Pevion Biotech's PEV7 Vulvovaginal Candidiasis Vaccine Enters Phase I
- Category: Vaccines
- Published on Monday, 22 March 2010 02:00
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Pevion Biotech announced that PEV7, the first vaccine for chronic recurrent thrush - recurrent vulvovaginal candidiasis (VVC) has entered Phase 1 clinical trial. PEV7 aims to provide relief for an estimated 3-6 % of women worldwide who suffer from this largely unrecognized but highly debilitating condition
BERN, Switzerland | March 22, 2010 | Pevion Biotech, the Swiss vaccine company, today announced that PEV7, the first vaccine for chronic recurrent thrush - recurrent vulvovaginal candidiasis (VVC) has entered Phase 1 clinical trial. PEV7 aims to provide relief for an estimated 3-6 % of women worldwide who suffer from this largely unrecognized but highly debilitating condition. PEV7 has already proven to be effective in clearing the infection and preventing recurrence in animal models, and first results from the Phase I trial are expected later this year. PEV7 is based on Pevion Biotech's proprietary virosome delivery technology in which antigens bind to the surface of a "hollowed-out" virus-like particle (VLP).
According to CEO Thomas Stauffer, Pevion Biotech's technology offers an array of advantages: "Subunit virosome-based vaccines have already been clinically validated in a number of studies, proving to hit the "sweet spot" of enhanced tolerability combined with efficacy. They are also commercially validated through their use in two marketed products. Finally, manufacturing is a semi-synthetic process that is easy to scale up. With VVC and our other vaccine candidates PEV4 for RSV and PEV8 for influenza, we aim to demonstrate the potential high-reward applications of the virosome platform to both established and new players in the growing vaccine market."
Recurrent vulvovaginal candidiasis affects 3-6% of women who are of childbearing age. Usually, sufferers have at least four acute attacks per year. It is difficult to control and is never completely cured until menopause. "The women who suffer from VVC are prone to it mostly because of their genetics, and it can have a significant effect on their quality of life, affecting not just their physical condition but their psychological state," says Dr. William Ledger, Professor Emeritus of Obstetrics and Gynecology at Weill Cornell Medical College, New York. Moreover, thrush is still considered somewhat of a taboo, and the sufferers feel that others consider it an unimportant minor problem.
In contrast to readily available pharmacy treatments, which merely treat the symptoms, the PEV7 vaccine targets and treats the root cause of Candidiasis.
"Over-the-counter treatments work on the short term problem but there's nothing to stop it coming back. If the vaccine works it will be a miracle to the women who suffer," continues Dr. Ledger.
Phase I will comprise 48 women of childbearing age who have not previously suffered from thrush. The women will receive three doses of the vaccine, either through an injection into the arm once a month for three months, or through a pessary inserted into the vagina three times a month for three months.
About Pevion Biotech
Pevion Biotech is a Swiss vaccine company based in Ittigen (Bern), founded in 2002 as an industrial spin-off of Bachem AG (SWX: BANB - News) and Berna Biotech, a Crucell Company (SWX: CRX - News). Based on its clinically and commercially validated virosome technology, Pevion Biotech has brought forth a well-focused product pipeline filled with vaccine candidates that will meet major unmet medical needs. The company has the expertise and capability to develop its candidate vaccines according to industry standards, including a state-of-the-art and industrially scalable GMP manufacturing process. In its initial years the company was supported by its two founding companies, which provided a total of CHF 20 million as start-up capital. In a second financial placement in 2007 the company raised an additional CHF 35 million. The current shareholders include Bachem Holding, BZ Bank, BB Biotech Venture II and Core Capital Partners.
Pevion Biotech's virosome technology is the only regulatory and market-approved vaccine carrier system for the delivery of immunologically active substances. Essentially, virosomes represent reconstituted empty influenza virus envelopes, devoid of the nucleocapsid including the genetic material of the source virus. Virosomes are not able to replicate and are thus an ideal adjuvant and carrier system for almost any given antigen, including peptide or protein antigens. Two virosome-based vaccines (Epaxal® against Hep A and Inflexal®V against influenza) have been registered by Crucell in Europe and other countries including Canada and Australia. The technology is distinguished by its excellent versatility, immunogenicity and safety profile. The application of this established and validated technology allows a faster time to market and a reduced developmental risk for novel vaccine candidates.
SOURCE: Pevion Biotech