Preliminary data from a voluntary open label extension (OLE) study indicates that the time to re-treatment with Liproca® Depot in prostate cancer patients is potentially longer than anticipated. This information comes from the OLE phase of the Phase IIb study, LPC-004. Data from the main study is currently being collected according to plan. Preliminary study results will be available during the third quarter of this year.
The voluntary open label extension (OLE) study involves a number of patients who participated in the Liproca® Depot Phase IIb clinical study. In the OLE phase, a second injection of Liproca® Depot was administered once the patient's PSA level (a biomarker for prostate cancer) had returned to its pre-treatment level.
-Preliminary information from the OLE study looks promising as it indicates a longer than expected anti-androgen effect from Liproca® Depot treatment, says Monica Wallter, CEO of LIDDS.
Earlier Phase II studies have shown that Liproca® Depot can be an effective anti-androgen treatment without the resulting hormonal side effects associated with current treatments that have a physical and psychological impact on patients.
- Patients who have participated in the voluntary open label extension study so far say they would be prepared to be treated with Liproca® Depot again, says Monica Wallter.
Liproca® Depot is based on LIDDS proprietary NanoZolid® technology that allows active anti-cancer drugs to be injected directly into a tumor and for the drugs to be released over an extended period of time. Liproca® Depot is currently in the final stage of a Phase IIb study at clinics in Canada, Finland and Lithuania.
One in every six men is diagnosed with prostate cancer and there is currently no standard drug treatment for prostate cancer patients at low risk of progression. The global drug market for prostate cancer is expected to grow to more than USD 8 billion by 2022.
Facts about the open label extension (OLE) study:
The voluntary OLE study involves patients who participated in the Liproca® Depot Phase IIb clinical study. A second injection of Liproca® Depot was administered once the patient's PSA level (a biomarker for prostate cancer) had returned to its pre-treatment level.
The rationale for conducting the OLE study is to understand the long-term anti-androgen efficacy of Liproca® Depot and to follow these patients for a further year to assess safety and quality of life parameters after a repeated Liproca® Depot injection.
For more information, please contact:
Monica Wallter, CEO, +46 (0)737 07 09 22, monica.wallter@liddspharma.com
LIDDS is required to disclose the information in this press release under the European Union's Market Abuse Regulation. The information was submitted through the agency of the aforementioned contact person for publication on 6 May 2019 at 08.45 CET.
LIDDS AB (publ) is a Swedish-based pharmaceutical company with a unique drug delivery technology: NanoZolid®. NanoZolid is clinically validated drug development technology and superior 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 clinical and 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