The last patient has been enrolled in LIDDS Phase IIb study for the localized treatment of prostate cancer. The Phase IIb study will identify the optimal dose for Phase III and test the safety of Liproca® Depot and its effectiveness in stopping cancer progression. Liproca® Depot is based on LIDDS unique NanoZolid® drug delivery technology.
-We are very pleased that patient recruitment is now finalized and we look forward to concluding the study and receiving the results in third quarter this year, says Monica Wallter, CEO.
-We expect this study to show that by injecting Liproca® Depot directly into the tumor, prostate cancer progression can be stopped and patients can avoid radical surgery and radiation therapy which are associated with side effects such as sexual dysfunction and incontinence, says Monica Wallter.
-A large prostate cancer patient group is currently not receiving any treatment and Liproca® Depot has the potential to provide a new treatment regimen that will benefit healthcare providers and prostate cancer sufferers in a market worth over USD 9 billion annually, says Monica Wallter.
The Phase IIb study for Liproca® Depot includes 60 patients and is being conducted at major urology clinics in Canada, Finland and Lithuania.
LIDDS has already signed an exclusive licensing agreement for Liproca® Depot in China with the Puheng Jiangxi pharmaceutical company. Preparations are ongoing in China for a Phase III clinical study that will be fully funded by the Chinese licensee. Prostate cancer is a very common disease in China and around 500 000 patients are diagnosed each year.
-We look forward to continuing our dialogue with major pharmaceutical companies on out-licensing Liproca® Depot in the US, Europe and the rest of the world. With more than USD 3 billion currently being spent each year on localized prostate cancer treatment, Liproca® Depot can offer a new regimen that benefits patients, healthcare providers and pharmaceutical companies, says Monica Wallter.
About the study:
The study (LPC-004) consists of two parts. The first part of the study is evaluating the tolerability and safety of substantially higher doses of the anti-androgen 2-HOF (2-hydroxyflutamide) compared to earlier Phase II studies with Liproca® Depot. In the second part, consisting of 40 patients, LIDDS will receive efficacy results measured with the biomarker PSA, prostate volume, MRI data and Quality of Life reports.
In the study, patients diagnosed with a localized non-aggressive prostate cancer received intra-prostatic injections of Liproca® Depot containing NanoZolid® and the anti-androgen drug 2-HOF. All participating subjects were defined as "Active Surveillance" patients, not chosen for surgery or radiation therapy. Patients are being followed for six months to assess the anti-androgen response and cancer control.
For more information, please contact:
Monica Wallter, CEO LIDDS, +46 (0)737 07 09 22, monica.wallter@liddspharma.com
LIDDS AB (publ) is a Swedish-based pharmaceutical company with a unique drug delivery technology: NanoZolid®. NanoZolid is superior to any drug delivery technology in its ability to provide a controlled and sustained release of active drug substances for up to six months. LIDDS has licensing agreements where NanoZolid is combined with antiandrogens and in-house development projects in preclinical phase for cytostatics and immunoactive agents. LIDDS shares (LIDDS) are listed on Nasdaq First North. Redeye AB, Certifiedadviser@redeye.se, +46 (0)8 121 576 90, is a certified adviser to LIDDS. For more information, please visit www.liddspharma.com
