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~ Revalesio, a clinical-stage pharmaceutical company, has recently announced the results of their Phase 2 RESCUE clinical trial for their lead product candidate, RNS60. The trial evaluated the safety and efficacy of RNS60 in patients with acute ischemic stroke (AIS) and the data was presented at the Late-Breaking Science session of the International Stroke Conference (ISC) 2024.
During the oral presentation at the conference, it was revealed that RNS60 showed significant benefits in preclinical models of acute and chronic neurological disorders. This is a major breakthrough as stroke remains a critical health issue with limited treatment options available.
RNS60 is a stable formulation of saline saturated with oxygen through a proprietary process. It initiates a cascade of biological effects that have been shown to be safe in previous trials with over 400 patients. This provides hope for a therapy that can improve upon the current standard of care for stroke patients.
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The RESCUE trial was a double-blinded, placebo-controlled, randomized proof-of-concept study that enrolled 82 participants with AIS eligible for endovascular thrombectomy (EVT). The participants were treated at five different sites, including Rhode Island Hospital's Comprehensive Stroke Center.
The primary endpoints of the trial were safety and mortality. Secondary endpoints included disability based on the modified Rankin Scale (mRS), change in stroke size as measured by MRI at 48 hours, and other standard stroke scales such as Barthel Index and NIHSS.
The results presented at ISC 2024 showed that RNS60 met its primary endpoints of safety and mortality. The rates of serious adverse events were similar between the groups receiving RNS60 and placebo, but there was a numerically lower rate of mortality in the RNS60 group (although no statistical comparison was made).
In addition, high dose RNS60 significantly reduced infarct growth by 50%, as compared to the placebo group (nominal p
During the oral presentation at the conference, it was revealed that RNS60 showed significant benefits in preclinical models of acute and chronic neurological disorders. This is a major breakthrough as stroke remains a critical health issue with limited treatment options available.
RNS60 is a stable formulation of saline saturated with oxygen through a proprietary process. It initiates a cascade of biological effects that have been shown to be safe in previous trials with over 400 patients. This provides hope for a therapy that can improve upon the current standard of care for stroke patients.
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The RESCUE trial was a double-blinded, placebo-controlled, randomized proof-of-concept study that enrolled 82 participants with AIS eligible for endovascular thrombectomy (EVT). The participants were treated at five different sites, including Rhode Island Hospital's Comprehensive Stroke Center.
The primary endpoints of the trial were safety and mortality. Secondary endpoints included disability based on the modified Rankin Scale (mRS), change in stroke size as measured by MRI at 48 hours, and other standard stroke scales such as Barthel Index and NIHSS.
The results presented at ISC 2024 showed that RNS60 met its primary endpoints of safety and mortality. The rates of serious adverse events were similar between the groups receiving RNS60 and placebo, but there was a numerically lower rate of mortality in the RNS60 group (although no statistical comparison was made).
In addition, high dose RNS60 significantly reduced infarct growth by 50%, as compared to the placebo group (nominal p
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