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seattle genetics inc (SGEN) Key Developments

Seattle Genetics Inc. Presents at Washington Biotechnology & Biomedical Association 14th Annual Life Science Innovation Northwest 2014, Jun-19-2014 09:30 AM

Seattle Genetics Inc. Presents at Washington Biotechnology & Biomedical Association 14th Annual Life Science Innovation Northwest 2014, Jun-19-2014 09:30 AM. Venue: Washington State Convention Center, Seattle, Washington, United States.

Seattle Genetics Inc. Presents Data from Phase 1 Clinical Trial of Antibody-Drug Conjugate (ADC) SGN-CD19A

Seattle Genetics Inc. will present interim phase 1 clinical data from SGN-CD19A, an antibody-drug conjugate (ADC) in development for the treatment of B-cell malignancies, at the American Society of Clinical Oncology. These interim phase 1 data in aggressive non-Hodgkin lymphomas presented at ASCO, along with previous phase 1 data in acute lymphoblastic leukemia, demonstrate that SGN-CD19A has encouraging antitumor activity with multiple complete remissions in a patient population with significant unmet needs. The safety profile of SGN-CD19A is generally manageable with a notable absence of significant neuropathy or bone marrow suppression, which may enable future clinical trials with novel combination regimens. Data were reported from 37 patients with relapsed or refractory aggressive B-cell non-Hodgkin lymphoma (NHL), including 32 patients with diffuse large B-cell lymphoma (DLBCL), four patients with mantle cell lymphoma (MCL) and one patient with Grade 3 follicular lymphoma. The median age of patients was 65 years and the median number of prior systemic therapies was two, with 10 patients (27%) having received a prior autologous stem cell transplant. Among enrolled patients, 8% were primary refractory, 54% were refractory to their last treatment and 38% had relapsed following a response to their last treatment. The primary endpoints of the ongoing clinical trial are to estimate the maximum tolerated dose and to evaluate the safety of SGN-CD19A. In addition, the trial is evaluating antitumor activity, pharmacokinetics, progression-free survival and overall survival. In this dose-escalation study, patients receive a single dose of SGN-CD19A on an every 3-week basis. Key findings included: No dose limiting toxicity was observed in the first cycle for any patients. Adverse events were observed in the 6 milligrams per kilogram (mg/kg) dosing regimen after the first cycle, therefore enrollment was discontinued. The 3, 4 and 5 mg/kg cohorts are being expanded, and the trial continues to enroll. At the time of data analysis, of the 37 patients treated across all dose levels, the objective response rate observed was 30% (11 patients). Six patients (16%) achieved a complete remission, five (14%) achieved a partial remission, 13 (35%) had stable disease and 13 (35%) had progressive disease as best response. The clinical trial is ongoing with nine of the 37 patients (24%) remaining on treatment and new patients continuing to be enrolled. The most common adverse events of any grade occurring in more than 30% patients were blurred vision (51%), fatigue (38%), dry eye (35%), constipation (30%) and keratopathy (30%). Grade 3 or higher adverse events observed in two or more patients included blurred vision (six patients), keratopathy (three patients), low platelet count (three patients) and anemia (three patients).

Seattle Genetics Inc. Presents at Jefferies 2014 Global Healthcare Conference, Jun-03-2014 02:00 PM

Seattle Genetics Inc. Presents at Jefferies 2014 Global Healthcare Conference, Jun-03-2014 02:00 PM. Venue: Grand Hyatt, New York, New York, United States. Speakers: Clay B. Siegall, Co-Founder, Chairman, Chief Executive Officer and President.

Seattle Genetics Reports Earnings Results for the First Quarter of 2014; Provides Sales Guidance for the Year 2014

Seattle Genetics reported earnings results for the first quarter of 2014. Total revenues in the first quarter of 2014 were $68.3 million, compared to $57.3 million in the first quarter of 2013. Revenues in the first quarter of 2014 included ADCETRIS net product sales of $38.7 million compared to $33.9 million for the same period in 2013. First quarter 2014 revenues also included royalty revenues of $12.7 million reflecting international sales of ADCETRIS by Takeda, including a $5 million sales milestone payment from Takeda. In addition, revenues include amounts earned under the company’s ADCETRIS and ADC collaborations totaling $16.9 million in the first quarter of 2014. Net loss was $16.3 million or $0.13 per basic and diluted share compared to a net loss of $16.3 million or $0.14 per basic and diluted share for the first quarter of 2013. Loss from operations was $16,371,000 against $16,387,000 a year ago. The company provided sales guidance for the year 2014. The company guided full-year Adcetris sales to $155 million to $165 million, only a modest improvement over the $144.7 million in sales reported in 2013.

Seattle Genetics Inc. to Report Q1, 2014 Results on May 01, 2014

Seattle Genetics Inc. announced that they will report Q1, 2014 results at 5:00 PM, Eastern Standard Time on May 01, 2014


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