Date: 2012-01-17
Type of information:
phase: 1
Announcement: results
Company: Pevion Biotech (Switzerland)
Product: PEV7 therapeutic Candida vaccine
Action
mechanism: PEV7 is a therapeutic vaccine based on a protein antigen, Sap2, a key virulence factor of vulvovaginal candidiasis, presented on the surface of virosomes. Pevion exclusively in-licensed the Sap2 antigen from its academic partner, the Istituto Superiore di Sanità (ISS) in Rome, Italy.
Disease: recurrent vulvovaginal candidiasis (RVVC)
Therapeutic area: Infectious diseases - Gynecology - Women's health
Country:
Trial
details: The ongoing PEV7 Phase I study is designed to assess the safety and immunogenicity of the therapeutic vaccine candidate in healthy volunteers. Half of the subjects will receive intramuscular injections, while the other half will receive capsules, administered intravaginally. In total, the study will enroll 48 healthy women of childbearing age.
Latest
news: * On January 17, 2012, Pevion Biotech AG has announced further data from the ongoing clinical study of its therapeutic Candida vaccine PEV7, demonstrating the generation of specific and functional B cell memory in 100% of vaccinees. Furthermore, the results again confirm the capability of Pevion\'s second generation virosomal vaccine platform to induce strong and long-lasting immunity in humans against otherwise weak antigens. Following the previously announced positive safety and immunogenicity results of PEV7, the Company further investigated the vaccine-induced generation of B cell memory (see below). To this end, half of the group of volunteers vaccinated with the intramuscular low dose of PEV7 received a single booster immunization fourteen months after the primary vaccination course. All vaccinees showed a rapid, specific response either in serum or in cervicovaginal secretion or in both, after antibody titers had come down to baseline six months prior to the boost in this low-dose group.
The follow-up of the group of volunteers vaccinated with the intramuscular high dose of PEV7 is ongoing and so far has shown high and persistent antibody titers until six months after completion of the vaccination course. In order to evaluate the intravaginal application of PEV7 in capsule form, an additional study arm is ongoing. First volunteers have already been safely vaccinated.
* On October 11, 2011, Pevion Biotech has announced latest results from the ongoing clinical study of its therapeutic Candida vaccine PEV7, showing high levels of specific antibodies and a 100% mucosal immune response rate. The announcement further included the results of the largest, international representative epidemiological survey to date on recurrent vulvovaginal candidiasis (RVVC), confirming that 7% of adult women suffer from the disease.The newly announced data come from the group of volunteers vaccinated with the intramuscular high dose of PEV7 and showed significantly increase immunogenicity over the previously vaccinated low-dose group, while confirming the excellent safety profile customary for virosome-delivered vaccines.
Particularly relevant for the postulated mode-of-action of PEV7 was the strong immune response detected in vaginal and cervical samples. All volunteers showed a mucosal immune response with consistently high titers across the group.
In order to further validate the disease burden and the commercial potential of PEV7, Pevion mandated the largest, international representative epidemiological survey on RVVC among 6’000 women, generating robust data on prevalence, incidence and the age structure of the RVVC patient population. The study was performed in the US and the five largest European markets by Ipsos Health, a leader in the field of independent market research.“The consistency of the Ipsos survey results across countries and with previous studies is very convincing. RVVC is a common problem throughout the Western world.” says Prof. Betsy Foxman, a leading RVVC epidemiologist from the University of Michigan School of Public Health, Ann Arbor, USA. “41% of women surveyed reported a least one episode of vulvovaginal candidiasis. Of those, one in five had a 12-month period with 4 or more yeast infections. Therefore, PEV7 has the potential to address a strong unmet medical need.”
