Papilocare Vaginal Gel 21 canulas of 5 ml

Product Information

This gel is formulated based on ingredients that help create a protective film that reepitalizes and helps treat cervico-vaginal dryness. Indicated to control and re-epithelialize the transformation zone of the cervix.

The only side effect I’ve noticed with the gel is some mild skin irritation, but some thrush ointment sorts it. As a secondary criterion, the Paloma Clinical Trial demonstrated a 57% increase in the clearance of the high-risk virus, managing to eliminate it in 63% of the patients treated with Papilocare® over 6 months, compared with 40% in the control group. In addition, there is a high level of consistency between the result and the results presented by 3 independent studies carried out by public university hospitals inSpainandItaly, which reported theefficacy of Papilocare® in the clearance of high-risk HPV to be between 50 and 70%.One clinical study concluded that Palomacare ® has shown “a clear tendency to repair the cervico-vaginal mucosa of women with nonspecific vaginitis”. In the study, 61 women with nonspecific vaginitis were divided into the treatment group (32 women) and the control group (29 women), who received no treatment. The treatment group was given a daily dose of Palomacare ® for one week and then twice a week for a total of 12 weeks. At the end of the 12-week study, the signs of vaginitis had disappeared among 66% of patients in the treatment group, compared to 41% of patients in the control group, who received no treatment. 88% of women in the treatment group (28 of 32 women) showed an improved vaginal health score (using a Likert scale), compared to 48% in the control group who received no treatment (14 of 29 women). This press release includes certain "forward-looking information" and "forward-looking statements" (collectively "forward-looking statements") within the meaning of applicable Canadian and United States securities legislation including the United States Private Securities Litigation Reform Act of 1995. All statements, other than statements of historical fact, included herein, without limitation, statements relating the future operating or financial performance of the Company, are forward looking statements. Forward-looking statements are frequently, but not always, identified by words such as "expects", "anticipates", "believes", "intends", "estimates", "potential", "possible", and similar expressions, or statements that events, conditions, or results "will", "may", "could", or "should" occur or be achieved. Forward-looking statements in this news release relate to, among other things, completion of the murine model study, regulatory approval for a Phase I study of its BVX-0320 Vaccine Candidate in humans and the overall development of BioVaxys' vaccines, including any haptenized SARS-Cov-2 protein vaccine. There can be no assurance that such statements will prove to be accurate, and actual results and future events could differ materially from those expressed or implied in such forward-looking statements. Approximately 30% of Spanish women younger than 30 years are HPV carriers. 25 The likelihood of HPV infection decreases over time, from 47% between the ages of 15 and 19 years to 12% in women older than 45 years. 26 The HPV is a fundamental factor for the development of cervical cancer. 27 The World Health Organization has recently established the elimination of cervical cancer as a priority medium-term objective. 28 This trial aimed to explore whether treatment with Papilocare provides better results than the conventional watchful waiting strategy in improving low-grade cervical lesions, which are the first step in the natural history of cervical cancer. 29 Clearance of LSILs after a conservative approach is of approximately 59% within 2 years of the diagnosis. Nevertheless, the likelihood of progression of these lesions to a high-grade squamous intraepithelial lesion within 5 years is 12.7%. 30 In addition, treatments for cervical cancer severely compromise the reproductive health of women. In a systematic review of Cochrane, Kyrgiou et al. 31 demonstrated a higher baseline risk for prematurity in women with cervical intraepithelial neoplasia, which increased with excisional and ablative treatments. Therefore, the scenario is conflicting, as choosing an excisional or ablative approach for the treatment of LSILs can result in negative reproductive outcomes, but avoiding treatment and just monitoring the disease results in its progression to high-grade lesions in 12 of 100 women. The current recommendation in Spain also includes monitoring the disease. 32,33 However, based on the results of this present study, a novel strategy involving Papilocare has become available. The results of this treatment in the repair of low-grade lesions have demonstrated to significantly exceed those obtained with the watchful waiting approach (8 in 10 women achieved a normalization in their lesions).

HPV(Human papillomavirus infection)infection is one of the most common STI (Sexually Transmitted Infections) worldwide, with around 80% of men and women becoming infected at some point in their life.Left untreated, HPV infection generally leads to cervical cancer (World Health Organization, HPV and Cervical Cancer, 11 November 2020). It is possible that a small amount of gel remains in the cannula. This dose not mean that a dose less than what is recommended has been administered, as the cannula releases a sufficient amount to cover the cervical-vaginal mucosa (3 ml). Once the cannula is used, it should be discarded. A cannula should not be reused nor shared between two patients. That has been treated but I have persistent HPV in the cervix. Last year I had a LLetz which got rid of the area of CN1 but not the HPV which is still high risk! The infection HPV infection has been on going since 2019 at least, but only since this date the presence of the virus has been reported. The Paloma Clinical which involved nine Spanish hospitals (4 public and 5 private), began inJuly 2016. It is a multicentre, open, and randomized study conducted in parallel groups and controlled using habitual clinical practice, with the aim of assessing the degree of healing of the cervical mucous in HPV+ women between 30 and 65 years old, with AS-CUS, L-SIL or AG-US smear results and consistent colposcopic image. These resultsdemonstrated normalization of low grade lesions on the cervix (ASCUS/LSIL) in 85% of the patients treated with Papilocare® after 6 months, and the result was even more significant in women infected with high-risk HPV, normalizing lesions in 88% of patients."The results of the Paloma trial are really good news for HPV patients thanks to the proven efficacy of Papilocare®. These results have been obtained after more than 4 years of research and their publication in an edition the prestigious JLGTD further strengthens their significance ," stated Javier Cortés, MD, Clinical Coordinator of the Paloma study and specialist in Gynecology and Cytology for the international Academy of Cytology (Chicago,USA), member of the Spanish association against Cancer (AECC) and of the European Cervical Cancer Association (ECCA). Papilocare Immunocaps has a unique and complete composition based on Reishi extract, a therapeutic fungus similar to Coriolus versicolor, different species of probiotic lactobacilli (L crispatus, L rhamnosus and L gasseri) and a multivitamin compound in which Quatrefolic stands out, the active and assimilable form of folic acid, essential for the proper functioning of the immune system.

The results of our study have been replicated in several independent, observational, noncontrolled studies performed in Spanish public university hospitals. 35– 37 The 6-month effectiveness of Papilocare was evaluated and confirmed in all of the studies (between 53% and 72.5% of cases achieved a negative cytology and/or HPV clearance/reduced viral load). An update of the study by Riera et al., 38 which included a watchful waiting control group, revealed a significantly higher percentage of responders in the group treated with Papilocare compared with the controls (80.0% vs 51.4%). Recent interim results from the observational, multicenter, prospective, single-cohort PAPILOBS study (#NTC04199260) revealed a notable effect of Papilocare at 6 months in repairing HPV-dependent low-grade cervical lesions and clearing HPV (66% and 63% of patients, respectively) under real-life conditions. 39 Data obtained in the present study in relation to the HPV clearance, especially in HR HPV patients, are consistent with real-world data obtained in other studies. 40 Moreover, in this trial, the degree of cervical re-epithelization was significantly higher with Papilocare compared with the control group. This beneficial effect on re-epithelization was also observed by Palacios et al. 15 in a pilot study performed with 21 asymptomatic non–HPV-infected women, in which women treated Papilocare achieved improved cervical re-epithelization (from 3.1 to 4.4 according to the same cervical epithelization scoring system used in the present study). Similarly, Gálvez et al. 16 reported a significant 20% improvement in cervical re-epithelialization in HPV-positive lesion-free women treated with Papilocare (3.8 vs 4.5) compared with baseline. Repair of HPV-dependent cervical lesions after 3 and 6 months of treatment in the total and HR HPV patient pools. *Normalized cytology together with concordant colposcopic observations. **χ 2 test. One high-risk HPV patient of the control group had missing data. Overall HPV Clearance A differential but nonsignificant trend in this parameter was observed between both groups, in such a way that it decreased in the treatment group (from a mean of 21.1 [SD = 8.8] at baseline, to a mean of 19.7 [SD = 9.0] at 3 months, and, finally, a mean of 19.0 [SD = 9.1] at 6 months) and increased in the control group (from a mean of 17.7 [SD = 7.2] at baseline, to a mean of 17.4 [SD = 6.3], and, finally, a mean of 20.7 [SD = 9.8] at 3 and 6 months, respectively). The number of patients reporting an improvement in perceived stress was higher at the 3-month (35 of 56 women [62.5%]) and 6-month visits (29 of 50 women [58.0%]) in the treatment group compared with the control group (15 of 31 women [48.4%] and 11 of 28 women [39.3%], respectively). Satisfaction With the Product and Therapeutic Adherence