Navigation Links
Sunesis Pharmaceuticals Reports Preliminary SNS-595 Activity in Ovarian Cancer Clinical Trial at AACR-NCI-EORTC International Conference

Criteria to Advance SNS-595 to Next Stage of Phase 2 Trial Achieved

SOUTH SAN FRANCISCO, Calif., Oct. 23 /PRNewswire-FirstCall/ -- /ADVANCE FOR RELEASE AT 3:30 P.M. EDT, TODAY/ -- Sunesis Pharmaceuticals, Inc. (Nasdaq: SNSS), a clinical-stage biopharmaceutical company developing novel anticancer therapeutics, today announced positive preliminary results from the first stage of the company's ongoing Phase 2 clinical trial of its lead product candidate, SNS-595, in platinum-resistant ovarian cancer patients.

Administered as a single agent, SNS-595 demonstrated anti-tumor activity, with 88 percent (15 of 17) of evaluable patients having best responses of stable disease or better, including two partial responses (PRs). Based on these results, SNS-595 has achieved the pre-specified criterion (two or more responses) for proceeding to Stage 2 of this trial.

Patients received SNS-595 once every three weeks by IV infusion for up to eight cycles. SNS-595 was generally well tolerated at the current dosing level among nineteen patients with sufficient follow-up to yield safety data. Incidence of febrile neutropenia was 11 percent (2 of 19) among these patients. In addition, five percent (1 of 19) of these patients experienced grade 3/4 nausea and 11 percent (2 of 19) of these patients experienced grade 3/4 fatigue.

"SNS-595 appears to be a promising novel agent for platinum resistant ovarian cancer," said Ursula Matulonis, M.D., Director of Medical Gynecologic Oncology at the Dana-Farber Cancer Institute. "This patient population remains underserved, and the initial stable disease and responses achieved thus far are encouraging. I look forward to seeing the continued progress of SNS-595 in this indication."

Of the 15 evaluable patients who achieved stable disease or PRs, eight remain on study and are continuing to receive additional cycles of treatment. Of note, four of the patients with measurable tumor shrinkage, including the two patients with PRs, previously failed prior platinum-containing regimens and treatment with doxorubicin HCl liposome injection (Doxil(R)). Of the 2 patients with PRs, one has received eight cycles of treatment and continues on study. The other patient progressed within 60 days of initial response.

Sunesis plans to enroll approximately 55 patients in this clinical trial. Thirty-one patients have been enrolled to date, and Sunesis expects to complete enrollment and present additional data in 2008.

"We are pleased to report SNS-595's early, yet positive, demonstration of clinical activity. We have met the pre-specified criterion to advance this compound to the second stage of our Phase 2 clinical trial, by showing sufficient evidence of anti-tumor activity," said Daniel C. Adelman, M.D., Senior Vice President, Development and Chief Medical Officer of Sunesis. "Additionally, the data suggests that SNS-595 may have potentially meaningful activity among platinum-resistant ovarian cancer patients who have also failed treatment with Doxil."

In parallel with the Phase 2 clinical trial, a non-clinical study was conducted to evaluate the activity of SNS-595 against 17 archived ovarian tumor biopsy specimens in the Extreme Drug Resistance (EDR(R)) cell proliferation assay. SNS-595 activity was compared to doxorubicin, etoposide and carboplatin -- agents used commonly in the treatment of ovarian cancer. Results from this study demonstrate that SNS-595 is a potent inhibitor of ovarian tumor cell growth, with activity comparing favorably to these agents. Further, none of the ovarian tumor samples showed any resistance to SNS-595.

These data were presented today during Poster Session A -- Clinical Trials at the AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics in a poster titled "A Phase 2 trial of SNS-595 in women with platinum refractory epithelial ovarian cancer," Abstract No. A158.

On Wednesday, October 24, 2007 at the AACR-NCI-EORTC meeting, Sunesis will present additional non-clinical data in a poster titled "SNS-595 potentiates the in vivo activity of carboplatin, cisplatin and gemcitabine in solid tumor xenografts," Abstract No. B285. This poster presentation will take place in Poster Session B -- Other Small Molecule Therapeutics.

About SNS-595

SNS-595 is a replication-dependent DNA damaging agent that causes irreversible G2 arrest and rapid apoptosis. A secondary mechanism for SNS-595 is a unique inhibition of topoisomerase II that causes highly selective DNA damage.

Data reported today build upon positive results from non-clinical studies, and from Sunesis' dose-escalating Phase 1 clinical trial of SNS-595 in which an ovarian cancer patient with advanced disease achieved a PR. In addition to the Phase 2 clinical trial in ovarian cancer patients, SNS-595 is currently being evaluated in two Phase 1b acute leukemia clinical trials. In clinical trials conducted to date, SNS-595 has been generally well tolerated and has shown objective responses in both solid and hematological tumor types. In non-clinical evaluations, SNS-595 demonstrates broad and potent activity in xenograft, syngeneic and drug-resistant models.

About Ovarian Cancer

In the United States, ovarian cancer remains the leading cause of death from gynecologic malignancies and is the fifth leading cause of cancer death overall in women behind lung, breast, colorectal and pancreatic cancers. According to the American Cancer Society, in 2007 there will be an estimated 22,430 new cases and more than 15,000 deaths from ovarian cancer in the U.S. alone. The front-line treatment for ovarian cancer is typically a combination of a taxane and a platinum drug, and an initial response rate of approximately 70 percent to this type of chemotherapy regimen can be anticipated. In spite of initial response rates, recurrence rates among ovarian cancer patients are high, and overall long-term survival has not changed significantly over the past 40 years, with five-year survival rates at less than 30 percent.

About Sunesis Pharmaceuticals

Sunesis is a clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of novel small molecule therapeutics for oncology and other serious diseases. Sunesis has built a broad product candidate portfolio through internal discovery and in-licensing of novel cancer therapeutics. Sunesis is advancing its product candidates through in-house research and development efforts and strategic collaborations with leading pharmaceutical and biopharmaceutical companies. For additional information on Sunesis Pharmaceuticals, please visit

SUNESIS and the logo are trademarks of Sunesis Pharmaceuticals, Inc. Other trademarks are the property of their respective owners.

Safe Harbor Statement

This press release contains forward-looking statements including without limitation statements related to the potential safety and efficacy and commercial potential of SNS-595, planned additional clinical testing and development efforts and the anticipated timing of the completion of enrollment in the ongoing Phase 2 clinical trial and the announcement of clinical results. Words such as "look forward," "suggests," "may," "plans," "expects," "appears" 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 discovery and development activities could be halted significantly or delayed for various reasons, the risk that Sunesis' clinical trials for SNS-595 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' preclinical 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 and manufacturing of SNS-595 and risks related to Sunesis' need for additional funding. These and other risk factors are discussed under "Risk Factors" and elsewhere in Sunesis' annual report on Form 10-K for the year ended December 31, 2006 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.

SOURCE Sunesis Pharmaceuticals, Inc.
Copyright©2007 PR Newswire.
All rights reserved

Related medicine technology :

1. Sunesis Pharmaceuticals to Present at the C. E. Unterberg, Towbin Emerging Growth Conference
2. Sunesis Pharmaceuticals Reports Positive Data From Studies of Two Anti-Cancer Agents, SNS-595 and SNS-032, at the 12th Congress of the European Hematology Association
3. Sunesis Pharmaceuticals to Present Data at the 12th Congress of the European Hematology Association
4. Sunesis Presents Data Supporting SNS-032s Potential Anticancer Activity in Multiple Myeloma at the American Association for Cancer Research Meeting
5. Sunesis Pharmaceuticals to Present Data at the Annual Meeting of the American Association for Cancer Research
6. Sunesis Pharmaceuticals Presents SNS-314 Aurora Kinase Inhibitor Data Showing Broad Anti-Tumor Activity, Dosing Flexibility
7. Inspiration Biopharmaceuticals Presents Data From Hemophilia Program at International Society On Thrombosis and Haemostasis (ISTH) Annual Meeting
8. BioSante Pharmaceuticals Announces New Findings for Potential Bird Flu Vaccine
9. Portola Pharmaceuticals Announces Positive Data from a Phase II Study of its Factor Xa Inhibitor at the XXI Congress of the International Society on Thrombosis and Haemostasis
10. Manhattan Pharmaceuticals Announces Results of Phase 2a Studies for Oral Oleoyl-estrone
11. Auxilium Pharmaceuticals to Present at the 2007 CEUT Emerging Growth Opportunities Conference
Post Your Comments:
(Date:3/24/2017)... 2017 Research and Markets has announced the addition ... Demand Forecast to 2022" report to their offering. ... The global wound care market was worth ... CAGR of 6.7% during 2016-2022 Among the various wound care ... in the global market in 2015. Among the various applications, surgical wound ...
(Date:3/24/2017)... News Commentary  ... According to new data published Arcview ... legal cannabis market is projected to continue to grow at ... the current presidential administration. The report created by Arcview,s data ... growth in this industry are the passage and subsequent implementation ...
(Date:3/24/2017)... Global Ampoules Market report provides ... applications and industry chain structure. The Ampoules market analysis ... competitive landscape analysis, and major regions, development status. ... ... providing 10 company profiles and 183 tables and figures ...
Breaking Medicine Technology:
(Date:3/24/2017)... ... 2017 , ... According to a new study by NCPA Senior Fellow John ... the rules Congress has directed the CBO to follow. The CBO itself previously recognized ... Yet, it estimates a reduction in employer-based coverage due to the GOP reform, which ...
(Date:3/24/2017)... ... March 24, 2017 , ... Shamanic healer and ... Shamanic Healing and Spiritual Awakening, proudly presents her Sacred Peru retreat with ... sacred and spiritual journey during the Summer Solstice will also be her final ...
(Date:3/24/2017)... ... 2017 , ... On June 9, 2017, Cassie Springer Ayeni ... in Chicago, Illinois. She will present on: , Filing Benefit Claims—Responding to ... involve claims for long-term disability benefits. This session will address the first ...
(Date:3/24/2017)... ... March 24, 2017 , ... Empower Brokerage, located in Southlake, ... leads programs. , In February, 2017, Empower Brokerage introduced their new “Performance Partners” ... designed to teach how to maximize their sales efforts, as well as how ...
(Date:3/24/2017)... ... March 24, 2017 , ... “Vintage and Harvest A ... minister and college Bible teacher residing in North Carolina with his wife, Anna Marie. ... blessed them with six grandchildren. David is also the author of “Shadow and Substance.” ...
Breaking Medicine News(10 mins):