Seattle Genetics Reports on SGN-30 Clinical Program at the American Society of Hematology Annual Meeting.BOTHELL, Wash. -- Preclinical data on SGN-35 also presented Seattle Genetics, Inc. (Nasdaq: SGEN SGEN Signal/System Generator ) today reported data from its ongoing clinical trials of SGN-30, an anti-CD30 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 , at the American Society of Hematology (ASH) 2005 Annual Meeting being held in Atlanta December 10-13. Data from these phase II clinical trials in systemic 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 ALCL Assembly Line Communications Link ) and cutaneous cutaneous /cu·ta·ne·ous/ (ku-ta´ne-us) pertaining to the skin. cu·ta·ne·ous adj. Of, relating to, or affecting the skin. Cutaneous Pertaining to the skin. ALCL demonstrate that SGN-30 is well tolerated and has antitumor an·ti·tu·mor also an·ti·tu·mor·al adj. Counteracting or preventing the formation of malignant tumors; anticancer. Adj. 1. activity, including complete and partial responses. The company is also giving an oral presentation of preclinical data from SGN-35, an anti-CD30 antibody-drug conjugate conjugate /con·ju·gate/ (kon´jdbobr-gat) 1. paired, or equally coupled; working in unison. 2. a conjugate diameter of the pelvic inlet; used alone usually to denote the true conjugate diameter; see (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. ) that is expected to enter clinical trials in mid-2006. "We continue to observe encouraging results from our phase II clinical trials of SGN-30, including multiple objective antitumor responses and a clean safety profile," said Clay B. Siegall, Ph.D., President and Chief Executive Officer at Seattle Genetics. "We are executing on our strategy to target CD30 with two distinct antibody-based programs. SGN-30 is a genetically engineered genetically engineered adjective Recombinant, see there antibody that has demonstrated clinical efficacy in T-cell lymphomas, as well as therapeutic potential in combination with chemotherapy for other oncology indications and possible applications in immunologic disease. SGN-35 is an ADC that extends our opportunities in CD30-positive malignancies, notably 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. , with a highly potent, targeted agent. We plan to continue to advance our studies of SGN-30 in 2006, as well as initiate 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 SGN-35 by mid-year." SGN-30 Phase II Clinical Trials The ongoing phase II clinical studies of SGN-30 for relapsed or refractory systemic ALCL and cutaneous ALCL are designed to assess antitumor activity, tolerability and pharmacokinetics of a multi-dose regimen of SGN-30. Systemic Anaplastic Large Cell Lymphoma (ALCL) Abstract #3356: SGN-30 (anti-CD30 mAb) is Active and Well Tolerated in Patients with Refractory or Recurrent Systemic Anaplastic Large Cell Lymphoma. Twenty-seven patients have received SGN-30 in the systemic ALCL study, of which twenty patients are currently evaluable. Patients received six weekly doses of 6 milligrams per kilogram (mg/kg) of SGN-30. The median age of enrolled patients is 55.5 years and the median number of prior therapies is 2.5. Ninety percent of patients were anaplastic an·a·plas·tic adj. 1. Relating to the surgical restoration of a lost or absent part. 2. Of, relating to, or characterized by cells that have become less differentiated. anaplastic 1. lymphoma kinase (ALK ALK Alkohol (German: alcohol) ALK Alkaline ALK Anaplastic Lymphoma Kinase ALK Automatisierte Liegenschaftskarte ALK Activin Receptor-Like Kinase ALK Alkylation ALK Srilankan Airlines (ICAO code) )-negative, a factor that is typically associated with a poor prognosis. In this heavily pretreated population, five patients demonstrated objective antitumor responses, including two complete responses ongoing at 19 months and three months respectively, and three partial responses. Two patients had stable disease and 13 had progressive disease. Multiple doses of SGN-30 have been well tolerated. Drug-related adverse events have been typically mild and consistent with antibody administration. Given the favorable tolerability profile, Seattle Genetics has escalated the dose to 12 mg/kg, and accrual is ongoing in both the United States and Europe. Cutaneous Anaplastic Large Cell Lymphoma (ALCL) Abstract #4802: Preliminary Phase II Results of SGN-30 (Anti-CD30 Monoclonal Antibody) in Patients with Cutaneous Anaplastic Large Cell Lymphoma (ALCL). In the cutaneous ALCL study, patients received SGN-30 at monthly doses of 4 mg/kg for a maximum of six consecutive doses. In the absence of an objective response after two doses, patients are eligible to receive an escalated dose of 12 mg/kg for the remaining infusions. Six patients have been enrolled in the study with a median age of 63 years and a median of three prior therapies, including at least one systemic therapy. Five patients achieved objective antitumor responses, including one ongoing complete response lasting more than 80 days and four partial responses. The study was recently amended to include two other related CD30-positive indications: transformed mycosis fungoides and lymphomatoid papulosis (LyP). Accrual to this phase II clinical trial is ongoing. SGN-35 Preclinical Studies Abstract #610: SGN-35, an Anti-CD30 Antibody-Drug Conjugate, Exhibits Potent Antitumor Activity for the Treatment of CD30+ Malignancies. Oral session: Lymphoma: Pre-Clinical - Biologic Therapy. Monday, December 12, 2005, 4:15 p.m. Eastern Time. SGN-35 is an ADC comprised of an anti-CD30 antibody linked by an enzyme cleavable cleave 1 v. cleft or cleaved or clove , cleft or cleaved or clo·ven , cleav·ing, cleaves v.tr. 1. To split with or as if with a sharp instrument. peptide linker to an auristatin derivative, monomethyl auristatin E (MMAE MMAE Multiple Model Adaptive Estimation (Bayesian technique using Kalman filters) MMAE Mechanical, Materials and Aerospace Engineering MMAE Multiple Model Adaptive Estimator MMAE Monomethyl Auristatin E ), using Seattle Genetics' proprietary ADC technology. SGN-35 has potent, selective activity in vitro, demonstrating that the ADC does not compromise the antibody's specific binding and internalization Internalization A decision by a brokerage to fill an order with the firm's own inventory of stock. Notes: When a brokerage receives an order they have numerous choices as to how it should be filled. . Treatment with SGN-35 resulted in complete regressions in preclinical models of Hodgkin's disease at doses of 2 mg/kg and in anaplastic large cell lymphoma (ALCL) at doses of 0.5 mg/kg. Seattle Genetics is advancing SGN-35 toward clinical trials in patients with CD30-positive hematology malignancies, including Hodgkin's disease, in mid-2006. About Seattle Genetics Seattle Genetics is a biotechnology company focused on the development of monoclonal antibody-based therapies for the treatment of cancer and immunologic diseases. The company is conducting multiple clinical trials of its three lead product candidates, SGN-30, SGN-40 and SGN-33, and preclinical development of several late-stage programs. In addition, Seattle Genetics has developed proprietary antibody-drug conjugate (ADC) technology comprised of highly potent synthetic drugs and stable linkers for attaching the drugs to monoclonal antibodies. The company currently has license agreements for its ADC technology with a number of leading biotechnology and pharmaceutical companies, including Genentech, Bayer, CuraGen and MedImmune. More information about Seattle Genetics' pipeline and technologies 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 the future advancement and therapeutic potential of SGN-30 and SGN-35. 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 SGN-30 advances in clinical trials, such as patients exhibiting progressive disease or severe adverse events, or delays in, or the inability to initiate, clinical trials for SGN-35. 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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