Ludwig Enterprises Receives IRB Approval on Bladder Cancer Study
mRNA Technology to Assess Patient Response to BCG Immunotherapy Treatment

SPARKS, NV / ACCESSWIRE / January 3, 2023 / (OTC PINK:LUDG) Ludwig Enterprises,Inc., with its wholly owned subsidiary, Precision Genomics, Inc., a leading-edge innovator of inflammatory genetic biomarkers to diagnose and manage chronic diseases, is pleased to announce Institutional Review Board (IRB) approval of a study titled "Using Measurements of mRNA and Elisa-based Cytokine/Protein Indices to Evaluate Pre- and Post- Diagnosis and Treatment Response of Patients With Urothelial Carcinoma of the Bladder."

The objective of this clinical study is to use messenger ribonucleic acid (mRNA) genomic-based cytokines and related proteins to establish a diagnostic paradigm for patients with urothelial carcinoma of the bladder and to use this data to evaluate the efficacy of BCG immunotherapy as a personalized score for the patient. Integrating these disciplines into a computational model can develop a personalized patient diagnostic and treatment response, 'L- genomic bladder cancer risk' score, to aid in BCG immunotherapy disease management at a clinical practice level.

Dr. Marvin S. Hausman, MD, Chairman of Ludwig's Scientific Advisory Board (SAB), stated, "this ground-breaking research study has the potential to transform cancer detection and treatment by producing a predictive model for early-stage cancer occurrences. The proprietary genomic language developed could change medical care by capturing an individual snapshot of disease progression in combination with a patient's response to certain treatments-enabling doctors to better serve their patients' needs proactively rather than reactively. Ludwig intends to make this research program available to Urology doctors and clinics throughout the United States."

Why Bladder Cancer

Urothelial carcinoma of the bladder is a major global public health concern. This cancer is the fourth most commonly diagnosed cancer in men and sixth most common overall in the United States, with an estimated incidence of 83,730 and mortality of 17,200 in the year 2021 (American Cancer Society, 2021). Muscle-invasive bladder cancer, a major source of morbidity and accounts for virtually all of the mortality from this disease, is initially diagnosed in about 25%-30% of patients. However, the remaining 70% of patients are initially diagnosed with superficial bladder tumors. These include patients diagnosed with carcinoma in situ (CIS), and this group is at high risk for tumor recurrence and progression to muscle-invasive and metastatic disease. These patients are typically treated with intra-bladder instillations of Bacillus Calmette Guerin (BCG), with an approximate 70% response rate. BCG immunotherapy uses the body's natural immune system to attack cancer cells. The FDA has approved Bacillus Calmette-Guérin (BCG), one of many vaccines designed to stimulate immunity against bladder cancer.

How the Study Will Work

This study aims to identify inflammatory genetic markers to understand better how BCG immunotherapy works. The study will observe patients who have been treated with BCG immunotherapy and measure their progress at regular intervals over a period of time. By looking at these markers, researchers can gain valuable insight into how well each patient responded to treatment and inform future treatment decisions.

The objective of this study is to develop a better understanding of the involvement of inflammation in the development of bladder cancer. With insight into how BCG immunotherapy works, doctors can provide more effective treatments geared toward individual patient needs. The genomic knowledge provided by mRNA clinical studies may ultimately lead to higher survival rates among bladder cancer patients.''

About Ludwig Enterprises, Inc.

Ludwig Enterprises is a publicly traded Medical Technology Holding Company with Precision Genomics, Inc. and MyRNA for Life, Inc as wholly owned subsidiaries. Advancements in medical technology and Artificial Intelligence (AI) have awarded us with cutting-edge genomic tools, unheard-of even a generation ago. These genomic tools have the potential to not only detect diseases early but also to customize treatments that may improve patient outcomes and, in some cases, even extend life. Ludwig is at the forefront of this new era of medicine with their proprietary mRNA genetic methodology that has the potential to detect genetic biomarkers for inflammatory-driven diseases, including but not limited to heart disease, diabetes, preeclampsia, and cancer. This early detection may allow doctors to take steps to diagnose and manage illness before it progresses and causes serious health problems. Precision Genomics' innovative testing approach is not only practical but also has the potential to save the healthcare industry billions of dollars in costs. With a virtually untapped market and a billion-dollar healthcare industry, Precision Genomics is poised to significantly impact how we think about disease and live longer healthier lives. More Info: http://www.ludwigent.com.

SAFE HARBOR

Forward-looking statements in this release are made under the "safe harbor" provision of the Private Securities Litigation Reform Act of 1995. Ludwig Enterprises Inc.'s forward-looking statements are not a guarantee of future performance. This news release includes forward-looking statements concerning the future level of business for the parties. These statements are necessarily subject to risk and uncertainty. Actual results could differ materially from those projected in these forward-looking statements due to certain risk factors that could cause results to differ materially from estimated results. Management cautions that all statements as to future results of operations are necessarily subject to risks, uncertainties, and events that may be beyond the control of Ludwig Enterprises, Inc., and no assurance can be given that such results will be achieved. Potential risks and uncertainties include, but are not limited to, the ability to procure, appropriately price, retain, and complete projects and changes in products and competition.

CONTACT:

Ludwig Enterprises
Anne Blackstone
786-235-9026

SOURCE: Ludwig Enterprises