Company: RVRC
Filing Date: 2025-02-14
Form Type: S-1
Source: 0001213900-25-013823
Chunk: 68

Company: Revium Rx.
Filing Date: 2025-02-14
Form: S-1
Chunk 68
---
, and prostate cancers. ARB has shown to improve tumour perfusion, enhance the     
 penetration and efficacy of chemotherapy and biological treatments, and, potentially, to      
 improve the survival and quality of life of the animals.                                      |

| ● | IP                                                                                         
 protection: ARB approach is patent pending. The below table summarizes the project related 
 IP estate.                                                                                 |

Liposomal Formulations Comprising AT1 Receptor Blockers )ARB( and Uses Thereof

We plan to obtain more evidence of the efficacy of the novel ARB and its safety and to conduct further pre-clinical development plan.

The company is currently conducting a dose-dependent study to evaluate the effect of the lead formulation on blood pressure in large animals. The results of this study will shape the next phase of preclinical activities. Following the large animal studies, the company plans to undertake a series of IND-enabling preclinical studies. These include therapeutic efficacy testing of the lead formulation in chosen cancer models to assess its anti-cancer activity. Preliminary pharmacokinetics and tumor biodistribution studies in mice will be performed to understand the absorption, distribution, metabolism, and excretion of the drug, as well as its accumulation in tumors. Concurrently, bioanalytical methods will be developed and validated to quantify the drug and its metabolites in biological samples.

The company will also scale up the manufacturing process from lab scale to pilot scale, ensuring consistency in the formulation. Stability studies will follow, involving the development of analytical methods to monitor stability and the performance of long-term and accelerated stability tests to define the shelf life and storage conditions of the lead formulation. Additionally, toxicity and toxicokinetic studies in rats will assess the safety of the formulation at clinically relevant doses, establishing the No Observed Adverse Effect Level (NOAEL).

In this way, the company will ensure readiness for submission of an IND application with the FDA and preparedness for clinical trials, presenting a robust safety, efficacy, and stability profile for the lead formulation. Clinical trials are planned to commence by end 2026.

We believe that our novel Nano-ARB approach addresses the unmet medical needs of millions of cancer patients worldwide and has the potential to achieve significant market success as a combination therapy, synergistic with leading anticancer therapeutics.

The global anticancer therapeutics market is undergoing rapid growth, driven by the rising incidence of cancer and advancements in treatment technologies. According to The Brainy Insights, the market was valued at approximately $222.71 billion in 2023 and is projected to reach around