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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.
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.
ots Originaltext: Pevion Biotech AG
Christian Spyr, PhD
Head Clinical Development & Project Management