05/02/2010

P-MAPA and FDA -- Regulatory aspects

Product description and project rationale

The P-MAPA belongs to a class of medicines known as biologic response modifiers.

Experiments performed on animal models and on humans have shown that P-MAPA can stimulate human toll-like receptors, proliferation of lymphocyte T, and increase cytokine production (mainly interferon-gamma and interleukin-2), NK cell activity and NO release by macrophages. 

The mechanism of action of P-MAPA was recently published. The data open the way to new therapeutic strategies to treat a wide range of pathologies including infectious diseases and cancer.

For instance, the compound is thought to play an important role in the eradication of virally infected cells and cancer cells by increasing immune system response.

 In summary, immunotherapy based on P-MAPA represents a valuable approach to fight cancer and infectious diseases. The P-MAPA could be used alone or in combination with existing therapies. 

Based on this rationale, Farmabrasilis and Immunotherapeutica, the R&D partner, are preparing two applications for P-MAPA to be submited to Food and Drug Administration (FDA). 

The first application concerns the therapeutic use of P-MAPA to  cancer alone and in co-administration with a chemotherapeutical drug to be selected.The main benefits are expected to be improvement in survival time and in the quality of life of patients with inoperable cancer.

The second application refers to the therapeutic use of P-MAPA as adjuvant immunotherapy to deter pathogens and infections .The main benefits are expected to be improvement in survival rates and patients´ quality of life.

The applications will be submitted to  FDA until 2020