You'll have to ask your competent? doctor which of the 5 causes of the neuronal cascade of death in the first week is being addressed!
I wish they had used the proper term; penumbra, and specified exactly how many millions of neurons were saved.
I consider the Rankin scale useless, not objective
except for #6, dead?
NIHSS and the Berthel Index ARE NOT DAMAGE
DIAGNOSES, they do not give you the 3d location of your dead and
damaged neurons. In my opinion, they are FUCKING WORTHLESS to getting
you recovered!
The latest here:
Revalesio has announced new analyses of the completed Phase 2 RESCUE clinical trial evaluating its drug candidate RNS60 in acute ischaemic stroke
that demonstrate a nominally significant lowering of infarct growth in
patients treated less than 12 hours from last known well. The lowering
of infarct growth correlated with clinically meaningful improvements in
several functional stroke measures for assessing a patient’s recovery(None of which are worth a damn, about helping you get recovered!),
including the modified Rankin scale (mRS), Barthel index (BI), and
National Institutes of Health stroke scale (NIHSS), the company claims
in a recent press release.
These results were delivered during an oral presentation at the
ongoing International Stroke Conference (ISC; 5–7 February, Los Angeles,
USA).
“This analysis of the RESCUE trial adds further information regarding
the beneficial effects of RNS60, confirming that it has favourable
effects on MRI [magnetic resonance imaging]-confirmed ischaemic lesion
growth that translated into improved clinical outcomes,” said former
World Stroke Organization (WSO) president Marc Fisher (Beth Israel
Deaconess Medical Center, Boston, USA). “These are exciting results that
suggest that RNS60 should be evaluated in a large Phase 3 clinical
trial that will hopefully confirm its benefits and lead to approval as
the first therapeutic agent in decades to demonstrate significant
efficacy in improving outcomes for acute ischaemic stroke patients.”
In RESCUE—a multicentre, double-blinded, placebo-controlled,
randomised Phase 2 clinical trial—Revalesio evaluated the safety and
initial efficacy of RNS60. Eighty-two participants with acute ischaemic
stroke eligible for endovascular therapy (EVT) were enrolled and
received either intravenous RNS60 0.5mL/kg/h (low dose), RNS60 1mL/kg/h
(high dose), or placebo, starting before completion of EVT and
continuing for 48 hours.
The trial had two primary endpoints: safety and mortality. Secondary
endpoints for the study assessed disability based on mRS scores, changes
in the size of the stroke measured via MRI at 48 hours, and additional
standard stroke scales like BI and NIHSS.
Highlights from the oral presentation—given by Revalesio’s acting
chief medical officer Jordan Dubow on 5 February at ISC 2025—are as
follows:
- The high dose of RNS60 significantly lowered infarct growth by 50%
(nominal p<0.05) when compared to placebo, based on imaging performed
at approximately 48 hours compared to immediately post-EVT, both in
patients treated within 12 hours and 24 hours of last known well
- The high dose of RNS60 was also numerically better than placebo for
each prespecified functional endpoint at day 90 (mRS, with 72% of
subjects on high-dose RNS60 being independent [mRS 0–2] at day 90
compared to 37% on placebo; BI, with 72% of subjects on high-dose RNS60
returning to normal activities of daily living [BI³ 95] compared to 37%
on placebo; and patient health status as measured by the EQ-5D-5L index,
with 1 being ideal, which was 0.79 for RNS60 subjects and 0.57 for
placebo)
- RNS60 was safe and well tolerated
“As the number-one cause of disability worldwide, the impact of
stroke is staggering, accounting for US$721 billion annually to the
global healthcare system,” said Bert van den Bergh, Revalesio’s
executive chairman of the board of directors. “Additionally, more than
80% of patients in the USA have no treatment options following a stroke,
underscoring the significant need for new and effective treatment
options. These highly encouraging results further demonstrate the
potential of RNS60 to greatly reduce the likelihood of disability in
patients following a stroke, and we plan to advance RNS60 into a Phase 3
clinical trial in order to bring this promising therapy to patients.”
Initial topline results from the RESCUE Phase 2 study—which evaluated
patients who were 24 hours from last known well, and saw RNS60 meet its
safety- and mortality-related endpoints—were presented as a late-breaking oral presentation at last year’s ISC (7–9 February 2024, Phoenix, USA).