Lixte Biotechnology Announces a Clinical Trial Agreement with Moffitt Cancer Center to Initiate Phase 1b/2 Trial Evaluating the Safety and Efficacy of LB-100 in Treatment of Patients with Low or Intermediate-1 Risk Myelodysplastic Syndrome

Lixte Biotechnology (OTCQB:LIXT) announced that it has entered into a Clinical Trial Agreement and Exclusive License Agreement with Moffitt Cancer Center to conduct a Phase 1b/2 study of the safety and therapeutic benefit of Lixte’s lead clinical compound, LB-100, in patients with myelodysplastic syndrome (MDS). The trial will enter low and intermediate-1 risk MDS patients, including those with del(5q) MDS who have failed or are intolerant of standard treatment.

As quoted in the press release:

Dr. John S. Kovach, founder and CEO of Lixte, said, “Certain cancers possessing unique genetic changes are vulnerable to inhibition of an enzyme, protein phosphatase 2A (PP2A), by LB-100. Among these is myelodysplastic syndrome (MDS), an increasingly common family of neoplastic diseases, especially in persons aged 65 and older. MDS is characterized by failure of the bone marrow often causing significant anemia and requiring frequent blood transfusions. In preclinical models of MDS, treatment with LB-100 inhibits the growth and/or induces the death of the abnormal blood cells. Cells of one variant of MDS, termed del(5q) MDS, are missing 50% of their PP2A activity rendering them sensitive to PP2A inhibition.”

Currently there is only one drug, lenalidomide, approved for the treatment of del(5q) MDS, and virtually all patients become resistant to this therapy.

“We are excited to embark on the clinical investigation of LB-100 in lower-risk MDS patients. If LB-100 proves to be effective in the clinic, it could be an important addition to the limited treatment options for patients failing standard treatment,” said David Sallman, M.D., assistant member of Moffitt’s Malignant Hematology Department.

Click here to read the full press release.