Nektar Therapeutics

The long wave goodbye to phantom PIs

Friday, April 15, 2016

Efforts to reduce the number of phantom investigators—principal investigators (PIs) who are not adequately supervising their staff and clinical trials—appear to be having a measurable impact. But problems associated with, and the issues that cause, phantom PIs and their causes linger.

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Advisory boards amplify patients’ voices

Tuesday, September 15, 2015

A strong and growing desire to solicit feedback directly from patients, ex­perienced participants and their sup­port network is prompting many sponsors and CROs to assess, plan and implement patient advisory panels.

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Baxalta’s shows positive data for BAX 855 in hemophilia A

Friday, July 17, 2015

Baxalta, a global biopharmaceutical provider dedicated to delivering transformative therapies to patients with orphan diseases and underserved conditions, has published complete data from the phase II/III pivotal study and phase I trial of BAX 855 in Blood, the journal of the American Society of Hematology. BAX 855 is Baxalta’s investigational, extended half-life recombinant factor VIII (rFVIII) treatment for hemophilia A based on ADVATE [Antihemophilic Factor (Recombinant)], a treatment for hemophilia A with more than 11 years of real-world patient experience.

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Auspex Pharmaceuticals appoints Lynn Bleil, Scott Greer to board of directors

Friday, May 9, 2014

Auspex Pharmaceuticals, a late clinical stage biopharmaceutical company focused on developing and commercializing novel medicines for the treatment of orphan diseases, has announced the expansion of its board of directors with the appointment of two new members: Lynn D. Bleil, former leader of McKinsey & Company’s West Coast Healthcare Practice and a leader of the worldwide Healthcare Practice; and R. Scott Greer, managing director of Numenor Ventures, and former founder, chairman and CEO of Abgenix. The total number of Auspex board members is increased to nine.

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Nektar presents positive data from a phase I study of Etirinotecan Pegol (NKTR-102)

Monday, January 20, 2014

Nektar Therapeutics presented favorable data today from a phase I study of etirinotecan pegol (EP, NKTR-102) in combination with 5-fluorouracil (5-FU)/Leucovorin (LV) in patients with advanced cancer. NKTR-102 is the first long-acting topoisomerase I-inhibitor designed to concentrate in tumor tissue, provide sustained tumor suppression throughout the entire chemotherapy cycle, and to reduce the peak exposures that are associated with toxicities of other cytotoxics.

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Etirinotecan Pegol (NKTR-102) passes interim efficacy analysis for phase III study

Wednesday, January 15, 2014

Nektar Therapeutics has announced that the Independent Data Monitoring Committee (DMC) created to provide safety oversight for the company’s pivotal clinical study for etirinotecan pegol (NKTR-102) has recommended continuation of the BEACON phase III trial, based upon the completion of a planned interim efficacy analysis in accordance with the DMC charter. The BEACON trial is evaluating NKTR-102 versus an agent of physician’s choice for the treatment of locally recurrent or metastatic breast cancer, with a primary efficacy endpoint of overall survival. NKTR-102 is the first long-acting topoisomerase I-inhibitor designed to concentrate in tumor tissue, provide sustained tumor suppression throughout the entire chemotherapy cycle and to reduce the peak exposures that are associated with toxicities of other cytotoxics.

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Nektar initiates phase III BEACON trial in women with metastatic breast cancer

Wednesday, December 14, 2011

Nektar Therapeutics has initiated a phase III global clinical trial evaluating NKTR-102 as a single agent in women with metastatic breast cancer. NKTR-102 is a next-generation topoisomerase I inhibitor designed using Nektar’s proprietary polymer conjugate technology, and is being developed in multiple tumor settings. The BEACON study is designed to include approximately 840 metastatic breast cancer patients who have had prior treatment with anthracycline, taxane and capecitabine in either the adjuvant or metastatic setting.

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