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NABI BIOPHARMACEUTICALS
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NABI BIOPHARMACEUTICALS : SNSS

05 avr. 201114:18

Millennium Pharmaceuticals and Sunesis Pharmaceuticals Announce Collaboration for Kinase Inhibitors in Oncology
Companies:Sunesis Pharmaceuticals, Inc. Related Quotes
Symbol Price Change
SNSS 1.95 0.00


{"s" : "snss","k" : "a00,a50,b00,b60,c10,g00,h00,l10,p20,t10,v00","o" : "","j" : ""} Press Release Source: Sunesis Pharmaceuticals, Inc. On Tuesday April 5, 2011, 7:00 am EDT

Sunesis Receives a $4M Payment

Sunesis to Host Conference Call Today, April 5th at 10:00 AM Eastern Time



SOUTH SAN FRANCISCO, Calif., and CAMBRIDGE, Mass., April 5, 2011 (GLOBE NEWSWIRE) -- Millennium: The Takeda Oncology Company and Sunesis Pharmaceuticals, Inc. (Nasdaq:SNSS - News) today announced a license agreement for the development of Sunesis' oral, selective pan-Raf kinase inhibitor and one additional undisclosed kinase inhibitor program in oncology.



These programs were part of Sunesis' 2004 multi-kinase inhibitor collaboration with Biogen Idec. Following Biogen Idec's November 2010 announcement to focus on neurology and spin out or outlicense its oncology assets, Millennium acquired two of these oncology assets and will continue the development of these in collaboration with Sunesis. Biogen Idec and Sunesis are continuing a separate collaboration focused on a unique preclinical kinase inhibitor program involved in immunology.



"We are very excited to be working with Millennium, a company that focuses on developing first-in-class and best-in-class oncology compounds," stated Daniel Swisher, Chief Executive Officer of Sunesis. "We look forward to Millennium's transition of the pan-Raf kinase investigational agent into clinical studies, while we continue to focus our resources and attention on our ongoing Phase 3 VALOR trial for vosaroxin in AML."



"These kinase inhibitor programs represent an important addition to our portfolio and reflect our strategy to develop novel oncology therapies by targeting the underlying pathways of the disease process," said Nancy Simonian, M.D., Chief Medical Officer, Millennium. "In addition, the Raf kinase inhibitor investigational agent offers a compelling development opportunity as it targets a clinically validated pathway. We look forward to building on the strong preclinical dataset as we advance this program into clinical trials."



Non-clinical data from the oral and selective pan-Raf inhibitor were presented at the EORTC-NCI-AACR meeting in November 2010. Data were presented that demonstrated potent pan-Raf kinase inhibition in biochemical kinase assays. Data were also presented that showed profound antitumor activity in both large B-Raf mutant melanoma tumor models, tumor models of B-Raf wild-type melanoma and other B-Raf wild-type tumor types.



Under the terms of the agreement with Biogen Idec and Millennium, Sunesis has received a $4 million upfront payment from Millennium. Sunesis continues to be eligible to receive up to $60 million in pre-commercial milestone program payments and royalties on sales of future collaboration products. In addition, Sunesis has retained its future co-development and co-promotion rights.



"We are delighted to transition our collaboration with Sunesis on these oncology programs to Millennium, a world-class oncology organization," said Steven Holtzman, Executive Vice President of Corporate Development at Biogen Idec. "We look forward to seeing the oncology programs progress under Sunesis and Millennium's new collaboration, as we continue to drive forward our partnership with Sunesis on our immunology program."



Conference Call Information



Sunesis will host a conference call on April 5, 2011, 10:00 a.m. Eastern time to discuss the license agreement. The call can be accessed by dialing 866.831.6267 (U.S. and Canada) or 617.213.8857 (international) and entering the passcode 12246875. To access the live audio webcast, or the subsequent archived recording, visit the "Investors and Media - Calendar of Events" section of the Sunesis website at www.sunesis.com. The webcast will be recorded and available for replay on Sunesis' website for two weeks.



About Raf Kinase Program



The Raf kinases (A-Raf, B-Raf and C-Raf) are key regulators of cell proliferation and survival within the mitogen-activated protein kinase (MAPK) pathway. The MAPK pathway is frequently disregulated in human cancers, often via activating mutations of Ras or Raf.



About Millennium



Millennium: The Takeda Oncology Company, a leading biopharmaceutical company based in Cambridge, Mass., markets a first-in-class proteasome inhibitor in the US, and has a robust clinical development pipeline of global product candidates. Millennium Pharmaceuticals, Inc. was acquired by Takeda Pharmaceutical Company Ltd. in May, 2008. The Company's research, development and commercialization activities are focused in oncology. Additional information about Millennium and Takeda are available through their respective websites.



About Takeda



Located in Osaka, Japan, Takeda is a research-based global company with its main focus on pharmaceuticals. As the largest pharmaceutical company in Japan and one of the global leaders of the industry, Takeda is committed to strive towards better health for patients worldwide through leading innovation in medicine. Additional information about Takeda is available through its corporate website, www.takeda.com.



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 www.sunesis.com.

48 réponses

  • 10 avril 201108:53


    http://seekingalpha.com/article/262701-sunesis-signs-deal-improves-pipeline-pros pects


  • 11 avril 201117:48


  • 11 avril 201118:05


  • 11 avril 201118:24

    pour l'instant bien vu !


  • 20 avril 201116:43

    toujours in david ?


  • 20 avril 201116:48


  • 29 avril 201116:38


  • 29 avril 201117:04

    Je dois dire que ta vivacité m'impressionne ...

    Son live est tout simplement splendide ...

    Juste à voir comment le bloc sur 2.60 s'est fait mangé ...

    Bonne chance et bon wk

    Kanttt

    Egalement re-rentré sur RPC avant hier


  • 29 avril 201117:17


  • 29 avril 201117:24

    repris une petite louchette à 2.6 çà me fera un compte rond suite au reverse split


  • 29 avril 201117:25

    merci merci ... c vrai que la semaine a été excellente


  • 29 avril 201117:26

    biomen !


  • 05 mai 201114:21


    http://finance.yahoo.com/news/Sunesis-Announces-Publication-pz-1707540560.html?x =0&.v=1


  • 12 mai 201115:25

    Sunesis Pharmaceuticals Reports First Quarter 2011 Financial Results

    tweet0EmailPrintCompanies:Sunesis Pharmaceuticals, Inc. Related Quotes
    Symbol Price Change
    SNSS 2.52 0.00


    {"s" : "snss","k" : "a00,a50,b00,b60,c10,g00,h00,l10,p20,t10,v00","o" : "","j" : ""} Press Release Source: Sunesis Pharmaceuticals, Inc. On Thursday May 12, 2011, 7:00 am EDT

    SOUTH SAN FRANCISCO, Calif., May 12, 2011 (GLOBE NEWSWIRE) -- Sunesis Pharmaceuticals, Inc. (Nasdaq:SNSS - News) today reported financial results for the quarter ended March 31, 2011. Net income for the three months ended March 31, 2011 was $1.8 million. As of March 31, 2011, cash, cash equivalents and marketable securities totaled $48.9 million, with no debt outstanding. This cash balance does not include $4.0 million received on April 4, 2011 under Sunesis' previously disclosed oncology kinase inhibitor collaboration with Millennium Pharmaceuticals, Inc.



    The Company also announced that an abstract reviewing the adaptive design of the VALOR trial has been accepted for presentation during a poster session at the 2011 American Society of Clinical Oncology (ASCO) Annual Meeting, which is being held June 3-7 in Chicago, Illinois.



    "Since the beginning of the year, we have achieved a number of milestones that enhance the prospects for vosaroxin, our lead program, as well as our earlier-stage pipeline programs," said Daniel Swisher, Chief Executive Officer of Sunesis. "For vosaroxin, we made progress on the clinical, regulatory and intellectual property fronts: the roll-out of our Phase 3 pivotal VALOR trial in relapsed/refractory AML is progressing well, we received U.S. FDA Fast Track designation for vosaroxin in AML and an important European patent has issued. Beyond vosaroxin, our newly formed oncology kinase inhibitor collaboration with Millennium Pharmaceuticals highlights the significant potential of our pipeline programs, including a pan-Raf kinase inhibitor candidate set for Phase 1 development. This collaboration will ensure these programs are supported with the capabilities and resources of a leading global oncology company while we continue to focus our internal investment on vosaroxin and the ongoing VALOR trial."



    First Quarter 2011 and Recent Highlights



    -- Announced collaboration with Millennium Pharmaceuticals for kinase inhibitors in oncology. In April, Millennium Pharmaceuticals, Inc. (Millennium), a wholly-owned subsidiary of Takeda Pharmaceutical Company Limited, and Sunesis announced a license agreement for the development of Sunesis' oral, selective pan-Raf kinase inhibitor and one additional undisclosed kinase inhibitor program in oncology. Under terms of the agreement, Sunesis received a $4.0 million upfront payment from Millennium on April 4, 2011 and is eligible to receive up to approximately $60.0 million in pre-commercial milestone program payments and royalties on sales of future collaboration products. Sunesis also retains co-development and co-promotion rights.



    The programs were originally part of Sunesis' 2004 multi-kinase inhibitor collaboration with Biogen Idec, Inc. Following Biogen Idec's November 2010 announcement to shift its strategic focus and spin out or outlicense its oncology assets, Millennium acquired two of these oncology assets and intends to continue the development of these in collaboration with Sunesis. Biogen Idec and Sunesis will continue with a more focused collaboration directed towards a unique preclinical kinase inhibitor program involved in immunology.



    -- Issued important European patent covering vosaroxin clinical formulation. In March, the European Patent Office (EPO) granted European Patent No. 1725233, which claims pharmaceutical compositions of vosaroxin. A corresponding patent was issued by the U.S. Patent and Trademark Office in November 2010, and related applications are also pending in other major markets throughout the world, including Japan, Australia and Canada. Sunesis is proceeding to validate this patent in several member states and the resulting national patents would expire in March 2025. The company believes this patent, which covers the formulation currently being used in the VALOR trial, may provide a significant additional exclusivity period for its vosaroxin franchise.



    -- Received FDA Fast Track designation. In February, the U.S. Food and Drug Administration (FDA) granted its Fast Track designation to vosaroxin for the potential treatment of relapsed or refractory AML in combination with cytarabine. This designation provides for the possibility of a "rolling submission," or submission of individual sections as they become available, for a marketing application and eligibility for a priority review period by the FDA.



    Financial Highlights



    -- Cash, cash equivalents and marketable securities totaled $48.9 million as of March 31, 2011, as compared to $53.4 million as of December 31, 2010. The decrease of $4.5 million was primarily due to $6.7 million of net cash used in operating activities, partially offset by net proceeds of $2.1 million from sales of Sunesis' common stock through its facility with Cantor Fitzgerald & Co. In April 2011, Sunesis received a $4.0 million payment from Millennium per the terms of the license agreement entered into by Sunesis and Millennium on March 31, 2011. The company believes that currently available and accessible funds are sufficient to fund the company to the planned unblinding of the VALOR trial.



    -- Total revenues for the three months ended March 31, 2011 were $4.0 million, as compared to $13,000 for the same period in 2010. Revenue in the 2011 period was related to the upfront payment of $4.0 million from Millennium.



    -- Research and development expenses increased to $4.1 million for the three months ended March 31, 2011, as compared to $3.1 million for the same period in 2010. The increase in 2011 was primarily due to an increase in clinical expenses incurred as a result of the launch of the VALOR trial.



    -- General and administrative expenses for the three months ended March 31, 2011 were $2.0 million, as compared to $1.6 million for the same period in 2010. The increase in 2011 was primarily due to higher legal and marketing costs, including legal costs related to the recently completed agreements with Biogen Idec and Millennium, and marketing costs related to the VALOR trial.



    -- Other income, net, was $3.9 million for the three months ended March 31, 2011 as compared to $4,000 for the same period in 2010. The income in the 2011 period was comprised of a non-cash credit of $3.6 million for the revaluation of warrants issued in the October 2010 offering to their fair value as of March 31, 2011, and net foreign exchange gains of $0.3 million.



    -- Sunesis reported net income of $1.8 million for the three months ended March 31, 2011 as compared to a net loss of $4.6 million for the same period in 2010.



    ASCO Presentation



    The Company will present the poster titled "Adaptive design of VALOR, a phase III trial of vosaroxin or placebo in combination with cytarabine for patients with first relapsed or refractory acute myeloid leukemia" at McCormick Place, Hall A, during the Trials in Progress Poster Session on Monday, June 6, 2011 from 8:00 a.m. to 12:00 p.m. local time (Poster #48G).



    About VALOR



    VALOR is a Phase 3, randomized, double-blind, placebo-controlled, pivotal trial in patients with first relapsed or refractory AML. The trial is expected to enroll 450 evaluable patients at approximately 100 leading sites in the U.S., Canada, Europe, Australia and New Zealand. The VALOR trial is currently open for enrollment and patients will be randomized one to one to receive either vosaroxin on days one and four in combination with cytarabine daily for five days, or placebo in combination with cytarabine. Additionally, the VALOR trial employs an innovative, adaptive trial design that allows for a one-time sample size adjustment by the DSMB at the interim analysis to maintain adequate power across a broad range of clinically meaningful and statistically significant survival outcomes. The trial's primary endpoint is overall survival. For more information on the VALOR trial, please visit www.valortrial.com.



    The VALOR logo is available at http://www.globenewswire.com/newsroom/prs/?pkgid=8774



    About Vosaroxin



    Vosaroxin 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. Vosaroxin both intercalates DNA and inhibits topoisomerase II, resulting in replication-dependent, site-selective DNA damage, G2 arrest and apoptosis.



    About Acute Myeloid Leukemia



    AML is a rapidly progressing cancer of the blood characterized by the uncontrolled proliferation of immature blast cells in the bone marrow. The American Cancer Society estimated that 12,330 cases of AML were diagnosed and approximately 9,000 deaths from AML occurred in the U.S. in 2010. Additionally, it is estimated that prevalence of AML is approximately 25,000 in the U.S. AML is generally a disease of older adults, and the median age of a patient diagnosed with AML is about 67 years. AML patients with relapsed or refractory disease and newly diagnosed AML patients over 60 years of age with poor prognostic risk factors typically die within one year, resulting in an acute need for new treatment options for these patients.



    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 www.sunesis.com.


  • 18 janvier 201222:05

    que j'en avais pas pris de celle là


  • 06 mars 201220:00

    joli UP malgré les marchés...

    Coverage initiated on Sunesis Pharma by Canaccord Genuity


  • 30 mars 201216:27

    http://finance.yahoo.com/news/sunesis-royalty-pharma-announce-25-202332942.html


  • 30 mars 201218:19


  • 30 mars 201219:27

    elo david
    bien joué ?ouais si on veut ....
    surtout bien joué d'avoir été très patient...
    je retrouve juste mon pru...plus d'1 an que je suis sur la bete pour te dire....
    et toi tu avais vendu ta ligne ???


  • 30 mars 201219:57

    j'interviens moins souvent mais n'oubliez pas que je vous surveille tous les jours !

    Tutu ? tu les choisis comment tes valeurs ?
    parce qu'avec Marina Biotech et SN"SS" je me demande pour qui tu vas voter aux présidentielles ? ;-))))))


  • 30 mars 201221:36

    pfff ... raté l'ouverture ... c"était
    facile pourtt de faire un AR car je surveillais la préopen qui paraissait bien timide ... et je l'ai zappé ... grrrrr


  • 31 mars 201219:30

    ah ma cochonne de sasane t'es là ??? je commençais à croire qu on avait coupé le net à SAINTE TULLE....
    au sujet de mes valeurs mon probleme c'est pas de les choisir c'est de les "QUITTER "...quand il faut ...


  • 13 avril 201208:58


    http://www.theflyonthewall.com/permalinks/entry.php/SNSSid1612732/SNSS-Sunesis-P harmaceuticals-initiated-with-a-Buy-at-Cantor


  • 09 mai 201220:22


    http://seekingalpha.com/article/573071-an-asco-bio-pharma-catalyst-trade-with-a- promising-leukemia-drug

    Sunesis Pharma (SNSS). 5/8/12 pps: $2.70. Market cap: $125.95M.

    To combine with the possible catalyst trade opportunity of presenting at ASCO, Sunesis just announced on May 3rd that the European Commission has granted orphan drug designation to vosaroxin, the company's lead development candidate; for the treatment of Acute Myeloid Leukemia (AML).

    The designation provides for 10 years of marketing exclusivity in all EU member countries following product approval. Vosaroxin has previously received orphan drug and fast track designations from the U.S. Food and Drug Administration (FDA).

    With the orphan drug designations for vosaroxin in both the EU and USA, I feel there are a lot of exciting things happening for Sunesis. One thing that increases my interest when looking at pharmaceutical companies is when I hear they are working on an indication that has seen next to zero progress recently. According to the CEO Daniel Swisher, there have been no new drugs to treat this disease in 30 years. If data for vosaroxin confirms the Phase III trials, the standard of care for patients who relapse from this form of Leukemia will change drastically. With no competing drugs, the company estimates potential vosaroxin sales, if approved, could range from $400-$600 million annually.

    Let's take a look on what Sunesis says about vosaroxin:


  • 23 mai 201213:58

    maintenant, je me placerai uniquement si elle consolide

    Cours : 2,8$
    CB : 131 Mlns $
    CASH : 34.9Mlns $
    CASH Burn 2012 : 37.3Mlns $

    Newsflow : résu. Phase III VALOR / vosaroxin (AML) au Q3 2012

    à partir des 2,50 ça pourra être intéressant ama


  • 29 mai 201216:56


    http://www.streetinsider.com/Analyst+PT+Change/RBC+Capital+Upgrades+Sunesis+Phar maceuticals+Inc.+(SNSS)+to+Outperform/7474718.html


  • 29 mai 201221:09


  • 29 mai 201221:39


  • 06 juillet 201215:24

    July 05 2012

    Sunesis Pharmaceuticals Inc. (NASDAQ:SNSS): Cowen sees Sunesis Pharmaceuticals with a favorable risk/reward going into its analysis of its crucial VALOR trial in relapsed/refractory AML. Cowen thinks the probable result will be to either proceed as is or extend the trial, both which would be seen as positive. Shares are rated
    Outperform.

    http://wallstcheatsheet.com/stocks/accretive-health-negotiates-re newal-with-ascension-and-four-equity-insights-not-to-miss.html/

    position: j'ai 1500 titres


  • 06 juillet 201215:44


  • 06 juillet 201215:49

    un seul ordre de 3000 exécuté à 3.1948$ , ce qui lui a fait perdre -4.06%
    là ça remonte un peu.. après un plus bas séance ce jour à 3,12
    mais je suis confiant pour la suite sur la petite


  • 06 juillet 201218:15

    on va péter les plus hauts ???


  • 16 août 201216:59

    Sunesis Poised For Run-Up Into Phase III Interim Analysis Next Month
    August 16, 2012 | about: SNSS
    Sunesis Pharmaceuticals (SNSS) is a cancer biotech which is currently evaluating lead product candidate vosaroxin as a DNA targeted anti-cancer agent in an ongoing pivotal Phase III (VALOR) clinical trial with a single, pre-planned interim analysis to be conducted in September. This anti-cancer compound has received US and European Orphan Drug designations in addition to US FDA Fast Track status for the bone marrow / blood-based cancer known as acute myeloid leukemia (AML).

    This adaptive Phase III study (ClinicalTrials.gov ID NCT01191801) is being conducted in combination with the approved anti-cancer drug cytarabine in patients with first relapsed or refractory AML and the interim analysis has three potential outcomes, including: halt trial early for efficacy or futility, continue thru unblinding in 2013 or increase patient enrollment by 50% (225) w/ results expected in 2014.

    As of early August, Sunesis has enrolled 391 of 450 planned subjects in the study and in June the independent data safety monitoring board (DSMB) recommended that the trial continue as planned based on an analysis of safety data from the study.

    Last December, Sunesis announced that the United Kingdom's National Cancer Research Institute Hematological Oncology Study Group included vosaroxin in the Less Intensive 1 (LI-1) Study, which is a Phase II/III clinical trial evaluating new treatment regimens compared to low-dose cytarabine for elderly patients with AML and high-risk myelodysplastic syndrome.

    As of 6/30/12, Sunesis reported $29.3 million in cash and equivalents and approximately 47M shares of common stock outstanding as of 7/31/12. The Company has about $9.6M in total debt in the form of notes payable with $8.7M classified as long-term debt and a second $15M tranche available through 9/30/12 based upon the DSMB recommendation in the upcoming interim analysis next month (i.e. if the VALOR study is either halted early for positive efficacy or continues in any form then Sunesis has access to an additional $15M in debt financing).

    Sunesis reported an operating loss of ($17.6M) during the first six months of 2012 which consisted mostly of research and development (R&D) expenses ($14.7M) associated with the ongoing Phase III trial. In March, Sunesis announced a $25M financing agreement with Royalty Pharma (RP) that is based on the outcome of the pending interim analysis as follows:

    1.) If Phase III VALOR trial halted early for efficacy, RP will invest $25M immediately and will receive 3.6% royalties;

    2.) If one-time sample size increase is implemented, RP will invest $25M immediately and will receive 6.75% royalties plus warrants for the purchase of 1M shares each at prices of $3.48 and $4.64 of Sunesis common stock;

    3.) If trial continues as planned w/ no changes, RP has option to invest $25M upon unblinding of results next year and will receive 3.6% royalties.

    The planned Phase III single interim analysis with a definitive near-term timeline in September sets up a high probability and favorable risk / reward trade for a share price run-up (mid $3-low $4 target) for Sunesis going into this key event which is very similar to the run-up experienced by Celsion (CLSN) heading into a similar event last year and more recently Synta Pharma (SNTA) ahead of interim Phase IIb/III trial results for its experimental lung cancer drug.

    In addition the near-term risk of dilution is very minimal since Sunesis has over three quarters of cash on hand to fund operations and also has access to potential financing of $40M based upon the DSMB interim analysis, which consists of $15M in debt financing (as long as trial either continues or is halted early for positive efficacy) and $25M as part of the Royalty Pharma agreement (i.e. Sunesis receives $25M at the time of interim analysis if the study is either halted early for positive efficacy or if the sample size is increased).

    The most likely outcomes of the interim analysis would be to either continue trial as planned through analysis next year or implement a one-time sample size increase with results expected in 2014. I estimate a very low probability (i.e. under 5%) for the trial being halted early for either efficacy or futility. As outlined earlier, I expect a run-up in shares of Sunesis going into the interim analysis to new 52-week highs in mid-$3 to low-$4 range which would likely result in a sell on the news reaction if trial continues as planned or the one-time sample size increase is implemented since this postpones the data until 2013 or 2014.

    If halted early for efficacy, I would estimate a mid-high single digit stock price for Sunesis (i.e. $5-7+) and obviously shares would plunge if the study is halted early for futility to sub-$1 prices as the remainder of the Company's pipeline is in very early-stage clinical or preclinical development.

    Disclosure: I am long SNSS.


  • 24 août 201218:10


  • 06 septembre 201216:25

    Leerink Swann Starts Sunesis Pharmaceuticals Inc. (SNSS) at Outperform


  • 06 septembre 201218:01

    objectif de 6 $ ... pour ma part, je pense sortir d"ici ce soir, c'est trop poussif.


  • 10 septembre 201215:40


  • 11 septembre 201200:36

    de sortie


  • 11 septembre 201214:04

    retour à la case départ dès aujourd hui
    +25 % en préopen

    Sunesis Pharmaceuticals to Implement One-Time Sample Size Increase to Phase 3 VALOR Trial in AML


    DSMB Recommends Increase Following Single, Pre-Planned Interim Efficacy and Safety Analysis of VALOR; Enrollment Completion Expected in 2013



    DSMB Recommendation Triggers $25.0 Million Investment in Sunesis from Royalty Pharma



    Sunesis to Host Conference Call Today at 9:00 AM Eastern Time










    SOUTH SAN FRANCISCO, Calif., Sept. 11, 2012 (GLOBE NEWSWIRE) -- Sunesis Pharmaceuticals, Inc. (Nasdaq:SNSS) today announced that it will implement a one-time, 225-patient sample size increase to its Phase 3 VALOR trial of vosaroxin in acute myeloid leukemia (AML), bringing target enrollment to 675 patients. This is in response to the recommendation of the trial's independent Data and Safety Monitoring Board (DSMB) following their completion yesterday of a single, pre-planned interim analysis of unblinded efficacy and safety data sets from VALOR.

    VALOR is a Phase 3, randomized, double-blind, placebo-controlled, pivotal trial of vosaroxin in patients with first relapsed or refractory AML. The pre-planned sample size increase of 225 additional patients is designed to maintain adequate statistical power over a broader range of survival outcomes. With the revised target sample size of 675 patients, Sunesis anticipates full enrollment of VALOR in 2013, with unblinding of the trial expected in the first half of 2014 upon reaching 562 events and final database lock. The DSMB recommendation also triggers Royalty Pharma's obligation to invest $25.0 million in Sunesis.

    "The completion of VALOR's interim analysis is an important milestone for Sunesis," said Daniel Swisher, Chief Executive Officer of Sunesis. "In light of the design of VALOR, the DSMB's recommendation that we implement a one-time, 225-patient sample size increase is a promising development. We thank the DSMB for their comprehensive analysis, and trial investigators for their continued support of VALOR, which has now enrolled 412 patients. Importantly, we are pleased that we have committed funding that will allow us to implement this enrollment expansion and complete the pivotal trial in AML."

    Sunesis' management and staff, VALOR clinical investigators, including members of the Study Steering Committee, and Royalty Pharma remain blinded to the interim trial data and analysis.

    Royalty Pharma's $25.0 million investment is made pursuant to the terms of an agreement with Sunesis announced March 29, 2012. In exchange for their investment, Royalty Pharma will receive a 6.75% royalty on future net sales of vosaroxin and warrants to purchase Sunesis common stock.


  • 11 septembre 201215:35

    oui grosse frayeur hier soir ....
    vraiment des enc....


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