Formula Pharmaceutiucals

FPI-01 lead Formula Asset, is new chemical entity for AML patients who are in first remission following standard induction / consolidation chemotherapy. This therapy is designed to prevent AML recurrence, thereby prolonging survival. FPI-01 elicits a potent, T-cell mediated immune response, specifically directed against the tumor. The therapeutic mechanism involves the synergistic activation of CD4 and CD8 mediated cytotoxic T-cells against tumors that over-express the Wilm’s Tumor 1 (WT1) antigen, such as AML. WT1 is a scientifically well-characterized target, and recently recognized by the US National Cancer Institute as the most relevant target for active immune therapy. FPI-01 consists of synthetic variants of the natural peptide sequence of WT1 that is recognized by T-cells. A strong rationale for FPI-01 exists in additional cancer indications, including malignant pleural mesothelioma and various liquid tumors, where WT1 is over-expressed on the tumor cells and where active immune therapy is clinically viable. In these cancers, WT1 over-expression occurs in over 80% of patients. A recently completed AML pilot study conducted at MSKCC demonstrated a median overall survival of over 44 months for patients treated with FPI-01, versus 9 to 18 months for comparable patients receiving standard chemotherapy. Furthermore, based upon available clinical data, the product has also shown an excellent safety and tolerability profile.