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Sunesis Pharmaceuticals, Inc. Message Board

  • sh0rtmimi sh0rtmimi Dec 10, 2009 11:55 PM Flag

    VorEloxin, unique anti-leukemic activity and tolerability

    http://finance.yahoo.com/news/Sunesis-Presents-Positive-iw-3142073650.html?x=0&.v=1

    In a poster presentation, investigators presented data from the fully enrolled REVEAL-1 (Response Evaluation of VorEloxin in AmL) trial, a Phase 2 dose optimization trial of single agent voreloxin in previously untreated, elderly AML patients who are unlikely to benefit from standard induction chemotherapy. 113 AML patients have been treated in the trial, all of whom had at least one additional adverse risk factor at enrollment, including intermediate or unfavorable cytogenetics in the majority of patients. Median age for patients in the trial was 74 years. The trial includes three dosing schedules: Schedule A, once weekly for three weeks (n=29); Schedule B, once weekly for two weeks (n=35); and Schedule C, on days one and four at either 72 mg/m2 (n=29) or 90 mg/m2 (n=20).

    * Median survival was 8.7 months in Schedule A; 5.8 months in Schedule B; and 7.3 months (preliminary) in Schedule C (72 mg/m2 on days one and four).
    * Median duration of remission was 10.7 months and one year survival was 38% for Schedule A. For the other schedules, median duration of remission has not been reached and one year survival is too early to evaluate.
    * Patients age 75 or older (N=49) with at least 1 additional risk factor at diagnosis, a population identified by the National Comprehensive Cancer Network (2010) AML Guidelines as having poor outcome to standard treatment, experienced a CR rate of 30% and a 30-day all-cause mortality of 5%. Survival in these patients was too early to evaluate.
    * Based on trial results, Schedule C has been determined to be the recommended pivotal dose regimen. For Schedule C, response rates (CR and CRp) are 38%; 30- and 60-day all-cause mortality are 7% and 17% with improved tolerability over Schedule A.

    "Voreloxin has demonstrated a unique combination of anti-leukemic activity and tolerability, important for patients who are unlikely to benefit from standard induction therapy," said Robert K. Stuart, M.D., Professor of Medicine, Division of Hematology/Oncology, Department of Medicine, Medical University of South Carolina, and an investigator in the Phase 2 clinical trial. "Particularly encouraging are the durable response, tolerability and promising survival results in the Schedule C group. I look forward to seeing further data from this trial as it matures, particularly voreloxin's durability and overall survival in Schedule C."

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    • VorEloxin, unique anti-leukemic activity and tolerability

    • SNSS-VorEloxin 31% REMISSION RATE & mkt cap $ 26.23m

    • 31% remission rate!! but price below 2$ !! naked short...

      31% remission rate!! but price below 2$ !! naked short...

      31% remission rate!! but price below 2$ !! naked short...

    • 31% REMISSION RATE.............ohhhhhhhhhhhhhh

    • Unique: Voreloxin for treatment of elderly patient, who can not be treated with chemotherapy. So, great efficacy (31% remission) and awesome tolerability. This is HUGE and makes Voreloxin special.

      Elderly people are in desperate need of VorEloxin, they are dying, man. Can't you understand?

      Voreloxin unique anti cancer...

    • Unique: Voreloxin for treatment of elderly patient, who can not be treated with chemotherapy. So, great efficacy (31% remission) and awesome tolerability. This is HUGE and makes Voreloxin special.

      Elderly people are in desperate need of VorEloxin, they are dying, man. Can't you understand?

      30$ billion market potential...

    • Unique: Voreloxin for treatment of elderly patient, who can not be treated with chemotherapy. So, great efficacy (31% remission) and awesome tolerability. This is HUGE and makes Voreloxin special.

      Elderly people are in desperate need of VorEloxin, they are dying, man. Can't you understand?
      huge

    • About Voreloxin

      Voreloxin is a first-in-class 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 fully enrolled single agent Phase 2 clinical trial (known as the REVEAL-1 trial) in previously untreated elderly AML patients and in a fully enrolled Phase 1b/2 clinical trial combining voreloxin with cytarabine for the

    • Voreloxin works on patients that failed on Avastin in ovarian cancerssssssssssssssssssssssss

    • Sunesis Poised for Phase 3 Trial of Voreloxin in Acute Myeloid Leukemia After Completing Formal End-of-Phase 2 Meetings With FDA
      Company on Track to Initiate Pivotal Study in Second Half of 2010

      SOUTH SAN FRANCISCO, CA--(Marketwire - February 25, 2010) - Sunesis Pharmaceuticals, Inc. (NASDAQ: SNSS) today announced that it has completed formal End-of-Phase 2 meetings with the U.S. Food and Drug Administration (FDA) related to its lead compound, voreloxin, in acute myeloid leukemia (AML). Sunesis has received feedback and guidance from the FDA in response to proposed plans for further development of voreloxin in the treatment of AML. Based on the development clarity achieved as a result of these meetings, Sunesis intends to proceed with its plan to conduct a randomized, double-blind, placebo-controlled, pivotal Phase 3 trial. This trial will evaluate the overall survival of voreloxin in combination with cytarabine, a widely used chemotherapy in AML, compared to cytarabine with placebo, in patients with relapsed or refractory AML. Sunesis anticipates initiating this multi-national, Phase 3 trial in the second half of 2010.

      Sunesis also reported today that, as part of its global development strategy, a pre-submission meeting has been scheduled for the current calendar quarter with the European Medicines Agency (EMA) to obtain EMA's scientific advice on the development program for voreloxin, including the proposed Phase 3 trial.

      "We are very pleased by the outcomes of these milestone meetings with the FDA and are looking forward to initiating our multi-national Phase 3 trial," stated Daniel Swisher, Chief Executive Officer of Sunesis. "We believe that voreloxin's novel anti-leukemic properties and encouraging Phase 2 clinical data hold significant potential in a patient population with few treatment options. As we evaluate how best to fund our voreloxin development program, including our planned Phase 3 trial, we are continuing discussions with potential pharmaceutical partners."

      About Voreloxin

      Voreloxin is a first-in-class 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,

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