Alessa Therapeutics has announced the enrollment of the first patient in its Biolen-PC clinical study in Australia.
Biolen-PC (NCT 04284761) is a first-in-man study evaluating the safety and patient tolerance of Biolen for the localised sustained delivery of bicalutamide into the prostate in patients scheduled for prostate surgery for treatment of non-metastatic prostate cancer. The Biolen-PC study will treat up to 20 patients in Australia and New Zealand.
Associate Professor Peter Chin, a urologist at Wollongong Private Hospital, said, “I am excited to be the first in Australia to enrol a patient in this study. The Biolen implant procedure went very smoothly with this gentleman who had a Gleason Grade Group 4 prostate cancer and is scheduled for a radical prostatectomy in a few months.
"I am encouraged that he can enrol in this trial for localized delivery of bicalutamide while awaiting his radical prostatectomy. I look forward to enrolling more patients in this important study to advance our understanding of this novel approach to treating prostate cancer.”
Prostate cancer is the second most prevalent cancer among men. In Australia, prostate cancer incidence is one of the highest among developed countries.
While some men with low-risk tumours choose to monitor their disease, most prostate cancer patients are treated with either surgery to remove their prostate or radiation therapy. Both surgery and radiation treatment have potential complications, including urinary incontinence and erectile dysfunction. Anti-androgen and testosterone-lowering drugs are approved for high-risk localised or metastatic disease due to side effects, including muscle mass loss, cognitive issues, sexual dysfunction, and cardiovascular events.
Alessa said its Biolen 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.
“We are excited to complete the first patient enrollment in Australia. All of us at Alessa are grateful for the support from Dr Chin and the research team at South Coast Urology and Wollongong Private Hospital and this patient’s participation in this important study, especially in these challenging times with COVID. With every procedure, we learn new things about our technology, and we look forward to conducting more cases at all of our investigational sites,” said Dr Pamela Munster, founder of Alessa Therapeutics.
“I founded this company three years ago to increase the treatment options for men diagnosed with prostate cancer and provide a higher quality of life while under treatment. The results from this study will be used to support our US IND submission to the FDA for additional studies and will get us one step closer to our eventual goal.”