New EXTEND Analyses Evaluate Efficacy of Single Agent PIXUVRI® in 3rd and 4th Line Salvage Setting With and Without Prior

New EXTEND Analyses Evaluate Efficacy of Single Agent PIXUVRI® in 3rd and 4th
       Line Salvage Setting With and Without Prior Rituximab Treatment

- Results Presented at 18th Congress of the European Hematology Association -

PR Newswire

SEATTLE, June 17, 2013

SEATTLE, June 17, 2013 /PRNewswire/ --Cell Therapeutics, Inc. (CTI) (NASDAQ
and MTA: CTIC) today announced results from sub-set analyses of data from the
Phase 3 EXTEND, or PIX301, clinical trial of PIXUVRI^® (pixantrone). The
analyses evaluated the efficacy of PIXUVRI in the subset of patients with
relapsed or refractory aggressive B-cell non-Hodgkin lymphoma (NHL), as
confirmed by central independent pathological review, who had failed 2 or 3
prior treatment regimens (3rd and 4th line in the licensed patient
population). Compared to physicians' choice of other agents given as
monotherapy, single agent PIXUVRI resulted in 30 percent of patients who had
previously received rituximab achieving a complete or unconfirmed durable
complete response lasting on average 9.5 months with 67 percent of patients
surviving at 2 years. In contrast, only 5.6 percent of patients in the
comparator arm achieved an unconfirmed complete response. The benefit of
PIXUVRI has not be established in patients when used as 5th-line or greater
chemotherapy. The analyses were presented by Professor Ruth Pettengell, M.D.,
St. George's Hospital, at the 18^th Congress of the European Hematology
Association (EHA) held June 13-16, 2013 in Stockholm, Sweden.

Abstract #P310: Pixantrone monotherapy in histologically confirmed, relapsed
or refractory aggressive B-cell non-Hodgkin lymphoma: post-hoc analyses from a
phase III trial. Poster session, Friday, June 14, 5:45 to 7:00 p.m. CEST.

"PIXUVRI is the first medicinal product approved in the E.U. for treatment of
patients with aggressive B-cell NHL," said Ruth Pettengell, M.D., of St.
George's Hospital, University of London, the lead investigator for the EXTEND
trial. "These subset analyses support PIXUVRI's use and benefit as a 3rd and
4th line treatment, whether or not the patient was previously exposed to
rituximab. Prior to PIXUVRI, treatment options were limited to palliative
therapy or clinical trials. PIXUVRI may provide the ability to re-introduce
effective salvage therapy even after patients fail standard aggressive second
line treatment."

Additional highlights from these post-hoc analyses include:

  oPIXUVRI demonstrated superior complete response rates and progression-free
    survival (PFS) in all the subgroups analyzed.

  oIn patients who had aggressive B-cell histology as determined by site
    pathologists only, who had failed two or three prior lines of therapy,
    PIXUVRI was more efficacious than physicians' choice of monotherapy, both
    in patients who had received prior rituximab and those who did not. Among
    the patients whose histology was confirmed by the panel and who had
    received rituximab prior to randomization, response rates and PFS were as
    follows for PIXUVRI compared to physicians' choice of therapy,
    respectively: CR/CRu=30.0 percent vs. 5.6 percent; ORR=45.0 percent vs.
    11.1 percent; PFS=5.4 vs. 2.8 months.

  oIn patients with aggressive B-cell NHL, there was a 48 percent improvement
    in PFS that were confirmed by central review compared to 15 percent
    improvement in PFS based on site determination. This suggests that the
    superior efficacy of PIXUVRI in the patients who had previously received
    rituximab was not due to inclusion of a disproportionate share of patients
    who could not be confirmed as having aggressive B-cell NHL on central
    pathological review.

InMay 2012, the European Commission granted conditional marketing
authorization for PIXUVRI as a monotherapy for the treatment of adult patients
with multiply relapsed or refractory aggressiveNHL based on the results of
the EXTEND, or PIX301, pivotal randomized Phase 3 clinical trial. 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 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 inthe United States.

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 cardiotoxicity.

About Non-Hodgkin Lymphoma

In the E.U., there are approximately 37,000 new cases of aggressive B-cell NHL
every year.^1,2 ^NHL is caused by the abnormal proliferation of lymphocytes,
cells key to the functioning of the immune system. It usually originates in
lymph nodes and spreads through the lymphatic system. NHL can be broadly
classified into two main forms—aggressive and indolent NHL. Aggressive NHL is
a rapidly growing form of the disease that moves into advanced stages much
faster than indolent NHL, which progresses more slowly.

There are many subtypes of NHL, but aggressive B-cell NHL is the most common
and accounts for about 50 percent of NHL cases.^2 After initial therapy for
aggressive NHL with anthracycline-based combination therapy, one-third of
patients typically develop progressive disease.^3 Approximately half of these
patients are likely to be eligible for intensive second-line treatment and
stem cell transplantation, although 50 percent are expected not to respond.^3
For those patients who fail to respond or relapse following second-line
treatment, treatment options are limited, and usually palliative only.^3

About Conditional Marketing Authorization

Similar to accelerated approval regulations intheUnited States, conditional
marketing authorizations are granted in the E.U. to medicinal products with a
positive benefit/risk assessmentthat address unmet medical needs and whose
availability would result in a significant public health benefit. A
conditional marketing authorization is renewable annually. Under the
provisions of the conditional marketing authorization for PIXUVRI, CTI will be
required to complete a post-marketing study aimed at confirming the clinical
benefit previously observed.

The European Medicines Agency's (the "EMA")Committee for Medicinal Products
for Human Usehas accepted PIX306, CTI's ongoing randomized controlled Phase 3
clinical trial, which compares PIXUVRI-rituximab to gemcitabine-rituximab in
patients who have relapsed after one to three prior regimens for aggressive
B‑cellNHLand who are not eligible for autologous stem cell transplant. As a
condition of approval, CTI has agreed to have available the PIX306 clinical
trial results byJune 2015.

AboutCell 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
inSeattle, WA.For additional information and to sign up for email alerts and
get RSS feeds, please

Safe Harbor Statement

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 and the market price of CTI's
securities. Specifically, the risks and uncertainties that could affect the
development of PIXUVRI include risks associated with preclinical and clinical
developments in the biopharmaceutical industry in general and with PIXUVRI in
particular including, without limitation, the potential failure of PIXUVRI to
prove safe and effective for the treatment of relapsed or refractory NHL
and/or other tumors; that PIXUVRI may not be able to reintroduce effective
salvage therapy to patients that have failed standard aggressive second line
treatment for patients with aggressive B-cell NHL; that results in future
studies of PIXUVRI may differ from the results of past studies; that CTI may
not be able to complete the PIX306 clinical trial of PIXUVRI-rituximab
compared to gemcitabine-rituximab in patients who have relapsed after one to
three prior regimens for aggressive B-cellNHL and who are not eligible for
autologous stem cell transplant byJune 2015or at all as required by the EMA
or have the results of such trial available byJune 2015or at all; 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; that CTI cannot predict or guarantee the pace
or geography of enrollment of its clinical trials or the total number of
patients enrolled; that CTI's average net operating burn rate may increase;
CTI's may not be able to continue to raise capital as needed to fund its
operations in general, and other risks, including, without limitation,
competitive factors, technological developments, costs of developing,
producing, and selling PIXUVRI, and the risk factors listed or described from
time to time in CTI's filings with theSecurities and Exchange
Commissionincluding, without limitation, CTI's most recent filings on Forms
10-K, 10-Q and 8-K. 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.

1. European Cancer Observatory, Cancer Fact Sheets, 2008
2. Harris NL, et al. Ann Oncol. 1999;10(12):1419-32
3. Friedberg ASH Education Book 2011;1:498-505

PIXUVRI is a registered trademark of Cell Therapeutics, Inc.

CTI Media and Investor Contacts:
Monique Greer
+1 206.272.4343

Ed Bell
+1 206.282.7100

In Europe
CTI Life Sciences Limited, Milan Branch
Laura Villa
T: +39 02 89659700

SOURCE Cell Therapeutics, Inc.

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