PIXUVRI® Launched In UK For Adult Patients With Multiply Relapsed Or Refractory Aggressive B-Cell Non-Hodgkin Lymphoma

     PIXUVRI® Launched In UK For Adult Patients With Multiply Relapsed Or
              Refractory Aggressive B-Cell Non-Hodgkin Lymphoma

- First and Only Approved Monotherapy in the EU for this Patient Population -

PR Newswire

BIRMINGHAM, England, April 29, 2014

BIRMINGHAM, England, April 29, 2014 /PRNewswire/ --Cell Therapeutics, Inc.
(CTI) (NASDAQ and MTA: CTIC) today announced the launch of PIXUVRI®
(pixantrone), the first new treatment for adult patients in the United Kingdom
(UK) with multiply relapsed or refractory aggressive B-cell non-Hodgkin
lymphoma (aggressive B-cell NHL), at the 54^th annual scientific meeting of
the British Society for Haematology.

PIXUVRI is the first monotherapy treatment option for this patient group and
the only therapy licensed for third and fourth line use in aggressive B-cell
NHL patients, which includes diffuse large B-cell lymphoma (DLBCL). There are
approximately 37,000 new cases of aggressive B-cell NHL every year in the
European Union (EU)^1,2, and CTI estimates that up to 1,600 to 1,800 people in
the UK are diagnosed with aggressive B-cell NHL each year. Patients with
aggressive B-cell NHL who relapse after second-line treatment have a poor
survival prognosis ranging from only several weeks to 12 months.^3,4

Professor Finbarr E. Cotter, Professor of Haematology and Chair of
Experimental Haematology, Centre for Haemato-Oncology, Barts Cancer Institute,
and representative for the British Society for Haematology (BSH) said, "The
availability of PIXUVRI in the UK is an important milestone for patients who
have aggressive B-cell NHL. DLBCL is the most common type of aggressive NHL
and despite undoubted progress in the last 10 years resulting from the
introduction of better first-line therapy, the disease still recurs in some
patients. A new therapy that delivers effective treatment with manageable side
effects offers real hope for these patients that fail second- or third-line
therapy."

PIXUVRI is a novel aza-anthracenedione with unique structural and
physiochemical properties. The PIX301 phase 3 clinical trial demonstrated
anti-lymphoma activity of PIXUVRI and a predictable and manageable side effect
profile compared to other treatments for this condition.^5

James A. Bianco, M.D., President and Chief Executive Officer of CTI, said, "At
CTI, we prioritise the patient experience and are committed to developing
therapeutic options for people living with cancer who want a chance at a
longer and better quality of life. We are pleased to be able to bring PIXUVRI
to patients in the UK, addressing a critical gap in care for patients at this
stage of the disease living with few, if any effective treatment options."

The launch in the UK of PIXUVRI follows conditional marketing authorization by
the European Commission (EC) in 2012 and the National Institute for Health and
Care Excellence final guidance recommending prescription of PIXUVRI as a
cost-effective monotherapy in early 2014. PIXUVRI is currently available in
Austria, Denmark, Finland, Germany, Italy, France, Netherlands, Norway, Sweden
and the UK. CTI intends to pursue making PIXUVRI available in other European
countries in 2014.

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.

In May 2012, the EC granted conditional marketing authorization for PIXUVRI as
a monotherapy for the treatment of adult patients with multiply relapsed or
refractory aggressive NHL. 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. The SmPC is
available at www.pixuvri.eu. PIXUVRI does not have marketing approval in the
United States.

About NHL
NHL is the sixth most common cancer in the UK; in 2010, 12,180 people were
diagnosed with the disease.^6 NHL is caused by the abnormal proliferation of
lymphocytes, cells that are 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 55 percent of NHL cases.^1 After initial therapy for
aggressive NHL with anthracycline-based combination therapy, one-third of
patients typically develop progressive disease.^7 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.^7
For those patients who fail to respond or relapse following second line
treatment, treatment options are limited, and usually palliative only.^7

About Conditional Marketing Authorization
Similar to accelerated approval regulations in the United States, conditional
marketing authorizations are granted in the E.U. to medicinal products with a
positive benefit/risk assessment that 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 Committee for Medicinal Products for Human Use
has 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‑cell NHL
and 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 by June 2015.

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.

Forward-Looking Statements
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 CTI's expectations with respect
to the development of CTI and its product and product candidate portfolio, the
expected number of people in the EU and UK with multiply relapsed aggressive
B-cell NHL per year and the survival prognosis, the expected benefits and
effectiveness of PIXUVRI and the potential availability of PIXUVRI in other
European countries during 2014. Risks that contribute to the uncertain nature
of the forward-looking statements include, among others, 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 CTI cannot predict or
guarantee the outcome of preclinical and clinical studies, that CTI may not
obtain reimbursement for PIXUVRI in certain markets in the EU as planned, that
the conditional marketing authorization for PIXUVRI may not be renewed, 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 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 of Cell Therapeutics, Inc.

References

1.Harris NL, et al. The World Health Organization classification of
    neoplastic diseases of the hematopoietic and lymphoid tissues. Report of
    the Clinical Advisory Committee meeting, Airlie House, Virginia, November,
    1997. Ann Oncol. 1999 Dec;10(12):1419-32.
2.European Cancer Observatory, Cancer Fact Sheets, 2008. Available at:
    http://eco.iarc.fr/EUCAN/. Last accessed April 2014.
3.Hagemeister FB. Treatment of relapsed aggressive lymphomas: regimens with
    and without high-dose therapy and stem cell rescue. Cancer Chemother
    Pharmacol. 2002 May;49 Suppl 1:S13-20. Epub 2002 Apr 12.
4.Cabanillas F. Pixantrone: a new agent for relapsed aggressive lymphomas.
    Lancet Oncol. 2012 Jul;13(7):654-6. doi: 10.1016/S1470-2045(12)70232-2.
    Epub 2012 May 30.
5.Pettengell R. et al. Pixantrone dimaleate versus other chemotherapeutic
    agents as a single-agent salvage treatment in patients with relapsed or
    refractory aggressive non-Hodgkin lymphoma: a phase 3, multicentre,
    open-label, randomised trial. Lancet Oncol. 2012 Jul;13(7):696-706. doi:
    10.1016/S1470-2045(12)70212-7. Epub 2012 May 30.
6.Cancer Research UK, Cancer incidence for common cancers. Available at:
    http://www.cancerresearchuk.org/cancer-info/cancerstats/incidence/commoncancers
    Last accessed April 2014.
7.Friedberg JW. Relapsed/refractory diffuse large B-cell lymphoma.
    Hematology Am Soc Hematol Educ Program. 2011;2011:498-505. doi:
    10.1182/asheducation-2011.1.498.

Contacts:
Monique Greer
+1 206-272-4343
mgreer@ctiseattle.com

Ed Bell
+1 206.282.7100
ebell@ctiseattle.com

In Europe
CTI Life Sciences Limited, Milan Branch
Laura Villa
T: +39 02 0061-6550
lvilla@CTI-Lifesciences.com
CTI_EUInvestors@CTI-Lifesciences.com

SOURCE Cell Therapeutics, Inc.

Website: http://www.celltherapeutics.com
 
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