ORLANDO, Calif. — CarraShield Labs, Inc. announced today that McGill University Medical School’s Division of Cancer Epidemiology has launched a large-scale study on the ability of Divine 9 personal lubricant, made with CarraShield, to block the transmission of HPV in gay and bisexual men.
“HPV is a serious health risk for the gay and bi-sexual community as it causes throat, anal and penile cancers as well as genital warts,” the company says. “CarraShield Labs’ proprietary CarraShield formula contains a unique type of carrageenan, a natural seaweed extract that has been shown in previous in vitro (laboratory) and in vivo (animal) studies conducted by the National Cancer Institute to act as an HPV blocking agent.”
The new McGill study is called “LIMIT-HPV,” an acronym for Lubricant Investigation in Men to Inhibit Transmission of HPV. The LIMIT-HPV study will involve tracking the presence of HPV infections in more than 300 male volunteers for a one-year period.
As with McGill University’s earlier CATCH study investigating the ability of CarraShield to prevent HPV infections in women, the LIMIT-HPV research will focus on determining the protective capabilities of CarraShield in the Divine 9 lubricant as compared to a placebo lubricant using a double blind procedure. Participants are instructed to use the lubricant as they normally would in an intimate encounter. Earlier research suggests the CarraShield in Divine 9 creates a protective barrier that traps the virus and thereby prevents infection, the company says.
The leader of the research team is Dr. Eduardo Franco, director of the division of cancer epidemiology. He is conducting this study in collaboration with colleagues at McGill and at University of Montreal. Professor Franco's research during the last 30 years has focused on molecular epidemiology and prevention of cervical cancer and human papillomavirus-associated diseases, Dr. Franco has published more than 400 scientific articles and edited two books on cancer epidemiology and prevention, according to the company.
“Many participants are being solicited at Montreal’s four major universities: McGill, Concordia, UQAM and the Université de Montréal, as well as at some inner-city clinics.” Dr. Franco said. “We will be splitting the men into two groups, about 110 at HIV clinics who are already HIV-positive and 270 men who are not, to be able to test the hypothesis of a reasonable protective effect.
“Health Canada has already approved this study,” he said. “Most of the complicated steps were completed with the first study — the female study — and we are delighted to have received joint funding from the Canadian Institutes of Health Research and the Canadian Cancer Society. CarraShield Labs has provided us the Divine 9 and the placebo in unmarked packaging so that no one knows which is which.
“While the HPV vaccine Gardasil protects against only four strains of the virus,” Dr. Franco says, “potentially, the carrageenan-based lubricant can provide total protection from HPV.”
According to the company, a U.S. Centers for Disease Control fact sheet on HPV says, “HPV, the most common sexually transmitted disease in the United States, is also a concern for gay, bisexual, and other men who have sex with men. Some types of HPV can cause genital and anal warts and some can lead to the development of anal and oral cancers. Gay, bisexual, and other men who have sex with men are 17 times more likely to get anal cancer than heterosexual men.”
Dean Fresonke, CEO of CarraShield Labs, says, “LIMIT-HPV is the first and only study on preventing HPV infection in gay and bisexual men using a protective barrier lubricant, in spite of the fact this community is reported to have the highest HPV infection rates of any single social group. We look forward to supporting Dr. Franco and his research team and are optimistic that the CarraShield in Divine 9 can help win the fight against HPV-induced cancers in men around the world.”