Pfizer Inc. (PFE) Gets First Patient In Phase 3 Trial Called RESET
Pfizer Inc. (NYSE:PFE) has enrolled its first patient for Phase 3 trial of Sickle cell disease study. The RESET (Rivipansel: Evaluating Safety, Efficacy and Time to Discharge) study will try to evaluate the efficacy and safety levels of Rivipansel for patients above six years old, suffering from the disease.
350 People To Be Enrolled
The enrollment of the first patient should go a long way in allowing Pfizer Inc. (NYSE:PFE) better understand the viability of Rivipansel as a treatment regimen for painful cries in patients with the disease. Rivipansel is part of the pan-selecting inhibitor known for regulating cellular interactions within blood vessels.
Pfizer Inc. (NYSE:PFE) plans to enroll about 350 people with the sickle cell disease as part of phase 3, placebo-controlled, parallel group study. Study participants must already be receiving treatment with intravenous opioids for vaso occlusive crisis to be considered. A first dose of the study drug will be administered within 24 hours of the start of the intravenous opioid therapy.
Some of the key secondary endpoints that Pfizer will be watching include cumulative IV opioid consumption, time discontinuation of the same, as well as the time to discharge. Time to readiness-for-discharge will act as the primary end point.
Pfizer takes over from GlycoMimetics Inc (NASDAQ:GLYC), which handled phase 2 trials as part of a worldwide agreement signed in 2011. Going forward, Pfizer will handle all future clinical development of the drug as it eyes regulatory approval that should trigger commercialization.
The US Food and Drug Administration drug has already approved the Orphan Drug and Fast Track status for Rivipansel. Phase 3 study is to be conducted under the Special Protocol Assessment as part of the agreement with the FDA.
Pfizer Inc. (NYSE:PFE) is renowned for applying science and its global resources in bringing up therapies that impact and significantly improve people’s lives. The company’s focus on rare disease has already given rise to more than 20 medicines approved worldwide.
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