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Pevion Biotech AG

Pevion´s breakthrough candida vaccine demonstrates safety and immunogenicity in Phase I clinical study

Ittigen, Berne (ots)

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."
About Pevion Biotech
Pevion Biotech is an independent Swiss vaccine company that 
develops next generation vaccines based on its clinically and 
commercially validated virosome technology. Its proprietary pipeline 
includes a clinical stage candidiasis vaccine and preclinical 
programmes in RSV and universal flu. A clinical stage malaria vaccine
candidate has been outlicensed and the Company`s technology is being 
used for an HIV vaccine currently in human trials. The Company has 
in-house development capability and expertise, including a 
state-of-the-art and industrially scalable GMP manufacturing process.
Located near Bern, Pevion was founded in 2002 as an industrial 
spin-off of Bachem AG (SWX: BANB) and Berna Biotech, now Crucell, 
(SWX: CRX), and raised a total of CHF 45 million to date from its 
founders and investors, BZ Bank, Core Capital Partners and BB Biotech
Ventures.
About Virosomes
Virosomes are the only regulatory and market-approved vaccine 
technology to fulfill carrier and adjuvant functions in one. 
Essentially, virosomes represent reconstituted empty influenza virus 
envelopes, devoid of the genetic material of the source virus. As 
such, virosomes do not replicate and are therefore an ideal 
combination of carrier plus adjuvant for almost any given antigen, 
including peptide or protein derived antigens. The technology allows 
the surface display and delivery of difficult antigens and thereby 
provides access to new indications and markets. Two virosome-based 
vaccines (Epaxal® and Inflexal® V, marketed by Crucell Switzerland 
AG) are licensed in over 40 countries, and more than 70 million doses
of these vaccines have been commercially distributed, thereby 
providing a solid safety and efficacy track record.

Contact:

Christian Spyr, PhD
Head Clinical Development & Project Management
Phone: +41/31/550'44'44
E-Mail: info@pevion.com