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"Voreloxin is a promising anti-cancer agent demonstrating encouragingsigns of single-agent clinical activity in ovarian cancer patients who havefailed prior rounds of treatment," said William McGuire, M.D., MedicalDirector of the Harry and Jeanette Weinberg Cancer Institute at FranklinSquare and principal investigator for the Phase 2 clinical trial."Importantly, treatment with voreloxin has resulted in disease control amongapproximately half of patients treated and the drug has been very welltolerated. Taken together, these data support a potentially broad therapeuticwindow for this product candidate and I look forward to seeing the outcomes oftreatment with voreloxin at the higher dose levels for patients now enrollingin this study."
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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-resistantovarian cancer patients. Thus far, of 62 women evaluable for best response atthat dose, one patient had a complete response, five patients had partialresponses (one unconfirmed) and forty-five patients achieved stable disease.Forty-eight percent of these 62 patients achieved disease control, defined asstable disease for 90 days or more or a complete or partial response. Thepreliminary median Progression Free Survival was 91 days, or 13 weeks, at the48 mg/m(2) dose; twenty-three patients treated at this dose remained on studyas of May 12, 2008.
All patients enrolled in the trial have previously failed treatment withplatinum-containing regimens, and 26 patients have also failed prior treatmentwith doxorubicin HCl liposome injection (Doxil(R)). Both platinum-resistantand Doxil-resistant patients in the Phase 2 clinical trial have responded tovoreloxin therapy.
In March, based on the indications of clinical activity and the acceptabletolerability profile demonstrated in this Phase 2 clinical trial, Sunesisincreased the dose of voreloxin in this trial to 60 mg/m(2) once every 28days. 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, onepatient has achieved a partial response.
Voreloxin has been well-tolerated in the platinum-resistant ovarian cancerpopulation. With 65 patients evaluable for safety at the 48 mg/m(2) dose and20 patients evaluable for safety at the 60 mg/m(2) dose, low rates of febrileneutropenia (<10%) or other Grade 3-4 adverse events (fatigue (12%), vomiting(5%) and infections (5% )) have been observed. Based on voreloxin's safetyprofile, Sunesis recently announced that the protocol for the ongoing Phase 2clinical trial was amended to increase the dose by 25 percent to 75 mg/m(2)given once every 28 days. Sunesis expects to enroll approximately 30 patientsat this new dose level by the end of this year.
"Voreloxin has demonstrated promising clinical activity and tolerabilityamong platinum-resistant ovarian cancer patients and we are focused onadvancing this compound in this indication toward late-stage trials," saidDaniel Swisher, Sunesis' Chief Executive Officer. "We are pleased by therapid progress of enrollment of voreloxin at 60 mg/m(2). We are optimisticthat the 75 mg/m(2) cohort of this Phase 2 trial will be fully enrolled byyear-end, and we look forward to reporting additional efficacy and safety datalater this year."
Data from Sunesis' ongoing Phase 2 clinical trial of voreloxin in ovariancancer were presented today during the Gynecologic Cancer: Ovarian
