Navigation Links
Pevion Mandated Patient Survey Confirms Disease Burden of Recurrent Vulvovaginal Candidiasis (RVVC) and Indicates Public Health Problem
Date:3/8/2012

BERN, Switzerland, March 8, 2012 /PRNewswire/ --

  • Quality of Life (QoL) is strongly diminished in RVVC patients
  • Current available treatment fails in two thirds of patients
  • High medical need demands novel effective treatment options

Pevion Biotech AG today announced results from a large, international survey on the Quality of Life (QoL) of recurrent vulvovaginal candidiasis (RVVC) patients. It is the first time that the overall disease burden of RVVC has been quantified by validated tools, thereby showing that QoL is strongly diminished and that RVVC has a significant impact on patients' daily activities and productivity. The survey furthermore confirmed previous findings that current use of antifungal drugs is inadequate and that it presents a therapeutic failure in more than two thirds of the RVVC patients.

"This study not only highlights the heavy burden associated with the disease, but also the very high unmet medical need," said Professor Mondher Toumi, Chair of Market Access at the University of Lyon 1, France. "The lack of effectiveness and constraint related to chronic treatment are a source of low compliance because there is low perceived benefit with current treatment. Based on cost per quality-adjusted life year (QALY) the society appears ready to pay a high price for an effective intervention in that indication."

"Pevion recently announced the outcome of the largest epidemiological survey ever performed regarding RVVC, confirming that 7% of all adult women suffer from this disease," commented Evert Kueppers, Pevion's Chief Executive Officer. "The outcome of this Quality of Life study confirms that RVVC not only is wide spread, but that it also has a significant impact on the lives of millions of women suffering from RVVC. Presently, RVVC is an under-recognized public health problem affecting mostly young and active parts of the society."

Recurrent vulvovaginal candidiasis (RVVC) is a common and moderate-to-severe chronic condition, which occurs in 7% of all adult women. To date, no study has been conducted to properly assess patients' QoL using validated questionnaires. The disease is characterized by the frequent recurrence of acute inflammations of the vagina and vulva, caused by an overgrowth of Candida albicans, and is defined as four or more acute episodes per year. Clinical symptoms cause extreme discomfort and pain and the quality of life (QoL) of patients is strongly impacted, both physically and psychologically.

Pevion has mandated a survey among more than 600 RVVC patients in the US and in the five largest European countries in order to assess the global QoL in a quantitative manner employing the validated EQ-5D and SF-36 scoring systems. The survey data show that the QoL is substantially diminished not only during an acute inflammatory episode, but also in the periods between recurrences. This reflects the maintained discomfort and stress in between acute episodes, which is accompanied by anxiety and depression in a large proportion of patients. The characteristics of a chronic disease are clearly given and the overall utility scores are significantly lower than the general population's reference value, and this, under the current standard of care. Moreover, the results show strong consistency between the six countries.

The survey revealed that there is a strong impact on patients' usual daily activities and work. A significant loss of productivity has been recorded, which represents a valuable economic damage.

The survey also investigated current treatment patterns among RVVC patients. In those patients who followed a long-term maintenance therapy with antifungal drugs, as recommended by guidelines from several medical societies, relapse occurred in two thirds of cases already within a few months. This low benefit explains why less than half of the patients actually receive such treatment.

Pevion is developing a first-in-class therapeutic vaccine, PEV7, to address this public health issue. PEV7 has recently demonstrated safety and immunogenicity in healthy volunteers.

About PEV7 therapeutic Candida vaccine

PEV7 is a clinical-stage therapeutic vaccine being developed for the treatment of recurrent vulvovaginal candidiasis (RVVC), a moderate-to-severe disease affecting 7% of all adult women. To date, there is no appropriate treatment for RVVC available. PEV7 is based on a protein antigen, Sap2, a key virulence factor of vulvovaginal candidiasis that is 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.

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. Positive interim results have already been announced.

About Virosomes

Virosomes are a regulatory and market-approved vaccine technology that fulfills 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 enables the use of poorly immunogenic 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. Pevion has developed and owns the second generation of virosomes, which have an excellent stability profile through lyophilization and allow alternative product formulations, such as capsules.

About Pevion Biotech AG

Pevion Biotech AG is a fully independent Swiss vaccine company that develops innovative vaccines for unmet medical needs based on its clinically and commercially validated virosome technology. Its proprietary clinical pipeline includes a first-in-class candidiasis vaccine. A clinical stage malaria vaccine candidate has been successfully out-licensed, and the Company's technology has been out-licensed for use as an HIV vaccine, currently in human trials. Pevion has in-house development capability and expertise, including a state-of-the-art and industrially scalable GMP manufacturing process. Located near Bern, Pevion was established by two founding companies, Bachem AG (SWX: BANB) and Berna Biotech (now Crucell, a Johnson & Johnson subsidiary). To date, Pevion has raised a total of CHF 45 million from its founders and investors, BZ Bank, Bachem, BB Biotech Ventures and private investors.

For more information, please visit http://www.pevion.com

For further information, please contact:

Julian Wagner, PhD, BBA, Business Development
Phone: +41-31-550-44-44, info@pevion.com


'/>"/>
SOURCE Pevion Biotech AG
Copyright©2010 PR Newswire.
All rights reserved

Related medicine technology :

1. Pevion Biotech Appoints New CEO and Secures CHF 10 Million Financing
2. Pevions Breakthrough Candida Vaccine Demonstrates Safety and Immunogenicity in Phase I Clinical Study
3. Pevion Grants CSL Option Right to its Therapeutic Candida Vaccine
4. Pevions Therapeutic Candida Vaccine Generates Functional B Cell Memory in all Vaccinees
5. Dendreon Announces Publication of Phase 1 Study Highlighting Immunologic and Clinical Activity of Lapuleucel-T (Neuvenge(R)) in Advanced Breast Cancer Patients
6. Cephalon Announces Positive Results from a Pivotal Study of FENTORA in Opioid-tolerant Patients with Non-cancer Breakthrough Pain
7. Millennium Initiates Clinical Trial to EVOLVE the Treatment of Patients with Newly Diagnosed Multiple Myeloma
8. Allos Therapeutics Initiates Study of PDX in Patients with Cutaneous T-Cell Lymphoma
9. Vion Pharmaceuticals Completes Accrual of 85 Patients to its Pivotal Phase II Trial of Cloretazine(R) (VNP40101M) in Elderly AML
10. Sixty-One Percent of Newly Diagnosed Parkinsons Disease Patients Do Not Receive Any Drug Treatment in the First Year of Diagnosis
11. TaiGen Biotechnology Successfully Completes Patient Recruitment for Phase II Trial of Nemonoxacin for Treatment of Adult Community Acquired Pneumonia (CAP)
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:5/10/2017)... 2017  The Corporate Whistleblower Center says, "We ... therapy clinics to call us anytime at 866-714-6466 if ... involved in a substantial scheme to overbill Medicare. ... an employee of a medical equipment company if ... provide medical practice groups with extra generous incentives to ...
(Date:5/9/2017)... , May 9, 2017  Demonstrating its commitment ... of directors for the Pharmaceutical Research and Manufacturers ... membership. Biopharmaceutical companies will now have to meet ... to be eligible to join PhRMA. ... board is sending a clear message that being ...
(Date:5/8/2017)... Mich. , May 8, 2017  Diplomat Pharmacy, ... WRB Communications, Inc. ("WRB"), a health care service ... . WRB specializes in relationship management programs ... WRB will join ... Diplomat,s commercialization support services for manufacturers, biotech firms, and ...
Breaking Medicine Technology:
(Date:5/26/2017)... Texas (PRWEB) , ... May 26, 2017 , ... Amir ... Stimulation System, a powerfully versatile, patient-centric spinal cord stimulation system. The Nuvectra™ Algovita SCS ... , “We are pleased to be the first in Arkansas to introduce the most ...
(Date:5/26/2017)... MN (PRWEB) , ... May 26, 2017 , ... A ... U.S. states with the healthiest seniors are located in the Midwest. With the average ... more and more people are concerned with both the quality and affordability of where ...
(Date:5/26/2017)... ... May 26, 2017 , ... ... copper, antimicrobial, mesh back 24/7 task chair specifically designed for clinical areas. Genie ... are thrilled to partner with Cupron® to provide customers with a game changing ...
(Date:5/26/2017)... ... May 26, 2017 , ... After raising nearly $30,000 on ... continue to be available at a discounted crowdfunding price on Indiegogo . , ... are, I also wanted to bring a fidget toy to the market that was ...
(Date:5/26/2017)... ... May 26, 2017 , ... Silver Birch of Hammond, a new ... on more than four acres of land at 5620 Sohl Avenue in Hammond, serves ... square-foot building includes 125 studio and one-bedroom apartments. Each of the private apartments at ...
Breaking Medicine News(10 mins):