Safety and Pharmacokinetics of Oleylphosphocholine (OlPC), Administered Orally in Healthy Adults: A Phase 1, Single Center, Open-label, Staggered, Dose-escalation Trial

The goal of this interventional study is to assess the safety and tolerability of OlPC and to characterize the pharmacokinetics (PK) of OlPC following single, ascending doses administered orally in healthy-fed subjects.

Start Date21 Jun 2023

Sponsor / Collaborator

University Hospital Tübingen

100 Clinical Results associated with Oleylphosphocholine

100 Translational Medicine associated with Oleylphosphocholine

100 Patents (Medical) associated with Oleylphosphocholine

Literatures (Medical) associated with Oleylphosphocholine

01 Feb 2024·Thoracic Cancer

A study protocol for an open‐label, single‐arm, single‐center phase I clinical study on tolerability, safety, and efficacy of dalpiciclib combined with apatinib in the treatment of patients with advanced or metastatic sarcoma

Article

Author: Huang, Huiying ; Cao, Baoshan ; Zhang, Hua

AbstractIntroductionThe prognosis of patients with advanced or metastatic sarcoma is very poor, and a new strategy for patients who fail systemic treatment is urgently required. Apatinib is a small molecule tyrosine kinase inhibitor of VEGFR‐2, which can exert an antitumor effect by blocking downstream PI3K/AKT and VEGFR2/STAT3 signaling pathways of sarcoma. Dysregulation of the cyclin D (CCND)‐cyclin‐dependent kinase 4/6 (CDK4/6)‐retinoblastoma 1 (Rb) pathway is highly prevalent in sarcoma. Thus, blocking VEGFR2 and CDK4/6 may exert a synergistic effect. We hypothesize that a combination of apatinib and dalpiciclib, an oral, highly effective, and selective small molecule CDK4/6 inhibitor, may result in higher antitumor efficacy in patients with refractory sarcoma.MethodsIn this open‐label, single‐arm, single‐center phase I trial, participants diagnosed with sarcoma who failed standard systemic treatment will be enrolled. Dose escalation will be conducted into three groups according to traditional 3 + 3 principle: dose 1, dalpiciclib 100 mg once daily oral d1‐21+ apatinib 250 mg once daily oral d1‐28, every 28 days as one cycle; dose 2, dalpiciclib 100 mg d1‐21+ apatinib 500 mg d1–28; dose 3, dalpiciclib 150 mg d–21+ apatinib 500 mg d1–28. The primary endpoint is the safety and tolerability of combined treatment. The secondary endpoint is to evaluate the initial efficacy, including objective response rate (ORR), disease control rate (DCR), duration of response (DoR), and progression‐free survival (PFS).DiscussionThis trial will provide evidence of the tolerability, safety, and efficacy of dalpiciclib in combination with apatinib in metastatic sarcoma patients who have failed first‐line systemic treatment.

05 Jul 2023·The Journal of antimicrobial chemotherapy

Efficacy of oleylphosphocholine in experimental cutaneous leishmaniasis.

Article

Author: Croft, Simon L ; Mcarthur, Kerri-Nicola ; Van Den Heuvel, Dennie ; Yardley, Vanessa ; Platteeuw, Johannes J ; Dixon, Jodie ; Harris, Andy ; Van Bocxlaer, Katrien ; Alavijeh, Mo

OBJECTIVESCutaneous leishmaniasis (CL) is a neglected tropical disease causing a range of skin lesions for which safe and efficacious drugs are lacking. Oleylphosphocholine (OLPC) is structurally similar to miltefosine and has previously demonstrated potent activity against visceral leishmaniasis. We here present the in vitro and in vivo efficacy of OLPC against CL-causing Leishmania species.METHODSThe antileishmanial activities of OLPC were evaluated and compared with miltefosine in vitro against intracellular amastigotes of seven CL-causing species. Following the confirmation of significant in vitro activity, the performance of the maximum tolerated dose of OLPC was evaluated in an experimental murine model of CL followed by a dose-response titration and the efficacy evaluation of four OLPC formulations (two with a fast-release and two with a slow-release profile) using bioluminescent Leishmania major parasites.RESULTSOLPC demonstrated potent in vitro activity of the same order as miltefosine in the intracellular macrophage model against a range of CL-causing species. A dose of 35 mg of OLPC/kg/day administered orally for 10 days was well-tolerated and able to reduce the parasite load in the skin of L. major-infected mice to a similar extent as the positive control paromomycin (50 mg/kg/day, intraperitoneally) in both in vivo studies. Reducing the dose of OLPC resulted in inactivity and modifying the release profile using mesoporous silica nanoparticles led to a decrease in activity when solvent-based loading was used in contrast to extrusion-based loading, which had no impact on its antileishmanial efficacy.CONCLUSIONSTogether, these data suggest that OLPC could be a promising alternative to miltefosine treatment for CL. Further investigations exploring experimental models with additional Leishmania species and skin pharmacokinetic and dynamic analyses are required.

01 Oct 2021·Thoracic CancerQ3 · MEDICINE

Study protocol: A single‐arm, multicenter, phase II trial of camrelizumab plus apatinib for advanced nonsquamous NSCLC previously treated with first‐line immunotherapy

Q3 · MEDICINE

ArticleOA

Author: Xu, Ziyi ; Zhong, Wei ; Chi, Yujia ; Wang, Mengzhao ; Zhao, Jun ; Li, Junling ; Xing, Puyuan

AbstractBackgroundFor advanced nonsquamous non‐small cell lung cancer (NSCLC), the mechanisms of resistance to first‐line immunotherapy are not clear. Immune checkpoint inhibitors (ICIs) in combination with agents targeting other pathways may serve as second‐line therapy options. Apatinib (a vascular endothelial growth factor receptor 2 tyrosine kinase inhibitor) could increase the efficacy of camrelizumab (an ICI agent). The efficacy and safety of this combination regimen as a second‐line therapy for NSCLC patients after failure on first‐line immunotherapy has not previously been evaluated.MethodsIn this single‐arm, multicenter, phase II trial, metastatic nonsquamous NSCLC patients previously treated with single‐agent ICI or ICI plus chemotherapy will be enrolled. Participants will receive intravenous camrelizumab 200 mg D1 and oral apatinib 250 mg D1‐21 for a 21‐day cycle. The study treatment will continue until disease progression, unacceptable toxicity, or withdrawal of consent. The primary endpoint is progression‐free survival by investigator. Secondary endpoints are overall survival, objective response rate, disease control rate, duration of response by investigator, quality of life, safety, and toxicity.ConclusionsThis trial will provide evidence of the benefit of treatment with camrelizumab combined with apatinib in advanced nonsquamous NSCLC patients who were previously treated with first‐line immunotherapy.

100 Deals associated with Oleylphosphocholine

R&D Status

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Indication	Highest Phase	Country/Location	Organization	Date
Chagas Disease	Phase 1	-	Max-Planck-Innovation GmbH	-
Cryptosporidiosis	Phase 1	-	Dafra Pharma NV	-
Cryptosporidiosis	Phase 1	BE	-	-
Cryptosporidiosis	Phase 1	-	Max-Planck-Innovation GmbH	-
Leishmaniasis	Phase 1	-	Max-Planck-Innovation GmbH	-
Leishmaniasis	Phase 1	-	Dafra Pharma NV	-
Leishmaniasis	Phase 1	BE	-	-
Mycoses	Phase 1	-	Dafra Pharma NV	-
Mycoses	Phase 1	-	Max-Planck-Innovation GmbH	-
Mycoses	Phase 1	BE	-	-

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