RXi Pharmaceuticals has announced the FDA lifted a Chemistry, Manufacturing and Controls (CMC) partial clinical hold that delayed Phase III trials of the company's vaccine. The developer initiated a clinical trial material manufacturing plan allowing RXi to meet its planned Phase III trial start date in early 2012.
NeuVax is a cancer immunotherapy targeted for low-to-intermediate HER2-expressing breast cancer patients whose disease is in remission. The vaccine stimulates cytotoxic (CD8+) T cells, causing them to attack any cells in the body that express HER2 while leaving healthy ones undamaged. NeuVax is administered once a month for 6 months, followed by a booster once every 6 months. RXi's cancer vaccine met the primary endpoint of disease-free survival in a Phase II study; now the shot will be tested for the prevention of recurrence of early-stage HER2-positive breast cancer.
"Our extensive progress to date, including the timely lifting of the clinical hold and significant headway with site IRBs, is testament to the team's operational excellence and its commitment to meeting program timelines," said Mark Ahn, president and CEO of RXi. "NeuVax is now the cornerstone for building a strong oncology pipeline as we continue to build momentum within the oncology community and look forward to presenting additional NeuVax data at key clinical meetings this fall."
RXi inherited NeuVax in its March 2011 merger with Apthera. Its pipeline also includes RNAi product candidate RXI-109, which targets CTGF (connective tissue growth factor).
- here's RXi's release