A new approach to treating ovarian cancer has taken an important step. Research developed in the lab of University of Iowa (UI) College of Pharmacy Dean, Jean M. Schmidt Chair, and Professor Jill Kolesar has received U.S. Food and Drug Administration (FDA) Investigational New Drug (IND) approval to move her novel research to clinical trials. She is one of just two UI researchers this year to receive IND clearance for a drug formulated in their lab. Trial enrollment is expected to begin next month, pending approval from the UI Institutional Review Board.
“I am excited and proud that the FDA agreed from our preclinical data that we’re ready for human trials. Ovarian cancer remains of the deadliest gynecologic malignancies and despite decades of research, outcomes for many patients remain unacceptably poor,” said Kolesar. “This is an opportunity to bring together innovative science, multidisciplinary collaboration, and clinical translation to develop therapies that can fundamentally change the trajectory of this disease for patients and their families.”
Ovarian cancer is projected to kill more than 12,450 women in the United States this year, according to the American Cancer Society. There is currently no early detection of the disease. Two of three women who are diagnosed with ovarian cancer and undergo chemotherapy experience a recurrence.
Converting Cancer Cells
The method leverages the production of extracellular vesicles — small, fluid-filled sacs released by cells — to convert ovarian cancer tumor-supporting immune cells into tumor-killing immune cells.
“Bringing a new therapy from an idea in the laboratory to a clinical trial is one of the most challenging endeavors in biomedical research, often requiring decades of work and millions of dollars,” explained Kolesar. Her research is financially supported in part by an Advanced Research Projects Agency for Health Sprint Women’s Health award.
Investigative Partnership
Kolesar noted the project is the product of an extraordinary partnership. She cited University of Kentucky College of Pharmacy Professor Chris Richards; UI Carver College of Medicine colleagues Professor George Weiner and Clinical Professor Annette Schlueter; and UI Health Care gynecologic oncologist Michael Goodheart as key contributors. She added that equally important to the work is the dedication of Laura Dallas of the UI Holden Comprehensive Cancer Center; Gaia Regulatory Sciences’ Jessica Foley; UI College of Pharmacy Associate Research Scientist Melissa Fath; and Jyoti Patel, research scientist at the UI Carver College of Medicine.
“The expertise and perseverance of all these individuals helped carry the project forward at every step,” said Kolesar. “Together, they transformed a scientific discovery into an opportunity to make a meaningful difference in patients' lives.”