CTI is headquartered in
Seattle, WA. For additional information and to sign up for email alerts and
get RSS feeds, please visit www.CellTherapeutics.com.
This press release includes forward-looking statements within the meaning of
the Safe Harbor provisions of the Private Securities Litigation Reform Act of
1995. Such statements are subject to a number of risks and uncertainties, the
outcome of which could materially and/or adversely affect actual future
results and the trading price of CTI's securities. Such statements include,
but are not limited to, statements regarding expectations with respect to the
development of the Company and its product and product candidate portfolio,
that PIXUVRI is unique in its mechanism for inducing tumor cell death, thereby
supporting the thesis that it is part of a new class of anti-cancer agents and
readily differentiated from the mechanism of action associated with
anthracyclines, and that PIXUVRI may cause delayed but efficient tumor cell
death probably through formation of stable DNA adducts. Risks that contribute
to the uncertain nature of the forward-looking statements include, among
others, risks that PIXUVRI may fail to prove safe and effective for the
treatment of relapsed or refractory NHL and/or other tumors; that results in
future studies or actual results of PIXUVRI may differ from the results of
past studies; that CTI may not be able complete a post-marketing study aimed
at confirming the clinical benefit observed in the PIX301 trial; that the
conditional marketing authorization for PIXUVRI may not be renewed; that CTI
may not obtain favorable reimbursement or pricing determinations for PIXUVRI
in certain markets in the E.U. as planned, and risks associated with the
biopharmaceutical industry in general and with CTI and its product and product
candidate portfolio in particular including, among others, risks associated
with the following: that CTI cannot predict or guarantee the pace or geography
of enrollment of its clinical trials, that the second Phase 3 clinical trial
of pacritinib will not occur as planned, that CTI may not obtain favorable
determinations by other regulatory, patent and administrative governmental
authorities, that CTI may experience delays in the commencement of preclinical
and clinical studies, risks related to the costs of developing, producing and
selling PIXUVRI, pacritinib, and CTI's other product candidates, and other
risks, including, without limitation, competitive factors, technological
developments, that CTI's operating expenses continue to exceed its net
revenues, that CTI may not be able to sustain its current cost controls or
further reduce its operating expenses, that CTI may not achieve previously
announced goals and objectives as or when projected, that CTI's average net
operating burn rate may increase, that CTI will continue to need to raise
capital to fund its operating expenses, but may not be able to raise
sufficient amounts to fund its continued operation as well as other risks
listed or described from time to time in CTI's most recent filings with the
Securities and Exchange Commission on Forms 10-K, 10-Q and 8-K. Except as
required by law, CTI does not intend to update any of the statements in this
press release upon further developments.
PIXUVRI is a registered trademark ofCell Therapeutics, Inc.
CTI Life Sciences Limited, Milan Branch
+39 02 89659706
SOURCE Cell Therapeutics, Inc.
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