Chiron and the Multiple Myeloma Research Consortium Announce Initiation of Phase I Clinical Trial for CHIR-258.EMERYVILLE, Calif. & NEW CANAAN, Conn. -- -- Chiron's Novel Oncology Compound Is First Drug Candidate to Undergo Clinical Study Through Innovative Development Consortium -- Chiron Corporation (Nasdaq:CHIR CHIR Chiricahua National Monument (US National Park Service) ) and the Multiple Myeloma Research Consortium (MMRC MMRC Multiple Myeloma Research Consortium MMRC Mature Market Resource Center MMRC Multi-Mode Radar Command MMRC Movable Mass Roll Control MMRC Mississippi Medical Reserve Corps MMRC Macrodiversity Maximal Ratio Combining MMRC Mobilization Material Repair Capability ) today announced the initiation of a Phase I clinical trial Noun 1. phase I clinical trial - a clinical trial on a few persons to determine the safety of a new drug or invasive medical device; for drugs, dosage or toxicity limits should be obtained phase I 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 dil·ly n. pl. dil·lies Slang One that is remarkable or extraordinary, as in size or quality: had a dilly of a fight. , 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 American Society of Clinical Oncology, or ASCO, is an organization that represents all clinical oncologists. Every year, ASCO holds a large symposium where physicians and researchers meet to convey and discuss research and ideas. . Unlike many kinase inhibitors that only target vascular endothelial growth factor Vascular endothelial growth factor (VEGF) is an important signaling protein involved in both vasculogenesis (the de novo formation of the embryonic circulatory system) and angiogenesis (the growth of blood vessels from pre-existing vasculature). (VEGF VEGF vascular endothelial growth factor. ), CHIR-258 inhibits receptors in the fibroblast growth factor Fibroblast growth factors, or FGFs, are a family of growth factors involved in wound healing and embryonic development. The FGFs are heparin-binding proteins and interactions with cell-surface associated heparan sulfate proteoglycans have been shown to be essential for FGF (FGF) pathway, as well as VEGF and platelet-derived growth factor platelet-derived growth factor n. A substance in platelets that is mitogenic for cells at the site of a wound, causing endothelial proliferation. (PDGF PDGF platelet-derived growth factor; interacting with cell surface receptors and stimulating hydrolysis of inositol 1,4,5-triphosphate (IP3). ). FGF receptor tyrosine kinase Receptor tyrosine kinases (RTK)s are the high affinity cell surface receptors for many polypeptide growth factors, cytokines and hormones. Of the ninety unique tyrosine kinase genes idenitified in the human genome, 58 encode receptor tyrosine kinase proteins. 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 Noun 1. tyrosine kinase inhibitor - a drug used in cases of chronic myeloid leukemia medicament, medication, medicinal drug, medicine - (medicine) something that treats or prevents or alleviates the symptoms of disease . Preclinical data show that CHIR-258 works to inhibit multiple kinases associated with different cancers, including acute myeloid leukemia (AML AML - A Manufacturing Language ) 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 plasma cell myeloma n. A malignant plasmacytoma of bone. , is a progressive hematologic hematological, hematologic pertaining to or emanating from blood cells. hematological tests total and differential white cell counts, hematocrit estimation, erythrocyte count. (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 Hypercalcemia Definition Hypercalcemia is an abnormally high level of calcium in the blood, usually more than 10.5 milligrams per deciliter of blood. , 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 The age of onset is a medical term referring to the age at which an individual acquires, develops, or first experiences a condition or symptoms of a disease or disorder. Diseases are often categorized by their ages of onset as congenital, infantile, juvenile, or adult. of multiple myeloma. Approximately 50,000 Americans currently have multiple myeloma, and the American Cancer Society American Cancer Society, n.pr established in 1913, this national volunteer-based health organization is committed to the elimination of cancer through prevention and treatment and to diminishing cancer suffering through advocacy, scholarship, research, 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 There are several Princess Margaret Hospitals :
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 actual 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. |
|
||||||||||||||||
Printer friendly
Cite/link
Email
Feedback
Reader Opinion