SOUTH SAN FRANCISCO, CA, USA I October 28, 2013 I Sunesis Pharmaceuticals, Inc. (Nasdaq:SNSS) today announced the initiation of a Phase I/II investigator-sponsored trial of vosaroxin, the company’s lead product candidate, in adult patients with previously treated intermediate-2 or high-risk myelodysplastic syndrome (MDS). The trial is being conducted at Weill Cornell Medical College and New York-Presbyterian Hospital under the direction of Gail J. Roboz, M.D., Associate Professor of Medicine and Director of the Leukemia Program.
“MDS remains a challenging disease in adult patients with few proven effective therapies,” said Dr. Roboz. “As a result, there is an urgent need for new treatments for MDS patients who have progressed after front-line treatment. We look forward to studying vosaroxin in this setting.”
The Phase I/II, open-label, dose escalating trial is expected to enroll approximately up to 40 patients with MDS who have previously failed treatment with hypomethylating agent-based therapy. Patient cohorts will initially receive escalating doses of vosaroxin over each 28 day treatment cycle. Once the maximum tolerated dose (MTD) is determined, an expanded evaluation of safety and hematologic response or improvement rate at this dose level will be conducted in additional subjects, so that the total number of subjects exposed to this dose level increases to up to 15 subjects. In addition to MTD and dose limiting toxicity, study endpoints include rate of complete remission, partial remission, hematologic improvement and blood transfusion requirements.
“In our early clinical work, single-agent vosaroxin has demonstrated promising anti-leukemic activity and a favorable tolerability profile in elderly patients,” said Adam R. Craig, M.D., Ph.D., Executive Vice President, Development and Chief Medical Officer of Sunesis. “Both elements provide a strong rationale for investigating its use as a treatment for MDS. We look forward to seeing the data collected by the team at Weill Cornell Medical College in this important area of unmet medical need, while we focus our internal resources on the completion of our fully-enrolled pivotal Phase 3 VALOR trial of vosaroxin in first relapsed or refractory AML patients.”
About Vosaroxin
Vosaroxin is a first-in-class anti-cancer quinolone derivative (AQD), a class of compounds that has not been used previously for the treatment of cancer. Vosaroxin both intercalates DNA and inhibits topoisomerase II, resulting in replication-dependent, site-selective DNA damage, G2 arrest and apoptosis. Both the U.S. Food and Drug Administration (FDA) and European Commission have granted orphan drug designation to vosaroxin for the treatment of acute myeloid leukemia (AML). Additionally, vosaroxin has been granted fast track designation by the FDA for the potential treatment of relapsed or refractory AML in combination with cytarabine.
About MDS
MDS is a hematopoietic stem cell neoplasm that features dysplasia of the myeloid lineage. Hematopoiesis in these patients is disordered and ineffective. As the numbers and quality of blood-forming cells decline irreversibly, blood production is further impaired and patients often develop severe anemia requiring frequent blood transfusions. In most cases, the disease worsens and the patient develops neutropenia and thrombocytopenia caused by progressive bone marrow failure. In about one third of patients with MDS, the disease progresses into AML, usually within months to a few years.
According to the American Cancer Society, an estimated 12,000 new cases of MDS are diagnosed each year in the United States. MDS is generally a disease of the elderly with about 80-90% of all cases occurring in patients older than 60 years. It is rarely observed in adults under age 40 years and is more common in men than women. The number of new cases diagnosed each year is expected to increase as the average age of the population increases.
About Sunesis Pharmaceuticals
Sunesis is a biopharmaceutical company focused on the development and commercialization of new oncology therapeutics for the treatment of solid and hematologic cancers. Sunesis has built a highly experienced cancer drug development organization committed to advancing its lead product candidate, vosaroxin, in multiple indications to improve the lives of people with cancer. For additional information on Sunesis, please visit http://www.sunesis.com.
SOURCE: Sunesis Pharmaceuticals
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SOUTH SAN FRANCISCO, CA, USA I October 28, 2013 I Sunesis Pharmaceuticals, Inc. (Nasdaq:SNSS) today announced the initiation of a Phase I/II investigator-sponsored trial of vosaroxin, the company’s lead product candidate, in adult patients with previously treated intermediate-2 or high-risk myelodysplastic syndrome (MDS). The trial is being conducted at Weill Cornell Medical College and New York-Presbyterian Hospital under the direction of Gail J. Roboz, M.D., Associate Professor of Medicine and Director of the Leukemia Program.
“MDS remains a challenging disease in adult patients with few proven effective therapies,” said Dr. Roboz. “As a result, there is an urgent need for new treatments for MDS patients who have progressed after front-line treatment. We look forward to studying vosaroxin in this setting.”
The Phase I/II, open-label, dose escalating trial is expected to enroll approximately up to 40 patients with MDS who have previously failed treatment with hypomethylating agent-based therapy. Patient cohorts will initially receive escalating doses of vosaroxin over each 28 day treatment cycle. Once the maximum tolerated dose (MTD) is determined, an expanded evaluation of safety and hematologic response or improvement rate at this dose level will be conducted in additional subjects, so that the total number of subjects exposed to this dose level increases to up to 15 subjects. In addition to MTD and dose limiting toxicity, study endpoints include rate of complete remission, partial remission, hematologic improvement and blood transfusion requirements.
“In our early clinical work, single-agent vosaroxin has demonstrated promising anti-leukemic activity and a favorable tolerability profile in elderly patients,” said Adam R. Craig, M.D., Ph.D., Executive Vice President, Development and Chief Medical Officer of Sunesis. “Both elements provide a strong rationale for investigating its use as a treatment for MDS. We look forward to seeing the data collected by the team at Weill Cornell Medical College in this important area of unmet medical need, while we focus our internal resources on the completion of our fully-enrolled pivotal Phase 3 VALOR trial of vosaroxin in first relapsed or refractory AML patients.”
About Vosaroxin
Vosaroxin is a first-in-class anti-cancer quinolone derivative (AQD), a class of compounds that has not been used previously for the treatment of cancer. Vosaroxin both intercalates DNA and inhibits topoisomerase II, resulting in replication-dependent, site-selective DNA damage, G2 arrest and apoptosis. Both the U.S. Food and Drug Administration (FDA) and European Commission have granted orphan drug designation to vosaroxin for the treatment of acute myeloid leukemia (AML). Additionally, vosaroxin has been granted fast track designation by the FDA for the potential treatment of relapsed or refractory AML in combination with cytarabine.
About MDS
MDS is a hematopoietic stem cell neoplasm that features dysplasia of the myeloid lineage. Hematopoiesis in these patients is disordered and ineffective. As the numbers and quality of blood-forming cells decline irreversibly, blood production is further impaired and patients often develop severe anemia requiring frequent blood transfusions. In most cases, the disease worsens and the patient develops neutropenia and thrombocytopenia caused by progressive bone marrow failure. In about one third of patients with MDS, the disease progresses into AML, usually within months to a few years.
According to the American Cancer Society, an estimated 12,000 new cases of MDS are diagnosed each year in the United States. MDS is generally a disease of the elderly with about 80-90% of all cases occurring in patients older than 60 years. It is rarely observed in adults under age 40 years and is more common in men than women. The number of new cases diagnosed each year is expected to increase as the average age of the population increases.
About Sunesis Pharmaceuticals
Sunesis is a biopharmaceutical company focused on the development and commercialization of new oncology therapeutics for the treatment of solid and hematologic cancers. Sunesis has built a highly experienced cancer drug development organization committed to advancing its lead product candidate, vosaroxin, in multiple indications to improve the lives of people with cancer. For additional information on Sunesis, please visit http://www.sunesis.com.
SOURCE: Sunesis Pharmaceuticals
Post Views: 39
