Liproca Depot (hydroxyflutamide) / Lidds, Jiangxi Puheng Pharma - LARVOL DELTA

LIDDS Interim report January – March 2021 (GlobeNewswire) - "JANUARY – MARCH 2021...Net sales amounted to MSEK 0.6 (0.0); New patients were recruited to the dose escalation part of the Phase I study NZ-DTX-001 where intratumoral injection of NanoZolid® in combination with docetaxel is being evaluated; The scientific journal European Urology Focus has accepted a scientific article describing LIDDS Phase IIb study results with Liproca® Depot; LIDDS has signed a manufacturing agreement for NZ-TLR9 with Pharmidea in Latvia; LIDDS has signed an R&D agreement with Johnson & Johnson Enterprise Innovation Inc. to develop an oncology product based on the NanoZolid® technology; LIDDS Chinese license partner, Puheng Pharma, informed that an international phase III multicenter study will be required, prior to market registration for Liproca Depot. Puheng Pharma will therefore not apply for Conditional Market Approval (CMA)."

Clinical • Enrollment status • Licensing / partnership • Sales • Oncology • Solid Tumor

LIDDS updates on the Clinical Program for Liproca Depot (GlobeNewswire) - "LIDDS AB (publ) announced today an update on the clinical program for the prostate cancer drug candidate Liproca® Depot. Based on the interactions that LIDDS’ licensee for China, Jiangxi Puheng Pharma, has had with the Chinese National Medical Products Administration (NMPA) it is recommended that clinics in China participate in an international multicenter study...LIDDS and Jiangxi Puheng Pharma has decided to plan a multicenter Phase III study...The aim is to launch the Phase III study in 2022."

New P3 trial • Non-US regulatory • Genito-urinary Cancer • Oncology • Prostate Cancer

LIDDS Interim report January – December 2020 (GlobeNewswire) - “LIDDS licensee Jiangxi Puheng Pharma is therefore aiming to submit the application for CMA for the prostate cancer drug candidate Liproca® Depot in China during Q1, 2021.”

Non-US regulatory • Genito-urinary Cancer • Oncology • Prostate Cancer

LIDDS and Pharmidea signs manufacturing agreement (GlobeNewswire) - “LIDDS…announced today that a collaboration agreement has been signed with the R&D and Production company PharmIdea…The collaboration enables LIDDS to expand the manufacturing of new product candidates, e.g. including biomolecules and cytostatics, in addition to the already existing collaboration with Recipharm for Liproca Depot…LIDDS is preparing a clinical Phase I trial with intratumoral injections of NZ-TLR9 for treatment of solid tumors in patients with head/neck-, breast cancer, melanoma, sarcomas and lymphomas.”

Licensing / partnership • Trial status • Breast Cancer • Head and Neck Cancer • Hematological Malignancies • Lymphoma • Melanoma • Oncology • Sarcoma • Solid Tumor

Liproca Depot: A New Antiandrogen Treatment for Active Surveillance Patients. (PubMed, Eur Urol Focus) - "PSA and prostate volume decreased in most patients. Indications of efficacy were shown by post-treatment MRI and biopsies demonstrating stabilization or regression in the majority of cases."

Clinical • Journal • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

European Urology Focus has accepted a scientific article describing LIDDS Phase IIb study results with Liproca Depot (GlobeNewswire) - P2b; N=61; LPC-004 (NCT03348527); Sponsor: Lidds AB; “LIDDS…announces that a scientific article will be published in the highly ranked European Urology Focus describing LIDDS clinical Phase IIb study, LPC-004, and its clinical results. The study met both primary and secondary endpoints by confirming efficacy and safety with Liproca Depot given as intraprostatic injection in low- and intermediate risk prostate cancer patients…Efficacy was shown by a maintained PSA decrease over 6 months, lower prostate volume and unchanged or improved MRI results. No hormonal side effects were shown.”

P2b data • Genito-urinary Cancer • Oncology • Prostate Cancer

Update on Chinese Conditional Market Approval (CMA) for Liproca Depot (GlobeNewswire) - "LIDDS AB (publ) A newly revised guideline from the Chinese National Medical Products Administration (NMPA) has extended the requirements to a full registration dossier for the conditional market approval (CMA). LIDDS licensee Jiangxi Puheng Pharma is therefore aiming to submit the application for CMA for the prostate cancer drug candidate Liproca® Depot in China during Q1, 2021."

Non-US regulatory • Genito-urinary Cancer • Oncology • Prostate Cancer

LIDDS Announces Data on Liproca Depot from Open Label Extension Study (GlobeNewswire) - P2b, N=60; NCT03348527; Sponsor: Lidds AB; "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 %."

P2b data • Genito-urinary Cancer • Oncology • Prostate Cancer

LIDDS licensee, Puheng Pharma, evaluates a novel expeditated regulatory path for Liproca Depot in China (GlobeNewswire) - "LIDDS...announces that its licensee Jiangxi Puheng Pharma is currently preparing documentation for an application targeting a newly issued regulatory guideline in China on conditional market approval (CMA) for the prostate cancer drug candidate Liproca® Depot...We plan to submit the application to NMPA this autumn."

Non-US regulatory • Genito-urinary Cancer • Oncology • Prostate Cancer

Liproca phase IIb study results indicate cancer control (GlobeNewswire) - P2b, N=60; NCT03348527; Sponsor: Lidds AB; "LIDDS AB...announces that final data from the LPC-004 study confirms Liproca® Depot’s potential as a safe and effective anti-androgen treatment for prostate cancer patients that currently are not treated but kept under ‘Active Surveillance’. The study met both primary and secondary endpoints...95% of the patients showed a decrease in PSA57% of the patients were classified as responders at month. PSA maximum response rate during the study period was 67%."

P2b data • Genito-urinary Cancer • Oncology • Prostate Cancer

LIDDS announces positive meeting with the Swedish Medical Products Agency, confirming the Liproca depot phase III study design (GlobeNewswire) - "LIDDS AB (publ) announces that the company has received positive responses from the Swedish Medical Products Agency (MPA) regarding the proposed design of the Phase III study of Liproca® Depot for patients with localized prostate cancer, within the intermediate risk group. The Swedish MPA decision is an important validation of LIDDS study results and Liproca® Depot’s potential and is a central part of the Company’s Phase III preparations."

Clinical protocol • European regulatory • Genito-urinary Cancer • Oncology • Prostate Cancer

LIDDS: Liproca Depot effects on prostate cancer to be presented at the Paris Symposium for Magnetic Resonance in Medicine (GlobeNewswire) - "The scientific results from intratumoral injections with Liproca® Depot as confirmed by Magnetic Resonance Imaging and Spectroscopy, have been accepted for presentation at the International Society for Magnetic Resonance in Medicine (ISMRM) in Paris in June 2018. The spectroscopy demonstrates metabolic atrophy and antitumor effects from Liproca® Depot."

Clinical • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor • Urothelial Cancer

LIDDS interview with the LPC-004 study investigator, professor Laurence Klotz, about the LIDDS Liproca depot phase IIb study results (GlobeNewswire) - “An interview with Professor Laurence Klotz, one of the LPC-004 study investigators was done in connection to the 11th European Multidisciplinary Congress on Urological Cancers, EMUC19 in which he summarizes the study results. At the conference, the Phase IIb clinical data from the LIDDS study LPC-004 prostate cancer study on Liproca® Depot was presented by Professor Klotz in an oral session at EMUC19 as 'Late Breaking News' on November 16, 2019.”

P2 data

LIDDS Liproca Depot phase IIb study results presented at EMUC19 showing both primary and secondary endpoints being met (GlobeNewswire, LIDDS AB) - P2, N=60; LPC-004 (NCT03348527); "The study met both its primary and secondary endpoints as well as demonstrated that a larger proportion of intermediate risk patients, which is the Liproca Depot target group, are PSA responders...The preliminary data recently released from the phase IIb study, LPC-004, confirms that 90 % of patients receiving 16 ml intraprostatic injection of Liproca® Depot experienced a PSA reduction and also that 16 ml is the optimal dosage for future Phase III studies. Further, the study showed no systemic hormonal adverse reactions, that Liproca® Depot is safe and well tolerated by the patients, and that 84 % of patients being treated were amenable to a second injection of Liproca® Depot."

P2 data

LIDDS licensee Jiangxi Puheng Pharma prepares for phase III trial in China (GlobeNewswire, LIDDS AB) - "LIDDS AB (publ) Jiangxi Puheng Pharma has after reviewing the preliminary results in LPC-004 decided to move ahead and has initiated discussions with Chinese medical authority, CFDA. The phase III study protocol will be developed in close collaboration with LIDDS....LIDDS signed in 2018 an exclusive license agreement for Liproca® Depot for Mainland China with Jiangxi Puheng Pharma, a company focusing on oncology and immuno-oncology. Liproca® Depot, is an injectable cancer drug candidate for local treatment of prostate cancer. LIDDS is with Liproca® Depot targeting patients under Active Surveillance with intermediate risk of progression, a patient group that are not getting surgery or radiation."

Clinical • Clinical data • Commercial

LIDDS: Liproca Depot open label extension study indicates PSA reduction for up to one year (GlobeNewswire) - "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."

Clinical data

Preliminary results from Phase IIb Liproca Depot dose-finding study show a strong maximum PSA decrease and sustained PSA reduction effect (GlobeNewswire) - P2, N=60; LPC-004 (NCT03348527); Sponsor: Lidds AB; "LIDDS has today announced 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...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."

Clinical data

LIDDS: Final patient enrolled in Phase IIb Liproca® Depot prostate cancer study (GlobeNewswire, LIDDS AB) - “The last patient has been enrolled in LIDDS Phase IIb study for the localized treatment of prostate cancer. The Phase IIb study will identify the optimal dose for Phase III and test the safety of Liproca® Depot and its effectiveness in stopping cancer progression….patient recruitment is now finalized and we look forward to concluding the study and receiving the results in third quarter this year…The Phase IIb study for Liproca® Depot includes 60 patients and is being conducted at major urology clinics in Canada, Finland and Lithuania.”

Enrollment closed