CTI Reports Final Results from Cooperative Group and NCI-Sponsored Trial of Brostallicin in Patients with Metastatic Triple

 CTI Reports Final Results from Cooperative Group and NCI-Sponsored Trial of
    Brostallicin in Patients with Metastatic Triple-Negative Breast Cancer

PR Newswire

CHICAGO and SEATTLE, June 1, 2013

CHICAGO and SEATTLE, June 1, 2013 /PRNewswire/ -- Cell Therapeutics, Inc.
(CTI) (NASDAQ and MTA: CTIC) today reported on final results from a
cooperative group and NCI-sponsored Phase 2 clinical trial of brostallicin in
combination with cisplatin for the treatment of women with metastatic
triple-negative breast cancer (mTNBC). Triple-negative breast cancer lacks
progesterone and estrogen receptors and the HER2 biomarker that is present in
most breast cancers, which makes standard therapy with hormone or targeted
therapy ineffective. The rationale for the present study in TNBC is based on
data the demonstrating that silencing of the breast cancer susceptibility
gene(s) (BRCA) is associated with substantially enhanced sensitivity to
brostallicin. BRCA is silenced or mutated in most patients with TNBC. In this
study of 48 patients with heavily pretreated mTNBC, the 3-month progression
free survival (PFS) was 51 percent with 10 confirmed responses (one complete
response and nine partial responses). Among the 25 patients who received a
reduced brostallicin dose, the overall response rate (ORR) was 28 percent,
with 3-month progression-free survival (PFS) of 61.5 percent and median
overall survival (OS) of 11.8 months. The final data are being presented
during a poster session at the 2013 American Society for Clinical Oncology
(ASCO) Meeting being held May 31 to June 4, 2013 in Chicago, Illinois.

Abstract #1059: Final clinical results and correlative data from the phase II
trial of cisplatin (C) and the novel agent brostallicin (B) in patients with
metastatic triple negative breast cancer (mTNBC). Poster session, Saturday,
June 1, 1:15 to 5:00 p.m. CDT in S Hall A2.

About the Study

The study enrolled women with confirmed measurable metastatic disease and
triple-negative subtype breast cancer. A total of 48 women were enrolled in
the study and 47 were evaluable for efficacy. Approximately half of the
patients had received between two and four prior chemotherapy regimens in the
metastatic setting. The primary endpoint of the trial was 3-month PFS.
Secondary endpoints included ORR, duration of response, 6-month PFS, OS and
safety. In this study, patients received cisplatin on Day 1, brostallicin on
Day 2, and GCSF or pegylated-GCSF on Day 3, with the cycle repeated every 21
days. The study was led by investigators at the Mayo Clinic in Florida. Key
findings include:

  oAs of this analysis, 10 of 47 evaluable patients achieved a confirmed
    tumor response. One patient had a complete response (CR) and nine patients
    had a partial response (PR),

  o3-month PFS was 51 percent and 6-month PFS was 28 percent; median time to
    progression was 3.2 months, and

  oAdverse events were mostly hematologic (75 percent) and consistent with
    other treatments in this setting.

In an exploratory analysis, patients who received a reduced dose of
brostallicin had an apparent increase in efficacy (ORR= 28 percent; 3-month
PFS=61.5 percent; median OS=11.8 months) with a significant decrease in
febrile neutropenia compared to cycle 1.

The authors concluded that in this study the combination of brostallicin and
cisplatin was an active regimen in heavily pre-treated metastatic
triple-negative breast cancer patients. A follow-up randomized Phase 2 trial
using the reduced dosing regimen is in development.

The poster is available at www.celltherapeutics.com.

About Triple-Negative Breast Cancer

This term is used to describe breast cancers (usually invasive ductal
carcinomas) whose cells lack estrogen and progesterone receptors, and do not
express HER2. Breast cancers with these characteristics occur more often in
younger women and African-American women. Triple-negative breast cancers are
diagnosed at a later stage and spread more quickly than most other types of
breast cancer. Because the tumor cells lack receptors, neither hormone therapy
nor drugs that target HER2 are effective.^1 Patients with TNBC may respond to
chemotherapy but responses are generally short and no therapy has been shown
to be effective in patients who have more than one relapse.^2 About 10 to 20
percent of breast cancers are triple-negative.^3

About Brostallicin

Brostallicin, a novel synthetic second-generation DNA minor groove binder, has
shown potent cancer killing activity, and has demonstrated synergism in
combination with standard cytotoxic agents as well as with newer targeted
therapies, in preclinical experimental tumor models. Brostallicin binds
covalently to DNA within the DNA minor groove, interfering with DNA division
and leading to tumor cell death. More than 200 patients have been treated
with brostallicin in single-agent and combination studies.

About Cell Therapeutics, Inc.

Cell Therapeutics (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.

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 brostallicin include risks associated with preclinical and
clinical developments in the biopharmaceutical industry in general, and with
brostallicin in particular, including, without limitation, the potential
failure of brostallicin to prove safe and effective for the treatment of women
with metastatic triple-negative breast cancer, either alone or in combination
with cisplatin, as determined by the U.S. Food and Drug Administration and/or
the European Medicines Agency; that additional clinical trials of brostallicin
may not occur as planned; CTI's ability to continue to raise capital as needed
to fund its operations; and 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.

References

1.American Cancer Society. Available at
    http://www.cancer.org/cancer/breastcancer/detailedguide/breast-cancer-breast-cancer-types
    Accessed May 2013.
2.Chacon, Renaldo;Constanzo Maria. "Triple-negative breast cancer." Breast
    Cancer Research. 12(suppl 2):S3 (2010). Available at
    http://breast-cancer-research.com/content/12/S2/S3. Accessed May 2013.
3.Living Beyond Breast Cancer: Guide to Understanding Triple-Negative Breast
    Cancer 2nd Edition 2012. Available at
    http://www.lbbc.org/Understanding-Breast-Cancer/Guides-to-Understanding-Breast-Cancer/Guide-to-Understanding-Triple-Negative-Breast-Cancer.
    Accessed May 2013.

CTI Media and Investor Contacts:

Monique Greer
+1 206.272.4343
mgreer@ctiseattle.com

Ed Bell
+1 206.282.7100
invest@ctiseattle.com

In Europe

CTI Life Sciences Limited, Milan Branch

Laura Villa
Elena Bellacicca

E: CTI_EUInvestors@CTI-Lifesciences.com
T: +39 02 89659700
F: +39 02 89659719
http://www.celltherapeutics.com/italiano

SOURCE Cell Therapeutics, Inc.

Website: http://www.celltherapeutics.com
 
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