In an exclusive interview with Paul Crowe, CEO of NuView, we delve into his perspectives driving the upcoming Phase 2 clinical trial of NV-VPAC1, a groundbreaking liquid biopsy technology designed to detect the overexpression of VPAC1 in shed urine. This trial is poised to involve a diverse cohort of participants, including those with elevated PSA levels and individuals undergoing conventional diagnostic procedures for prostate cancer. Key elements of the trial design include stringent participant selection criteria, non-invasive urine sample collection, and the innovative analysis of VPAC1 receptors using the proprietary NV-VPAC1 technology.
What are the key design elements of your upcoming Phase 2 clinical trial for the liquid biopsy to detect prostate cancer in shed urine?
Our upcoming Phase 2 clinical trial is designed to assess the efficacy and accuracy of NV-VPAC1, our liquid biopsy technology for detecting the overexpression of VPAC1 in shed urine. The trial will involve a diverse cohort of participants, including those with elevated PSA levels and those undergoing standard diagnostic procedures for prostate cancer. Key design elements include specific participant selection criteria, non-invasive urine sample collection, and the analysis of VPAC1 receptors in biofluids using the NuView proprietary NV-VPAC1 technology. Comparative analysis will be conducted against traditional diagnostic methods and histopathological findings from biopsies to establish sensitivity, specificity, and overall diagnostic accuracy. By incorporating these elements, we aim to evaluate our liquid biopsy’s performance comprehensively.
How will you ensure the robustness and reliability of the trial results?
The trial will be randomized and, where possible, blinded to reduce bias. Advanced statistical methods will be employed to analyze data and validate results. Control groups, with efforts to balance the homogeneity of patient populations across different trial sites, will be included for comparative analysis against standard diagnostic methods. An independent committee will review the trial design and results to ensure objectivity and compliance with regulatory standards. Additionally, we will conduct multi-center trials to validate the reproducibility of results across different populations and settings. These measures will help ensure that our findings are both reliable and credible.
Considering the use of radiopharmaceuticals Copper-64 and Copper-67 in NV-VPAC1™, what measures are being taken to ensure the safety and minimize the side effects for patients undergoing these diagnostics and treatments?
Ensuring the safety and well-being of patients undergoing diagnostics and treatments with NV-VPAC1 is paramount. The dosages of the NV-VPAC1 radiopharmaceuticals will be calculated and administered to minimize radiation exposure while ensuring diagnostic and therapeutic efficacy. Patients will be continuously monitored for any adverse effects during and after the Copper-64 (Cu-64) and Copper-67 (Cu-67) administration. Adherence to stringent radiation safety protocols and guidelines will protect both patients and healthcare providers. Additionally, we will conduct regular follow-up appointments to monitor long-term health and address any delayed side effects. These safety measures are designed to minimize risks and enhance patient care.
In what ways does NV-VPAC1™ offer a comparative advantage over other emerging diagnostic and theranostic technologies in oncology? Can you provide specific examples or data points from your research to support this?
NV-VPAC1 offers several significant advantages over other emerging diagnostic and theranostic technologies in oncology. By targeting the overexpression of VPAC1 receptors, NV-VPAC1 provides highly specific and sensitive detection of cancer cells. This technology is versatile, being used for both in vitro diagnostics and in vivo theranostics, offering a comprehensive solution for cancer detection and treatment. The minimally invasive liquid biopsy approach for detecting the overexpression of VPAC1 in shed urine is less invasive than traditional biopsy methods, reducing patient discomfort and risk. In our research, NV-VPAC1 demonstrated high sensitivity by detecting VPAC1 receptors in 100% of tested breast cancer subtypes without interference from ER, PR, and HER2 variants. Additionally, it successfully imaged cancerous lesions in patients with positive F18-FDG PET/CT scans, corroborated by Cu-64-NV-VPAC1 PET/CT scans. These data points highlight the effectiveness and reliability of our technology.
What is your regulatory strategy for gaining approval from agencies such as the FDA for NV-VPAC1™? What are the main challenges you anticipate, and how do you plan to address them?
Our regulatory strategy for gaining FDA approval for NV-VPAC1 involves conducting comprehensive clinical trials to generate robust data on the safety and efficacy of our technology. Thorough documentation and submission of trial data, including preclinical and clinical results, manufacturing processes, and safety protocols, will be essential. Potential regulatory challenges, such as safety concerns and manufacturing scalability, will be identified and addressed through additional studies and safety measures. By proactively managing these challenges, we aim to streamline the approval process and bring NV-VPAC1 to market efficiently.
Once NV-VPAC1™ receives regulatory approval, what steps will NuView take to commercialize the product and ensure it is accessible to the wider patient population? How do you plan to work with healthcare providers and insurers to integrate this technology into standard cancer care protocols?
Upon receiving regulatory approval, NuView will take several steps to commercialize NV-VPAC1 and ensure its accessibility to a wider patient population. We will scale manufacturing to maximize market opportunities, leveraging the increased availability and reduced costs of Cu-64 and Cu-67 produced by radiopharmaceutical companies and contract development and manufacturing organizations (CDMOs). This approach will enable us to benefit from the economies of scale created by the increased production of these isotopes while ensuring we maintain quality and consistency in isotope manufacturing. Establishing a robust distribution network will ensure the widespread availability of NV-VPAC1. We will partner with healthcare providers to integrate NV-VPAC1 into standard cancer care protocols, providing training and support for its use.
Moe Alsumidaie is Chief Editor of The Clinical Trial Vanguard. Moe holds decades of experience in the clinical trials industry. Moe also serves as Head of Research at CliniBiz and Chief Data Scientist at Annex Clinical Corporation.
