Rich Pharmaceuticals, Inc., a biopharmaceutical company, announced that it has received approval from the US Food and Drug Administration (FDA) to commence its phase 1/2 clinical for the treatment of acute myelocytic leukemia (AML) and myelodysplastic syndrome (MDS) patients.
The FDA has approved Rich Pharmaceuticals' Investigational New Drug (IND) application and has approved the company's commencement of a clinical programme titled "A Phase 1/2, Evaluation of the Safety and Efficacy of RP-323 in Combination with all-trans-Retinoic Acid, Sodium Butyrate, and 1a, 25-dihydroxyvitamin D3 in Subjects with Relapsed or Refractory Acute Myeloid Leukemia (AML) or Myelodysplastic Syndromes (MDS)". This approval gives Rich Pharmaceuticals an immediate go ahead to start patient enrollment for a phase 1/2 study using the company's lead compound RP-323 in clinical trials.
"This is a very exciting time at Rich Pharmaceuticals. I am pleased to announce that we have reached our most significant milestone to date," said chief executive officer, Ben Chang.
"Our team is enthusiastic with this development and we look forward to considerable advancement as we plan to begin clinical trials in the upcoming year."
AML, also known as acute myelogenous leukemia, is the most common acute leukemia type that affects mostly adults. AML is an aggressive form of cancer of the blood and the bone marrow, characterized by the rapid growth of abnormal white blood cells that accumulate in the bone marrow and interfere with the production of normal white blood cells. In the US, over 20,000 new cases of AML are diagnosed annually.
MDS occurs when the blood-forming cells in the bone marrow are damaged which leads to low numbers of one or more types of blood cells. In MDS, some of the cells in the bone marrow are damaged and have problems making new blood cells. Many of the blood cells that are made by these damaged cells are not normal. The abnormal blood cells die sooner than normal cells, leaving the person without enough normal blood cells and with low blood counts. MDS can turn into a fast-growing cancer of bone marrow cells called acute myelocytic leukemia and occurs in about 1 out of 3 people with MDS.