Evaluation of the Safety and Efficacy of Esperanza Extract (PA001)

This is a phase Ib/II clinical study that has two phases. In phase Ib, the safety evaluation of the extract of Petiveria alliacea (Esperanza) will be carried out in patients with metastatic gastrointestinal tumors (colon, pancreas, stomach, and biliary tract) and patients with newly diagnosed and relapsed acute leukemia. In phase IIb, the safety will continue to be evaluated, and the efficacy of the Esperanza extract will be explored in combination with chemotherapy in patients with metastatic gastrointestinal tumors (colon, pancreas, stomach, and biliary tract) with newly diagnosed acute leukemias and relapses.

Anamú, Petiveria alliacea, has been used by traditional medicine to treat leukemia and breast cancer. However, its activity on tumor metabolism makes it a therapeutic candidate for many tumors with alterations in glycolytic metabolism, but also uses the mitochondria to produce energy. Given the glycolytic nature of some tumor cells, the modulating activity of cell metabolism exerted by anamú extract may be partly responsible for the anti-tumor activity. Previous reports show that some patients with ALL or AML whose response to treatment was evaluated in vitro are sensitive to a standardized extract of Petiveria alliacea. Even more interesting is the fact that when we treat the cells with allopathic therapy, explicitly established for each of these pathologies, the sensitivity of the blasts increases when they are treated concomitantly with the extract, which suggests that the intrinsic resistance of each one of tumor cells in the different tissues evaluated can be reduced by the action of the phytomedicine. The same thing was observed when spheres obtained from human breast cancer were co-treated with the anamú extract and anthracyclines. These observations allow to validate the traditional use of anamú in the treatment of some tumors, such as leukemia and breast cancer, among others. However, to observe the safety and effects on patients, it is necessary to develop a clinical study that would allow the anamú phytomedicine produced in the appropriate pharmaceutical conditions, to be included as a complementary therapy based on a standardized extract of the plant and that can overcome the resistance of tumor cells to conventional treatments, improving response and increasing overall survival of patients in Colombia. Although the explosion of new therapies in solid tumors and hematological alterations is not so high, countries such as Germany, France, and Italy have used traditional medicine from which herbal pharmaceutical preparations are derived in the treatment of different types of diseases, including cancer. , estimating the use of these products between 30 and 75% of patients worldwide. These herbal products are mainly used to reduce allopathic therapies' side effects and organic toxicity, protect and stimulate the immune system, or prevent future neoplasms or their recurrence. Currently, various extracts from natural products are in clinical trials in the United States, and there is significant evidence about some plants' role in leukemia's evolution. This is a phase Ib/II clinical study that has two phases. In phase Ib, the safety evaluation of the extract of Petiveria alliacea (Esperanza) will be carried out in patients with metastatic gastrointestinal tumors (colon, pancreas, stomach, and biliary tract) and patients with newly diagnosed and relapsed acute leukemia. In phase IIb, the safety will continue to be evaluated, and the efficacy of the Esperanza extract will be explored in combination with chemotherapy in patients with metastatic gastrointestinal tumors (colon, pancreas, stomach, and biliary tract) with newly diagnosed acute leukemias and relapses.