BioVaxys Announces Final Clinical Trial Results of HPV Product

BioVaxys Technology Corp. (CSE: BIOV) (FRA:5LB) (OTC:LMNGF(“BioVaxys”), the world leader in haptenized antigen vaccines for antiviral and cancers applications, is pleased to announce the results of a clinical study conducted by ProCare Health Iberia, its EU partner for marketing its gynecological cancer and viral vaccines, which demonstrated the efficacy of Papilocare® in preventing and treating lesions caused by HPV. BioVaxys has the right of refusal for US marketing of Papilocare®, the world’s first and only product to prevent and treat HPV-dependent cervical 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).

Published in the April 2021 Issue of the Journal of Lower Genital Tract Disease (JLGTD), the official journal of the American Society for Colposcopy and Cervical Pathology (ASCCP), the main conclusions from the Paloma Clinical Trial (PALOMA trial, #NCT04002154) include the normalization of cervical lesions in 88% of patients infected with high-risk HPV and a clearance of HPV in 63% of the same group of patients. These results are confirmed by the JLGTD following a detailed review that began after the presentation of the results of the study in June 2019.

The Paloma Clinical which involved nine Spanish hospitals (4 public and 5 private), began in July 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 results demonstrated 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).

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 in Spain and Italy, which reported the efficacy of Papilocare® in the clearance of high-risk HPV to be between 50 and 70%.

The results of the Paloma Clinical Trial have also been accepted and presented to gynaecologists at the most prestigious European Congresses in the sector, such as the European Federation for Colposcopy (EFC) in Rome in September 2019, the European Society of Gynecology (ESG) in Vienna in October 2019, and the European Society of Gynaecological Oncology (ESGO) in Athens in November 2019.

Under the February 2021 agreement between BioVaxys and ProCare, BioVaxys has the right of first refusal for US marketing of Procare Health’s vaginal gel product, Papilocare, the world’s first and only product to prevent and treat HPV-dependent cervical lesions.  Formed in 2012 as a spin-out from Procter & Gamble Pharmaceuticals, Procare Health is a market leader in the women’s health field in the European Union (“EU”), with marketed products including Papilocare™, Libicare™, Palomacare™, Idracare™, Pronolis HD™ and Ovosicare™.

About BioVaxys Technology Corp.

Based in Vancouver,BioVaxys Technology Corp. is a British Columbia-registered, early-stage biotechnology company that is developing viral and oncology vaccine platforms, as well as immuno-diagnostics.  The Company is advancing a SARS-CoV-2 vaccine based on its haptenized viral protein technology and is planning a clinical trial of its haptenized autologous cell vaccine used in combination with anti-PD1 and anti-PDL-1 checkpoint inhibitors that will initially be developed for ovarian cancer. Also in development is a diagnostic for evaluating the presence or absence of a T cell immune response to SARS-CoV-2, the virus that causes COVID-19. BioVaxys has two issued US patents and two patent applications related to its cancer vaccine, and pending patent applications for its SARS-CoV-2 (Covid-19) vaccine and diagnostic technologies. BioVaxys common shares are listed on the CSE under the stock symbol “BIOV” and trades on the Frankfurt Bourse (FRA: 5LB) and US OTC: LMNGF.

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