UPPSALA, SWEDEN – LIDDS AB (publ) announces that a scientific article will be published in the highly ranked European Urology Focus describing LIDDS clinical Phase IIb study, LPC-004, and its clinical results. The study met both primary and secondary endpoints by confirming efficacy and safety with Liproca Depot given as intraprostatic injection in low- and intermediate risk prostate cancer patients.
“We are pleased that this manuscript is accepted in a highly recognized scientific paper and the results further validates NanoZolid® as being an innovative technology platform,” said Monica Wallter, CEO of LIDDS.
Liproca Depot, which comprises the NanoZolid technology combined with an antiandrogen drug (2-hydroxyflutamide) injected into the prostate, met both the primary and secondary endpoints in the study. Efficacy was shown by a maintained PSA decrease over 6 months, lower prostate volume and unchanged or improved MRI results. No hormonal side effects were shown. LIDDS concludes that Liproca® Depot can be a new potential local treatment that is effective in controlling cancer for intermediate risk patients under “Active Surveillance”. The manuscript has the title “Liproca Depot – A new antiandrogen treatment for active surveillance patients" and is planned to be published on the European Urology Focus webpage during February.
“The results confirm that Liproca® Depot can offer a completely novel approach to complement active surveillance in intermediate risk prostate cancer patients. Liproca® Depot is well tolerated without the hormonal side effects otherwise associated with anti-androgen therapy and is equally easy to administer as performing a prostate biopsy. Liproca® Depot treatment could contribute to the benefit of prostate cancer patients in the future, says Professor Laurence Klotz, a world leading expert and one of the study investigators and Professor at the University of Toronto Division of Urology.
The NanoZolid® technology has during the last years been shown to enable a local controlled release of a wide range of drugs following a single injection, resulting in stable and pharmacologically relevant effects over the desired time-period, to overcome issues with systemic adverse effects or local frequent treatments. LIDDS has active projects where NanoZolid is successfully combined with cytotoxic- and immune modulating compounds with the intention to treat solid cancer tumors.
About the LPC-004 study
The LPC-004 study was a single blind, two-part dose finding study aimed to determine the highest tolerable dose of Liproca® Depot and to determine the level of PSA reduction for part II patients at month 5 (primary endpoints). The study was conducted at specialist urology clinics in Canada, Lithuania and Finland. The study involved 61 patients diagnosed with localized non-aggressive prostate cancer who were on Active Surveillance. Patients were followed for six months to assess response and tolerability. Following the LPC-004 study, a voluntary open label extension study was initiated offering patients a second injection of Liproca® Depot once the patient’s PSA level had returned to its pre-treatment level. Results showed that 50 % of the patients in the open label extension study remained at low PSA levels for at least 10 months from their first Liproca® Depot injection and were therefore not treated with a second injection.
For more information, please contact:
Monica Wallter, CEO, +46 (0)737 07 09 22, e-mail: 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 for cytostatics and immunoactive agents. LIDDS shares are listed on Nasdaq First North (LIDDS). Redeye AB is the Certified Adviser to LIDDS (+46 (0) 8 121 576 90, email: certifiedadviser@redeye.se) For more information, please visit www.liddspharma.com.