Pevion announces positive results of PEV7 Phase I study for recurrent vulvovaginal candidiasis

Nov 11 2010

Pevion Biotech AG today announced positive preliminary results from a Phase I study of PEV7, the first vaccine against recurrent vulvovaginal candidiasis (RVVC). Also known as chronic recurrent thrush, RVVC is a highly debilitating condition, which affects an estimated 3-6% of women worldwide. Vaccination of the first study group has been completed and demonstrated that PEV7 is safe and well-tolerated in all subjects and elicits an immune response even at low doses.

"This is an important step for both PEV7 and Pevion as we aim for proof of concept in humans with our innovative approach to disease management using a state-of-the-art subunit vaccine," comments Evert Kueppers, CEO of Pevion. "The fact that in the first volunteers we see immunogenicity at low doses of the vaccine's subunit antigen is very encouraging. In addition, the excellent tolerability of our virosome-delivered vaccines is once more confirmed in a human trial."

"A vaccine has the potential to break new ground here: the prevention of recurrencies, that no drug can provide," says Prof. Jack Sobel, a world leading specialist in the field of recurrent VVC from the Department of Internal Medicine at Wayne State University, Detroit, USA. "An efficient vaccine would bring relief to millions of women who are severely impacted by this disease."

The ongoing PEV7 Phase I study is designed to assess the safety and immunogenicity of the vaccine candidate. Half of the volunteers 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. Pevion's announcement follows the review by an independent Data and Safety Monitoring Board (DSMB) of the results from the first study group that received the vaccine intramuscularly at a low dose.

"The DSMB has now recommended that the trial should proceed with the next study group. This is an important development milestone," adds Kueppers. "RVVC is a major problem, as sufferers have at least four acute attacks per year with a significant effect on quality of life, affecting not just their physical condition, but also their psychological state. It is clear that a well-tolerated and effective vaccine will serve an important unmet medical need. Cure rates of RVVC with existing drug therapy remain disappointing. Reliable long-term protection does not exist and there is no prophylactic treatment available."

SOURCE Pevion Biotech AG