Healthcare Industry News: OPAXIO
News Release - May 5, 2008
European Regulatory Agency Supports OPAXIO(TM) Brand Name for Cell Therapeutics' Lung Cancer DrugImportant step toward commercialization: CTI selects OPAXIO(TM) as global brand name to replace XYOTAX(TM)
SEATTLE, May 5 (HSMN NewsFeed) -- Cell Therapeutics, Inc. (CTI) (Nasdaq: CTIC; MTA) today announced that it received a positive opinion from the European Medicines Agency (EMEA) for the brand name OPAXIO(TM) (paclitaxel poliglumex), which replaces XYOTAX(TM) as the brand name.
"We are pleased the EMEA has provided a favorable review of the OPAXIO brand name, which tested well in market research. This is a key step toward commercialization as we prepare for the potential introduction of this novel biologically enhanced chemotherapeutic in Europe, to establish OPAXIO as the global brand name for paclitaxel poliglumex," noted Jim Fong, Vice President of Commercial Operations at CTI.
In April, the EMEA accepted for review CTI's Marketing Authorization Application (MAA) for OPAXIO (paclitaxel poliglumex, CT-2103) for first-line treatment of patients with non-small cell lung cancer (NSCLC) with ECOG (Eastern Cooperative Oncology Group) performance status 2 (PS2). The EMEA's review process generally takes 15 to 18 months; if the MAA is approved by the EMEA at the end of its review, CTI will be authorized to begin selling OPAXIO in the European Union.
Lung cancer remains the biggest cancer killer in Europe. The incidence of lung cancer in Europe is more than 13 percent of all cancers, and in 2000 resulted in nearly 350,000 deaths.
OPAXIO(TM) (paclitaxel poliglumex, CT-2103), which was previously branded 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. Preclinical and clinical studies support that OPAXIO metabolism by lung cancer cells may be influenced by estrogen, which could lead to enhanced release of paclitaxel and efficacy in women with lung cancer compared to standard therapies.
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.CellTherapeutics.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 OPAXIO include risks associated with preclinical and clinical developments in the biopharmaceutical industry in general and with OPAXIO in particular including, without limitation, risks that the OPAXIO brand name may be objected to at any time prior of after the potential granting of the marketing authorization, that the OPAXIO brand name may not be acceptable to other markets, including the U.S. market, where a request for regulatory approval may be submitted, marketing approval review of the OPAXIO MAA may not result in a marketing approval in Europe, determinations by regulatory, patent and administrative governmental authorities, competitive factors, technological developments, costs of developing, producing and selling OPAXIO in the various countries in Europe, 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 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
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