CLJI Worldwide Trial Enrolls First Patient in Clinical Study Evaluating the Performance of VIBLOK as a Barrier for Herpes Simplex Virus Transmission in Men and Women

Food and Healthcare Press Releases Tuesday May 23, 2017 16:15
BAY HARBOR ISLANDS, Florida--23 May--PRNewswire/InfoQuest
CLJI Worldwide Sponsored Study Assessing the Safety and Performance of VIBLOK in HSV-2 infected adults as a barrier for virus transmission; Principal Investigators Named; First Patient Enrolled

CLJI Worldwide reports the start of the VIBLOK Safety And perFormancE Trial (SAFE Trial). The CLJI Worldwide SAFE Trial will evaluate the performance of VIBLOK for adults infected with herpes simplex virus-2 (HSV-2), the cause of genital herpes. VIBLOK is an investigational device developed to help reduce skin-to-skin HSV-2 transmission.

The global burden of HSV-2 is large, leaving over 400 million people living with the infection [1]. Genital lesions due to herpes are often very painful, can lead to substantial psychological morbidity, increase the risk of acquiring HIV [2-8], and can be transmitted from mother to infant during childbirth with potentially serious consequences [9, 10]. There is, however, no treatment eradicating the herpes simplex virus from the body, and disease management focuses on symptom relief, reducing recurrent episodes, and preventing viral transmission between sexual partners.   Despite the use of medical treatments and condoms, genital herpes transmission may still occur through unprotected areas of the skin via micro-sized lesions, which are often exacerbated by grooming practices of the genital area, such as shaving and waxing [11].

VIBLOK is a virtually colorless, odorless, and tasteless cream designed to create a protective skin barrier that prevents the passage of viruses (e.g., HSV-2). Laboratory testing indicates that the cream can block virus passage at over 80% efficacy at the correct dosage. The SAFE Trial will provide an indication as to whether VIBLOK can safely and effectively block virus passage from the skin in HSV-2 infected people and in doing so, target the currently high prevalence of this sexually transmitted infection (STI) in industrialized and developing countries.

Dr. Annet Muetstege, PhD, is the clinical project manager, and the coordinating investigator for this clinical trial in The Netherlands is Dr. Vivienne van de Walle, M.D., PhD, CPI from PreCare Trial & Recruitment. The clinical trial strategy and protocol has been developed with help of the Study Steering Committee members Prof. Anna Wald, M.D., MPH at the University of Washington School of Medicine in Seattle, USA, Dr. Annemarie Wensing, M.D., PhD at the Utrecht University in Utrecht, The Netherlands, and Prof. Charles Boucher, M.D., PhD at the Erasmus University, Erasmus Medical Center in Rotterdam, The Netherlands. The prospective, non-randomized, comparative multi-center SAFE Trial is anticipated to last for 12 months in which up to 48 participants with HSV-2 will be enrolled and followed for one month. HSV will be measured from daily self-collected genital swabs before and after the application of VIBLOK.

The investigational centers will include six participating sites in The Netherlands and Germany. As a follow-up to the preclinical tests, this trial is designed to provide further supportive evidence for the efficacy of this skin barrier product to reduce the occurrence of HSV-2 transmission in a clinical setting. EB FlevoResearch in Almere, with Dr. Aletha Veenendaal as its principal investigator, enrolled the first trial participants at the beginning of April.

VIBLOK is an investigational device being evaluated in Europe and the outcomes of this clinical trial will be used to support the product application for CE Mark. It does not have an approved Investigational Device Exemption in the United States.

The clinical trial is being sponsored and managed by CLJI Worldwide which is committed to 'empowering people worldwide to make smart health decisions, and reducing global suffering by protecting them from the physical pain and emotional suffering of preventable diseases.' CLJI Worldwide was established by Craig Lichtblau, M.D. and Jose Iparraguirre, M.D.; two practicing medical doctors in different specialties, who have been friends for over 30 years. They decided to combine their knowledge with that of a CEO and business leader in order to build an organization that strives to reduce pain and suffering in the world. The SAFE Trial reflects just one of the pioneering studies sponsored by CLJI Worldwide, that aims at investigating overlooked aspects of healthcare and subsequently solving real problems with scientifically and clinically proven products. "We are excited about the start of the SAFE Trial as it represents a significant milestone in our quest to revolutionize STI prevention and ultimately help millions of women and men across the globe live healthier, happier lives" says Ty Cross, President and Chief Executive Officer of CLJI Worldwide.

References
1. Looker KJ et al. Global estimates of prevalent and incident herpes simplex virus type 2 infections in 2012. PLoS One. 2015 Jan 21;10(1):e114989. doi: 10.1371/journal.pone.0114989.
2. Wald A, Link K. Risk of human immunodeficiency virus infection in herpes simplex virus type 2-seropositive persons: a meta-analysis. J Infect Dis. 2002; 185: 45-52.
3. Strick LB, Wald A, Celum C. Management of herpes simplex virus type 2 infection in HIV type 1-infected persons. Clin Infect Dis. 2006; 43: 347-56.
4. Celum C, Levine R, Weaver M, Wald A. Genital herpes and human immunodeficiency virus: double trouble. Bull World Health Organ. 2004; 82: 447-53.

5. Serwadda D, Gray RH, Sewankambo NK, Wabwire-Mangen F, Chen MZ, Quinn TC, et   al. Human immunodeficiency   virus   acquisition associated with genital ulcer disease and herpes   simplex   virus   type   2   infection:   a   nested   case-control   study   in   Rakai,   Uganda. J Infect Dis. 2003; 188: 1492-7.

6. Freeman EE, Weiss HA, Glynn JR, Cross PL, Whitworth JA, Hayes RJ. Herpes simplex virus 2 infection increases HIV acquisition in men and women: systematic review and meta-analysis of longitudinal studies. AIDS. 2006; 20: 73-83.

7. Reynolds SJ, Quinn TC. Developments in STD/HIV interactions: the intertwining epidemics of HIV and HSV-2. Infect Dis Clin North Am 2005; 19: 415-25.
8. Reynolds SJ. The role of HSV-2 suppressive therapy for HIV prevention. Future Microbiol. 2009; 4: 1095–1097.
9. Brown ZA, Selke S, Zeh J, Kopelman J, Maslow A, Ashley RL, et al., et al. The acquisition of herpes simplex virus during pregnancy. N Engl J Med. 1997; 337: 509-15.
10. Brown Z.   Preventing herpes simplex virus transmission to the neonate. Herpes2004; 11: 175A-86A.
11. Osterberg EC et al. Correlation between pubic hair grooming and STIs: results from a nationally representative probability sample. Sex Transm Infect 2016;0:1–5. doi:10.1136/sextrans-2016-052687
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