On February 11, 2020 LIDDS reported that the last patient has been dosed in the voluntary open-label extension (OLE) of LPC-004 (Press release, Lidds, FEB 11, 2020, View Source [SID1234555897]). This means that all patients included in the clinical study have been dosed. The patients in the OLE study are followed for 6 months and the last visit will be in July 2020.

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The voluntary OLE study involves twelve patients who participated in the Liproca Depot Phase IIb clinical study. In the OLE study, a second injection of Liproca Depot was administered once the patient’s PSA level (a biomarker for prostate cancer) had returned to its level before treatment. Of 12 patients included, 6 patients were given a second Liproca Depot injection while 6 patients remained below their baseline PSA-value at the cut-off at 10 months from the initial injection of Liproca Depot.

– It is encouraging that six patients remained below their baseline PSA-value at the cut-off at 10 months from the initial injection of Liproca Depot, indicating a substantially longer effect than the earlier communicated effect of six months, says Monica Wallter, CEO of LIDDS.

All Phase II studies have shown that Liproca Depot can be an effective anti-androgen treatment without the hormonal side effects associated with current treatments that have a physical and psychological impact on patients.

The preliminary data recently released from the Phase IIb study, LPC-004, confirms that 90 % of patients receiving intraprostatic injection of Liproca Depot experienced a PSA reduction and that 16 ml is the optimal dosage for future Phase III studies.

Liproca Depot is based on LIDDS proprietary NanoZolid technology that allows active anti-cancer drugs to be injected directly into a tumour and for drugs to be released over an extended period of time. The Phase IIb study with Liproca Depot was performed 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 or intermediate 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 up to a further year to assess safety and quality of life parameters after a repeated Liproca Depot injection.