Sunesis Pharmaceuticals könnte sehr interessant

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07.06.07 09:29

7303 Postings, 6684 Tage Mme.EugenieFilter ließ sich wieder nicht setzen

_

SUNESIS PHARMAC. DL-,0001

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ISIN: US8673285024   Symbol: SNSSEinfügen in: Watchlist | Depot

 

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__________________________________________________ "Malo mori quam foederari - Lieber sterben als sich entehren"

 

10.12.09 19:23

1398 Postings, 6273 Tage CosmicTradeSunesis Pharma + 65 % USA.

.

Hat lange gedauert bis dieser Wert interessant wurde...aber heute war es soweit.

Biotec und Pharma haben gewaltigen Aufholbedarf...

Auch in Deutschland schlummern noch einige Perlen im Abseits...warten darauf wachgeküsst zu werden.

Wer schlau ist schaut genauer hin.

 

Nasdaq USA

USA

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Sunesis Pharma, wer investieren will sollte einen Rücksetzer abwarten!

Fällt  MORGEN weit unter 1,00 $

 

-----------
Emotionen und Psychologie leiten die Börse...

Y M

11.12.09 00:14

5662 Postings, 6028 Tage _bbb_:-)

11.12.09 14:03

408 Postings, 7007 Tage dEsiSchESup again

11.12.09 16:38

408 Postings, 7007 Tage dEsiSchESwow

17.12.09 04:46

408 Postings, 7007 Tage dEsiSchESund jetzt runter wow

09.01.10 00:07

116 Postings, 5198 Tage techno-tomNews

StockPreacher Initiates Independent Research Coverage for Sunesis Pharmaceuticals Inc.


Jan 8, 2010 6:50:00 AM

2010 GlobeNewswire, Inc.

DALLAS, Jan. 8, 2010 (GLOBE NEWSWIRE) -- StockPreacher.com announces an investment report featuring Sunesis Pharmaceuticals Inc. (Nasdaq:SNSS). The report includes financial and investment analysis, analyst consensus, and pertinent industry information you need to know to make an educated investment decision.

The full report is available at: http://www.stockpreacher.com/n/SNSS

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Sunesis Pharmaceuticals Inc. (SNSS), a clinical-stage biopharmaceutical company, focuses on the development and commercialization of oncology therapeutics for hematologic and solid tumor cancers. The Company has built a highly experienced cancer drug development organization committed to advancing its lead product candidate, voreloxin, in multiple indications to improve the lives of people with cancer. Voreloxin is currently being evaluated as a single agent in a phase 2 clinical trial in platinum-resistant ovarian cancer, in a phase 2 clinical trial (known as the REVEAL-1 trial) in previously untreated elderly acute myeoloid leukemia (AML) patients unlikely to benefit from standard induction chemotherapy and in a phase 1b/2 clinical trial combining voreloxin with cytarabine for the treatment of patients with relapsed/refractory AML. SNSS has formed strategic research and drug discovery partnerships with leading pharmaceutical and biopharmaceutical companies, including Biogen Idec Inc.and SARcode Corp.

Message Board Search for SNSS: http://www.boardcentral.com/boards/SNSS

In the report, the analyst notes:

"SNSS focuses on the development of voreloxin, 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. Seeing voreloxin's favorable competitive profile, SNSS has built a highly experienced cancer drug development organization committed to advancing its lead product candidate.

"In December, SNSS presented positive phase 2 clinical data of voreloxin in AML at the American Society of Hematology 2009 Annual Meeting, which highlighted voreloxin's strong efficacy and safety profile when used as a single agent or in combination with chemotherapy in patients with difficult to treat AML. 'These results provide us with the efficacy and safety data to move voreloxin forward into pivotal testing,' Steven Ketchum Ph.D., SNSS senior vice president of Research and Development, said in a company press release."

To read the entire report visit: http://www.stockpreacher.com/n/SNSS

StockPreacher.com is a small-cap research and investment commentary provider. StockPreacher.com strives to provide a balanced view of many promising small-cap companies that would otherwise fall under the radar of the typical Wall Street investor. We provide investors with an excellent first step in their research and due diligence by providing daily trading ideas, and consolidating the public information available on them. For more information on StockPreacher, please visit: http://www.stockpreacher.com

StockPreacher.com Disclosure

StockPreacher.com is not a registered investment advisor and nothing contained in any materials should be construed as a recommendation to buy or sell any securities. StockPreacher.com is a Web site wholly-owned by BlueWave Advisors, LLC. Please read our report and visit our Web site, StockPreacher.com, for complete risks and disclosures.

CONTACT: StockPreacher.com
       Nic Lesmeister
       (469)-252-3505
       info@stockpreacher.com  

09.01.10 08:16
1

465 Postings, 5250 Tage erdo@all

gibts irgendweleche kursziele? bzw. Analysen. Oder muß ich auf Highmaster warten;-)  

09.01.10 08:19

1488 Postings, 8810 Tage cubiak@erdo

DAUSEND ;-)

Gruss
-cubiak

 

09.01.10 12:33
1

116 Postings, 5198 Tage techno-tomKursziele vom 15.01.2007 Neues Musterdepot II

Hier mal ein Bericht von vor 3 Jahren vom "Der Aktionär"

Hier war noch die Phase I , jetzt sind am Ende der Phase 2 !

Also kann die Party bald losgehen !  

Die Experten von Global Biotech Investing schreiben, dass sieben von insgesamt acht Analysten die Papiere von Sunesis Pharmaceuticals (WKN A0DP2J) mit einem Kursziel von durchschnittlich neun US-Dollar zum Kauf empfehlen würden. Das 132-Millionen-Dollar-Unternehmen erforscht den Wirkstoff „SNS-595“ gegen kleinzellige und nicht-kleinzellige Tumoren sowie gegen Leukämie. Anfang Dezember meldete die Firma vielversprechende Daten einer Phase-I-Studie bei traditionell therapie-resistenten Leukämiefällen. Analysten schätzen, dass Sunesis noch im ersten Halbjahr die Ergebnisse verschiedener Phase-II-Studien präsentieren und eine ganze Reihe neuer Studien beginnen wird. Überdies bewerten die Analysten von Needham das Management als bemerkenswert stark besetzt, wie auch die Aktionärsliste. Das Investmenthaus Warburg Pincus hält 12,4 Prozent, Biogen-Idec knapp zehn Prozent, zwei institutionelle Investoren weitere elf Prozent und Bristol Myers fast 4,5 Prozent. Nun scheinen auch einige Investmentfonds auf das Unternehmen aufmerksam geworden zu sein..





http://www.deraktionaer.de/xist4c/web/...CB00666682D40707E8A6ADF04D0C  

14.01.10 16:28

116 Postings, 5198 Tage techno-tomSunesis z.Z. schließt Studien der Phase 2

Sunesis Announces Publication of Nonclinical Voreloxin Data in Leukemias

Studies Demonstrate Voreloxin Acts Synergistically With Cytarabine and Induces Bone Marrow Aplasia

SOUTH SAN FRANCISCO, CA, Jan 14, 2010 (MARKETWIRE via COMTEX News Network) -- Sunesis Pharmaceuticals, Inc. (NASDAQ: SNSS) today announced the publication of new nonclinical studies with the Company's lead drug candidate, voreloxin, in the journal Cancer Chemotherapy and Pharmacology. The results demonstrate voreloxin's potent cytotoxic activity in human acute leukemia cell lines and in an in vivo model when used alone, and enhanced or synergistic activity when used in combination with cytarabine. Sunesis is currently completing Phase 2 studies of voreloxin as a single-agent or in combination with cytarabine in acute myeloid leukemia (AML) and expects to begin Phase 3 testing in AML later in 2010.

"These data contribute to our growing understanding of voreloxin's nonclinical profile, and, in keeping with our philosophy of clinical development informed by translational research, are directly relevant to our clinical program," said Judith A. Fox, Ph.D., Vice President of Product and Preclinical Development at Sunesis. "We studied voreloxin alone and in combination with cytarabine in leukemia cell lines, as well as in a mouse model of bone marrow ablation. The additive and synergistic effects of the combination in vitro, coupled with the supra-additive effects of the drugs in vivo, translate directly to our ongoing Phase 2 AML program. Importantly, the effects of voreloxin and the combination regimen on bone marrow were fully reversible, mirroring the treatment paradigm for AML."

Voreloxin, alone and in combination with cytarabine, was evaluated in 3 human acute leukemia cell lines: HL-60 (acute promyelocytic leukemia), MV4-11 (AML with a FLT3 mutation) and CCRF-CEM (acute lymphoblastic leukemia). Voreloxin was active in all the leukemia cell lines, including the AML cell line, which is relatively resistant to cytarabine in vitro. Using a combination index (CI) analysis, voreloxin with cytarabine demonstrated synergistic cytotoxic activity HL-60 and MV4-11 cells, and additive activity in CCRF-CEM cells.

In a series of elegant in vivo studies, a murine model of bone marrow ablation was used to evaluate the activity of voreloxin and cytarabine alone and in combination. Bone marrow cellularity, peripheral white blood cell and platelet counts were monitored to assess the impact of and recovery from the study treatments. Voreloxin alone or in combination with cytarabine caused reversible bone marrow ablation accompanied by profound reductions in peripheral white blood cells that were reversible within one week, consistent with the therapeutic goals of AML treatment. The activity of voreloxin at maximum tolerated dose (MTD) was superior to cytarabine at MTD. In addition, the combination demonstrated supra-additive activity in vivo, with a substantially enhanced, but fully reversible, reduction in bone marrow cellularity as compared to each agent alone.

The Cancer Chemotherapy and Pharmacology article and full, published data set are available online at www.springerlink.com/content/n7577n7281832171/.

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 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.

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 Leukemia and Lymphoma Society estimates that nearly 13,000 new cases of AML will be diagnosed and approximately 9,000 deaths from AML will occur in the U.S. in 2009. 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, voreloxin, in multiple indications to improve the lives of people with cancer. For additional information on Sunesis Pharmaceuticals, please visit http://www.sunesis.com. SUNESIS and the logo are trademarks of Sunesis Pharmaceuticals, Inc.

This press release contains forward-looking statements, including without limitation statements related to voreloxin's efficacy, safety profile and effects as a single agent and in combination with other AML treatments in both clinical and nonclinical studies, voreloxin's mechanism of action and results that may warrant further clinical evaluation of voreloxin. Words such as "demonstrate," "enhanced," "contribute," "translate," "active," "caused," "demonstrated" and similar expressions are intended to identify forward-looking statements. These forward-looking statements are based upon Sunesis' current expectations. Forward-looking statements involve risks and uncertainties. Sunesis' actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of these risks and uncertainties, which include without limitation, the risk that Sunesis' drug development activities for voreloxin could be halted or significantly delayed for various reasons, the risk that Sunesis' clinical trials for voreloxin may not demonstrate safety or efficacy or lead to regulatory approval, the risk that preliminary data and trends may not be predictive of future data or results, the risk that Sunesis' nonclinical studies and clinical trials may not satisfy the requirements of the FDA or other regulatory agencies, risks related to the conduct of Sunesis' clinical trials, risks related to the manufacturing of voreloxin, and the risk that Sunesis' proprietary rights may not adequately protect voreloxin. These and other risk factors are discussed under "Risk Factors" and elsewhere in Sunesis' Quarterly Report on Form 10-Q for the quarter ended September 30, 2009 and other filings with the Securities and Exchange Commission. Sunesis expressly disclaims any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein to reflect any change in the company's expectations with regard thereto or any change in events, conditions or circumstances on which any such statements are based.

Investor and Media Inquiries:
Andrea Rabney
Argot Partners
212-600-1902

Eric Bjerkholt
Sunesis Pharmaceuticals, Inc.
650-266-3717


SOURCE: Sunesis  

21.01.10 16:09

116 Postings, 5198 Tage techno-tomJanuary 21, 2010

Sunesis Completes Enrollment of Voreloxin Phase 1b/2 Combination Trial in Acute Myeloid Leukemia
SOUTH SAN FRANCISCO, CA--(Marketwire - January 21, 2010) - Sunesis Pharmaceuticals, Inc. (NASDAQ: SNSS) today reported that it has completed enrollment in its Phase 1b/2 clinical trial evaluating voreloxin, the company's lead compound, in combination with cytarabine, a widely used chemotherapy, in patients with relapsed or refractory acute myeloid leukemia (AML). A total of 110 patients with relapsed or refractory AML were enrolled in this study, including 50 primary refractory or first relapse AML patients enrolled in the expansion Phase 2 segments of the trial.

"Full enrollment of this trial marks an important step in our development of voreloxin in AML, a disease in which we plan to begin Phase 3 clinical testing later this year," said Daniel Swisher, Chief Executive Officer of Sunesis. "The Phase 1b/2 combination trial has already generated valuable data regarding voreloxin's anti-leukemic activity, including low 30- and 60-day all-cause mortality and favorable complete remission, safety and preliminary survival results in a difficult to treat patient population. Furthermore, we have treated nearly 300 AML patients to date, including 113 patients in REVEAL-1, the Phase 2 single agent voreloxin study in older patients unlikely to benefit from standard induction chemotherapy. We are very encouraged by the results of our AML clinical program, and believe voreloxin could provide a meaningful advancement to current standards of care."

The Phase 1b/2 trial is designed to evaluate the safety, pharmacokinetics and anti-leukemic activity of escalating doses of voreloxin when administered on days one and four with cytarabine, given either as a continuous infusion of 400 mg/m2 daily for five days or as a two hour IV bolus of 1 g/m2 daily for five days. A recommended pivotal dose-regimen of voreloxin used in combination with cytarabine has been identified based on results of the Phase 1b/2 clinical trial to date.

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 treatment of patients with relapsed/refractory AML. A Phase 2 single agent trial in platinum-resistant ovarian cancer has also completed enrollment. Sunesis expects to begin Phase 3 testing in AML later in 2010.

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 Leukemia and Lymphoma Society estimates that nearly 13,000 new cases of AML will be diagnosed and approximately 9,000 deaths from AML will occur in the U.S. in 2009. 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, voreloxin, in multiple indications to improve the lives of people with cancer. For additional information on Sunesis Pharmaceuticals, please visit http://www.sunesis.com.

SUNESIS and the logo are trademarks of Sunesis Pharmaceuticals, Inc.

This press release contains forward-looking statements, including without limitation statements related to voreloxin's efficacy and safety profile both as a single agent and in combination with other AML treatments in clinical studies, voreloxin's mechanism of action, results that may warrant further clinical evaluation of voreloxin and the timing of Phase 3 studies of voreloxin in AML. Words such as "plan," "encouraged," "believe," "expects" and similar expressions are intended to identify forward-looking statements. These forward-looking statements are based upon Sunesis' current expectations. Forward-looking statements involve risks and uncertainties. Sunesis' actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of these risks and uncertainties, which include without limitation, the risk that Sunesis' drug development activities for voreloxin could be halted or significantly delayed for various reasons, the risk that Sunesis' clinical trials for voreloxin may not demonstrate safety or efficacy or lead to regulatory approval, the risk that preliminary data and trends may not be predictive of future data or results, the risk that Sunesis' nonclinical studies and clinical trials may not satisfy the requirements of the FDA or other regulatory agencies, risks related to the conduct of Sunesis' clinical trials, risks related to the manufacturing of voreloxin, and the risk that Sunesis' proprietary rights may not adequately protect voreloxin. These and other risk factors are discussed under "Risk Factors" and elsewhere in Sunesis' Quarterly Report on Form 10-Q for the quarter ended September 30, 2009 and other filings with the Securities and Exchange Commission. Sunesis expressly disclaims any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein to reflect any change in the company's expectations with regard thereto or any change in events, conditions or circumstances on which any such statements are based.

Investor and Media Inquiries:
Andrea Rabney
Argot Partners
212-600-1902

Eric Bjerkholt
Sunesis Pharmaceuticals Inc.
650-266-3717  

15.02.10 19:59
1

116 Postings, 5198 Tage techno-tomRating-Update:

Sunesis Pharmaceuticals buy
12.02.2010 - 17:09

Rating-Update:

New York (aktiencheck.de AG) - Die Analysten von Jefferies & Co stufen die Aktie von Sunesis Pharmaceuticals (ISIN US8673285024/ WKN A0DP2J) weiterhin mit "buy" ein. Das Kursziel werde von 1,50 USD auf 2 USD erhöht. (12.02.2010/ac/a/u) Analyse-Datum: 12.02.2010


Quelle: Finanzen.net  

27.03.10 09:08
1

4487 Postings, 5395 Tage storm 300018Sunesis Pharmaceutics

Denke am Montag gibt es Gewinnmitnahmen. Hoffe nur das der Kurs nicht allzustark abfällt.

What Hedge Fund Managers Are Doing Before Dawn

Hedge Fonds-Manager Nr. 3: Spezialisiert auf kleine Biotechs.

"Meine Position als Nummer eins bei weitem Sunesis Pharmaceuticals (SNSS)," erzählte er mir. SNSS macht Vorolexin, ein Medikament zur Behandlung von AML Leukämie. Phase-II-Ergebnisse zeigten, dass sie die Überlebensfähigkeit von AML-Patienten erhöht.

Hedge Fonds-Manager Nr. 3 hat mir drei atalysts auf SNSS:

"1). 1Q10 regulatorische Änderung am Voreloxin von der FDA
2.) Mehrere Präsentationen auf der ASCO Jahrestagung, Anzeigen Voreloxin in reifen Datensätzen, einschließlich der Kombination Cytarabin Daten
3) Abschluss eines Partner für ph. III-Tests bei AML.
Ich erwarte, dass dies zu einem $ 3 - $ 5 hat in wenigen Monaten sein ", schloss er.

http://blogs.wsj.com/financial-adviser/2010/03/26/...ing-before-dawn/

http://www.emailwire.com/release/...ABIO-SNSS-GENZ-AEN-ARIA-DNDN.html

Chart-SUNESIS PHARMACEUTICALS INC (A0DP2J) 6 Monate

Genau deshalb schwankte der Kurs zw. 0,76-1,05 USD. Denke am Montag gibt es heftige Gewinnmitnahmen. Hoffe nur das der Kurs nicht allzustark abfällt.

Dies soll keine Handelsaufforderung darstellen.Nur Meine Meinung.

 

12.04.10 13:07

116 Postings, 5198 Tage techno-tomBitte anschnallen , Rakete müßte gleich zünden !

12.04.10 13:28

116 Postings, 5198 Tage techno-tomOh je , da hab ich wohl was verwechselt !

Sun Pharmaceutical  

14.05.10 12:37

5662 Postings, 6028 Tage _bbb_:-)

Sollte wieder steigen, es ist bald ASCO !  

06.06.10 14:33

4951 Postings, 6012 Tage 0815axSNSS Corporate Presentation - May 2010

07.06.10 21:15

4951 Postings, 6012 Tage 0815axNEWS 07.06.2010 21:04

07.06.2010 21:04
http://www.finanznachrichten.de/...sed-or-refractory-patients-256.htm

Sunesis Announces Data From Phase 2 Clinical Program of Voreloxin in Acute Myeloid Leukemia Support Phase 3 Trial in Relapsed or Refractory Patients / Updated, Positive Phase 2 Data in AML and Ovarian Cancer Presented at the ASCO 2010 Annual Meeting;


...weiter siehe LINK
-----------
*amM - keine Kaufempfehlung

14.07.10 14:22

521 Postings, 5067 Tage Schabo04Insiderkäufe

Ich glaube hier ist was im Busch, warum kaufen soviele Insider Ihre eigene Aktie. Doch nur wenn Sie daran glauben und was wissen !!!
http://www.bloggingstocks.com/2010/07/13/...is-unify-corp-and-others/  

15.07.10 14:52

4951 Postings, 6012 Tage 0815axEuropean Patent Covering Voreloxin Combination

Sunesis Issued European Patent Covering Voreloxin Combination

Date : 07/15/2010 @ 8:00AM
Source : MarketWire
Stock : Sunesis Pharmaceuticals, Inc. (SNSS)

http://ih.advfn.com/...pid=nmona&article=43614381&symbol=SNSS

Sunesis Pharmaceuticals, Inc. (NASDAQ: SNSS) today announced that the European Patent Office (EPO) has granted a European patent covering combinations of the Company's lead drug candidate, voreloxin, with cytarabine. Cytarabine is the standard-of-care treatment for Acute Myeloid Leukemia (AML), and the therapy used in combination with voreloxin in a fully enrolled Phase 2 trial in patients with relapsed and/or refractory AML. Sunesis has also announced plans to initiate a multinational, randomized, double-blind, placebo-controlled, pivotal Phase 3 clinical trial of voreloxin in combination with cytarabine in a relapsed/refractory AML patient population in the second half of this year. European Patent No. 1 729 770 B1, titled "SNS-595 [voreloxin] and Methods of Using the Same," following completion of the patent validation process, will provide patent coverage for such combination products in 30 member states of the European Patent Convention, including the major European markets, through 2025. Corresponding patent applications are pending in major markets throughout the world including Australia, Canada, Japan and the United States.

"This patent is an important new addition to our intellectual property estate, as it covers the combination of voreloxin and cytarabine, the contemplated initial market application," stated Daniel Swisher, Chief Executive Officer of Sunesis. "We are pursuing a sophisticated and deliberate strategy to provide exclusive coverage in the voreloxin patent estate out to 2030. Beyond our granted patents, we have filed patent applications covering formulations, combination uses, dosing, manufacturing processes and composition of matter claims. We look forward to the successful prosecution of these patent applications in multiple territories around the world."

...(weiter siehe LINK)
-----------
*amM - keine Kaufempfehlung

27.10.10 21:57

43 Postings, 5546 Tage Blocktraderinsider kaufen massiv zu 0.28$

erst bei 2.01 in hohen stückzahlen abverkauft, nun wieder in noch höheren stückzahlen zu 0.28$ eingekauft.

bei dem titel passiert was!?  

21.12.10 14:20

4951 Postings, 6012 Tage 0815axSunesis Launches Phase 3 VALOR Trial of Vosaroxin

Sunesis Launches Phase 3 VALOR Trial of Vosaroxin in AML

Date : 12/21/2010 @ 8:00AM
Source : MarketWire
Stock : Sunesis Pharmaceuticals (SNSS)

http://ih.advfn.com/p.php?pid=nmona&article=45739543

unesis Pharmaceuticals, Inc. (NASDAQ: SNSS) today announced that the first patient has been randomized and dosed with blinded study treatment in its pivotal Phase 3 VALOR trial of vosaroxin, the company's lead drug candidate, in combination with cytarabine in patients with first relapsed or refractory acute myeloid leukemia (AML). The VALOR trial is a multinational, randomized, double-blind, placebo-controlled, pivotal trial which is expected to enroll 450 evaluable patients at leading sites in the U.S., Canada, Europe, Australia and New Zealand.

"The initiation of VALOR marks the culmination of many years of work and is a gratifying moment for Sunesis in its ongoing efforts to develop a new therapeutic option for AML patients," stated Daniel Swisher, Chief Executive Officer of Sunesis. "AML is a challenging disease, especially for relapsed and refractory patients, yet in our robust Phase 2 program we have shown in this AML setting that vosaroxin plus a leading standard of care, cytarabine, exhibit a combination of efficacy and tolerability that has led to promising results. The support of key opinion leaders, top international trial sites, specialized service providers and a rigorously designed Phase 3 protocol should provide the VALOR trial with a strong foundation for operational success."

"Patients with relapsed or refractory AML have a poor prognosis and are often intolerant of or do not respond to currently available treatment options," said Farhad Ravandi, M.D., Associate Professor, Department of Leukemia, Division of Cancer Medicine, The University of Texas M. D. Anderson Cancer Center, and a principal investigator of VALOR. "Despite the unmet medical need, treatment standards have not appreciably changed in more than 30 years. Vosaroxin's differentiated treatment profile from the Phase 2 program is characterized by strong remission rates, low all-cause early mortality and long leukemia free survival, which have led to survival outcomes that compare favorably with published results for current treatment standards. The VALOR trial is a well designed, highly anticipated trial which should provide a clear understanding of vosaroxin's efficacy and safety profile when added to cytarabine in this disease setting."

Patients in the VALOR trial will be randomized one-to-one to receive in a blinded manner either vosaroxin or placebo on days one and four of each treatment cycle in combination with cytarabine daily for five days of each treatment cycle. The trial's primary endpoint is overall survival. The VALOR trial employs an adaptive design that provides for a single interim analysis by an independent Data and Safety Monitoring Board (DSMB) which will meet to examine pre-specified efficacy and safety data sets and decide whether to implement a one-time sample size adjustment of 225 additional evaluable patients to maintain adequate power across a broad range of clinically meaningful and statistically significant survival outcomes. The interim analysis by the DSMB is expected to take place in mid-2012. For more information on VALOR please visit www.valortrial.com.  

21.12.10 14:32

4951 Postings, 6012 Tage 0815axRating-Update: Sunesis Pharmaceuticals outperform

RBC Capital Markets - Sunesis Pharmaceuticals "outperform"

16:46 20.12.10
http://www.ariva.de/news/...ls-outperform-RBC-Capital-Markets-3609274

Rating-Update:

Toronto (aktiencheck.de AG) - Die Analysten von RBC Capital Markets stufen die Aktie von Sunesis Pharmaceuticals (Profil) von "sector perform" auf "outperform" hoch. Das Kursziel werde von 2 USD auf 1 USD gesenkt. (20.12.2010/ac/a/u)  

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