In the 1970s, while working in the Department of Urology at
Queen's University in Kingston, Ontario, Canada, Morales developed a hypothesis considering the use of
BCG, a live tuberculosis vaccine, to treat non muscle invasive urothelial bladder cancer (NMIBC). His initial request for research funding from the National Cancer Institute of Canada was rejected with the note that "BCG is not only ineffective and dangerous but a throwback to the stone age of tumor immunology." Eventually developed with funding from the Cancer Research Institute of New York, the therapy involved introducing BCG to infect the bladder, provoking an immune system response sufficiently robust to eliminate some tumors without the use of chemicals.
BCG immunotherapy was found to be effective in up to 2/3 of superficial tumors, and in
randomized trials has been shown to be superior to standard
chemotherapy. In 1990, the treatment became the first therapy approved for use by the
FDA against solid NMIBC tumors and remains the "gold standard" treatment more than 40 years later. In 2018, BCG was described in the Canadian Urological Association Journal as "the most effective, and longest continually used immunotherapy for any cancer." Morales' research on the treatment, published in 1976, has been described as "the seminal paper on the use of intravesical BCG in human patients" and was hailed by the
Journal of Urology as one of the most important papers on bladder cancer research in the past 100 years. ==Medical and Academic Career==