Sunesis Pharmaceuticals Presents Updated Clinical Data From Ongoing Phase 2 Trial of Voreloxin (Formerly SNS-595) in Ovarian Can
01 June 2008 - 12:00AM
PR Newswire (US)
Positive Interim Safety and Efficacy Data Reported SOUTH SAN
FRANCISCO, Calif., May 31 /PRNewswire-FirstCall/ -- Sunesis
Pharmaceuticals, Inc. (NASDAQ:SNSS) today presented an update of
interim data from the company's ongoing Phase 2 clinical trial of
its lead product candidate, voreloxin (formerly SNS-595), in
platinum-resistant ovarian cancer patients at the 44th American
Society of Clinical Oncology (ASCO) Annual Meeting in Chicago,
Illinois. "Voreloxin is a promising anti-cancer agent demonstrating
encouraging signs of single-agent clinical activity in ovarian
cancer patients who have failed prior rounds of treatment," said
William McGuire, M.D., Medical Director of the Harry and Jeanette
Weinberg Cancer Institute at Franklin Square and principal
investigator for the Phase 2 clinical trial. "Importantly,
treatment with voreloxin has resulted in disease control among
approximately half of patients treated and the drug has been very
well tolerated. Taken together, these data support a potentially
broad therapeutic window for this product candidate and I look
forward to seeing the outcomes of treatment with voreloxin at the
higher dose levels for patients now enrolling in this study." To
date, voreloxin administered as a single agent at a dose of 48
mg/m(2) once every 21 days has demonstrated clinical activity in
platinum-resistant ovarian cancer patients. Thus far, of 62 women
evaluable for best response at that dose, one patient had a
complete response, five patients had partial responses (one
unconfirmed) and forty-five patients achieved stable disease.
Forty-eight percent of these 62 patients achieved disease control,
defined as stable disease for 90 days or more or a complete or
partial response. The preliminary median Progression Free Survival
was 91 days, or 13 weeks, at the 48 mg/m(2) dose; twenty-three
patients treated at this dose remained on study as of May 12, 2008.
All patients enrolled in the trial have previously failed treatment
with platinum-containing regimens, and 26 patients have also failed
prior treatment with doxorubicin HCl liposome injection (Doxil(R)).
Both platinum-resistant and Doxil-resistant patients in the Phase 2
clinical trial have responded to voreloxin therapy. In March, based
on the indications of clinical activity and the acceptable
tolerability profile demonstrated in this Phase 2 clinical trial,
Sunesis increased the dose of voreloxin in this trial to 60 mg/m(2)
once every 28 days. Thirty-four patients have been enrolled at the
60 mg/m(2) dose level. To date, with an initial eight patients
evaluable for efficacy response, one patient has achieved a partial
response. Voreloxin has been well-tolerated in the
platinum-resistant ovarian cancer population. With 65 patients
evaluable for safety at the 48 mg/m(2) dose and 20 patients
evaluable for safety at the 60 mg/m(2) dose, low rates of febrile
neutropenia (
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