Mr. James Passin reports
BIOVAXYS ANNOUNCES FINAL CLINICAL TRIAL RESULTS OF HPV PRODUCT FROM EU PARTNER PROCARE HEALTH IBERIA PUBLISHED BY AMERICAN SOCIETY FOR COLPOSCOPY AND CERVICAL PATHOLOGY
Biovaxys Technology Corp. has released the results of a clinical study conducted by ProCare Health Iberia, its European Union partner for marketing its gynecological cancer and viral vaccines, which demonstrated the efficacy of Papilocare in preventing and treating lesions caused by HPV (human papillomavirus infection). Biovaxys has right of refusal for United States marketing of Papilocare, the world's first and only product to prevent and treat HPV-dependent cervical lesions.
HPV is one of the most common STI (sexually transmitted infections) worldwide, with around 80 per cent 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, Nov. 11, 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, No. NCT04002154) include the normalization of cervical lesions in 88 per cent of patients infected with high-risk HPV and a clearance of HPV in 63 per cent 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 study, which involved nine Spanish hospitals (four public and five 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-positive 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 (AS-CUS/L-SIL) in 85 per cent of the patients treated with Papilocare after six months, and the result was even more significant in women infected with high-risk HPV, normalizing lesions in 88 per cent 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 four years of research and their publication in an edition of the prestigious JLGTD further strengthens their significance," stated Javier Cortes, MD, clinical co-ordinator of the Paloma study, and specialist in gynecology and cytology for the International Academy of Cytology (Chicago), 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-per-cent increase in the clearance of the high-risk virus, managing to eliminate it in 63 per cent of the patients treated with Papilocare over six months, compared with 40 per cent in the control group. In addition, there is a high level of consistency between the result and the results presented by three 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 per cent and 70 per cent.
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 in Rome in September, 2019, the European Society of Gynecology in Vienna in October, 2019, and the European Society of Gynacological Oncology in Athens in November, 2019.
Under the February, 2021, agreement between Biovaxys and ProCare, Biovaxys has right of first refusal for U.S. 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 spinout from Procter & Gamble Pharmaceuticals, Procare Health is a market leader in the women's health field in the European Union, with marketed products including Papilocare, Libicare, Palomacare, Idracare, Pronolis HD and Ovosicare.
About Biovaxys Technology Corp.
Based in Vancouver,
Biovaxys 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 COVID-19 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 COVID-19. Biovaxys has two issued U.S. patents and two patent applications related to its cancer vaccine, and pending patent applications for its COVID-19 vaccine and diagnostic technologies.
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