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ارتفاع لأنهم أعلنوا الاجتماع السنوي راح يكون 19 مايو بالنسبه لملاك الأسهم من 1 أبريل
وهذا الخبر نزل يوم 18 ابريل
Chiron and XOMA Announce Initiation of Phase I Clinical Trial for CHIR-12.12 in Chronic Lymphocytic Leukemia
Monday April 18, 8:02 am ET
First Antibody Drug Candidate to Enter Clinical Study under Companies' Collaboration Agreement
EMERYVILLE, Calif. & BERKELEY, Calif.--(BUSINESS WIRE)--April 18, 2005--Chiron Corporation (Nasdaq:CHIR - News) and XOMA Ltd. (Nasdaq:XOMA - News) today announced the initiation of Phase I clinical testing of CHIR-12.12, a fully human, antagonist antibody that targets the CD40 antigen. Treatment has begun in the first Phase I trial, for patients with advanced chronic lymphocytic leukemia (CLL). CHIR-12.12 is the first drug candidate to enter clinical testing under the collaborative agreement between Chiron and XOMA for the development and commercialization of antibody products for the treatment of cancer.
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"We are pleased to move forward with Phase I studies of CHIR-12.12 as part of Chiron's translational-medicine approach to early stage oncology drug development," said Stephen Dilly, M.D., chief medical officer, Chiron BioPharmaceuticals. "Based on compelling preclinical data, we believe that this unique compound and its dual mechanisms of action could prove effective in the treatment of a variety of B-cell malignancies."
"For patients with advanced CLL, today's announcement is very encouraging," said John L. Castello, president, chairman and CEO of XOMA. "The news also demonstrates how well our collaboration strategy is working to rapidly advance promising new therapeutics into the clinic."
The single-agent, open-label Phase I study of CHIR-12.12 is designed to evaluate the safety, dose tolerability and pharmacokinetic profile of CHIR-12.12 in patients with advanced CLL. Translational medicine will be used to monitor biomarkers in real time. The study is expected to enroll up to 40 patients at three leading cancer centers in the United States. Chiron and XOMA also plan to initiate clinical testing of CHIR-12.12 in patients with multiple myeloma in 2005.
About CHIR-12.12
CHIR-12.12 is a fully human, antagonist antibody that targets the CD40 antigen. As shown in vitro in cell lines, in vivo in animal models and ex vivo in patient cells, CHIR-12.12 binds to tumor cells that express CD40 and antagonizes (prevents) CD40 ligand-mediated growth and survival of malignant B cells. CHIR-12.12 also induces antibody-dependent cellular cytotoxicity (ADCC), killing CD40 expressing tumor cells by immune effector cells. This dual mechanism of action makes CHIR-12.12 a promising drug candidate for the treatment of B-cell malignancies.
About Chronic Lymphocytic Leukemia
Chronic lymphocytic leukemia (CLL) is a form of slow-progressing leukemia, a disease characterized by an accumulation of abnormal lymphocytes in the blood and bone marrow. These lymphocytes interfere with production of other blood cells that are necessary for the normal functioning of the blood. In CLL, B lymphocytes, or B cells, are the most commonly affected lymphocytes. CLL is most common in individuals 50 years of age and older, and the five-year survival rate for CLL patients is approximately 46 percent. According to the American Cancer Society, approximately 9,730 new cases of CLL will be diagnosed in the United States during 2005.
About Chiron
Chiron delivers innovative and valuable products to protect human health by advancing pioneering science across the landscape of biotechnology. The company works to deliver on the limitless promise of science and make a positive difference in people's lives. For more information, please visit
www.chiron.com.
About XOMA
XOMA develops and commercializes antibody and other protein-based biopharmaceuticals for cancer, immune disorders and infectious diseases. The company pipeline includes products from collaborative product development programs with Chiron Corporation, Millennium Pharmaceuticals, Inc., and Aphton Corporation, and also includes RAPTIVA®, a product marketed worldwide that came from a collaboration with Genentech, Inc. For more information about XOMA's product pipeline and antibody product development capabilities and technologies, please visit XOMA's website at
www.xoma.com.
Chiron Forward-Looking Statements
This news release contains forward-looking statements, including statements regarding the success of the collaboration and clinical trials, product development initiatives, and patient enrollment that involve risks and uncertainties and are subject to change. A full discussion of the company's operations and financial condition, including factors that may affect its business and future prospects, is contained in documents the company has filed with the SEC, including the form 10-K for the year ended December 31, 2004, and will be contained in all subsequent periodic filings made with the SEC. These documents identify important factors that could cause the company's actual performance to differ from current expectations, including the outcome of clinical trials, regulatory review and approvals, manufacturing capabilities, intellectual property protections and defenses, stock-price and interest-rate volatility, and marketing effectiveness. In particular, there can be no assurance that Chiron will increase sales of existing products, successfully develop and receive approval to market new products, or achieve market acceptance for such new products. There can be no assurance that Chiron's out-licensing activities will generate significant revenue, nor that its in-licensing activities will fully protect it from claims of infringement by third parties. In addition, the company may engage in business opportunities, the successful completion of which are subject to certain risks, including approval by Novartis and regulatory approvals and the integration of operations.
We do not undertake an obligation to update the forward-looking information we are giving today.
XOMA Forward-Looking Statements
Statements made in this press release related to progress or timing of product development or collaborative arrangements, or that otherwise relate to future periods, are forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. These statements are based on assumptions that may not prove accurate. Actual results could differ materially from those anticipated due to certain risks inherent in the biotechnology industry and for companies engaged in the development of new products in a regulated market. These risks, including those related to the results of pre-clinical testing, the timing or results of pending and future clinical trials (including the design and progress of clinical trials; safety and efficacy of the products being tested; action, inaction or delay by the FDA, European or other regulators, their advisory bodies; and analysis or interpretation by, or submission to, these entities or others of scientific data), changes in the status of existing collaborative relationships, the ability of collaborators and other partners to meet their obligations, market demand for products, scale up and marketing capabilities, competition, availability of additional licensing or collaboration opportunities, international operations, share price volatility, XOMA's financing needs and opportunities, uncertainties regarding the status of biotechnology patents, uncertainties as to the cost of protecting intellectual property and risks associated with XOMA's status as a Bermuda company, are discussed in the Company's most recent annual report on Form 10-K and in other SEC filings. Consider such risks carefully in evaluating XOMA's prospects.
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Contact:
Chiron Corporate Communications & Investor Relations
Media, 510 923-6500
Investors, 510-923-2300
or
XOMA
Deb McManus, APR, 510-204-7240 (Media)
or
Kureczka/Martin Associates for XOMA
Ellen M. Martin, 510-832-2044 (Investors)
