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Sunesis Appoints Steering Committee and Clinical Partners for Vosaroxin Pivotal Phase 3 Trial in AML
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Sunesis Pharmaceuticals, Inc. has announced the Steering Committee and other clinical trial partners for its pivotal Phase 3 trial of vosaroxin in acute myeloid leukemia (AML).
Sunesis also announced that it requested, and that the United States Adopted Names (USAN) Council has accepted the new nonproprietary name "vosaroxin" for its lead drug candidate (formerly known as voreloxin). The USAN Council aims for global standardization and unification of drug nomenclature and related rules to ensure that drug information is communicated accurately and unambiguously.
The Phase 3 trial, known as VALOR (Vosaroxin and Ara-C combination evaLuating Overall survival in Relapsed/refractory AML), is a multinational, randomized, double-blind, placebo-controlled, pivotal trial of vosaroxin in combination with cytarabine in 450 patients with first relapsed or primary refractory AML. It is expected to begin enrollment later this year.
"We have made important progress toward ensuring that our pivotal Phase 3 AML trial is a well-executed study, and continue to work diligently toward ensuring its timely launch," said Daniel Swisher, Sunesis' Chief Executive Officer. "Our internal clinical leadership, which includes individuals with extensive late-stage development experience, is now supplemented by clinical partners and a Steering Committee with significant, international hematology experience. We are in the process of compiling and finalizing the documentation needed for local regulatory authority and ethics committee submissions, and we remain on track to initiate the VALOR trial later this year."
"Refractory and relapsed AML are disease settings for which there is an enduring unmet medical need. Currently no Phase 3 trial is enrolling both first relapsed or primary refractory AML patients," said Eric Feldman, MD, Chair of the VALOR Steering Committee and Professor of Medicine and Director of the Leukemia Program and Hematological Malignancies at Weill Cornell Medical College.
"The VALOR trial is a rigorously designed study which will provide randomized data assessing the potential incremental contribution of vosaroxin to underlying cytarabine therapy in relapsed or refractory AML, with overall survival serving as the primary endpoint. I look forward to the initiation of this trial and to serving as a member of its Steering Committee," Feldman added.
The Steering Committee will provide scientific oversight for the VALOR trial as well as communicate its recommendations regarding trial conduct with the trial's Data Safety Monitoring Board and Sunesis. Steering Committee members are:
• Eric Feldman, MD, Chair of Steering Committee, Professor of Medicine and Director of the Leukemia Program and Hematological Malignancies at Weill Cornell Medical College
• Harry Erba, MD, PhD, Associate Professor, Department of Internal Medicine at the University of Michigan and Executive Officer of the Southwest Oncology Group
• Gary Schiller, MD, Professor of Medicine, Director of the Hemapherisis Unit and Chairman of the Medical Specialties College of the David Geffen School of Medicine at the University of California, Los Angeles
• Robert Stuart, MD, founding director of the Aplastic Anemia & Myelodysplastic Syndrome Foundation, Director of the clinical component of the Hollings Cancer Center's Hematological Malignancies Program and Medical Director of the Clinical Trials Office at the University of South Carolina
• Norbert Vey, MD, Professor of Medicine, Leukemia and MDS Unit, Department of Hematology at the Institut Paoli-Calmettes, Marseille, France
Among the clinical trial partners appointed by Sunesis are (i) ICON, a contract research organization with global capabilities, hematology expertise and extensive Phase 3 experience; (ii) Catalent Pharma Solutions, a global provider of advanced technologies, and development, clinical, manufacturing and packaging services, including global comparator procurement, secondary packaging and logistics; and (iii) Cytel, a statistical services provider.
Sunesis has also retained the Clinical Development Group, LLC to augment Sunesis' Phase 3 strategic development support for the VALOR trial, including clinical site management and patient recruitment. Key individuals from the Clinical Development Group have recent, multinational Phase 3 AML trial experience, including Ann Cahill, formerly the Vice President of Clinical Development at Vion Pharmaceuticals.
Sunesis also announced that it requested, and that the United States Adopted Names (USAN) Council has accepted the new nonproprietary name "vosaroxin" for its lead drug candidate (formerly known as voreloxin). The USAN Council aims for global standardization and unification of drug nomenclature and related rules to ensure that drug information is communicated accurately and unambiguously.
The Phase 3 trial, known as VALOR (Vosaroxin and Ara-C combination evaLuating Overall survival in Relapsed/refractory AML), is a multinational, randomized, double-blind, placebo-controlled, pivotal trial of vosaroxin in combination with cytarabine in 450 patients with first relapsed or primary refractory AML. It is expected to begin enrollment later this year.
"We have made important progress toward ensuring that our pivotal Phase 3 AML trial is a well-executed study, and continue to work diligently toward ensuring its timely launch," said Daniel Swisher, Sunesis' Chief Executive Officer. "Our internal clinical leadership, which includes individuals with extensive late-stage development experience, is now supplemented by clinical partners and a Steering Committee with significant, international hematology experience. We are in the process of compiling and finalizing the documentation needed for local regulatory authority and ethics committee submissions, and we remain on track to initiate the VALOR trial later this year."
"Refractory and relapsed AML are disease settings for which there is an enduring unmet medical need. Currently no Phase 3 trial is enrolling both first relapsed or primary refractory AML patients," said Eric Feldman, MD, Chair of the VALOR Steering Committee and Professor of Medicine and Director of the Leukemia Program and Hematological Malignancies at Weill Cornell Medical College.
"The VALOR trial is a rigorously designed study which will provide randomized data assessing the potential incremental contribution of vosaroxin to underlying cytarabine therapy in relapsed or refractory AML, with overall survival serving as the primary endpoint. I look forward to the initiation of this trial and to serving as a member of its Steering Committee," Feldman added.
The Steering Committee will provide scientific oversight for the VALOR trial as well as communicate its recommendations regarding trial conduct with the trial's Data Safety Monitoring Board and Sunesis. Steering Committee members are:
• Eric Feldman, MD, Chair of Steering Committee, Professor of Medicine and Director of the Leukemia Program and Hematological Malignancies at Weill Cornell Medical College
• Harry Erba, MD, PhD, Associate Professor, Department of Internal Medicine at the University of Michigan and Executive Officer of the Southwest Oncology Group
• Gary Schiller, MD, Professor of Medicine, Director of the Hemapherisis Unit and Chairman of the Medical Specialties College of the David Geffen School of Medicine at the University of California, Los Angeles
• Robert Stuart, MD, founding director of the Aplastic Anemia & Myelodysplastic Syndrome Foundation, Director of the clinical component of the Hollings Cancer Center's Hematological Malignancies Program and Medical Director of the Clinical Trials Office at the University of South Carolina
• Norbert Vey, MD, Professor of Medicine, Leukemia and MDS Unit, Department of Hematology at the Institut Paoli-Calmettes, Marseille, France
Among the clinical trial partners appointed by Sunesis are (i) ICON, a contract research organization with global capabilities, hematology expertise and extensive Phase 3 experience; (ii) Catalent Pharma Solutions, a global provider of advanced technologies, and development, clinical, manufacturing and packaging services, including global comparator procurement, secondary packaging and logistics; and (iii) Cytel, a statistical services provider.
Sunesis has also retained the Clinical Development Group, LLC to augment Sunesis' Phase 3 strategic development support for the VALOR trial, including clinical site management and patient recruitment. Key individuals from the Clinical Development Group have recent, multinational Phase 3 AML trial experience, including Ann Cahill, formerly the Vice President of Clinical Development at Vion Pharmaceuticals.
