UPPSALA, SWEDEN. LIDDS AB (publ) - The last patient has been dosed in the voluntary open-label extension (OLE) of LPC-004. 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.
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.
For more information, please contact:
Monica Wallter, CEO, +46 (0)737 07 09 22, e-mail: monica.wallter@liddspharma.com
This information is such that LIDDS AB (publ) is obliged to disclose pursuant to the EU Market Abuse Regulation. The information was released for public disclosure, through the agency of the contact persons above, at 08:30 CET on February 11, 2020.
LIDDS AB (publ) is a Swedish-based pharmaceutical company with a unique drug delivery technology NanoZolid®. NanoZolid® is a 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 (LIDDS) shares are listed on Nasdaq First North Growth Market. 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.
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