Ludwig Enterprises announced that the Company has started discussions with Emerson Urology Associates, Concord, MA regarding initiation of a clinical study to evaluate the response of bladder cancer patients to BCG immunotherapy. A confidentiality agreement has been signed with Dr. John Libertino, MD, Director of Emerson Urology Associates. Bladder cancer is the sixth most common cancer in the United States and the ninth most common worldwide.

Cancers of the bladder make up about 5% of new U.S. cancer cases each year, mostly in older people. In 2021, there will be an estimated 83,000 new cases diagnosed and approximately 17,000 deaths in the U.S. alone. Standard treatment for patients with bladder cancer that has invaded muscle tissue includes cisplatin-based chemotherapy followed by surgical removal of the bladder or radiation therapy and concomitant chemotherapy.

An additional treatment approach is an immunotherapy, a class of treatments that uses a person's own immune system to help kill cancer cells. Bacillus Calmette-Guérin (BCG) is a cancer vaccine that uses weakened bacteria to stimulate the immune system. BCG has received U.S. FDA approval for the treatment of early-stage bladder cancer.

The objective of the joint research program between Ludwig Enterprises and Emerson Urology Associates is to use Ludwig's proprietary genetic inflammatory markers to study patients with early-stage superficial bladder cancer and assess therapeutic response to BCG immunotherapy. Ludwig's proprietary genetic inflammatory biomarker panel is in the process of being submitted to the U.S. Patent office.