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RXi advances breast cancer vaccine
Boston Business Journal - by Julie M. Donnelly
Date: Monday, June 6, 2011, 9:56am EDT
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RXi Pharmaceuticals Corporation (NASDAQ: RXII), has announced positive three-year phase II data for its vaccine candidate to treat certain types of breast cancer, called NeuVax.
The Worcester, Mass.-based biotechnology company said if approved, the vaccine would potentially serve patients who are not eligible to take the blockbuster drug Herceptin, marketed by Swiss drug maker Roche (Swiss: RO.SW).
According to the National Cancer Institute,
about 75 percent of breast cancer patients test positive for Human Epidermal growth factor Receptor 2 (HER2). However only 25 percent of all patients are eligible for Herceptin, which targets the subset of patients with the highest expression of HER2. RXi's drug candidate would target the 50 percent of patients who are HER2 positive but cannot be helped by Herceptin.
The trial included 182 patients who were in remission at the start of the trial. Following enrollment, eligible patients were administered the NeuVax vaccine once a month for six months, followed by booster shots one every 6 months thereafter. The efficacy endpoint for the trial was disease-free survival.
The vaccine-treated group showed no recurrences of cancer after 36 months, while the control group demonstrated a 22 percent recurrence rate, which is consistent with historical norms, the company said. RXi said there were no serious adverse events.
The company has received a Special Protocol Assessment (SPA) from the U.S. Food and Drug Administration for the phase III trial, which means the design of the study is acceptable for approval.
“These promising results strongly build upon and support previously reported efficacy and safety data,” CEO Dr.
Mark Ahn said in a statement. “We are committed to initiating the Phase 3 trial per the approved SPA in the first half of 2012, in order to accelerate this treatment for women who suffer from this terrible disease and who are not eligible for other HER2 directed therapies.”
There is currently just one FDA-approved cancer vaccine: prostate cancer vaccine Provenge, marketed by Dendreon Corp. (Nasdaq: DNDN).
juliedonnelly@bizjournals.com
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