Alessa Therapeutics Announces First Patient Enrolled in Biolen-PC Study for Localized Drug Delivery for Prostate Cancer

SAN CARLOS, CALIFORNIA, US, October 13, 2020 /  

Alessa Therapeutics, Inc., a privately held drug development company developing an innovative and proprietary localized drug delivery technology for the treatment of prostate disease, announced the enrollment of the first patient in the company’s Biolen-PC clinical study. Biolen-PC is a first-in-man study evaluating safety and patient tolerance of Biolen for the localized sustained delivery of bicalutamide into the prostate of men scheduled for prostate surgery for treatment of non-metastatic prostate cancer. The company received approval in Australia and New Zealand for this study earlier this year. The Biolen-PC study will treat up to 20 patients in Australia and New Zealand.

Dr. Mark Fraundorfer, a practicing urologist at Tauranga Urology Research in New Zealand, who enrolled the first patient, noted “I am honored to be the first in the world to enroll a patient in this study. The introduction of the device delivering bicalutamide selectively to the prostate of my patient with a sizable tumor was a very straightforward procedure.”

Prostate cancer is the second most prevalent cancer among men in the United States. According to the American Cancer Society, over 192,000 men in the U.S. are newly diagnosed each year, and three million men are living with prostate cancer. The rate of prostate cancer in New Zealand is 103 cases per 100,000 men resulting in more than 3,700 annual cases. In Australia, the rate of prostate cancer is one of the highest among developed countries at 110 cases/100,000 men.

While some men with low-risk tumors choose to monitor their disease, most prostate cancer patients are treated with surgery to remove their prostate or with radiation therapy. Both surgery and radiation treatment have high rates of complications including urinary incontinence and erectile dysfunction. Anti-androgen drugs are approved only for high-risk localized or metastatic disease due to side effects including muscle mass loss, cognitive issues, sexual dysfunction, and cardiovascular events. Alessa’s Biolen implant is designed to deliver an anti-androgen drug to the target tissue in the prostate, eliminating significant side effects and improving quality of life for men living with prostate cancer while avoiding surgery or radiation therapy.

“We are excited to be conducting the first-in-man study of our revolutionary technology in patients with prostate cancer. I am grateful for the dedicated efforts of our UCSF and Alessa teams together with the research group at Tauranga Urology for reaching this important milestone. “We look forward to further enrollment at all of our investigational sites.” said Dr. Pamela Munster, founder of Alessa Therapeutics. “The findings from the Biolen-PC study will be used to support our U.S. IND submission to the FDA for our Phase 2 trial. We believe this novel implant therapy will increase the treatment options for men diagnosed with prostate cancer and provide a higher quality of life while under treatment.”

In addition to Dr. Fraundorfer at Tauranga Urology, Professor Henry Woo, Associate Professor Peter Chin, Associate Professor Daniel Moon and Associate Professor Jeremy Grummet are participating in the Biolen-PC study at their centers in Australia.

About Alessa Therapeutics
Founded in 2018 and based on technology developed at the University of California San Francisco, Alessa Therapeutics is a privately held company with a focus on developing selective and sustained localized drug delivery for the treatment of prostate cancer and benign prostate hyperplasia. Alessa also has development efforts underway in breast cancer. Alessa is financed by Mission Bay Capital and BioInnovation Capital (now Mission Biocapital: For more information on Alessa Therapeutics, visit or email

Timothy Hay
for Alessa Therapeutics
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Alessa Therapeutics Announces First Australian Patient Enrolled in Biolen-PC Study for Localized Drug Delivery for Prostate Cancer