Model ACB2003.4 - Sphingosine 1-Phosphate Lyase Inhibitor
Our medical objective is to validate and bring to clinical use, a novel approach to improve the treatment of metastatic pancreatic adenocarcinoma using a proangiogenic molecule S1P lyase inhibitor acting as a tumor vascular normalizer.
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Our S1P lyase inhibitor ACB2003.4, patented for on...
Our S1P lyase inhibitor ACB2003.4, patented for oncology applications, is a repurposed molecule LX2931/LX3305 originally developed by Lexicon Pharmaceuticals Inc. in the United States for the treatment of rheumatoid arthritis. All pre-clinical and regulatory studies were completed for this molecule in accordance with U.S. regulatory guidelines, and Phase 1 and 2 clinical studies were conducted under an Investigational New Drug application (IND). As part of a collaboration agreement with Lexicon Pharmaceuticals Inc., we have now been granted the rights to use this drug in oncology applications and to make use of all their previous pharmacological, CMC and clinical trial Phase 1 data; favourable comments received from a Scientific Advice submitted to the European Medicines Agency (EMA) for oncology applications now clears the way for a CTA to the regulatory authority in France to commence with a clinical trial Phase 2/3 in mid-2022. Clinical trials will be carried out at the Salpétrière Hospital in Paris.
A successful clinical proof of concept study in metastatic pancreatic adenocarcinoma patients would provide a premise for a similar strategy to be implemented for all poorly vascularized solid tumors, thus, providing a transformative new standard for cancer treatment.
Pancreatic cancer is characterized by excessive de...
Pancreatic cancer is characterized by excessive dense extracellular matrix deposition associated to vascular collapse and hypoxia with low
drug delivery, explaining at least partly the low efficacy of antiangiogenic drugs in this cancer (Longo et al. 2016, Katsuta et al., 2019).
Frequent failures of chemotherapy treatments in clinical applications are due to their inability to reach the tumor cells, particularly in instances of a vascular disruption of abnormal tumor vessels. Re-instating vascular normalization is therefore one of the key prerequisites for efficient therapy.
The proangiogenic S1P metabolism modulators act as a tumor vascular normalizer. They work by re-building a functional vascular network, thereby improving the blood flow to – and oxygenation of – tumor tissue. Along these lines, and based on clinical observations, the company has developed a new paradigm – in contrast to the prevailing antiangiogenic doctrine – in the form of a neo-adjuvant therapy using a proangiogenic molecule acting as a tumor vascular normalizer and in fine improving drug delivery and treatment efficacy for all type of chemotherapy (except those with antiangiogenic molecules) and radiotherapy. Experimental proof of concept has been demonstrated both in clinical observations and also in a mouse model bearing a pancreatic adenocarcinoma where the combination of gemcitabine and S1P lyase inhibitor displayed a strong antitumor superiority compared to gemcitabine alone.
A functional plasmatic biomarker has been identified, allowing the selection of a subpopulation of eligible patients for such therapy.
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