Today, Saol Therapeutics, a privately held, clinical-stage pharmaceutical company, announced an exciting new agreement with Medosome Biotec, LLC that will allow them to use their patented genotype test for all potential indications where SL-1009 might be used as a therapy. The genotype test can identify mutations in the GSTZ1 enzyme, which helps to categorize individuals as fast or slow metabolizers of DCA (SL-1009). By utilizing this genotype testing, Saol will be able to customize dosing for individual patients, potentially reducing the incidence of treatment-related adverse events. Previously, Saol only had rights to the patented genotype test for the indication of Pyruvate Dehydrogenase Complex Deficiency (PDCD). This new agreement opens up a world of possibilities for Saol and its patients.
Saol is proud to support the Phase IIA Trial of DCA in Glioblastoma Multiforme (GBM), an aggressive and incurable form of primary brain cancer, with additional funding and resource support. This study, sponsored by the University of Florida and the Food and Drug Administration (FDA) (NCT05120284), is further bolstered by a partnership with Medosome Biotec and Saol. It is a bold step towards finding a cure for GBM and providing hope to those affected.
Dr. Peter Stacpoole, Professor of Medicine at the University of Florida and Principal Investigator for both the PDCD and GBM trials, is thrilled to be expanding his partnership with Saol Therapeutics. The PDCD trial (NCT02616484) has over-enrolled due to their collaboration, and the two are now looking to apply the potential of DCA, a prototypic inhibitor of Pyruvate Dehydrogenase Kinases (PDKs), to additional indications. Additionally, the GBM trial will be adding more study sites in order to speed up the recruitment of patients. With high hopes, Dr. Stacpoole believes that DCA could be a game-changer in the treatment of GBM.
Saol is excited to announce a new sponsored research agreement with a renowned cancer center to evaluate the potential of its revolutionary drug, DCA, as a treatment for rare pediatric solid tumors. In this preclinical research, DCA will be tested alone and in combination with chemotherapy to determine its efficacy in treating Wilms, Neuroblastoma, Rhabdoid Tumor, Osteosarcoma, Ewing Sarcoma, and Rhabdomyosarcoma. We anticipate that this research will be an important step in understanding the potential of DCA in treating these pediatric tumors.
“At Saol, we’re excited to be studying the potential of DCA as an effective treatment for rare, pediatric, solid tumors. Our proprietary formulation, specifically developed for pediatric use, is currently being tested in a clinical trial (NCT02616484). Our pre-clinical assessment provides encouraging data, which could allow us to quickly transition towards clinical investigation – a move that is being championed by our Chairman and Chief Medical Officer, Dr. Virinder Nohria. DCA has a mechanism of action that could override the Warburg effect observed in cancer cells, and has already been widely studied in animals and humans – making it an intriguing prospect for treating pediatric tumors.”
Saol Therapeutics is taking a big step forward in its journey to become an emerging pharmaceutical company. After completing enrollment in the PDCD trial, the company is now rapidly transitioning to develop treatments for adult and pediatric oncology indications where there are limited treatment options. With the newly executed agreements, Saol CEO David Penake is excited to pursue exciting opportunities beyond PDCD. “We are thrilled to have finalized these agreements in order to support our ambitious goals for the future,” said Penake.
Saol is on track to publish groundbreaking results from its PDCD trial in the 3rd quarter of 2023. If the data demonstrates efficacy, this will be the first and only medicine approved to treat this rare pediatric condition, revolutionizing the lives of countless children and their families.
About Dichloroacetate (DCA; SL-1009)
Introducing DCA – the first approved medication that could revolutionize the way we treat mitochondrial disease! With DCA, a pan-PDK inhibitor, we can now turn to an effective, oral solution to treat PDCD, a congenital mitochondrial disease caused by gene mutations in the Pyruvate Dehydrogenase Complex (PDC). DCA works by inhibiting PDKs to stimulate residual PDC activity and increase energy (ATP) production by mitochondria. Plus, DCA dosing is tailored to each individual, based on a proprietary genetic test that identifies “fast” and “slow” drug metabolizers. Get ready for a new era of mitochondrial disease management – DCA is here!
About Saol Therapeutics
Saol Therapeutics (pronounced “Sail”) is an innovative, clinical-stage pharmaceutical company that is pioneering the development of modern therapies to combat CNS disorders such as spasticity and pain management, as well as orphan diseases. With operations in Roswell, GA, Dublin, Ireland and Hamilton, Bermuda, Saol is devoted to providing patients with the most advanced treatments and empowering physicians with the tools to treat these challenging conditions.
About Medosome Biotec
Medosome Biotec, LLC is a pioneering pharmaceutical company on a mission to revolutionize pediatric healthcare. With operations in Alachua, FL and Bloomington, IN, Medosome is dedicated to developing and offering cutting-edge genetic tests for diagnosing rare diseases, as well as personalized dosing of pharmaceutical drugs to improve the lives of children everywhere.