Currently one of the largest and most respected cancer conferences – the annual meeting of the American Society of Clinical Oncology (ASCO) – is ongoing. Over 30.000 oncology professionals (including our CEO Edwin Klumper) are attending the meeting in Chicago, Illinois. The theme of this years meeting is Illumination and Innovation: Transforming Data into Learning.
We’re particularly excited that one of our clients is presenting their first in human study at the ASCO 2015 meeting (abstract 2513) and that we have the privilege to collaborate on this trial.
Lipopharma is a Spanish biotech company with their headquarters in the always sunny Palma de Mallorca. They are focusing on “Membrane-Lipid Therapy” (MLT). Their lead compound 2-OHOA (Minerval) is a synthetic hydroxylated lipid that activates sphingomyelin synthase (SMS) and regulates the lipid content of cell membranes. This in turn results in the translocation of Ras to the cytoplasm and inactivation of several signal transduction pathways involved in cancer.
At the ASCO meeting an update is given of their ongoing phase I/IIa study with Minerval in patients with solid tumors or grade III/IV glioblastoma (GBM). This study is performed at sites in Spain and the UK with the drug being given as a PO suspension, BID in 21-day cycles. The dose escalation phase of the trial is still ongoing. Thus far the treatment was well tolerated and the pharmacokinetic profile was dose-proportional. The first 4 cohorts showed no accumulation, whereas the higher dose cohorts do. Already in the dose escalation phase of the trial promising early signs of efficacy have been seen in 4 patients. One patient with GBM has an ongoing partial response and is currently at cycle 23 of treatment and two other GBM patients achieved stable disease (SD) and remain on treatment. A fourth patient with progressive mesothelioma achieved SD which lasted up to cycle 15.
In the planned exploratory phase IIa part of the study, up to 20 patients will be enrolled in two groups. The first group will consist of patients with glioma and the second group of patients with biopsiable solid-tumors for biomarker evaluation. For Lipopharma, the ASCO annual meeting is a great opportunity to present and discuss their work with colleagues and key opinion leaders in the field.
In line with the theme of this years ASCO meeting, we at SMS-oncology turn the often complex data collected during the conduct of a clinical trial into meaningful insights on an ongoing basis. These insights can be used for the preparation of posters/presentations for conferences but can also help to make informed decisions, identify opportunities and drive risk mitigated studies. We’re always open to discuss how we could use our oncology drug development expertise and clinical experience to make a success out of your oncology projects and hopefully see the results of those at future ASCO meetings.