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Seattle Genetics Reports on SGN-30 and SGN-40 Clinical Programs at the American Society of Hematology Annual Meeting

Posted on: Monday, 6 December 2004, 09:00 CST

Seattle Genetics, Inc. (Nasdaq:SGEN) reported data from its SGN-30 and SGN-40 clinical programs at the American Society of Hematology (ASH) 2004 Annual Meeting in San Diego. Data from ongoing phase II studies of SGN-30 in anaplastic large cell lymphoma (ALCL) and Hodgkin's disease demonstrate that it is well tolerated and has antitumor activity. Dose escalation is continuing in a phase I trial of SGN-40 in multiple myeloma, with preliminary data indicating that the product candidate is well tolerated at low doses. Preclinical studies of SGN-30 and SGN-40 suggest synergies with conventional chemotherapy regimens.

"We are pleased with the continued progress of our SGN-30 and SGN-40 programs as demonstrated by the data we are presenting as ASH," stated Clay B. Siegall, Ph.D., President and Chief Executive Officer of Seattle Genetics. "We continue to enroll patients in multiple clinical trials of both product candidates and to expand into other indications, including our recent initiation of SGN-40 in non-Hodgkin's lymphoma. We expect to report additional data from both programs in 2005."

SGN-30 Phase II ALCL Clinical Trial

SGN-30 is a monoclonal antibody that targets CD30, which is highly expressed on T-cell lineage hematologic malignancies. Seattle Genetics reported preliminary data from an ongoing phase II clinical trial designed to evaluate SGN-30's antitumor activity, safety and pharmacokinetic profile in patients with relapsed or refractory systemic ALCL.

ALCL patients receive six milligrams per kilogram (mg/kg) of SGN-30 for six consecutive weeks followed by a four-week observation period. To date, eight patients with a median age of 59 years and a median of 2.5 prior therapies have been enrolled in the study. Multiple doses of SGN-30 have been well tolerated. Of the six evaluable patients, two exhibited objective responses, including one complete response and one partial response. One patient had stable disease and three patients had progressive disease. Drug-related adverse events have been typically mild and consistent with antibody administration.

SGN-30 Phase II Hodgkin's Disease Clinical Trial

SGN-30 is also being evaluated as therapy for patients with Hodgkin's disease. In this study, a total of 22 patients have been enrolled to date. Fifteen patients received SGN-30 at a dose of six mg/kg and seven patients received a dose of 12 mg/kg, in each case on a weekly basis for six consecutive weeks. Patients are evaluated for a four-week period following treatment. The median age of enrolled patients is 34 years and median number of prior therapies is three. Seventy-three percent of the patients enrolled in the study had received prior bone marrow transplant. Of the 16 evaluable patients, six patients had stable disease with an average duration of 4.8 months. Ten patients experienced disease progression. The most common drug-related adverse event has been fatigue. Newly enrolled Hodgkin's disease patients will be administered a dose of 12 mg/kg.

SGN-40 Phase I Multiple Myeloma Clinical Trial

SGN-40 is a humanized monoclonal antibody that targets the CD40 antigen, which is expressed on most B-cell lineage hematologic malignancies, including multiple myeloma, non-Hodgkin's lymphoma and chronic lymphocytic leukemia. Seattle Genetics is conducting an open-label, multi-dose, single-arm phase I study designed to evaluate the safety, antitumor activity and pharmacokinetic profile of escalating doses of SGN-40 in patients with relapsed or refractory multiple myeloma.

To date, a total of ten patients in cohorts of at least three have been treated with SGN-40 at dose levels of 0.5, 1.0 or 2.0 mg/kg on a weekly basis for four weeks. Patients are followed for up to six weeks after their last dose. All patients had progressive disease upon enrollment and were heavily pretreated with a median of five prior therapies and median age of 58 years. Two of the 10 patients had stable M-protein levels over the four-week treatment period. No grade 3 or 4 non-hematologic dose limiting toxicities have been observed.

Seattle Genetics is continuing to dose escalate in this phase I study of SGN-40 in multiple myeloma and plans to report additional data during 2005. In addition, the company recently expanded its SGN-40 clinical program by initiating a phase I study in non-Hodgkin's lymphoma.

SGN-30 Preclinical Studies

Preclinical studies of SGN-30 in combination with conventional chemotherapeutics commonly used in CD30-positive malignancies, such as bleomycin, demonstrate a synergistic response that significantly enhances antitumor activity compared to either agent administered alone. The data suggest that a clinical regimen combining SGN-30 and chemotherapy may result in increased efficacy. Based on these preclinical findings, Seattle Genetics plans to initiate a clinical trial of SGN-30 in combination with chemotherapy in patients with Hodgkin's disease in 2005.

SGN-40 Preclinical Studies

SGN-40 was evaluated in preclinical studies in combination with several immunomodulatory drugs (IMiDs) used in the treatment of multiple myeloma. Results indicate that the combination induced enhanced cell-killing activity compared with either single agent, suggesting that a clinical regimen combining SGN-40 and IMiDs may result in increased efficacy.

About Seattle Genetics

Seattle Genetics discovers and develops monoclonal antibody-based therapeutics to treat cancer and other human diseases. The company has built a diverse portfolio of product candidates targeted to many types of cancer, including three being tested in multiple ongoing clinical trials, SGN-30, SGN-15 and SGN-40, and three in preclinical development, SGN-35, SGN-75 and SGN-17/19. The product candidates encompass three platform technologies: genetically engineered monoclonal antibodies, antibody-drug conjugates (ADCs) and antibody-directed enzyme prodrug therapy (ADEPT). Seattle Genetics has developed leading 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 Genentech, Celltech Group, Protein Design Labs, CuraGen and Bayer and for its ADEPT technology with Genencor International. More information about Seattle Genetics can be found at www.seattlegenetics.com.

Certain of the statements made in this press release are forward-looking. Actual results or developments may differ materially from those projected or implied in these forward-looking statements. Specifically, statements regarding therapeutic potential and ongoing and planned clinical trials are forward-looking and actual results may differ materially from these statements for various reasons. 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 collaborators or failure of those collaborators to perform their contractual obligations. 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.

Source: Business Wire

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