Chiron's Novel Oncology Compound Is First Drug Candidate to Undergo Clinical Study Through Innovative Development Consortium
EMERYVILLE, Calif. & NEW CANAAN, Conn. June 2, 2005 - Chiron Corporation (Nasdaq:CHIR) and the Multiple Myeloma Research Consortium (MMRC) today announced the initiation of a Phase I clinical trial of CHIR-258 in multiple myeloma, a type of cancer. CHIR-258, an orally available kinase inhibitor developed by Chiron, is the first drug candidate to undergo clinical study through the MMRC, a non-profit organization that integrates leading academic institutions with the goal of accelerating drug development in multiple myeloma. The MMRC member institutions expected to enroll patients in the trial are Dana-Farber Cancer Institute, H. Lee Moffitt Cancer Center && Research Institute and the Mayo Clinic. Emory University also is expected to enroll patients in the trial.
"We are pleased to be working with some of the world's leading investigators through the MMRC," said Stephen Dilly, M.D., chief medical officer, Chiron BioPharmaceuticals. "The MMRC model fits well with Chiron's translational medicine approach to oncology drug development, and the multitargeted specificity of CHIR-258 makes it a promising candidate for development in solid and hematologic malignancies, including multiple myeloma."
"This is a significant milestone for the MMRC and an important development for multiple myeloma patients," said Kathy Giusti, president of the Multiple Myeloma Research Consortium Inc. "It clearly illustrates how the MMRC is holding true to its mission to accelerate drug discovery for multiple myeloma, especially when you consider that the consortium was launched only nine months ago."
This Phase I trial of CHIR-258 in multiple myeloma is designed to evaluate the safety, tolerability, and pharmacokinetic and pharmacodynamic profiles of CHIR-258 in these patients. The maximum tolerated dose for CHIR-258 has not been reached in current Phase I trials, as demonstrated by preliminary data from a Phase I trial of CHIR-258 in solid tumors recently presented in an award-winning poster at the 2005 annual meeting of the American Society of Clinical Oncology.
Unlike many kinase inhibitors that only target vascular endothelial growth factor (VEGF), CHIR-258 inhibits receptors in the fibroblast growth factor (FGF) pathway, as well as VEGF and platelet-derived growth factor (PDGF). FGF receptor tyrosine kinase inhibition is potentially of therapeutic significance to a group of myeloma patients whose cancer cells express high levels of surface FGF receptors. This specific efficacy hypothesis, to be examined in this Phase I trial, was derived from prior collaborative work between Chiron and MMRC, which was published in the April 1, 2005, issue of "Blood," the medical journal of the American Society of Hematology. This incorporation of preclinical data into clinical trial design is an example of Chiron's translational medicine approach to oncology drug development.
About CHIR-258
CHIR-258 is a novel, orally available tyrosine kinase inhibitor. Preclinical data show that CHIR-258 works to inhibit multiple kinases associated with different cancers, including acute myeloid leukemia (AML) and multiple myeloma. Chiron currently has three ongoing Phase I clinical trials for CHIR-258: one in mixed solid tumors, one in AML, and, with the initiation of the MMRC trial, one in multiple myeloma. An additional Phase I trial in multiple myeloma is expected to begin enrolling patients in 2005. Selection of a first indication and dosing regimen for Phase II development is planned for 2005.
About Multiple Myeloma
Multiple myeloma, also known as myeloma or plasma cell myeloma, is a progressive hematologic (blood) cancer of the plasma cell, an important part of the immune system that produces immunoglobulins (antibodies) to help fight infection and disease. Clinical manifestations of multiple myeloma include hypercalcemia, anemia, renal damage, increased susceptibility to bacterial infection, and impaired production of normal immunoglobulin. The disease also is characterized by diffuse osteoporosis (bone destruction), usually in the pelvis, spine, ribs and skull. Multiple myeloma is the second most prevalent blood cancer after non-Hodgkin's lymphoma, representing approximately 1 percent of all cancers and 2 percent of all cancer deaths. The median age at diagnosis is about 71 years, and only 2 percent of cases are diagnosed in individuals under the age of 45. Statistics indicate both increasing incidence and earlier age of onset of multiple myeloma. Approximately 50,000 Americans currently have multiple myeloma, and the American Cancer Society estimates that approximately 15,980 new cases of multiple myeloma will be diagnosed in 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 the Multiple Myeloma Research Consortium
The Multiple Myeloma Research Consortium (MMRC) is comprised of the Multiple Myeloma Research Consortium Inc. and four member institutions: Dana-Farber Cancer Institute, H. Lee Moffitt Cancer Center & Research Institute, Mayo Clinic and University Health Network (Princess Margaret Hospital). The Multiple Myeloma Research Consortium Inc. is a 509a3 non-profit organization that integrates leading academic institutions to accelerate drug development in multiple myeloma. The Multiple Myeloma Research Consortium Inc. was founded by Kathy Giusti, the founder and president of the Multiple Myeloma Research Foundation, which is an early funder of the Multiple Myeloma Research Consortium Inc. Through the Multiple Myeloma Research Consortium Inc., the MMRC was created to rapidly address critical challenges in accelerating drug development and explore opportunities in the most promising areas of myeloma research. The MMRC is the only consortium to join academic institutions through membership agreements, customizd IT systems and an integrated tissue bank. For more information, please visit www.themmrc.org.
Chiron Forward-Looking Statements
This news release contains forward-looking statements, including statements regarding product development initiatives, new product indications and new product marketing that involve risks and uncertainties and are subject to change. Forward-looking statements often address our expected future performance and often contain words such as "expects," "anticipates," "intends," "plans," "believes," "seeks" or "will." A discussion of the company's operations and financial condition, including factors that may affect its business and future prospects that could cause actual results and developments to differ materially from those expressed or implied by forward-looking statements, is contained in documents the company has filed with the SEC, including the form 10-K for the year ended December 31, 2004, and the Form 10-Q for the quarter ended March 31, 2005, and will be contained in all subsequent periodic filings made with the SEC. These documents identify important factors that could cause the company's actul performance to differ from current expectations, including, among others, 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 addition, the company may engage in business opportunities, the successful completion of which is subject to certain risks, including approval by Novartis AG, regulatory approvals, and the integration of operations.
Chiron does not undertake an obligation to update the forward-looking information the company is giving today.
