ProCervix® is BT PHARMA’s lead product is initially being developed for the treatment of cervical precancerous lesions which are known to be at high risk of evolving into a cancerous lesion.

Cervical cancer and associated neoplasia are a major healthcare problem. They are the result of infection by the Human Papillomavirus (HPV), the most common sexually transmitted diseases in the world. In the US and Europe, more than 60 million women are infected and about 1 million of these develop precancerous cervical lesions each year. Despite extensive screening programmes focused on early detection, 35,000 women still die from cervical cancer in the US and Europe annually.

ProCervix® is based on BT PHARMA’s unique CyaA vector system which is able to deliver the appropriate HPV antigens needed to induce strong and specific T-cell responses to eliminate HPV-infected cells. ProCervix® is the only bivalent therapeutic vaccine developed which targets two of most common HPV strains infecting women, HPV16 and HPV18. These two strains account for 65-70% of all cervical cancers.

ProCervix® is expected to cure women bearing pre-cancerous lesions provoked by HPV. Only a handful of companies are developing HPV therapeutic vaccines. In addition, ProCervix® could play a significant complimentary role in the treatment of this disease alongside the recently introduced preventive vaccines (prophylactic vaccines) by Merck and GlaxoSmithKline which cannot help women that are already infected with HPV (HPV positive).

To date pre clinical results with ProCervix® have been encouraging. Work has shown that the therapeutic vaccine candidate has been able to induce strong CD4+ and CD8+ T-cell responses against the HPV antigens targeted, with only one injection in mice.

These immune responses have shown to induce complete regression of tumours in a cervical cancer pre clinical murine model. These complete remissions have been observed in all of the different routes of administration, which can be used in humans, and with doses of product as low as 10 micrograms.

Moreover, preclinical studies to-date have shown that the immunity induced by ProCervix® is long lasting. Cured mice are still fully protected against a second injection of tumour cells performed 3 months later. Finally, the active ingredients of ProCervix® have been shown to induce a strong specific T-cell response in “humanized” mice, indicating that the product is active in a human molecular context.