Seattle Genetics Reports Findings From SGN-30 Phase I Clinical Study.Business Editors & Health/Medical Writers BOTHELL, Wash.--(BUSINESS WIRE)--Sept. 4, 2002 Seattle Genetics, Inc. (Nasdaq:SGEN SGEN Signal/System Generator ) today reported the successful completion of its first 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 with the therapeutic monoclonal antibody monoclonal antibody, an antibody that is mass produced in the laboratory from a single clone and that recognizes only one antigen. Monoclonal antibodies are typically made by fusing a normally short-lived, antibody-producing B cell (see immunity) to a fast-growing SGN-30. The study was designed as a rapid dose escalation to evaluate the safety and pharmacokinetic profile of a single dose of SGN-30 in patients with hematologic malignancies such as Hodgkin's disease Hodgkin's disease, a type of cancer of the lymphatic system. First identified in 1832 in England by Thomas Hodgkin, it is a type of malignant lymphoma. Incidence peaks in young adults and the elderly. , anaplastic large cell lymphoma Anaplastic large cell lymphoma (ALCL) is a type of non-Hodgkin lymphoma that features in the World Health Organisation (WHO) classification of lymphomas. Diagnosis To make this diagnosis under its present system of classification, the WHO: Requires Thirteen patients were treated on the study, which was initiated in March 2002 and completed accrual in July 2002. The results demonstrated that SGN-30 was well-tolerated up to a single dose of 15 milligrams per kilogram with no drug-related toxicities observed. While the study focused on safety and the measurement of various clinical parameters, antitumor an·ti·tu·mor also an·ti·tu·mor·al adj. Counteracting or preventing the formation of malignant tumors; anticancer. Adj. 1. activity was also observed. An abstract detailing the phase I results has been submitted for consideration to the 2002 American Society of Hematology conference being held in Philadelphia, PA, December 6-10, 2002. "We are encouraged by the results of this phase I study indicating that SGN-30 is safe to administer and by the early evidence of antitumor activity with only a single dose," stated Clay B. Siegall, Ph.D., President and Chief Scientific Officer at Seattle Genetics. "Based on these findings, we intend to launch a second trial with SGN-30 later this year, designed as a phase I/II multi-dose study," added Amy P. Sing, M.D., Senior Director of Medical and Regulatory Affairs Regulatory Affairs (RA), also called Government Affairs, is a profession within regulated industries, such as pharmaceuticals, medical devices, energy, and banking. Regulatory Affairs professionals usually have responsibility for the following general areas: SGN-30 is a monoclonal antibody that targets CD30, a cell surface receptor expressed in high density on a variety of hematologic malignancies but which has limited expression on normal tissue. In preclinical studies preclinical studies, n.pl a term used to describe research done before a clinical study. May be laboratory or epidemiologic research. , SGN-30 induced tumor cell death in culture and demonstrated efficacy in models of Hodgkin's disease. These preclinical findings provided the basis for the company's phase I study. Seattle Genetics is presently investigating the use of SGN-30 for the treatment of autoimmune disease autoimmune disease, any of a number of abnormal conditions caused when the body produces antibodies to its own substances. In rheumatoid arthritis, a group of antibody molecules called collectively RF, or rheumatoid factor, is complexed to the individual's own gamma in preclinical models. About Seattle Genetics Seattle Genetics discovers and develops monoclonal antibody-based therapeutics to treat cancer and related diseases. The Company has four technologies: engineered monoclonal antibodies, antibody-drug conjugates (ADC (1) See A/D converter. (2) (Apple Display Connector) A peripheral connector from Apple that combines digital video display, USB and power in one cable. ), single-chain immunotoxins and antibody-directed enzyme product therapy (ADEPT). Seattle Genetics has built a diverse portfolio of product candidates targeted to many types of human cancers, including three currently being tested in multiple ongoing clinical trials. Seattle Genetics has agreements with many organizations including Genentech, Bristol-Myers Squibb, Genencor International, Aventis and Medarex. The company also has license agreements for its ADC technology with Genentech, Celltech Group and Eos Biotechnology. More information about Seattle Genetics can be found at www.seattlegenetics.com. Certain of the statements made in this press release are forward-looking, such as those, among others, relating to planned clinical trials and the potential therapeutic benefits of SGN-30. Actual results or developments may differ materially from those projected or implied in these forward-looking statements. Factors that may cause such a difference include risks related to adverse clinical results as our product candidates move into and advance in clinical trials, risks inherent in early-stage development and failure by Seattle Genetics to secure or maintain relationships with collaborators. More information about the risks and uncertainties faced by Seattle Genetics is contained in the Company's filings with the Securities and Exchange Commission. Seattle Genetics disclaims any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise. |
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