A new injectable flutamide formulation called Liproca Depot is safe, well-tolerated and shows sustained efficacy in untreated men with localized prostate cancer, according to early results of a Phase 2b clinical trial.
The LPC-004 Phase 2b trial (NCT03348527) is ongoing at specialist urology clinics in Canada, Lithuania, and Finland. It aims to identify the optimal dose of Liproca Depot to be used in further testing, and to demonstrate the therapy’s ability to prevent the progression of early-stage prostate cancer over a period of six months. Patient enrollment is ongoing. Find more information on locations and contacts here.
Lidds‘ Liproca Depot combines NanoZolid — a technology to deliver cancer therapies — with 2-HOF (2-hydroxyflutamide). 2-HOF is a byproduct of flutamide, which is given as oral capsules in prostate cancer treatment under the brand name Eulexin.
The experimental therapy is injected into the tumor region, after which NanoZolid forms a solid depot that will release the therapeutically active compound over a period of up to six months. This depot is absorbed harmlessly by the body as the active compound is released.
“Administering Liproca Depot is similar to performing a prostate biopsy,” Laurence Klotz, MD, professor at the University of Toronto and one of the study’s investigators, said in a press release.
Compared to Eulexin, this new delivery method is thought to increase the concentration of 2-HOF in the target tissue up to 40,000 times, according to the company.
In three clinical trials — LPC-001, LPC-002 (NCT00913263), and LPC-003 (NCT02341404) — with a total of 57 participants, Liproca Depot had already shown positive tolerability and safety data, as well as potential anti-prostate cancer activity. Higher doses showed increased effects, including greater decreases in prostate specific antigen (PSA) — a biomarker of active prostate cancer — without the hormonal side effects commonly associated with Eulexin.
Updated LPC-004 results from the first 61 men enrolled showed that Liproca Depot could effectively induce a strong and sustained reduction of PSA levels. All the men had been diagnosed with localized non-aggressive prostate cancer, were under active surveillance with low or intermediate risk of cancer progression, and were not receiving any other therapy.
Approximately 90% of the patients who had received a 16-ml dose of Liproca Depot experienced PSA reduction, with 67% showing a decrease of 15% or more. PSA decreases at month 6 were in line with those seen at months 2–4.
The findings will be presented Nov. 16 at the 11th European Multidisciplinary Congress on Urological Cancers (EMUC19), to be held in Vienna. Eligible participants in LPC-004 may be offered an opportunity to take part in an open-label extension study.
“Patients under active surveillance have a risk of cancer progression which places additional stress on them. Liproca Depot could provide an option for physicians to address an unmet medical need,” said Anders Bjartell, MD, PhD, professor and senior consultant in the department of urology at Sweden’s Skåne University Hospital, and a board member at Lidds.
“These results validate the continued clinical development of Liproca Depot,” said Monica Wallter, CEO of Lidds. Wallter further noted that the Sweden-based company has already signed a license agreement for China with Jiangxi Puheng Pharmaceuticals, which plans to conduct a Phase 3 study.
“Lidds will now continue the commercial activities in order to sign further licensing agreements in other major markets,” she said.