OPAXIO Phase II Study in Patients with Advanced Esophageal Cancer Results to be Presented at the American Society of Clinical Oncology 2010 Annual Meeting
SEATTLE, May 24 Cell Therapeutics, Inc. ("CTI") (NASDAQ and MTA: CTIC) announced today that phase II study results from Brown University will be presented by Kimberly Perez, M.D., Hematology/Oncology Fellow with the Warren Alpert School of Medicine of Brown University, at the American Society of Clinical Oncology Annual Meeting in Chicago, Illinois on Sunday, June 6, 2010. The abstract, #4085, title is "Neoadjuvant Paclitaxel Poliglumex (PPX), Cisplatin and Radiation (RT) for Esophageal Cancer." The trial studied OPAXIO in patients with cancer of the lower esophagus giving OPAXIO(TM) (paclitaxel poliglumex), a biologically enhanced paclitaxel, administered in combination with standard cisplatin and concurrent radiation. CTI plans to meet with the FDA in the second half of 2010 to explore a potential phase III registration study based on these results.
Additionally, an abstract, #10037 titled, "Brostallicin versus doxorubicin as first-line chemotherapy in patients with advanced or metastatic soft tissue sarcoma: An EORTC Soft Tissue and Bone Sarcoma Group randomized phase II study" will be presented on Sunday, June 6.
OPAXIO(TM) (paclitaxel poliglumex, CT-2103), which was formerly known as XYOTAX(TM), is an investigational, biologically enhanced, chemotherapeutic that links paclitaxel, the active ingredient in TaxolŽ, to a biodegradable polyglutamate polymer, which results in a new chemical entity. When bound to the polymer, the chemotherapy is rendered inactive, potentially sparing normal tissue's exposure to high levels of unbound, active chemotherapy and its associated toxicities. Blood vessels in tumor tissue, unlike blood vessels in normal tissue, are porous to molecules like polyglutamate. Based on preclinical studies, it appears that OPAXIO is preferentially distributed to tumors due to their leaky blood vessels and trapped in the tumor bed allowing significantly more of the dose of chemotherapy to localize in the tumor than with standard paclitaxel. Once inside the tumor cell, enzymes metabolize the protein polymer, releasing the paclitaxel chemotherapy.
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.
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 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 CTI's securities. Specifically, the risks and uncertainties that could affect the development of OPAXIO and brostallicin include risks associated with preclinical and clinical developments in the biopharmaceutical industry in general, and with OPAXIO and brostallicin in particular, including, without limitation, the potential for OPAXIO and brostallicin to be proved safe and effective (or to achieve response rates) for the treatment of the indications noted in this press release or any other indication, determinations by regulatory, patent and administrative governmental authorities, the potential that OPAXIO and brostallicin will not produce high rates of complete remission in patients with advanced esophageal or other cancers, the possibility that the registration trial for OPAXIO as a radiation sensitizer will not occur, the possibility that the U.S. Food and Drug Administration will not approve a phase III registration strategy for paclitaxel poliglumex if proposed by CTI, the potential that Novartis will not exercise its option, CTI's ability to continue to raise capital as needed to fund its operations, competitive factors, technological developments, and costs of developing, producing and selling OPAXIO and brostallicin. You should also review 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.
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