Lipopharma presents latest results of 2OHOA study in cancer at Bio-Europe 2015

Dose-escalation part of the MIN-001-1203 clinical study completed, confirming an excellent safety profile up to very high doses and very promising anticancer activity observed in 4 patients, including one GBM patient with sustained and almost complete tumour regression after 26 months of treatment.

Palma de Mallorca, November 3rd, 2015.– Lipopharma presented today updated results of the ongoing Phase I/IIA clinical trial with 2OHOA in patients with advanced solid tumours, including malignant glioma (MIN-001-1203), within the next-generation presentation track at Bio-Europe 2015 in Munich.

In this pitch presentation, Vicenç Tur, Lipopharma’s CEO, announced that 7 cohorts of the MIN-001-1203 study have been completed, with doses ranging from 500mg/day to 16g/day, with a total of 32 patients (12 with glioblastoma, GBM) participating in these first 7 cohorts, of which 28 have completed at least one cycle of treatment and are evaluable for safety assessment. The study drug, administered as PO suspension, 2 or 3 times daily, has been generally well tolerated up to 12 g/day, while patients have had difficulties to handle the large volume of medication required for the 16g/day (8g twice daily) dose, experiencing frequent gastrointestinal effects that in some cases were difficult to manage. No drug-related serious adverse events (SAE), or other relevant toxicity effects associated to the investigational product have been reported in any of the 32 patients treated, other than the tolerability issues experienced at the highest dose levels (gastrointestinal effects). Two additional safety expansion cohorts treated with the Maximum Tolerated Dose, one with 10 glioma patients and another with 10 patients with solid biopsiable tumours, will start in about two weeks in order to evaluate the effect of 2OHOA in different biomarkers and to further explore preliminary efficacy in glioma patients.

Although this is safety study and in the dose escalation part there are no patient selection criteria with a view of exploring efficacy, clinical benefit has been reported in 4 patients, 3 of them with GBM, including one GBM patient (ongoing) that has achieved a sustained partial response (PR) on RANO criteria (tumour shrinkage ˃91%) lasting now for more than 26 months. Two other GBM patients have had Stable Disease (SD) for 6 months and a fourth patient with progressive mesothelioma had SD lasting up to cycle 15 (10 months).

Lipopharma announced also that, following the excellent results of the MIN-001-1203 PI/IIa study, the company will shortly open a new financial round in order to rise funds to conduct a PIIb study with 2OHOA in GBM which, if successful, could lead to a conditional approval in Europe for the treatment of newly-diagnosed GBM in combination with radiotherapy and temozolomide.

Bio-Europe is the most important bio-partnering event held in Europe, bringing together close to 3.500 top executives from biotechnology and pharmaceutical companies, leading specialized investors and scientific thought leaders from all around the world. Lipopharma attended this year's edition of Bio-Europe in Munich with the objective of pursuing ongoing contacts with key industry players, as well as to explore new additional collaborations with potential industrial partners and investors that would facilitate the development of its innovative MLT-based R&D programs.



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