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sunesis pharmaceuticals inc (SNSS) Details

Sunesis Pharmaceuticals, Inc., a biopharmaceutical company, focuses on the development and commercialization of oncology therapeutics for the treatment of solid and hematologic cancers. The company’s lead product candidate is vosaroxin, an anti-cancer quinolone derivative for the treatment of acute myeloid leukemia or AML. It has completed a Phase III, randomized, double-blind, placebo-controlled, and pivotal clinical trial of vosaroxin in combination with cytarabine in patients with relapsed or refractory AMl. The company also completed a Phase II single-agent trial of vosaroxin in platinum-resistant ovarian cancer. In addition, it is involved in the initiation of an investigator-sponsored trial of vosaroxin in combination with decitabine in older patients with untreated AML and high-risk myelodysplastic syndrome. Sunesis Pharmaceuticals, Inc. has a collaboration agreement with Biogen Idec to discover, develop, and commercialize small molecule inhibitors of the human protein Raf kinase; and licensing agreements with Millennium to provide worldwide license to develop and commercialize preclinical inhibitors of PDK1. The company was founded in 1998 and is headquartered in South San Francisco, California.

32 Employees
Last Reported Date: 03/6/14
Founded in 1998

sunesis pharmaceuticals inc (SNSS) Top Compensated Officers

Chief Executive Officer, President and Direct...
Total Annual Compensation: $469.9K
Chief Financial Officer, Principal Accounting...
Total Annual Compensation: $378.8K
Chief Medical Officer and Executive Vice Pres...
Total Annual Compensation: $408.8K
Compensation as of Fiscal Year 2013.

sunesis pharmaceuticals inc (SNSS) Key Developments

Sunesis Pharmaceuticals, Inc. Announces Presentation of Positive Updated Results from Ongoing MD Anderson-Sponsored Trial of Vosaroxin in Aml and High-Risk Mds at Ash Annual Meeting

Sunesis Pharmaceuticals, Inc. announced presentation of updated results from an ongoing Phase 1b/2 University of Texas MD Anderson Cancer Center-sponsored trial of vosaroxin in combination with decitabine in older patients with previously untreated acute myeloid leukemia (AML) and high-risk myelodysplastic syndrome (MDS). The results will be presented in an oral session titled ‘Acute Myeloid Leukemia: Novel Therapy, excluding Transplantation: New Drugs II’ taking place from 10:30 AM to 12:00 PM PT at the 56th American Society of Hematology Annual Meeting in San Francisco, California. The Phase 1b/2 trial is expected to enroll up to a total of approximately 70 patients. Patients in the ongoing trial are being followed for response, leukemia-free survival, overall survival and safety. To date, 41 patients (38 AML, 3 high-risk MDS) with a median age of 70 years (range, 41-78) have been enrolled; 97% were older than 60 years and 51% were older than 70 years. Of the 37 patients evaluable for response, 22 patients (59%) achieved complete response (CR), 5 patients (14%) achieved CR with incomplete platelet recovery (CRp), and 1 patient (3%) achieved CR with incomplete peripheral blood count recovery (CRi), for an overall response rate of 76%. Preliminary median overall survival was 8.3 months. Median duration of response for patients achieving CR/CRp/CRi has not been reached. Patients have received a median of 2 (1 - 7) treatment cycles with median number of cycles to response being 1 (1 - 4). Six patients (16%) have proceeded to allogeneic stem cell transplant (ASCT) and 6 patients have relapsed.

Sunesis Pharmaceuticals Announces Presentation of Results from Phase 3 VALOR Trial of Vosaroxin and Cytarabine

Sunesis Pharmaceuticals, Inc. announced that results from the company's Phase 3 VALOR trial of vosaroxin and cytarabine in patients with relapsed or refractory acute myeloid leukemia (AML). The randomized, double-blind, placebo-controlled Phase 3 VALOR trial enrolled 711 adult patients with first relapsed or refractory AML at 124 leading sites in 15 countries. Patients were stratified for age, geographic region and disease status and randomized one to one to receive either vosaroxin and cytarabine or placebo and cytarabine. Patients treated with vosaroxin achieved increased overall survival compared to those treated with placebo (7.5 months vs 6.1 months, HR=0.865), the primary endpoint, but this difference did not achieve statistical significance (p=0.06).  The complete remission (CR) rate, the sole secondary efficacy endpoint in the trial, did demonstrate a significant difference for the vosaroxin combination arm (30.1% vs 16.3%, p < 0.0001). In a pre-planned analysis accounting for the stratification factors at randomization, a significant improvement in overall survival was demonstrated (HR=0.830, p=0.02).  The pre-planned analysis of all treatment strata included the following poor-prognosis patient categories: over 60 years old (7.1 months vs 5.0 months, HR=0.75, p=0.006, n=451), refractory disease (6.7 months vs 5.0 months, HR=0.87, p=0.26, n=301), and early relapsed disease (6.7 months vs 5.2 months, HR=0.77, p=0.05, n=256). Outcomes in patients under 60 years old or with late relapsed disease were comparable between treatment arms, with no improvement in overall survival. Across all strata, the CR and Composite CR (CR+CRp+Cri) rates were higher in the vosaroxin combination arm. Given the complexity of interpreting the impact of transplantation therapy, a sensitivity analysis of overall survival censoring for hematopoietic stem cell transplantation was planned. In this analysis, patients receiving the vosaroxin combination had a median overall survival of 6.7 months versus 5.3 months for patients receiving placebo and cytarabine (HR=0.809, p=0.02). Grade 3 or higher non-hematologic adverse events that were more common in the vosaroxin combination arm were gastrointestinal and infection-related toxicities, consistent with those observed in previous company trials. The rate of serious adverse events was 55.5% in the vosaroxin combination arm compared to 35.7% in the placebo and cytarabine arm. All-cause mortality were comparable between the treatment arms (7.9% vs 6.6% for 30-day and 19.7% vs 19.4% for 60-day).

Sunesis Pharmaceuticals, Inc. - Special Call

Sunesis Pharmaceuticals, Inc. - Special Call


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