On September 24, 2019 LIDDS has reported preliminary data from the LPC-004 study that aimed to determine the tolerability of Liproca Depot and the Prostate-Specific Antigen (PSA) effect at month 5 on patients in part II of the study (Press release, Lidds, SEP 24, 2019, View Source [SID1234555904]).
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The PSA reduction for part II patients was in line with the expected pattern for Liproca Depot’s sustained release and maximum PSA reduction (PSA nadir) occurred during months 2-4. The patients in part II showed a strong PSA decrease and a continued PSA reduction at month 5 as well as over the full study period of six months, confirming the NanoZolid technology’s sustained release profile.
67 % of patients receiving 16 ml dose were determined as responders. A responder is defined as a patient experiencing a PSA decrease of 15% or more. 90% of patients who received a 16 ml injection experienced a PSA decrease during their Liproca Depot treatment.
The positive preliminary results show Liproca Depot’s ability to reduce PSA levels over a period of six months, proving the NanoZolid technology´s suitability for local cancer treatment. The study also confirms the technology’s favorable toxicity and tolerability profile.
All patients in the study were under Active Surveillance with low or intermediate risk of cancer progression and these patients currently receive no treatment.
– Patients under Active Surveillance have a risk of cancer progression which places additional stress on them. Liproca Depot could provide an option for physicians to address an unmet medical need, says Anders Bjartell, Professor and Senior Consultant at the Department of Urology, Skåne University Hospital, and LIDDS Board Member.
– Liproca Depot was well tolerated without the hormonal side effects associated with anti-androgen therapies and a majority of patients in the study were positive to receiving a second injection. Administering Liproca Depot is similar to performing a prostate biopsy, says Professor Laurence Klotz, a world leading expert and one of the study investigators and Professor at the University of Toronto Division of Urology.
– These results validate the continued clinical development of Liproca Depot. LIDDS has already signed a license agreement for China with the pharmaceutical company Jiangxi Puheng which plans to conduct and finance a Phase III study. LIDDS will now continue the commercial activities in order to sign further licensing agreements in other major markets, says Monica Wallter, CEO, LIDDS.
Professor Klotz will present the Phase IIb study results in detail at the 11th European Multidisciplinary Congress on Urological Cancers (EMUC19) in Vienna, Austria, on November 16, 2019. A paper reporting the results of the Phase IIb study will be submitted to leading scientific journals for publication.
For more background information about the Phase IIb Liproca Depot clinical trial, please see enclosed file.
About prostate cancer and the market:
Of the 1.2 million men diagnosed with prostate cancer globally each year, about 420,000 are assessed as intermediate risk and placed on ‘Active Surveillance’ where they are monitored regularly. There is no standard drug treatment for these cancer patients and many treating doctors see an unmet need.
According to 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 exceeding USD 3 billion per year.