Biolen (bicalutamide implant) / Alessa Therap - LARVOL DELTA

A phase 1 safety and feasibility study of intratumoral placement of bicalutamide implants combined with radiotherapy for localized prostate cancer. (ASCO 2024) - P1 | "Patients diagnosed as one of the following: a) NCCN intermediate risk prostate cancer, b) NCCN high risk prostate cancer due to Gleason Grade 4 or 5 AND refuses to receive systemic ADT, c) NCCN high risk prostate cancer due to PSA > 20 AND refuses to receive systemic ADT. Trial Status: The study is ongoing at the NCI and 9 patients have been enrolled to date."

Clinical • P1 data • Cardiovascular • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

A Phase 1 Safety, PK and Preliminary Efficacy Study of Localized Therapy using Biolen (Bicalutamide) Implants for Early-Stage Prostate Cancer (AUA 2024) - P1 | "Our data showed that 16 implants could be safely deployed into the prostate via a minimally invasive procedure using a common image-guided transperineal approach. High drug levels in the prostate months after placement, combined with minimal systemic exposure, demonstrates proof of principle for localized delivery of bicalutamide and other antiandrogens within the prostate. This new antiandrogen delivery method could have meaningful applications for clinically localized prostate cancer patients managed with active surveillance, focal therapy, radiation therapy, or radical prostatectomy."

Clinical • P1 data • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

A Phase 1 Safety, PK and Preliminary Efficacy Study of Localized Therapy using Biolen (Bicalutamide) Implants for Early-Stage Prostate Cancer (EAU 2024) - No abstract available

Clinical • P1 data • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

Triple-Drug Therapies Usher in Sea Change for Men With High-Risk Prostate Cancer, Journal Club - Rashid Sayyid & Zachary Klaassen (Urotoday) - "...and Zach Klaassen discuss the amended AUA guidelines for advanced prostate cancer, focusing on triplet therapy for metastatic hormone-sensitive prostate cancer (mHSPC) and non-metastatic castrate-resistant prostate cancer (M0 CRPC)."

Video

Biolen-PC: A Study to Establish the Feasibility of Biolen for the Local Delivery of Bicalutamide in Patients With Prostate Cancer (clinicaltrials.gov) - P1 | N=17 | Completed | Sponsor: Alessa Therapeutics Inc. | Recruiting ➔ Completed | Trial completion date: Dec 2021 ➔ May 2023 | Trial primary completion date: Sep 2021 ➔ May 2023

Trial completion • Trial completion date • Trial primary completion date • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

Prostate specific sustained anti androgen delivery to delay early stage prostate cancer progression (AACR 2023) - "Recent data suggest that systemic anti-androgen therapy with enzalutamide reduced the risk of prostate cancer progression in men on active surveillance but was associated with considerable side effects. The design characteristics of the implant facilitates minimally invasive surgical implantation under standard image guidance and withstands the concomitant use of prostate radiation. This novel technology warrants future clinical exploration of prostate specific anti-androgen therapy for (neo)adjuvant therapy or in active surveillance.TissueBicalutamide oral (2m)(ng/g)Bicalutamide implant (6m)(ng/g)Plasma18,170 (3820)5.9 (0.2)Prostate3,809 (638)3,250 (1622)Liver35,407 (8510)11.3 (4.3)Cerebrum8,870 (1797)5.4 (0.8)Cerebellum8,737 (1550)6.2 (1.3)Spleen7,727 (1288)4.2 (0.9)Lung27,013 (2896)11.3 (4.3)Heart11,737 (3491)10.0 (1.9)Kidneys17,413 (6581)8.5 (2.0)"

Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor • STAT3

A 62-Year-Old Man with Metastatic Castration-Resistant Prostate Cancer - Episode 3: Frontline Treatment Options for mCRPC (Targeted Oncology) - "Tomasz M. Beer, MD, FACP: For initial treatment of metastatic disease when it's diagnosed, I'd be happy to expand on that. Historically, we have used conventional hormonal therapy, and the classic approach is a month of oral first-generation androgen signaling inhibitor like bicalutamide and conventional ADT [androgen deprivation therapy] with injectable, typically leuprolide."

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Biolen + RT: Bicalutamide Implants (Biolen) With Radiation Therapy in Patients With Localized Prostate Cancer (clinicaltrials.gov) - P1; N=20; Recruiting; Sponsor: Alessa Therapeutics Inc.; Not yet recruiting ➔ Recruiting

Clinical • Enrollment open • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor • MRI

Biolen + RT: Bicalutamide Implants (Biolen) With Radiation Therapy in Patients With Localized Prostate Cancer (clinicaltrials.gov) - P1; N=20; Not yet recruiting; Sponsor: Alessa Therapeutics Inc.

Clinical • New P1 trial • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor • MRI

Alessa Therapeutics Announces IND Clearance for a Study in Collaboration with the National Cancer Institute (BioSpace) - "Alessa Therapeutics, Inc...announced that the U.S. Food and Drug Administration (FDA) has accepted the Investigational New Drug application (IND) for Biolen®. Alessa, in collaboration with the Radiation Oncology Branch of the National Cancer Institute (NCI), will initiate a Phase 1 clinical study of Biolen in conjunction with radiation therapy...The first patient enrollment is anticipated in the third quarter of 2021."

IND • New P1 trial • Trial status • Genito-urinary Cancer • Oncology • Prostate Cancer

Biolen-PC: A Study to Establish the Feasibility of Biolen for the Local Delivery of Bicalutamide in Patients With Prostate Cancer (clinicaltrials.gov) - P1; N=20; Recruiting; Sponsor: Alessa Therapeutics Inc.; Trial completion date: Dec 2020 ➔ Dec 2021; Initiation date: Mar 2020 ➔ Oct 2020; Trial primary completion date: Sep 2020 ➔ Sep 2021

Clinical • Trial completion date • Trial initiation date • Trial primary completion date • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor • Urothelial Cancer

Biolen-PC: A Study to Establish the Feasibility of Biolen for the Local Delivery of Bicalutamide in Patients With Prostate Cancer (clinicaltrials.gov) - P1; N=20; Recruiting; Sponsor: Alessa Therapeutics Inc.; Not yet recruiting ➔ Recruiting

Clinical • Enrollment open

Biolen-PC: A Study to Establish the Feasibility of Biolen for the Local Delivery of Bicalutamide in Patients With Prostate Cancer (clinicaltrials.gov) - P1; N=20; Not yet recruiting; Sponsor: Alessa Therapeutics Inc.

Clinical • New P1 trial