[Translation] A single-center, randomized, double-blind, placebo-controlled phase I study to evaluate the safety, tolerability, and pharmacokinetics of HL-300 ointment after single and multiple doses in healthy adult volunteers

评估HL-300软膏在中国健康成年志愿者中单次和多次局部给药后的安全性、耐受性以及PK特征。

[Translation]

To evaluate the safety, tolerability, and PK characteristics of HL-300 ointment after single and multiple topical administration in healthy Chinese adult volunteers.

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Sponsor / Collaborator

Hangzhou Highlightll Pharmaceutical Co., Ltd.

100 Clinical Results associated with HL-300

100 Translational Medicine associated with HL-300

100 Patents (Medical) associated with HL-300

Literatures (Medical) associated with HL-300

01 Oct 2022·Clinical Lymphoma Myeloma and Leukemia

HL-300 Efficacy of Brentuximab Vedotin Plus Conventional Chemotherapy Regimens as Pre–Autologous Stem Cell Transplantation Re-Induction Salvage Therapy in Relapsed/Refractory Classical Hodgkin Lymphoma

Article

Author: Kochoski, Bozidar ; Dukovski, Dushko ; Trajkova, Sanja ; Chadievski, Lazar ; Krstevska-Balkanov, Svetlana ; Popova-Labachevska, Marija ; Stojanoski, Zlate ; Milovska, Dijana ; Grivchevska, Milena ; Pivkova-Veljanovska, Aleksandra ; Cvetanoski, Milche ; Stojanovska-Jakimovska, Simona ; Ivanovski, Martin ; Ridova, Nevenka ; Panovska-Stavridis, Irina ; Jakjimovski, Mario ; Kostojchinoska, Viktorija

CONTEXTAdding brentuximab vedotin (BV) to traditional chemotherapy protocols, followed by autologous stem cell transplantation (ASCT), has effected fundamental change in the treatment approach of relapsed/refractory (R/R) classical Hodgkin lymphoma (cHL). Several studies have shown a superior rate of complete remission (CR) up to 70%-87% in patients receiving BV-based salvage chemotherapy.OBJECTIVEPrevious studies exposed pre-ASCT PET-CT negativity as the most important factor affecting the post-transplant outcome. Therefore, our objective was to evaluate the efficacy of BV-chemotherapy regimens by PET CT assessment of response rate.DESIGNSingle-center, descriptive retrospective analysis of 20 patients with R/R cHL, eligible for ASCT, treated at the University Clinic for Hematology - Skopje between January 2017 and January 2022.PATIENTS AND METHODSWe reviewed demographic and clinical characteristics pointing to disease stage and the presence of unfavorable prognostic factors, treatment, and outcome. Patients received BV-chemotherapy combinations, including BV-DHAP and BV-ICE, or PET-adapted sequential chemotherapy with BV followed by augmented ICE. In patients receiving a BV combination, PET-CT was performed after 3 cycles. In patients treated with sequential chemotherapy who did not achieve response by 3 cycles of BV and received augmented ICE, PET-CT was performed after the second cycle.RESULTSFourteen patients (70%) had refractory disease and 6 patients (30%) had relapsed disease (3 with early relapse). The majority were male (70%). The mean age at the time of assessment was 39 (range: 15-63). According to the EORTC staging system, 14 patients (70%) were initially defined to have advanced stage. Patients had received 1-3 previous treatment lines. Seven patients with refractory disease received BV-DHAP. After 3 cycles, PET negativity was achieved in 4 patients (57.1%) and these patients proceeded to ASCT. All 5 patients with relapsed disease treated with BV-DHAP achieved CR. Two patients with refractory disease received BV-ICE and both of them progressed. Among 5 patients with refractory disease receiving sequential therapy, CR was confirmed in 3 (60%). One patient with early relapse received BV-augmented ICE and achieved CR.CONCLUSIONSBV-based salvage chemotherapy is an effective treatment strategy for patients with R/R cHL, and it is reasonable to be moved forward as standard second-line therapy in R/R CD30+ cHL.

100 Deals associated with HL-300

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Indication	Highest Phase	Country/Location	Organization	Date
Dermatitis, Atopic	Phase 1	CN	Hangzhou Highlightll Pharmaceutical Co., Ltd.	29 May 2024
Plaque psoriasis	IND Approval	CN	Hangzhou Highlightll Pharmaceutical Co., Ltd.	28 Apr 2024

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