Cell Therapeutics Announces Data Safety and Monitoring Board Recommendation to Continue the GOG-0212 Phase 3 Clinical Trial of

Cell Therapeutics Announces Data Safety and Monitoring Board Recommendation to
   Continue the GOG-0212 Phase 3 Clinical Trial of OPAXIOTM as Maintenance
                          Therapy in Ovarian Cancer

First Planned Interim Survival Analysis Passes Futility Boundary

PR Newswire

SEATTLE, Jan. 31, 2013

SEATTLE, Jan. 31, 2013 /PRNewswire/ -- Cell Therapeutics, Inc. (CTI) (NASDAQ
and MTA: CTIC) today announced that the Gynecologic Oncology Group (GOG)
informed CTI that an independent Data Safety Monitoring Board (DSMB)
recommended continuation of the GOG-0212 Phase 3 clinical trial of OPAXIO^TM
(paclitaxel poliglumex) as maintenance therapy in ovarian cancer with no
changes following a planned interim survival analysis. CTI remains blinded to
the interim analysis results. GOG-0212 is the largest maintenance study in
this setting, having enrolled approximately 1,000 of the planned 1,100
patients. Enrollment is expected to be completed in 2013.

The trial is being conducted and managed by the GOG, which is one of the
National Cancer Institute's (NCI) funded cooperative cancer research groups
focused on the study of gynecologic malignancies.

"This is an important milestone for our OPAXIO clinical development program
and potentially for women with advanced ovarian cancer," noted Steve Benner,
M.D., Chief Medical Officer of CTI. "GOG-0212 seeks to address an important
question on the role OPAXIO may play in maintenance therapy for ovarian cancer
and potentially other solid tumors."

The GOG-0212 study is a randomized, multicenter, open label Phase 3 trial of
either monthly OPAXIO or Taxol^® for up to 12 consecutive months compared to
surveillance among women with advanced ovarian cancer who have no evidence of
disease following first-line platinum-taxane based therapy. For purposes of
registration, the primary endpoint of the study is overall survival of OPAXIO
compared to surveillance. Secondary endpoints are progression-free survival,
safety and quality of life. The statistical analysis plan calls for four
interim analyses and one final analysis, each with boundaries for early
closure for superior efficacy or for futility. The Company expects the next
interim analysis to occur in the second half of 2013.Additional information
about GOG-0212 may be found at www.clinicaltrials.gov, study ID NCT00108745.

In September 2006, CTI and Novartis entered into a worldwide licensing
agreement to grant Novartis a right to develop and commercialize CTI's OPAXIO
and an option to negotiate a license to pixantrone.

About Ovarian Cancer

Ovarian cancer is the eighth most commonly diagnosed cancer in women and the
seventh leading cause of cancer death among women worldwide. Annually, over
220,000 women will be diagnosed with ovarian cancer around the world and
approximately 140,000 will die from the disease.^1 In 2012, it was estimated
that 22,280 new cases of ovarian cancer would be diagnosed in the U.S. and
15,500 deaths would result. Ovarian cancer is the most lethal of the
gynecologic malignancies. Treatment for ovarian cancer usually involves
advanced surgery and chemotherapy.^2


OPAXIO™ (paclitaxel poliglumex, CT-2103), is an investigational, biologically
enhanced, chemotherapeutic that links paclitaxel, the active ingredient in
Taxol®, to a biodegradable polyglutamate polymer, which results in a new
chemical entity. When bound to the polymer, paclitaxel is inactive,
potentially sparing normal tissue's exposure to high levels of paclitaxel and
its associated toxicities. Blood vessels in tumor tissue, unlike blood vessels
in normal tissue, are porous to macromolecules such as OPAXIO. Based on
preclinical studies, it appears that OPAXIO is preferentially distributed to
tumors due to their leaky blood vessels and trapped in the tumor bed, allowing
significantly more of the dose of chemotherapy to localize in the tumor than
with standard paclitaxel. Once inside the tumor cell, enzymes metabolize the
protein polymer, releasing active paclitaxel.Unlike standard radiosensitizing
agents, OPAXIO appears tumor selective and does not appear to enhance
radiation toxicity to normal tissues.

About the Gynecologic Oncology Group

The Gynecologic Oncology Group (GOG) is a not-for-profit organization of more
than 300 member institutions with the purpose of promoting excellence in the
quality and integrity of clinical and basic scientific research in the field
of gynecologic malignancies. The GOG is committed to maintaining the highest
standards in clinical trials development, execution, analysis and distribution
of results. Continuous evaluation of the Group's processes is utilized in
order to constantly improve the quality of patient care. To promote this
mission, the GOG receives support from the National Cancer Institute of the
National Institutes for Health. The GOG is the only group that focuses its
research on women with pelvic malignancies, such as cancer of the ovary,
uterus, and cervix. The GOG is multi-disciplinary in its approach to clinical
trials, and includes gynecologic oncologists, medical oncologists,
pathologists, radiation oncologists, nurses, statisticians, basic scientists,
quality of life experts, data managers, and administrative personnel.

About CTI

Cell Therapeutics, Inc. (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.

OPAXIO is a trademark of Cell Therapeutics, Inc. All other trademarks are the
property of their respective owners.


1.WHO, IARC GLOBOCAN, Cancer Incidence and Mortality Worldwide in 2008
2.American Cancer Society Fact Sheet, http://tinyurl.com/b35gtwb, Accessed
    January 27, 2013

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 OPAXIO include risks associated with preclinical and clinical
developments in the biopharmaceutical industry in general, and with OPAXIO in
particular, including, without limitation, the potential failure of OPAXIO to
prove safe and effective for the treatment of patients with , either ovarian
cancer or in combination regimens, as determined by the U.S. Food and Drug
Administration and/or the European Medicines Agency ; that OPAXIO may not
satisfy a medical need not currently addressed with existing ovarian cancer
treatments; that the GOG-0212 clinical trial of OPAXIO may not occur as
planned; that 1,100 patients may not enroll in the GOG-0212 clinical trial;
that CTI may not be able to successfully implement its plans, strategies and
objectives related to the development of OPAXIO; CTI's ability to continue to
raise capital as needed to fund its operations, competitive factors,
technological developments, costs of developing, producing and selling CTI's
product candidates; and the risk factors listed or described from time to time
in CTI's filings with the Securities and Exchange Commission including,
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.


Monique Greer
+1 206.272.4343

Ed Bell
+1 206.282.7100

SOURCE Cell Therapeutics, Inc.

Website: http://www.celltherapeutics.com
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