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
LIDDS AB) For more information, please visit www.liddspharma.com.
