Innovation

Clinical Trials

A Phase 1/2A Dose Escalation Study of 2-hydroxyoleic acid (2-OHOA) in Adult Patients with Advanced Solid Tumours including Malignant Glioma

EudraCT  #2012-001527-13 – clinicaltrials.gov #NCT01792310

This trial is an open label, non-randomized study in patients with advanced solid tumours including malignant glioma and consists of two phases 1) a dose-escalation phase following a standard “3+3” design to establish dose-limiting toxicity (DLT) and a safe dose of 2-OHOA and 2) an expansion phase with two expanded safety cohorts (approximately 10 of whom have malignant glioma and approximately 10 of whom have other advanced solid tumours that are suitable for biopsy) treated at the maximum tolerated dose (MTD). MIN-001-1203 trial has been conducted in leading investigational sites in London, Newcastle, Barcelona, San Sebastian and Bilbao.

 

Recruitment and treatment of patients in MIN-001-1203 study have completed. A total of 54 patients have been treated, of which 46 are evaluable for safety assessment. 32 patients were recruited in 7 cohorts in the Dose-Escalation Phase and 22 patients in two safety expansion cohorts in the expanded phase. Results of the study are currently being evaluated and have confirmed an excellent safety profile, while promising clinical activity (by RANO / RECIST v1.1) has been reported in several cases, including patients with recurrent malignant glioma.

A Phase Ib Dose Finding Study of the Safety of 2-Hydroxyoleic acid sodium salt (2-OHOA) Administered Orally in Combination with Temozolomide and Radiation Therapy (Concurrent Phase) or Temozolomide Alone (Maintenance Phase) in the First Line Treatment of Subjects with Glioblastoma

EudraCT #2018-000317-21 – clinicaltrials.gov #NCT03867123

First-line treatment for patients with GBM consists of a concurrent phase (one 6-week cycle with daily administration of temozolomide (TMZ)) during which TMZ is given with Radiation Therapy (RT), followed by a rest phase (4 weeks in duration;), and a maintenance phase, during which patients receive TMZ for up to six 28-day cycles. The purpose of this study is to determine the highest safe dose of 2-OHOA administered orally in combination with temozolomide (TMZ) and radiation therapy (RT) during the concurrent phase, and in combination with TMZ alone during the maintenance phase. This study is currently recruiting participants in 3 hospitals in Spain

A Phase I Study of 2-hydroxyoleic acid in Pediatric Patients with Malignant Glioma and Other Advanced Solid Tumors.

EudraCT #2018‐000365‐37 – clinicaltrials.gov: information to be validated by the server

An open label, non-randomized study in pediatric patients with advanced high-grade gliomas and other solid tumors. The study will be performed in two phases – a dose escalation phase in up to 18 patients following a standard “3+3” design to establish dose limiting toxicity (DLT) and a “safe” dose of 2-OHOA followed by an expanded safety cohort of up to 10 patients treated at the MTD. If the MTD is well tolerated in the expanded safety cohort, that dose becomes the RP2D.

 

IND approved. Patient recruitment to open in Q2 2019 in four leading paediatric clinical research institutions in the USA lead by Hackensack UMC, NJ.

A phase IIb, randomised, double-blind, adaptive, placebo-controlled adjuvant trial in newly diagnosed glioblastoma (ndGBM) patients  to assess the efficacy and safety of 2-hydroxyoleic acid (LP561) in combination with radiotherapy and temozolomide standard of care treatment.

clinicaltrials.gov: information to be validated by the server

This is a randomized, double-blind, placebo-controlled, 3 parallel arms (1:1:1 ratio), adjuvant trial to assess the efficacy and safety of two doses of 2-hydroxyoleic acid (LP561) versus placebo in patients with newly diagnosed GBM IDH wildtype. In all arms, patients will receive the SoC and will be randomized to receive either placebo (Arm A), low-dose of LP561 (Arm B) or high-dose of 2-OHOA (Arm C).

 

PIIB Protocol design and regulatory strategy agreed with EMA (Sep. 2018) CTA process ongoing in IL, SP, FR, UK, IT & NL. Up to 25 sites planned to recruit patients as of Q1 2019

Current Public Funding

This research is supported by:

  • European Commission H2020 Framework Programme (agreement number 755179)

  • Spanish Ministerio de Economía y Competitividad and European Regional Development Fund (grant numbers RTC-2015- 3542 and RTC-2015-4094)

  • Spanish research agency (Grants DI-14-06701 and DI-17-09187)

  • Balearic Island Government and European Regional Development Fund (grants number ES01/TCAI/53_2016; PROCOE/5/2017; ES01/TCAI/21_2017)

  • Balearic Island Government and European Social Fund (grants number PD/036/2016; FPI/1981/2016; FPI/2063/2017; FPI/2177/2018)