Key Developments For Sunesis Pharmaceuticals, Inc.
Sunesis Pharmaceuticals, Inc. (SNSS.O) (Consolidated Issue listed on NASDAQ Capital Market)
Sunesis Pharmaceuticals, Inc. Announces Data From Nonclinical Studies of Voreloxin
Sunesis Pharmaceuticals, Inc. announced data from two nonclinical studies of voreloxin. In one study, clinical proof-of-mechanism is established in samples from patients treated with voreloxin in the Company's ongoing Phase 2 clinical study of voreloxin in combination with cytarabine in relapsed or refractory acute myeloid leukemia (AML). In an additional study, voreloxin's synergistic and additive effects are demonstrated in combination with cytarabine, azacitidine, decitabine and clofarabine, agents which are currently used in the treatment of AML. Results from both of these studies support the current combination study and identify potential opportunities for further clinical evaluation. Sunesis presented nonclinical data that demonstrated mechanism-based pharmacodynamic activity of voreloxin in patients enrolled in an ongoing phase 1b/2 clinical study of voreloxin in combination with cytarabine in relapsed or refractory AML. The study identified pDNA-PKcs and pCHK2 as mechanism-based pharmacodynamic markers of response to voreloxin. These observations were consistent in cancer cell lines and in peripheral blood mononuclear cells (PBMC) of AML patient donors that were treated ex vivo with voreloxin. Furthermore, the DNA damage response to voreloxin, which was activated in PBMC from AML patients who received voreloxin at doses equal to or greater than 34 mg/m2, was differentiated from that of cytarabine.
Sunesis Pharmaceuticals, Inc. Announces Nonclinical Voreloxin Combination Data
Sunesis Pharmaceuticals, Inc. announced that it will present new data from nonclinical studies of voreloxin at the upcoming AACR-EORTC-NCI Molecular Targets and Cancer Therapeutics Conference, which is being held in Boston, MA from November 15-19, 2009. Clinical proof-of-mechanism is demonstrated in samples from patients treated with voreloxin in the Company's ongoing Phase 2 clinical study of voreloxin in combination with cytarabine in relapsed or refractory AML. Studies also provide evidence of voreloxin's synergistic and additive effects when combined with other acute myeloid leukemia (AML) treatments, supporting the current combination study and identifying potential opportunities for further clinical evaluation. Voreloxin is a anticancer quinolone derivative, or AQD, a class of compounds that has not been used previously for the treatment of cancer. Voreloxin both intercalates DNA and inhibits topoisomerase II, resulting in replication-dependent, site-selective DNA damage, G2 arrest and apoptosis. Voreloxin is currently being evaluated in a Phase 2 clinical trial (known as the REVEAL-1 trial) in previously untreated elderly AML patients and in a Phase 1b/2 clinical trial combining voreloxin with cytarabine for the treatment of patients with relapsed/refractory AML, as well as in an ongoing Phase 2 single-agent trial in platinum-resistant ovarian cancer.
Sunesis Pharmaceuticals, Inc.'s Voreloxin Receives FDA Orphan Drug Designation For Acute Myeloid Leukemia
Sunesis Pharmaceuticals, Inc. announced that the U.S. Food and Drug Administration has granted voreloxin orphan drug designation for the treatment of acute myeloid leukemia (AML). Sunesis is currently conducting two Phase 2 clinical trials of voreloxin in AML: a single-agent study, known as REVEAL-1, of voreloxin in newly diagnosed elderly AML patients unlikely to benefit from standard induction chemotherapy and a study evaluating voreloxin in combination with cytarabine in relapsed/refractory AML.
Sunesis Pharmaceuticals, Inc. Completes Second Tranche Of Private Placement
Sunesis Pharmaceuticals, Inc. announced the closing of a private placement of $5.0 million of units consisting of convertible preferred stock and common stock warrants on October 30, 2009. This closing constitutes the second tranche of the private placement of up to $43.5 million of Sunesis' securities announced in April 2009. The private placement contemplated the sale of up to $15.0 million of units consisting of convertible preferred stock and warrants to purchase common stock, of which $10.0 million of units were sold in the initial closing in April 2009 and the remaining $5.0 million of units were sold in the second closing held on October 30, 2009. The remaining tranche of up to $28.5 million of common stock may be invested at the election of the holders of a majority of the convertible preferred stock, in their sole discretion, with the date of termination of the preferred stockholders' right to make such an election subject to Sunesis Pharmaceuticals' future cash balance. In connection with the second closing, Sunesis issued approximately 1.45 million shares of convertible preferred stock, which are convertible into approximately 14.5 million shares of common stock, and warrants to purchase approximately 14.5 million shares of common stock.
Sunesis Pharmaceuticals, Inc. Announces New Data From Three Ongoing Clinical Trials
Sunesis Pharmaceuticals, Inc. announced new data from three ongoing clinical trials demonstrating that Sunesis' lead drug candidate, voreloxin, shows promising safety and efficacy in acute myeloid leukemia (AML) and in platinum-resistant ovarian cancer. Phase 2 Study of Single Agent Voreloxin in Newly Diagnosed Elderly AML (REVEAL-1 Trial) REVEAL-1 (Response Evaluation of VorEloxin in AmL) is a Phase 2 dose regimen optimization study of single agent voreloxin in newly diagnosed elderly AML patients who are unlikely to benefit from standard induction chemotherapy. Interim clinical data from this study continue to show that voreloxin can induce durable complete remissions. In Schedule A (72 mg/m2 of voreloxin weekly for three weeks), 29 patients have been enrolled and treated, 20 of 29 patients were 70 years of age or older. the majority of patients had intermediate or unfavorable cytogenetics, 12 patients achieved a complete remission or complete remission without full platelet recovery for an overall remission rate of 41%, 8 of 12 responders received one consolidation cycle of voreloxin and no responders received a second consolidation cycle. In Schedule B (72 mg/m2 of voreloxin dosed weekly for two weeks), 35 patients have been enrolled and treated. Data from these patients suggest that Schedule B is better tolerated. In Schedule C (72 mg/m2 of voreloxin dosed on days one and four), 28 patients have been enrolled and treated.
