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Avelas Biosciences, which is working on fluorescent cancer imaging technology, announced that the FDA has awarded the company a breakthrough therapy for pegloprastide (AVB-620) to detect and test positive cut margins in breast cancer surgery.
Pegloprastide aims to deliver a fluorescent marker to cancer cells, helping surgeons identify positive scissor in real time during surgery.
positive cut may be a sign of cancer tissue residue, and patients usually need secondary surgery.
positive cut is a major challenge for breast-feeding surgery.
postoperative pathology analysis showed the presence of cancer cells at the edge of the excision tissue, indicating that cancer may remain after surgery.
estimates that more than 260,000 women in the United States undergo mastectomy each year, one-third of them repeatedly, with the goal of obtaining a negative cut.
addition, many of the approximately 90,000 women who opted for a mastectomy opted for a mastectomy because of concerns about incomplete initial mastectomy or positive for the first mastectomy.
Pegloprastide (AVB-620) is a fluorescent-based clinical cancer detection product.
two different fluopho clusters are coupled to a molecule.
metal protease secreted by the tumor is able to cut AVB-620, causing changes in the fluorescence spectrum.
Avelas has teamed up with Quest MedicalImaging to produce dedicated fluorescent imaging equipment for Avelas using its Quest SPECTRUM platform technology.
allows doctors to observe fluorescence changes in tissue in real time during surgery, improving the success rate of the complete removal of tumor tissue.
green fluorescence (where the arrow points) shows cancer cells in positive cut-off and excision tissue (Photo: Avelas's official website, click on the visible graph) after Avelas completed phase 2/3 clinical studies and reported positive topline data.
women who underwent surgery for primary, non-relapsed breast cancer, pegloprastide reached the primary endpoint of cancer tissue in real-time detection edge samples .
6 percent of patients who used pegloprastide underwent resection surgery.
patients who under undergo a first mastectomy, the current resection rate is estimated to be 20-40%.
addition to breast cancer, Avelas plans to explore the use of pegloprastide in other types of cancer surgery, including ovarian cancer, colorectal cancer, head and neck cancer, melanoma and sarcoma.
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