North Central Cancer Treatment Group (NCCTG) to Conduct Phase II Study of Cell Therapeutics’ Brostallicin in Metastatic Triple Negative Breast Cancer
SEATTLE, April 28 /PRNewswire-FirstCall/ — Cell Therapeutics, Inc. (Nasdaq and MTA: CTIC) (the “Company”) today announced that the North Central Cancer Treatment Group (“NCCTG”) plans to conduct a Phase II study of brostallicin in combination with cisplatin in patients with metastatic triple-negative breast (“mTNBC”) cancer, defined by tumors lacking expression of estrogen, progesterone receptors and without over-expression of HER2. Additionally, the majority of breast cancers that are associated with the susceptibility mutation (BRCA1) are of the triple-negative type. BRCA1 is a tumor suppressor gene which, when mutated, is associated with the development of hereditary breast cancers. Changes in the BRCA1 status can make tumors rapidly acquire resistance to chemotherapy requiring development of new agents to effectively treat these patients. Brostallicin is a novel synthetic second-generation DNA minor groove binder with enhanced efficacy in the presence of the BRCA1 mutation and has demonstrated synergy in combination with cisplatin, an active therapeutic for this disease. Brostallicin has also demonstrated a unique ability to retain activity in tumors that are resistant to other cancer drugs (Mol Cancer Ther 2009; 8(7) July 2009; 1985-94). Women with mTNBC have very limited effective treatments and based on the novel mechanism of action of brostallicin and the recognized activity of cisplatin in this disease, the combination of the two agents will be explored by the NCCTG.
In addition to standard clinical efficacy measures, biological endpoints will also be evaluated to assist in understanding the specific activity of the therapeutic in this disease.
“As we determine the underlying genetic background of disease, we believe we will be able to select the appropriate patients for testing of novel agents such as brostallicin. In the development of brostallicin, studies have indicated significant responses in particular genetic backgrounds (one being triple negative breast cancer),” said Christina Waters, Ph.D., MBA, President of CTI Europe and Systems Medicine, LLC and former Director of Scientific Development at Genomics Institute of the Novartis Research Foundation. “We are moving to a more sophisticated clinical treatment paradigm, from general cell ablation to targeted therapy, which we believe will improve patient response in select populations and decrease exposure to patients that cannot respond.”
The demonstration of tumor sensitization to brostallicin in the presence of BRCA1 suppression was completed in collaboration with Translational Genomics Research Institute (TGEN) and Systems Medicine, LLC a wholly-owned subsidiary of the Company.
Brostallicin is a new class of cancer drug–a synthetic DNA minor groove binding agent with a unique mechanism of action. Most cytotoxic agents bind DNA’s major groove, have little sequence-specificity, and are severely toxic to normal tissues (including topoisomerase inhibitors, such as camptothecins and anthracyclines). Brostallicin binds covalently to DNA within the DNA minor groove interfering with DNA division and leading to tumor cell death. Data in more than 230 patients treated in single-agent and combination phase I/II clinical trials reveal evidence of activity in patients with refractory cancer. Brostallicin has also demonstrated synergy with new targeted agents as well as established treatments for common tumor types in preclinical trials.
DNA minor groove binders such as brostallicin possess high affinity and selectivity for interaction with either GC- or AT-rich regions of DNA. All minor groove binders bind to the same DNA structure. However, brostallicin has a unique and very interesting mechanism of action. Brostallicin binds to DNA only in the presence of glutathione (GSH) and glutathione S-transferase (GST), which are produced to a greater extent in cancer cells, but not typically in normal cells. This gives brostallicin a novel and highly selective mechanism of action that is superior to other minor groove binding agents. Brostallicin had predictable and predominantly hematologic toxicities.
Brostallicin was discovered at Pharmacia and developed by Nerviano Medical Sciences (“NMS”) the largest pharmaceutical research and development facility in Italy and one of the largest oncology-focused, integrated discovery and development companies in Europe. Following a merger between Pfizer and Pharmacia, the rights to brostallicin were assigned to NMS, which continued its development and ultimately licensed worldwide rights to Systems Medicine LLC, a wholly-owned subsidiary of the Company.
The North Central Cancer Treatment Group (NCCTG) is a national clinical research group sponsored by the National Cancer Institute. NCCTG consists of a network of cancer specialists at community clinics, hospitals and medical centers in the United States and Canada. NCCTG is dedicated to bringing clinical trials with promising new cancer therapies to communities where patients live. NCCTG specializes in researching methods of treating and preventing cancer, and in researching methods to alleviate the side effects of cancer and cancer treatments.
For additional information on NCCTG and NCI’s Clinical Trials Cooperative Group Program please visit http://www.cancer.gov/cancertopics/factsheet/NCI/clinical-trials-cooperative-group.
About Cell Therapeutics, Inc.
Headquartered in Seattle, the Company is a biopharmaceutical company committed to developing an integrated portfolio of oncology products aimed at making cancer more treatable. For additional information, please visit www.CellTherapeutics.com.
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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 trading price of the Company’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 mTNBC and that the shift in the Company’s clinical treatment paradigm, from general cell ablation to targeted therapy, may not improve patient response in select populations and decrease exposure to patients that cannot respond. Further risks and uncertainties include the Company’s ability to continue to raise capital as needed to fund its operating expenses and that the Company may not be able to raise sufficient amounts to fund its continued operation, competitive factors, technological developments, costs of developing, producing and selling the Company’s product candidates, and the risk factors listed or described from time to time in the Company’s filings with the Securities and Exchange Commission including, without limitation, the Company’s most recent filings on Forms 10-K, 10-Q and 8-K. Except as may be required by law, the Company does not intend to update or alter its forward-looking statements whether as a result of new information, future events, or otherwise.
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