PhorMed, Inc. has undertaken a progressive and comprehensive clinical study of a phorbol ester, RP-323, our proprietary drug, toward commercialization through regulatory requirements with appropriate Pipeline procedures.
A number of studies in vitro with hematopoietic cells from patients indicated that RP-323 was able to induce several cellular effects, namely, morphological changes, proliferation and differentiation. In addition, molecular parameters such as the synthesis of isoenzymes critical for normal cellular functions, was evident in our studies. Patients with a variety of hematological malignancies treated with low dose of RP-323 also showed a positive response. Using established molecular parameters as indicators in patients responsive to RP-323 revealed the restoration of normal gene expressions. Immunophenotypic analysis of leukemic cells from several patients with monoclonal antibodies showed positive reactions with one single treatment of RP-323. Side effects in these patients treated with RP-323 were mild and transient within hours shortly after administration. Clinical studies in China were in agreement with those Phase 1 studies here in the USA for Acute Myeloid Leukemia. Another characteristic of RP-323 is its ability to penetrate the’ Blood-Brain-Barrier’. With this knowledge, PhorMed Inc. has initiated an additional Pipeline on a possible molecular therapy of a neurological disorder, the Parkinson’s disease.
With the results of our clinical studies with our proprietary RP-323 compound summarized above together with those published in clinical literatures, we are in the process undertaking five Pipelines in the treatment of oncological and neurological diseases.