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The Phase 3 RESET trial testing the effectiveness and safety of rivipansel (GMI-1070), Pfizer‘s investigational candidate to treat vaso-occlusive crisis (VOC) in hospitalized patients with sickle cell disease (SCD), failed to reach both its primary and secondary goals, top-line study results show.
“We are disappointed with the results, as we have been working in close partnership with the SCD community to advance rivipansel as a potential treatment option for acute VOC,” Brenda Cooperstone, MD, senior vice president and chief development officer, Rare Disease, Pfizer Global Product Development, said in a press release.
“We plan to share the study data at an upcoming scientific meeting as we want to ensure the learnings from this trial help inform future sickle cell programs,” Cooperstone added. “We express our sincere gratitude to everyone who made this study possible, including the study investigators, and in particular, the patients and their families.”
VOC, characterized by a reduced blood flow and ultimate closing of blood vessels due to the adhesion of sickle cells to vessel walls, is a serious complication of SCD linked with severe pain. Currently, VOC symptoms are managed with analgesics, including opioids and non-steroidal anti-inflammatory drugs (NSAIDs), but more effective therapies are needed.
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This platform is made possible through a partnership with the Sickle Cell Disease Association of America, Inc. (SCDAA) and its member organizations. SCDAA's mission is to advocate for people affected by sickle cell conditions and empower community-based organizations to maximize quality of life and raise public consciousness while advancing the search for a universal cure.