UPPSALA, SWEDEN – LIDDS AB (publ) announced today results from the voluntary open-label extension (OLE) of LPC-004 in prostate cancer following the Liproca® Depot Phase IIb. Results showed that 50 % of the patients 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. PSA levels in the remaining six patients were in average reduced by 28 % at 2 months post treatment and reduced PSA levels remained in 2 patients at the end of the study with PSA reductions of 43 % and 73 %.
The voluntary OLE study involved twelve patients who participated in the Liproca® Depot Phase IIb clinical study. These were to receive a second Liproca® Depot injection, within 6-10 months from the initial injection, when their PSA levels had returned to the pre-study levels. 50 % of the patients (6 of 12) 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.
The patients who received a second Liproca® Depot injection (6 of 12) were followed for another 6 months and their PSA levels were monitored. At 2 months post treatment, PSA levels were in average reduced by 28 %. PSA levels remained reduced over the full study period in 2 of the treated patients – PSA reductions were 43 % and 73 %, respectively.
-The rationale for conducting the OLE study was to understand the long-term anti-androgen efficacy of Liproca® Depot after a repeated injection and these results have strengthened our data package. The results are encouraging for prostate cancer patients placed under Active Surveillance given that they indicate a substantially longer effect, and thereby potentially controlling the prostate cancer. In addition to that, Liproca® Depot has no hormonal side effects and does not alter erectile function, which are seen with conventional anti-androgen treatment, said Monica Wallter, CEO of LIDDS.
Of the 1.3 million men diagnosed with prostate cancer globally each year, about 420,000 are assessed as intermediate risk and candidates for ‘Active Surveillance’ where they are monitored regularly. There is no standard treatment for these cancer patients and many treating physicians see an unmet need. According to the market research firm GlobalData, the global market for prostate cancer drugs is expected to grow to USD 8.3 billion annually by 2023. Liproca® Depot’s target group is an untapped market, potentially USD 3 billion per year.
About Liproca® Depot and NanoZolid®
NanoZolid® is a safe, flexible and functional method of delivering drugs. When injected, NanoZolid® forms a solid depot releasing the active drug over periods of up to six months or more. As it releases its drug load, the NanoZolid® depot dissolves and is absorbed harmlessly into the body.
Liproca® Depot is based on LIDDS proprietary NanoZolid® technology that allows active anti-cancer drugs to be injected directly into a tumor and for drugs to be released over an extended period of time. Liproca® Depot combines NanoZolid® and 2-HOF (2-hydroxyflutamide), a well-established prostate cancer drug. Liproca® Depot’s target group is patients under Active Surveillance (AS) with intermediate risk of cancer progression. The Phase IIb study with Liproca® Depot was performed at clinics in Canada, Finland and Lithuania.
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 on September 30, 2020 at 08:30 CET.
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, firstname.lastname@example.org, +46 (0)8 121 576 90, is a certified adviser to LIDDS. For more information, please visit liddspharma.com.