2008 Projected Financial Highlights and Potential Milestones include:
- Grow Zevalin sales
- XYOTAX(TM) Marketing Authorization Application submission in Q1
- Pixantrone phase III results and New Drug Application submission
- Brostallicin phase II interim results
SEATTLE, Jan. 30 /PRNewswire-FirstCall/ -- Cell Therapeutics, Inc. (CTI) (Nasdaq and MTAX: CTIC) announced today that with the return of CTI to a commercial operating company through its acquisition of Zevalin(R) (Ibritumomab Tiuxetan), the company will focus its resources on increasing the sales of Zevalin in the United States and preparing the marketing applications for XYOTAX (paclitaxel poliglumex, CT-2103) and pixantrone (BBR 2778), while supporting the advancement of brostallicin to a phase III trial. The move will reduce the Company's projected net cash operating expenses to a forecasted $77 million in 2008. The primary reduction in operating expenses stems from deferring or curtailing some phase III clinical trials for pixantrone and XYOTAX until planned regulatory filings and the completion of phase III studies result in product approvals. CTI expects to file for approval of XYOTAX in Europe in March. The Company will expand its commercial infrastructure for Zevalin and possible future drug sales while achieving an overall reduction in headcount.
"We believe the best way to maximize shareholder value now is to focus our resources on our marketed and late-stage products," noted James A. Bianco, M.D., President and CEO of CTI.
"Recently published data describing the clinical benefit of Zevalin are compelling and support the potential to expand its application into first-line treatment of follicular non-Hodgkin's lymphoma, leading us to expand our commercial operations staffing from 11 percent to 21 percent of our total headcount with corresponding reductions elsewhere. We will continue to support our two lead drug candidates, XYOTAX and pixantrone. This year we will continue to prepare for submission of a marketing authorization application for XYOTAX and the evaluation of pivotal trial data for pixantrone. Our goal is to ensure that we succeed with Zevalin and are prepared for the future market introductions of XYOTAX and pixantrone."
"On a personal note, while we are adding staff in some areas, it is with great disappointment that we must reduce headcount elsewhere in order to meet these goals," Bianco added.
CTI has begun building a new sales and marketing department to support Zevalin sales. The company will be adding more than 13 positions for Zevalin and other potential drug sales. The Company has also increased staffing in regulatory and manufacturing in preparation for filing for approval of XYOTAX in Europe in March.
Zevalin (Ibritumomab Tiuxetan) is a form of cancer therapy called radioimmunotherapy and is indicated for the treatment of patients with relapsed or refractory low-grade or follicular B-cell NHL, including patients with Rituximab-refractory NHL. It was approved by the FDA in February of 2002 as the first radioimmunotherapeutic agent for the treatment of NHL.
Deaths associated with an infusion reaction symptom complex have occurred within 24 hours of rituximab infusions. Yttrium-90 Zevalin administration results in severe and prolonged cytopenias in most patients. Severe cutaneous and mucocutaneous reactions have been reported. The most serious adverse reactions of the Zevalin therapeutic regimen were primarily hematologic, including neutropenia, thrombocytopenia, and anemia. Infusion-related toxicities were associated with pre-administration of rituximab. The risk of hematologic toxicity correlated with the degree of bone marrow involvement prior to Zevalin therapy. Myelodysplasia or acute myelogenous leukemia was observed in 2 percent of patients (8 to 34 months after treatment). Zevalin should only be used by health care professionals qualified by training and experience in the safe use of radionuclides.
Patients and healthcare professionals can visit http://www.zevalin.com for more information.
XYOTAX(TM) (paclitaxel poliglumex, CT-2103) is an investigational, biologically-enhanced, chemotherapeutic that links paclitaxel, the active ingredient in Taxol(R), 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 XYOTAX 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 XYOTAX 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.
Pixantrone is an investigational agent under development for the potential treatment of various hematological malignancies, solid tumors and immunological disorders. It was developed to improve the activity and safety of the anthracycline family of anti-cancer agents. Anthracyclines have been shown to be very active clinically in a number of tumor types. However, they are usually associated with cumulative heart damage that prevents them from being used in a large proportion of patients. Pixantrone has been designed to reduce the potential for these severe cardiotoxicities, as well as to potentially increase activity and simplify administration compared to the currently marketed anthracyclines. The main adverse events associated with pixantrone in clinical trials to date include myelosuppression and alopecia.
Brostallicin, which was initially developed by Nerviano Medical Sciences, the largest pharmaceutical research and development facility in Italy, is a synthetic second-generation DNA minor groove binder with potent cancer killing activity in experimental tumors models. More than 200 patients have been treated with brostallicin in single-agent and combination studies, and it is now in a first-line phase II study that is currently being conducted by the European Organization for Research and Treatment of Cancer (EORTC).
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 marketing and development of ZEVALIN,
or the development of XYOTAX, pixantrone and brostallicin include risks
associated with preclinical and clinical developments in the
biopharmaceutical industry in general and with ZEVALIN, XYOTAX, pixantrone
and brostallicin in particular including, without limitation, the potential
failure of these product candidates to prove safe and effective for
treatment of non-small cell lung cancer, ovarian cancer, non-Hodgkin's
lymphoma, and sarcoma, determinations by regulatory, patent and
administrative governmental authorities, competitive factors, technological
developments, costs of developing, producing and selling ZEVALIN, XYOTAX,
pixantrone and brostallicin. In addition, we may not be able to achieve the
sales projected for ZEVALIN in 2008. There is no guarantee that we will
receive approval for additional uses of ZEVALIN, or that we will receive
approval from any regulatory agency for any approved use of XYOTAX,
pixantrone or brostallicin. If we are able to obtain such approval, we may
not be able to successfully market and sell such products. You should also
review 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 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.|
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