On January 9, 2024 Alessa Therapeutics, Inc., a privately held drug development company developing an innovative and proprietary localized drug delivery technology for the treatment of prostate disease, reported the enrollment of the first patient in the company’s Enolen clinical study at the National Cancer Institute (NCI), part of the National Institutes of Health (Press release, Alessa Therapeutics, JAN 9, 2025, View Source [SID1234649535]).
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The Phase I Study (View Source) is a first-in-man study evaluating the safety, tolerability, and preliminary efficacy of Enolen for localized sustained delivery of enzalutamide into the prostate. The Enolen study will treat up to 20 patients in the US. Enrollment for the NCI study is through the NIH Clinical Center in Bethesda, Maryland.
"We are excited to complete the first patient enrollment with our partners at the NCI. As a medical oncologist and Phase I drug developer, it has been a long-held dream to be able to administer an effective anti-cancer agent without its side effects. Our prostate selective therapy spares men from the disabling side effects of unnecessarily blocking testosterone in the rest of the body and the brain." said Dr. Pamela Munster, Professor of Medicine at UCSF and founder and CSO of Alessa Therapeutics.
Prostate cancer is the second most prevalent cancer among men in the United States. According to the American Cancer Society, there were about 299,010 men in the U.S. in 2024, and 3.3 million men live with prostate cancer. (View Source)
While some men with low-risk tumors choose to monitor their disease, most prostate cancer patients are treated by completely removing or radiating their prostate. Both surgery and radiation treatment have expected complications, including urinary incontinence and erectile dysfunction. Systemic anti-androgen and testosterone-lowering drugs are approved for high-risk localized or metastatic disease but associated with side effects, including muscle mass loss, cognitive issues, sexual dysfunction, metabolic syndrome and cardiovascular events. Alessa’s Enolen implant is designed to deliver an anti-androgen drug directly to the target tissue in the prostate, eliminating significant side effects and improving the quality of life for men living with prostate cancer while avoiding surgery or radiation therapy.
Dr. Peter Pinto, Head of the Prostate Cancer Section at the National Cancer Institute, and Principal Investigator on the study noted, "There is a clear unmet therapeutic need for effective treatment options for men with localized prostate cancer that avoids definitive surgery or radiation or androgen ablating systemic therapy."
To learn more about this study, please visit View Source