Brostallicin Trial Data Demonstrates Encouraging Anti-tumor Activity in Patients With Chemotherapy-Resistant CancersTargeting tumor's vulnerability yields durable responses in Phase I/II Trial
SEATTLE, November 21, 2007 /PRNewswire-FirstCall/ -- Systems Medicine, LLC (SM), a wholly-owned subsidiary of Cell Therapeutics, Inc. (CTI) , announced that cumulative preliminary results of a phase I trial combining cisplatin with brostallicin in patients with solid tumors that had relapsed or were resistant to front-line treatment were presented at the Highlights in Oncology meeting in Naples, Italy, on Tuesday, November 20, 2007. Cristina Geroni, Ph.D. of Nerviano Medical Sciences (NMS), which developed brostallicin, summarized the basis for the phase I trial design. The trial is based on data demonstrating tumors with high levels of GSH/GST, common in platinum-resistant disease, are more susceptible to the killing effects of brostallicin. High levels of GSH and GST are associated with resistance to most standard chemotherapy drugs
"Our phase I and II experience with brostallicin in over 160 patients demonstrates encouraging anti-tumor activity in a variety of solid tumors, with more than 50% of the patients experiencing at least disease stabilization," said Steven Weitman, M.D., of Systems Medicine.
The preliminary results from the first 21 patients treated in the phase I combination trial with cisplatin showed similar results, with 14 of the patients experiencing stable disease and half (50%) of those 14 patients having durable stable disease for more than six cycles of therapy. Toxicities were mainly hematological and were manageable and reversible in this heavily pretreated patient population. Phase II studies using this combination in patients resistant to standard therapy are planned.
About the Phase I Study
The phase I, multicenter, dose-escalation study of brostallicin in combination with cisplatin (cDDP) was conducted in patients with recurrent or metastatic solid tumors. Treatment cycles were three weeks. Brostallicin was escalated from 5 to 7 to 9 mg/m2 with a fixed dose of cDDP of 75 mg/m2. To review the poster for more detailed information, please go to http://www.CTICSeattle.com.
Brostallicin, a novel synthetic second-generation DNA minor groove binder, has potent cancer killing activity and has demonstrated synergism in combination with standard cytotoxic agents as well as with newer targeted therapies in preclinical experimental tumors 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. Brostallicin had predictable and predominantly hematologic toxicities. Activity was demonstrated in a number of solid tumor types. A phase II study of brostallicin in relapsed/refractory soft tissue sarcoma met its pre-defined activity and safety hurdles and resulted in a first-line phase II study that
is currently being conducted by the European Organization for Research and Treatment of Cancer (EORTC).
About Systems Medicine (SM)
In July 2007, CTI acquired Systems Medicine (SM), a privately-held oncology company, in a stock-for-stock merger. SM applies a systems biology approach to drug development, combining pharmacogenomics and bioinformatics with experienced preclinical, clinical, and regulatory expertise to find and exploit a specific cancer's 'context of vulnerability.' Specifically, SM defines the molecular and genetic alterations (context) that cause cancer cells to be particularly sensitive (vulnerable) to a drug or combination of drugs -- the 'context of vulnerability'.
About Cell Therapeutics, Inc.
Headquartered in Seattle, CTI is a biopharmaceutical company committed to developing an integrated portfolio of oncology products aimed at making cancer more treatable. For additional information, please visit http://www.cticseattle.com.
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. 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 treatment of solid tumors, determinations by regulatory, patent and administrative governmental authorities, competitive factors, technological developments, costs of developing, producing and selling brostallicin, 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, 8-K, and 10-Q. Except as may be required by Italian law, CTI is under no obligation to (and expressly disclaims any such obligation to) update or alter its forward-looking statements whether as a result of new information, future events, or otherwise.
Media Contact: Dan Eramian T: 206.272.4343 C: 206.854.1200 Susan Callahan T: 206.272.4472 F: 206.272.4434 E: www.cticseattle.com/media.htm Investors Contact: Leah Grant T: 206.282.7100 F: 206.272.4434 E: firstname.lastname@example.org email@example.com
CONTACT: Media, Dan Eramian, +1-206-272-4343, Cell, +1-206-854-1200, orSusan Callahan, +1-206-272-4472, Fax, +1-206-272-4434, both at, or Investors, Leah Grant, +1-206-282-7100,+1-206-272-4434, , all of Cell Therapeutics, Inc. firstname.lastname@example.org email@example.com
Web site: http://www.cticseattle.com/
Ticker Symbol: (NASDAQ-NMS:CTIC)
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Posted: November 2007