Cell Therapeutics Reports on Cooperative Group Sponsored Trial of Brostallicin
in Patients with Metastatic Triple-Negative Breast Cancer
SEATTLE, Dec. 5, 2012
SEATTLE, Dec. 5, 2012 /PRNewswire/ --Cell Therapeutics, Inc. (CTI) (NASDAQ
and MTA: CTIC) today reported on interim results from a cooperative group
sponsored Phase 2 clinical trial of brostallicin in combination with cisplatin
for the treatment of women with metastatic triple-negative breast cancer that
were presented at the San Antonio Breast Cancer Symposium (SABCS) held from
December 4-8, 2012.
The study enrolled women with confirmed measurable metastatic disease and
triple negative subtype breast cancer. At the time of data analysis, 48 women
had been 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 is 3-month progression-free survival (PFS). Secondary endpoints include
overall response rate (ORR), duration of response, 6-month PFS, overall
survival (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 is led by principal investigator Dr. Alvaro
Moreno-Aspitia, Assistant Professor of Medicine, Mayo Clinic, Jacksonville,
FL. Key findings include:
oAs of this analysis, 10 of 47 evaluable patients (21%) achieved a
confirmed tumor response. Nine patients had a partial response (PR) and
one confirmed response (CR).
oDespite the heavily pretreated population, 3-month PFS was at 51% and
6-month PFS is currently 26%.
oMedian duration of response was 3.4 months; median time to progression was
oAdverse events were mostly hematologic (74.5%) and consistent with other
treatments in this setting.
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 authors
concluded that in this study the combination of brostallicin and cisplatin
showed promising activity in heavily pretreated metastatic triple-negative
breast cancer patients and achieved its primary endpoint comparing favorably
to other Phase 2 clinical trials in this disease. Final results of this trial
are expected to be presented at the American Society of Clinical Oncology 2013
Annual Meeting. A follow-up randomized Phase 2 trial is in development.
About Triple-negative Breast Cancer
This term is used to describe breast cancers (usually invasive ductal
carcinomas) whose cells lack estrogen receptors and progesterone receptors,
and do not have an excess of the HER2 protein on their surfaces. Breast
cancers with these characteristics tend to occur more often in younger women
and in African-American women. Triple-negative breast cancers tend to grow and
spread more quickly than most other types of breast cancer. Because the tumor
cells lack these certain receptors, neither hormone therapy nor drugs that
target HER2 are effective treatments (but chemotherapy can still be useful if
needed). About 10% to 20% of breast cancers are triple negative.
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.
1.American Cancer Society. Available at
Accessed November 2012.
2.Living Beyond Breast Cancer: Guide to Understanding Triple-Negative Breast
Cancer 2nd Edition 2012. Available at
Accessed November 2012.
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.
SOURCE Cell Therapeutics, Inc.
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