Divine Corporation has announced that its Divine 9 lube containing Carragel has been selected by McGill University’s Division of Cancer Epidemiology for use in their large-scale, double-blind human trial on the ability of a carrageenan-based gel to prevent the transmission of human papillomavirus (HPV).
The study is called CATCH, an acronym for Carrageenan-gel Against Transmission of Cervical HPV, and will involve tracking HPV infections in nearly 500 female volunteers for a one year period. Divine Corporation will be supplying its carrageenan-based personal lubricant Divine 9 as the active product as well as the placebo gel for all the women in the study. CATCH is funded by the Canadian Institutes of Health Research.
The possibility that a topical gel, applied before sexual contact, can block the transmission of HPV would be a breakthrough with worldwide medical significance.
The McGill University research team is led by Dr. Eduardo Franco, director of the Division of Cancer Epidemiology and is coordinated by Joseph Tota (PhD candidate).
“The CATCH study is a major initiative to determine if using a carrageenan-based gel can prevent the acquisition and transmission of HPV in a real world setting,” Dr. Franco says. “I’m extremely encouraged by the results of the laboratory studies by Dr. John Schiller’s team at the National Cancer Institute. If the trial is successful, it would mean that women have another option for protecting themselves against HPV, the causative agent for cervical cancer.”
According to the company, a research team at the National Cancer Institute has conducted both in vitro and in vivo studies and found Divine 9 was effective in inhibiting infection rates.
“The possibility that a topical gel, applied before sexual contact, can block the transmission of HPV would be a breakthrough with worldwide medical significance,” the company says. “As a result, the Canadian Institutes of Health Research is funding Dr. Franco and his team to complete the CATCH study.”
The CATCH study will recruit 465 female volunteers and each will be supplied with either the carrageenan gel or placebo gel. The volunteers will use the gels whenever they are in intimate situations. During their one-year follow-up, the women will visit designated clinics for monitoring of HPV infection rates.
“We are gratified that Dr. Franco and his team at McGill University chose Divine 9 for this remarkable study on HPV prevention,” said Dean Fresonke, CEO of Divine Corporation. “With positive results, the world will have a powerful new weapon in the battle against cancer.”
Divine Corporation was formed in April of 2000 to pursue a concept originated by two business executives, Stephanie Leavine and Dean Fresonke. The goal was to create a personal lubricant that would have great playtime characteristics but eliminate the stickiness and resulting skin irritation that could result in the evaporation cycle of lube.
Dr. Mario Tremblay, who has a PhD in chemistry, also is part of the founding team and, having managed new product development for Max Factor and CoverGirl Cosmetics, brought with him the expertise to establish an accomplished product formulation team.
The formulation team had not created personal lubricants prior and approached the task using a broad spectrum of compounds, the company said. The formulation team strived to move away from waxes and silicone, which cannot be absorbed by the skin and have to be washed off, as well as parabens and glycerins that can cause skin irritation. According to the company, it found that skin irritation problems occur from residual deposits and partial absorption of ingredients.
“After sequencing through many different compounds, a vial labeled simply ‘9’ was delivered for testing” the company says. “Unlike any of the others, it exhibited superior slip characteristics and a unique evaporation cycle which, when finished, left the skin with a smooth and silky ‘baby powder’ feel. With further refinement, composition ‘9’ became the basis of Divine 9.”
The key ingredient of Divine 9 is a special extract of sea algae commonly referred to as carrageenan. Carrageenan is an edible compound Generally Recognized As Safe (GRAS) by the Food and Drug Administration (FDA). According to the company, carrageenan is used as a thickener and smoothing agent in such products as baby formula and ice cream.
With many different types of sea algae and variety of methods for the extraction of carrageenan, Divine 9’s unique carrageenan extract and formulation technique is a trade secret.