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Seattle Genetics Reports Preliminary Data from Phase I Clinical Trial of SGN-75

SEATTLE--(BUSINESS WIRE)--Oct 11, 2010 - Seattle Genetics, Inc. (Nasdaq:SGEN) today reported data from a phase I clinical trial of SGN-75 in patients with non-Hodgkin lymphoma or renal cell carcinoma (RCC). Preliminary results demonstrate tolerability and antitumor activity, including two objective responses in the first 16 patients treated. Dose-escalation is continuing. SGN-75 is an antibody-drug conjugate (ADC) targeted to CD70. The data were presented at the 35th European Society for Medical Oncology (ESMO) Congress being held in Milan, Italy.

“These preliminary data are encouraging, and show initial evidence of antitumor activity with SGN-75 in patients with relapsed/refractory non-Hodgkin lymphoma or metastatic RCC,” said Jonathan Drachman, M.D., Senior Vice President, Research and Translational Medicine of Seattle Genetics. “We are continuing to dose escalate in this trial to further assess the safety and activity of SGN-75, as well as to establish the optimal dosing regimen for future clinical trials.”

Data were reported from 16 patients in the open-label phase I clinical trial, including seven with non-Hodgkin lymphoma and nine with RCC. Cohorts of patients received SGN-75 either every three weeks at doses ranging from 0.3 to 2.0 milligrams per kilogram (mg/kg) or on a weekly basis at a dose of 0.3 mg/kg. Enrolled patients in each indication had received a median of three prior systemic therapies.

Best clinical response among non-Hodgkin lymphoma patients included one patient with a complete remission, four patients with stable disease, one patient with progressive disease and one patient who was not evaluable. Best clinical response among RCC patients included one patient with a partial response, three patients with stable disease and five patients with progressive disease. The most common adverse events were fatigue, nausea and peripheral edema (swelling). A maximum tolerated dose has not been established with either dosing schedule and dose escalation continues. (Abstract #532P)

The single-agent phase I study of SGN-75 was initiated in November 2009 and is designed to enroll up to approximately 80 patients at multiple centers in the United States. The trial is evaluating the safety, tolerability, pharmacokinetic profile and antitumor activity of SGN-75. Patients enrolled in the trial must have received at least one prior therapy and have confirmed CD70 expression.

SGN-75 is an ADC comprising an anti-CD70 antibody attached to a potent, synthetic cell-killing agent, monomethyl auristatin F (MMAF), using Seattle Genetics' proprietary technology. The ADC is designed to be stable in the bloodstream, and to release its cell-killing agent upon internalization into CD70-expressing tumor cells. This approach is intended to spare non-targeted cells and thus reduce many of the toxic effects of traditional chemotherapy while enhancing the antitumor activity.

About Non-Hodgkin Lymphoma

Non-Hodgkin lymphoma represents a diverse group of cancers that develop in the lymphatic system and are characterized by uncontrolled growth and accumulation of abnormal lymphocytes. Lymphocytes are white blood cells that are responsible for defending the body against infection. The most common forms of non-Hodgkin lymphoma are follicular and diffuse large B-cell lymphoma. According to the American Cancer Society, more than 65,000 cases of non-Hodgkin lymphoma are expected to be diagnosed in the United States during 2010 and more than 20,000 patients will die from the disease.

About Renal Cell Carcinoma

Renal cell carcinoma (RCC) forms in the kidney, which filters and cleans the blood. Metastatic RCC occurs when the cancer has spread to other parts of the body. RCC is the most common type of kidney cancer in adults, representing approximately 90 percent of cases. The American Cancer Society estimates that there will be more than 58,000 new cases of kidney cancer in the United States during 2010, and approximately 13,000 people will die from the disease.

About Seattle Genetics

Seattle Genetics is a clinical-stage biotechnology company focused on the development and commercialization of monoclonal antibody-based therapies for the treatment of cancer and autoimmune disease. The company's lead product candidate, brentuximab vedotin, is being evaluated in a variety of lymphoma treatment settings including the relapsed and refractory Hodgkin lymphoma indication for which top-line pivotal data have been reported. Brentuximab vedotin is being developed in collaboration with Millennium: The Takeda Oncology Company. In addition, Seattle Genetics has four other clinical-stage programs: SGN-75, ASG-5ME, dacetuzumab (SGN-40) and SGN-70. Seattle Genetics has collaborations for its ADC technology with a number of leading biotechnology and pharmaceutical companies, including Bayer, Celldex Therapeutics, Daiichi Sankyo, Genentech, GlaxoSmithKline, Millennium: The Takeda Oncology Company and Progenics, as well as ADC co-development agreements with Agensys, an affiliate of Astellas, and Genmab. More information 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 therapeutic potential and continuation of the ongoing phase I clinical trial of SGN-75. 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 medical events or inconclusive clinical trial results in the ongoing phase I clinical trial, including the inability to show that SGN-75 is effective or to show sufficient safety in such clinical trials, and risks related to Seattle Genetics' ability to recruit and enroll a sufficient number of patients to participate in such clinical trials. More information about these and other risks and uncertainties faced by Seattle Genetics is contained under the heading “Risk Factors” in the company's quarterly report on Form 10-Q for the quarter ended June 30, 2010 filed 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.

 

 

Contact: Seattle Genetics, Inc.
Peggy Pinkston, 425-527-4160
ppinkston@seagen.com

 

Posted: October 2010

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