LIDDS has received positive responses from the Swedish Medical Products Agency and Phase IIb study results indicate cancer control.
The company has received positive responses from the Swedish Medical Products Agency (MPA) regarding the proposed design of the Phase III study of Liproca Depot for patients with localized prostate cancer, within the intermediate risk group. The Swedish MPA decision is an important validation of LIDDS study results and Liproca Depot’s potential and is a central part of the company’s Phase III preparations, it states.
An important milestone
The proposed study design, discussed with the MPA, involves patients with localized prostate cancer, having an intermediate risk profile. The phase III primary endpoint is time to disease progression, prompting a radical treatment (i.e. surgery or radiation), over 24 months for Liproca Depot compared to an active surveillance schedule. The Swedish MPA also confirmed that a single Phase III study can be sufficient for a future registration of Liproca Depot, provided positive results. The MPA proposed no changes to LIDDS’ suggested study design.
“The meeting with the MPA is an important milestone in the planning of the Phase III study and it confirms LIDDS’ strategy to offer local cancer control treatment for this patient category. Liproca Depot will benefit prostate cancer patients both in terms of efficacy and maintained quality of life. Prostate cancer is a fast-growing cancer disease and the incidence level is expected to increase with 80 percent globally until 2040. Therefore, research and development in this field is of great importance,” says Monica Wallter, CEO of LIDDS.
Study results indicate cancer control
In addition, LIDDS has announced that final data from the LPC-004 study confirms Liproca Depot’s potential as a safe and effective anti-androgen treatment for prostate cancer patients that currently are not treated but kept under ‘Active Surveillance’. The study met both primary and secondary endpoints. MRI data shows no progression of the prostate cancer in any patients, and even regression in some patients. The final study data completes the LIDDS data room needed for external parties that are interested in licensing or acquiring Liproca Depot.
The best efficacy was seen in the group that received 16 ml injection; 95% of the patients showed a decrease in PSA, 57% of the patients were classified as responders at month, PSA maximum response rate during the study period was 67%. And the MRI analyses showed that PI-RADS score was unchanged or improved for all patients, in the second part of the study, 7 of the 41 patients showed an improvement in PI-RADS score at month 5, which indicates lower grade of cancer
After an optional biopsy, taken by 6 patients, 5 patients were stable while 1 patient showed a decrease in Gleason score (less aggressive cancer).
“The results from the final analysis confirm the benefits seen in earlier studies and from the preliminary results already presented. Our objective is to control prostate cancer with Liproca Depot. We are pleased to see the promising biopsy and MRI results, indicating disease control and tumor regression,” says Wallter.
The safety and quality of life assessment also showed positive results.
“Patients are placed under Active Surveillance today to avoid the unfavorable side effect profile of the treatments currently available. Liproca Depot is an appealing drug candidate as it has no hormonal side effects, does not alter erectile function, and is free of long-term side effects. In addition, it is easy to administer,” says Laurence Klotz, one of the study investigators and Professor at the University of Toronto Division of Urology at the Sunnybrook Health Sciences Centre in Canada.
Photo of Monica Wallter: LIDDS