BioVaxys Announces Final Clinical trial results of HPV product from EU partner ProCare Health Iberia published by American Society for Colposcopy and Cervical Pathology

Rhea-AI Summary

BioVaxys Technology Corp. announces its clinical study results on Papilocare® for HPV treatment, highlighting a 88% normalization rate of cervical lesions and a 63% clearance rate of high-risk HPV. Conducted by ProCare Health Iberia, the study involved nine hospitals across Spain and was published in the Journal of Lower Genital Tract Disease. BioVaxys holds marketing rights in the U.S. for Papilocare®, further enhancing its portfolio in gynecological cancer and viral vaccine applications.

Positive

• 88% normalization of cervical lesions in high-risk HPV patients
• 63% clearance of high-risk HPV among treated patients over 6 months
• BioVaxys holds U.S. marketing rights for Papilocare®

Negative

• None.

VANCOUVER, BC, April 14, 2021 /PRNewswire/ --  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 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 gynacologists 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 Gynacological Oncology (ESGO) in Athens in November 2019.

Under the February 2021 agreement between BioVaxys and ProCare, BioVaxys has 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.

ON BEHALF OF THE BOARD

Signed "James Passin"
James Passin, CEO
+1 646 452 7054

Media Contacts BioVaxys Technology Corp.
Nikita Sachdev
Luna PR
info@lunapr.io

Cautionary Statements Regarding Forward Looking Information

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.

These forward-looking statements reflect the beliefs, opinions and projections on the date the statements are made and are based upon a number of assumptions and estimates, primarily the assumption that BioVaxys will be successful in developing and testing vaccines, that, while considered reasonable by the Company, are inherently subject to significant business, economic, competitive, political and social uncertainties and contingencies including, primarily but without limitation, the risk that BioVayxs' vaccines will not prove to be effective and/ or will not receive the required regulatory approvals. With regards to BioVaxys' business, there are a number of risks that could affect the development of its biotechnology products, including, without limitation, the need for additional capital to fund clinical trials, its lack of operating history, uncertainty about whether its products will complete the long, complex and expensive clinical trial and regulatory approval process for approval of new drugs necessary for marketing approval, uncertainty about whether its autologous cell vaccine immunotherapy can be developed to produce safe and effective products and, if so, whether its vaccine products will be commercially accepted and profitable, the expenses, delays and uncertainties and complications typically encountered by development stage biopharmaceutical businesses, financial and development obligations under license arrangements in order to protect its rights to its products and technologies, obtaining and protecting new intellectual property rights and avoiding infringement to third parties and their dependence on manufacturing by third parties.

The Company does not assume any obligation to update the forward-looking statements of beliefs, opinions, projections, or other factors, should they change, except as required by law.

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SOURCE BioVaxys Technology Corp.

FAQ

What are the main findings from BioVaxys' clinical trial on Papilocare®?

The trial showed an 88% normalization of cervical lesions and a 63% clearance of high-risk HPV among treated patients.

What is Papilocare® and its significance?

Papilocare® is the world's first product designed to prevent and treat HPV-dependent cervical lesions.

When was the Paloma Clinical Trial conducted?

The Paloma Clinical Trial began in July 2016 and involved nine Spanish hospitals.

What are the implications of the trial results for BioVaxys stock (LMNGF)?

Positive results from the clinical trial may enhance investor confidence and potentially increase stock value for BioVaxys.

When was the study published and where?

The results were published in the April 2021 issue of the Journal of Lower Genital Tract Disease.