Currently, the study of many extracts in different types of cancer has allowed the validation of scientific knowledge either as a therapy that reduces the size of the tumor or that helps to improve the quality of life of the patient by reducing the associated effects of the treatment.
In the Immunobiology and Cell Biology group of the Pontificia Universidad Javeriana, a standardized extract of Caesalpinia spinosa (Dividivi) called P2Et has been obtained. This extract has been shown to have cytotoxic activity in different human and murine tumor cell lines, favoring the induction of immunogenic cell death with the release of danger signals such as calreticulin, HMGB1 and ATP. Additionally, treating mice with murine melanoma and sinus tumors significantly reduces tumor size and metastases. On the other hand, induction of complete autophagic flux and synergistic effects with anthracycline-type chemotherapeutics have been shown in human cell lines and in animal models of breast cancer.
With this background, and the results of the Phase I clinical study carried out in healthy volunteers that showed that the extract is safe, the investigators propose that treatment with the P2Et extract in patients with breast cancer could improve their general condition, impacting their quality of life. , and induce antitumor immune response, improving the immune infiltrate and acting as a transforming agent from a cold tumor to a warm tumor. This would lead to an improvement in the long-term survival of patients treated with the phytomedicine in conjunction with the chemotherapeutic treatment selected by the treating oncologist.
In order to advance on this path, and responding to the adjustments suggested in the phase I study in healthy individuals, it is proposed to carry out a clinical study that allows determining the optimal biological dose of the P2Et extract in a design based on randomized simulations of adaptive form and considering the safety of the extract as an objective in patients with breast cancer. Additionally, those parameters that allow defining the best indicators of effectiveness of P2Et in this group of patients will be evaluated, such as modulation of the immune response, quality of life, reduction of adverse effects and progression-free survival.

Start Date01 Mar 2022

Sponsor / Collaborator

Hospital Universitario San Ignacio

[+1]

NCT04410510

/ Unknown statusPhase 2/3IIT

Study of the P2Et Extract Obtained From Caesalpinia Spinosa in the Symptomatic Treatment of Subjects With COVID-19 at the Hospital Universitario San Ignacio, Colombia.

Antioxidants, and particularly polyphenols, have shown protection in respiratory pathologies, which is related to the decrease in the severity of the clinical picture and suppression of inflammation. This suppression of inflammation may be related to the inhibition of NF-kB polyphenols, where its activation is related to the stimulation of 150 stimuli including cytokines (IL-1β, IL-6, THF-α, GM-CSF, MCP-1), TLRs, among others. There may be other additional mechanisms that can help control virus-induced respiratory pathologies, among which are the regulation of reactive oxygen species (ROS) associated with tissue destruction caused by the virus and a selective antiviral action can be reported. direct.
The standardized P2Et extract obtained from C. spinosa, by the Immunobiology Group of the Pontificia Universidad Javeriana, is highly antioxidant, decreases lipid peroxidation and tissue damage and induces complete autophagy in stressed or tumor cells. The induction of a full autophagic flow could inhibit the replication of beta-coronaviruses like SARS-CoV-2. Furthermore, P2Et can decrease the factors involved in tissue damage by reducing IL-6 and decrease ILC2 cells of the lung in animals with lung metastases (unpublished data).
These antecedents suggest that the supplementation of patients with COVID-19 with the extract P2Et, could improve their general condition and decrease the inflammatory mediators and the viral load.

Start Date30 Sep 2020

Sponsor / Collaborator

Hospital Universitario San Ignacio

[+1]

NCT03663881

/ CompletedPhase 1IIT

Open-label, Single Arm, Phase 1 Study to Assess the Safety of P2Et Extract Obtained From Caesalpinia Spinosa, in Voluntary Subjects in Colombia

Caesalpinia spinosa extract is rich in gallotannins and other well characterized polyphenols and has a major antioxidant activity. The extract shows immunomodulatory activity in healthy animals and anti-tumor activity in animals with breast cancer and melanoma as well.
The use of P2Et in animals with tumors shows a synergistic effect with doxorubicin in drug-resistant cell lines. In addition, an increase in survival of transplanted animals with a TS/A breast cancer tumor model and treated with P2Et, in conjunction with calreticulin increase is observed.
This open-label, single arm, Phase 1 study intends to assess the safety of P2Et extract obtained from Caesalpinia spinosa, with dose escalation, in healthy voluntary participants in Colombia.

Start Date30 Apr 2019

Sponsor / Collaborator

Hospital Universitario San Ignacio

[+1]

100 Clinical Results associated with Tara spinosa Extract

100 Translational Medicine associated with Tara spinosa Extract

100 Patents (Medical) associated with Tara spinosa Extract

Literatures (Medical) associated with Tara spinosa Extract

10 Apr 2024·Journal of toxicology

Assessment of Acute and Chronic Toxicity in Wistar Rats (Rattus norvegicus) and New Zealand Rabbits (Oryctolagus cuniculus) of an Enriched Polyphenol Extract Obtained from Caesalpinia spinosa

Article

Author: Ballesteros-Ramírez, Ricardo ; Lasso, Paola ; Fiorentino, Susana ; Saturno, Jenny ; Urueña, Claudia

Although herbal drugs are often considered safe for consumption, there is increasing evidence that some can generate undesirable health effects. However, polyphenols found in certain plants have been shown to provide a range of benefits for human health. In previous work, a standardized and quantified extract (P2Et) obtained from Caesalpinia spinosa (Dividivi) plant showed promising antioxidant, immunomodulatory, and anti-inflammatory properties in animal models of cancer and COVID-19 patients. The extract has also been subjected to genotoxicity, mutagenicity, and 28-day oral chronic toxicity evaluations, demonstrating a good safety profile. To advance preclinical and clinical development, further acute and chronic toxicity evaluations of the P2Et extract were performed. Acute toxicity tests were performed orally in Wistar rats at a dose of 2000 mg/kg, indicating that the lethal dose 50% (LD50) value exceeded 2000 mg/kg and classifying the P2Et extract as category 5 according to the Globally Harmonized System of Classification (GHS). In this work, chronic toxicity tests were conducted for 180 days on Wistar rats and New Zealand rabbits at a dose of 1000 mg/kg under Good Laboratory Practice (GLP) conditions. No weight loss or alterations in biochemical and hematological parameters associated with treatment were observed in the animals, suggesting the absence of toxicity in the assessed parameters. These results indicate that the P2Et extract is safe for oral administration at doses up to 1000 mg/kg body weight over a six-month period.

23 Feb 2022·Evidence-based complementary and alternative medicine : eCAMQ4 · MEDICINE

Safety Evaluation in Healthy Colombian Volunteers of P2Et Extract Obtained from Caesalpinia spinosa: Design 3+3 Phase I Clinical Trial

Q4 · MEDICINE

ArticleOA

Author: Torregrosa, Lilian ; Urueña, Claudia ; Galvis, Silvia ; Ballesteros-Ramírez, Ricardo ; Fiorentino, Susana ; Tellez, Angélica ; Olejua, Peter A ; Duran, María I

The polyphenol-enriched extract called P2Et derived from Caesalpinia spinosa (C. spinosa) had antitumor and immunomodulatory activities reported in breast cancer, leukemia, and melanoma. The aim of this study was to evaluate the safety and maximum tolerated dose of P2Et extract in Colombian healthy volunteers in a phase 1 clinical trial, open labelled, single-arm, dose-escalation design 3 + 3. Seven healthy volunteers were included; P2Et was administrated in capsules of 600 mg/d for 28 days. Analysis by intention to treat was performed. 4 volunteers showed adverse events and discontinued the intervention. 94.6% of AE were grade 1, and most of AE had a reasonable possibility of a relationship with the P2Et (83.8%). We found that the oral administration of P2Et is safe in healthy humans with a maximum tolerated dose of 600 mg/d. There was no severe toxicity; most of the adverse events were mild, without significant changes in the safety parameters evaluated.

01 Jan 2021·Toxicology reports

Genotoxicity and mutagenicity assessment of a standardized extract (P2Et) obtained from Caesalpinia spinosa

Article

Author: Durán, M I ; Fiorentino, S ; Ballesteros-Ramírez, R

The standardized P2Et extract obtained from Caesalpinia spinosa has shown antioxidant, and direct antitumor activity, but also activation of specific immune response through the induction of tumor immunogenic cell death in breast and melanoma cancer models. The present work evaluated the mutagenicity and genotoxicity profile of P2Et to continue the development of the P2Et. Genotoxicity was evaluated by OECD 1997 a guideline and mutagenicity by OECD 2016. At P2Et's doses of 500, 1000, and 2000 mg/kg body weight in mice (Mus musculus), the difference between the number of micronuclei in PCE of the groups were not statistically significant (17 (negative control), 15 (500 mg/kg), 15 (1000 mg/kg), 19 (2000 mg/kg) and 271 (positive control). Similarly, P2Et did not induce gene mutations by base pair changes or frameshifts in the genome of Salmonella Typhimurium strains TA98, TA100, TA102, TA1535 and TA1537 at the tested range of concentrations up to 5000 μg/plate in the absence and presence of metabolic activation. Therefore, the P2Et was considered as non- mutagenic and non-genotoxic at the conditions of the tests.

100 Deals associated with Tara spinosa Extract

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Indication	Highest Phase	Country/Location	Organization	Date
COVID-19	Phase 3	Colombia	Hospital Universitario San Ignacio	30 Sep 2020
Invasive Mammary Carcinoma	Phase 2	Colombia	Hospital Universitario San Ignacio	01 Mar 2022
Toxicity	Phase 1	Colombia	Hospital Universitario San Ignacio	30 Apr 2019

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04410510 (Pubmed)	Phase 2	COVID-19	-	P2Et	ytugobqwez(lcjznquxds) = iayegrgmuk eeoktaqgfp (xchggkywbd )	Positive	01 Jan 2022
				Placebo	ytugobqwez(lcjznquxds) = fvyjpentch eeoktaqgfp (xchggkywbd )

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