PAPILOMA PROJECT
PAPILOMA intends to treat women with low- and high-grade CIN with a new vaginal gel for topical application that targets HPV at the source of the cervical lesions.
Ref: CENTRO-01-0145-FEDER-181235
TEAM
PAPILOMA benefits from a multidisciplinary team composed by researchers and PhD students with different backgrounds, Chemistry, Biomedical Sciences, Biotechnology, Medicinal Chemistry, Pathology, clinicians and a company Labfit-HPRD.
PAPILOMA OBJECTIVES
The project PAPILOMA has the following objectives:
1 – To develop a topically applied vaginal gel for the treatment of low and high grade intraepithelial lesions caused by HPV;
2 – To characterize the stability and quality of the prototype;
3 – To characterize the virucidal action of the prototype (in vitro, EN 14476 standard);
4 – To characterize the clinical safety and efficacy profile in vivo (K14-HPV16 transgenic model);
5 – To test the application of the gel in human samples, namely, biopsies from patients with low and high grade intraepithelial lesions caused by HPV;
6 – To design and study the packaging (tube with applicator/cannula) of the prototype in order to assess mechanical and functional aspects, as well as stability over time;
7 – To demonstrate the semi-industrial production (pilot study) and prepare the regulatory process.
The prototype concept was designed to ensure the attributes of simplicity, efficacy, safety and low cost, with a semi-industrial production profile and does not require investment in advanced technology by the stakeholders (promoters and partners).
PAPILOMA TASKS
The project PAPILOMA has the following tasks:
1 – Optimization and scale-up of vaginal gel for topical application (Functional prototype). The formulation will be designed on a semi-industrial scale in order to test the manufacturing methods of the different components and the reproducibility of their properties.
2 – Technological characterization of the vaginal gel for topical application (Tests and trials). To this purpose, there will be 5 interrelated tasks that will comprise the physical, chemical and biological characterizations (microbiological tests, in vitro) to obtain a final validation of the conditions/requirements/characteristics of the prototype.
3 – Demonstration of the vaginal gel activity and efficacy in vivo. The proposed animal model is the genetically modified mouse (K14HPV16) that was developed by P. Oliveira at CITAB-UTAD, a partner of the project PAPILOMA, and expresses early HPV16 genes with a fully functional immune system, allowing modulation of the tumor immune response in HPV16-induced lesions.
4 – Vaginal gel assays in human samples. Volunteers with HPV positive cervical lesions will be included in the study. Samples will be organized and provided by the CHUCB clinicians and pathologists, partners of the project PAPILOMA.
5 – Promotion and dissemination of results. The results obtained throughout the project will be disseminated in the appropriate national and international channels.
PROJECT
WORKFLOW
PAPILOMA
OPPORTUNITIES
Research Fellowship (BI)
research fellowship for master students or BSc degree holders enrolled in a non-academic degree course (BI), within the research project PAPILOMA - Vaginal gel for topical application in precancerous lesions caused by the Human Papilloma Virus
APPLICATION DEADLINE - 12/08/2022 23:00 - Europe/London
PAPILOMA
OUTPUTS
Research Fellows
1 - Izamara Maocha, Research Fellowship (BI),
Research activities with a view to develop a vaginal gel based on the formulation of nanoparticles of drug-aptamers. Their production, characterization (physicochemical, biological) will be carried out in scaling up phase, adapting the translational from laboratory purity to semi-industrial purity, concentration of excipients, methods among others, in order to develop a marketable vaginal gel.
MSc Students
1 - Beatriz Rosado, Master Student in Biochemistry, “Development of a vaginal gel for HPV-related intraepithelial lesions”
2 - Melanie Lopes, Master Student in Biochemistry, “Development of a vaginal gel for HPV-related intraepithelial lesions”
Conferences
1 - Jéssica Lopes-Nunes, Paula A. Oliveira, and Carla Cruz, Development and Evaluation of AT11-guided Liposomes for Human Papilloma Virus cancer, 8th International Electronic Conference on Medicinal Chemistry, online, 2022
Contests
1 - 3th place at Arrisca'C Contest, organized by the University of Coimbra, on February 28th in Miranda do Corvo.