Data from a voluntary open label extension (OLE) study indicates longer PSA effect with Liproca Depot in prostate cancer patients than anticipated.
In half of the patients it has taken between 8 to 10 months from the initial Liproca Depot injection until they have returned to the same PSA levels as before treatment. In some patients the PSA levels remain below baseline PSA for at least 12 months.
The voluntary open label extension (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.
“The results from the OLE study is very promising as it indicates a longer anti-androgen effect with Liproca Depot treatment than anticipated, and substantially longer 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.
“90% of patients who have participated in the voluntary open label extension study say they would be prepared to be treated with Liproca Depot again,” says Monica Wallter.
Liproca Depot is based on LIDDS 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.
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.