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:
- As 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).
- Despite the heavily pretreated population, 3-month PFS was at 51% and 6-month PFS is currently 26%.
- Median duration of response was 3.4 months; median time to progression was 3.2 months.
- Adverse 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.
- American Cancer Society. Available at http://www.cancer.org/cancer/breastcancer/detailedguide/breast-cancer-breast-cancer-types. Accessed November 2012.
- 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 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.