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Sunesis Pharmaceuticals, Inc. Message Board

  • sh0rtmimi sh0rtmimi Dec 12, 2009 7:14 AM Flag

    ALERT*** Estimated VorEloxin marekt opportunity is $3.5 bln

    Voreloxin has an estimated market opportunity of more than $1 billion in the acute myeloid leukemia indication and about $2 billion to $2.5 billion marketing potential in the ovarian cancer indication.

    http://www.nasdaq.com//aspxcontent/newsstory.aspx?symbol=SNSS&selected=SNSS&textpath=20091211\ACQRTT200912110423RTTRADERUSEQUITY_0135.htm&cdtime=12%2F11%2F2009+4%3A23AM

    ++++

    I'm buying more shares, next weeks.

    SNSS is next DNDN.

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    • VorEloxin marekt opportunity is $3.5 bln

    • market opportunity important..

    • 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


      bump

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

    • 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

    • 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, 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


      25 feb

    • WORTH BILLIONS NICE???

    • after hours............cheers///////////

    • Voreloxin In-License

      In October 2003, Sunesis entered into a licensing agreement with Dainippon Pharmaceuticals Co., Ltd., now Dainippon Sumitomo Pharmaceuticals, under which we obtained a worldwide exclusive license, including the right to sublicense, to voreloxin and related compounds.

      Under the terms of the agreement, Sunesis provides Dainippon with an upfront payment and milestone payments for starting Phase 2 clinical testing, Phase 3 clinical testing, and for filing New drug Applications (NDAs) and receiving regulatory approval in the United States, Europe and Japan for cancer treatment. Upon commercialization, Sunesis will also make royalty payments to Dainippon.

      Voreloxin is currently being evaluated as a single agent in a Phase 2 clinical trial (known as the REVEAL-1 trial) in previously untreated elderly Acute myeloid leukemia (AML) patients, in a Phase 1b/2clinical trial combining voreloxin with cytarabine for the treatment of patients with relapsed/refractory AML, and as a single agent in a Phase 2 clinical trial in platinum-resistant ovarian cancer. In clinical trials conducted to date, voreloxin has been generally well tolerated and has shown objective responses in both solid and hematologic tumor types.

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