Company: RVRC
Filing Date: 2025-10-03
Form Type: S-1/A
Source: 0001213900-25-096094
Chunk: 101

Company: Revium Rx.
Filing Date: 2025-10-03
Form: S-1/A
Chunk 101
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 for pancreatic
cancer patients, particularly those with the poorest prognosis and limited treatment options. The results of the study are presented
below.

Figure 11: Kaplan– Meier curves for overall survival by treatment groups. The median overall survival was 15.1 months in the ACEI/ARB group, 8.9 months in the non-ACEI/ARB with hypertension group, and 9.5 months in the non- hypertension group (1)

In another clinical study evaluating the combination
of gemcitabine and candesartan (2), the investigators recommended a candesartan dose of 16 mg alongside gemcitabine for the treatment
of advanced pancreatic cancer. The study concluded that this regimen is both feasible and safe in normotensive patients, with encouraging
efficacy reflected in a high disease control rate and prolonged progression-free survival. The authors further recommended continued
investigation of this approach in larger trials.

Additionally, a retrospective study by Wilop et al. (3) examined the impact of ARBs and other agents on survival in patients with advanced non-small-cell lung cancer undergoing
first-line platinum-based chemotherapy. The researchers found that the addition of an ARB to platinum-based therapy was associated with
prolonged survival. This clinical observation aligns with previous experimental findings suggesting that ARBs may exert direct antiproliferative
effects on tumor cells and/or their microenvironment.

Fig. 12. Estimated survival from 1st
cycle of chemotherapy in the entire patient group according to long-term medication with (n = 52) or without (n =235) ACEI (Angiotensin
converting enzyme inhibitor) or ARB (P =0.03, log rank test) (3)

Described above clinical and preclinical findings
suggest that blockade of the angiotensin receptor may favorably modulate the tumor microenvironment, reduce immunosuppressive signaling,
and enhance responsiveness to anticancer agents. Based on this, we believe that administration of our novel formulation of Nano-Candesartan
could provide dual benefits: maintaining stable blood pressure profiles in patients while offering a clinically significant and tolerable
therapeutic effect in oncology settings.

Pre-clinical Studies on Nano-Candesartan

Preclinical exploratory studies performed
in Prof. Barenholz’s laboratory evaluated liposomal formulations of angiotensin receptor blockers (ARBs), including Candesartan,
in animal models of several solid tumors. These studies investigated toler