Avelas Biosciences Presents Phase 2, Period 2 Data in Virtual Poster Session at the 22nd Annual Meeting of The American Society of Breast Surgeons
April 29, 2021
SAN DIEGO, CA – Avelas Biosciences, Inc., a pioneer in the field of fluorescence imaging for real-time cancer detection, presented the results from Period 2 of its most recent clinical trial in a virtual poster session at the 22nd Annual Meeting of The American Society of Breast Surgeons. The poster, titled “Pegloprastide Based Ratiometric Fluorescence Imaging Detects Intraoperative Positive Margins in Real-Time,” is available at the conference’s website. Top-line results from the trial were previously reported by Avelas Biosciences.
“At Avelas, our mission is to increase the precision of cancer surgery to improve outcomes for patients,” commented Steven Chen, M.D., MBA, Avelas’ Chief Medical Officer. “Period 2 demonstrated in a prospective trial that fluorescent imaging with pegloprastide can both accurately detect positive cancer margins in real-time during surgery and guide surgeons to remove additional tissue to achieve negative margins. We are pleased with the findings and would like to thank our investigators and the patients who played a vital role in this trial.”
As previously reported, the primary endpoint of Period 2 of the registration study was the ability to detect cancer in margin-relevant tissue, using pegloprastide fluorescence imaging, in sufficient number of patients to demonstrate efficacy. This was achieved with high statistical significance (p-value < 0.001). Additional results are as follows:
- The secondary endpoint of intraoperative patient-level cancer detection performance in margin-relevant tissue, using prespecified thresholds, indicated that up to 75% of patients that would have had a positive margin could benefit from this investigational product at a statistically significant level.
- During the trial, patients were administered pegloprastide either the day before surgery or the day of surgery; reported data supports pegloprastide administration the day before the surgery as the preferred dosing time.
- During the trial, the re-excision rate was ~6%, which is markedly lower than typically reported in national studies.
- The study showed no serious adverse events or laboratory abnormalities attributable to the infusion of pegloprastide.
About Avelas Biosciences
Avelas Biosciences is a drug-device company focused on developing pegloprastide (AVB-620), a novel drug-device combination product for use during cancer surgery. Pegloprastide is designed to improve surgery by detecting cancer in real time and has the potential to become part of standard-of-care treatment for a variety of cancer surgeries. Avelas was founded on technology from Roger Y. Tsien, Ph.D., co-winner of the Nobel Prize in Chemistry 2008. Avelas is headquartered in San Diego, CA. For more information, visit www.avelasbio.com or email email@example.com.
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