Rich Pharmaceuticals currently is focused on the clinical development of the chemical molecule TPA (12-O-tetradecanoylphorbol-13-acetate) for the treatment of acute myelogenous leukemia (AML). The Company has technical evidence to suggest that it may also be useful to treat other important diseases resulting in it being a widely used drug with major market potential.
TPA is a naturally occurring molecule that is isolated and purified from croton oil which is obtained from the seeds of Croton tiglium, a leafy shrub native to Southeast Asia. While this has been the major source of TPA for clinical studies conducted by Rich Company scientists recently devised a synthetic route for preparation of the drug which will ensure providing the necessary supply of highly pure drug for clinical use. TPA has characteristics that are unique to this chemical class including a potent ability to accelerate differentiation of the myeloid cell lines, HL-60 and THP-1, as well as mononuclear phagocytes from bone marrow and peripheral blood. The best characterized receptor for TPA is protein kinase C (PKC) which, once activated, induces substrate phosphorylation that propagates signals to the MAPK cascades. The effects of TPA on MAPK pathways may be particularly relevant to the differentiating and pro-apoptotic effects of TPA in certain cells. The capacity of TPA to activate PKC and to induce phenotypic changes characteristic of differentiation and/or apoptosis led investigators to study its effect in AML.
Acute myelogenous leukemia (AML) is an aggressive disease that requires urgent and intensive therapy. Patients diagnosed with AML are, on average, between 64 and 68 years of age. Patients over 60 treated with standard chemotherapy are cured of their disease less that 20 percent of the time. In addition, patients who develop AML after an antecedent hematologic disorder or prior leukemogenic chemotherapy/radiation have similarly poor outcomes as do patients whose disease is associated with specific cytogenetic and clinical features. Most patients diagnosed with AML have a poor prognosis. For patients with relapsed disease, no standard non-transplant therapy has demonstrated the capacity for cure and AML is often fatal.
In view of the above facts, it is obvious that new approaches to therapy are needed. The clinical studies completed and those currently in progress with TPA report feasibility and potential efficacy of this drug in patients with relapsed/refractory myeloid malignancies.
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