A NEW ANTI-VIRAL TECHNOLOGY
CarraShield Labs (CSL) has developed and patented a personal lubricant technology based on a long chain polysaccharide molecule derived from special sea algae extract that has a body of research supporting the fact it creates an environment not conducive to human papillomavirus variants.
The most recent and compelling research has been led by a highly credentialed team at the McGill University Medical School. Results from the world's first human clinical trial involving hundreds of women show that Divine 9 with CarraShield reduced the likelihood of HPV infection as compared to a placebo lubricant. The HPV prevention characteristics of Divine 9 have been previously validated by series of laboratory studies at the National Cancer Institute, Albert Einstein College of Medicine and Rutgers University Medical School.
A briefing on each research study and links to peer-reviewed journal articles are available by scrolling down this page.
Dr. Mario Tremblay, Chief Science Officer of CarraShield Labs, reviews the history of the medical research and the results of the McGill CATCH study
INFORMATION FOR MEDICAL PROFESSIONALS
"While the HPV vaccine protects against at the most nine strains of the virus, potentially, the carrageenan-based lubricant can provide total protection from HPV."
Dr. Eduardo Franco, Principle Investigator, University of McGill Medical School
"Given the issues with vaccines, a topical gel that can reduce HPV infection rates will revolutionize the industry.".
Dr. Mark Einstein, Principle Investigator, Chair of the Dept. of Obstetrics and Gynecology, Rutgers New Jersey Medical School
The McGill University Phase 2b study results represent the first time in the history of HPV research that a topical gel in the form of a personal lubricant has been shown to decrease the likelihood of HPV infections in study participants.
The CarraShield technology captures HPV virions in the vaginal tract, before they attacks the cell walls. This protective barrier effect means the Divine 9 lubricant is not a drug, as it has no chemical reaction with the body.
Divine 9 is a available today to patients as an OTC personal lubricant. Patient recommendations should be based on the fact that Divine 9 is a pleasant to use, plant-based personal lubricant similar to natural vaginal lubrication.
Be sure to clarify with patients that the research studies are not complete, that CarraShield Labs makes no claim of HPV prevention or mitigation, and the FDA has not approved the use of Divine 9 in the prevention of HPV.
What About Vaccines?
The HPV vaccine is a tremendous step forward in HPV prevention but there remain issues that a protective gel could help solve...
Limited Protection For All HPV Types - Vaccines protects against, at the most, 9 of the over 150 types of HPV.
No Effect if Previously Infected - If the patient has already been exposed to one of the 9 types covered by the vaccine, then the vaccine will not protect her for that type.
Low Uptake - Less than 5% of the world's 2.7 billion women are vaccinated.
Cost Limits Availability - Initial cost and the requirement for 2 refrigerated doses limits use in developing countries.
Fear of Side Effects - Some people refuse the vaccine because of reports of side effects.
Religious or Moral Issues - Some parents refused to vaccinate their children because of sexual connotations.
An Estimated 107 Million Women Worldwide are Vaccinated, Leaving 2.7 Billon Women Still at Risk of Serious HPV Infections
McGILL CLINICAL STUDY ON WOMEN
McGill Medical School Large Scale, Double-blind Clinical Trial on Sexually Active Women
Their published conclusion:
"... (Our) analysis suggests that using (Divine 9) lubricant gel can reduce the risk of genital HPV infections in women."
McGill University Medical School
The McGill University Medical School study to reduce HPV infections through use of Divine 9® personal lubricant has yielded its first results. Based on data from 280 participants, the women using the Divine 9 personal lubricant with proprietary CarraShield® plant extract had fewer new HPV infections over a 6 to 12 month period as compared to women using a placebo lubricant.
These new results represent the first time in the history of HPV research that a topical gel in the form of a personal lubricant has been shown to have any effect on the number of HPV infections in women in a clinical setting.
The study is called CATCH, an acronym for Carrageenan-gel Against Transmission of Cervical HPV, and involves tracking HPV infections in over four hundred female volunteers for a one year period. Divine 9 with CarraShield was the active product for the study and a standard, chemical-based lubricant was used as the placebo.
The McGill University research team is led by Dr. Eduardo Franco, Director of the Division of Cancer Epidemiology. Dr. Franco, a renowned expert on the prevention of cervical cancer and HPV-associated diseases, has published over 400 scientific articles.
Dr. Eduardo Franco, Chair of the Department of Oncology at McGill University, Talks About HPV and the CATCH Study using Divine 9
"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. If the trial is successful, it would mean that women have another option for protecting themselves against HPV, the causative agent for cervical cancer."
Dr. Eduardo Franco, Principle Investigator, University of McGill Medical School
AECOM INHIBITION TIME STUDY
Albert Einstein College of Medicine (AECOM) and Rutgers University Research on Effectiveness of Divine 9 in Woman From Time of Application
Both the Albert Einstein College of Medicine (AECOM) at Yeshiva University in New York City as well at the Rutgers New Jersey Medical School have conducted studies to determine the ability to reduce transmission of HPV using Divine 9 personal lubricant made with a special sea algae extract called CarraShield.
Funded by the National Cancer Institute through a multi-million dollar grant, the studies at AECOM and Rutgers were a two-phase laboratory and clinical trial to determine how well Divine 9 personal lubricant works to block HPV. In the first set of published results, AECOM partnered with the non-profit Population Council to compare Divine 9 with a gel the Population Council had used in HIV prevention studies. Read the full journal article...
The second study conducted at AECOM was a human clinical study to determine Divine 9's inhibitory effect over time. AECOM recruited participants who applied Divine 9, engaged in a sexual encounter, and then were analyzed hours later. Samples of Divine 9 were taken from the vaginal tracts of the participants and subjected to laboratory challenge tests with HPV. The researchers found the inhibition effect of Divine 9 was active in the women more than 8 hours after initial application. Read the full journal article...
The principal investigator for the studies was Mark Einstein, M.D., M.S., and formerly Professor of Obstetrics & Gynecology and Women’s Health and Professor of Epidemiology & Population Health at the Albert Einstein College of Medicine and now Chair of the OB/GYN & Women’s Health Department at Rutgers Medical School. Dr. Einstein is one of the world’s leading authorities on cervical cancer prevention and consults with the World Health Organization, National Cancer Society and Society of Gynecologic Oncology.
STUDIES BY THE NATIONAL CANCER INSTITUTE
Studies at the National Cancer Institute Found That Divine 9 Lubricant Blocked HPV in Both the Laboratory and a Mouse Model
A July 14, 2006 research paper titled "Carrageenan Is a Potent Inhibitor of Papillomavirus Infection" by Christopher B. Buck, Cynthia D. Thompson, Jeffrey N. Roberts, Martin Müller, Douglas R. Lowy and John T. Schiller demonstrated the potential of Divine products to block viral infections. The article was published in the Public Library of Science.
The researchers cited carrageenan as an exceptionally potent inhibitor of papillomavirus infectivity and that Divine 9 products containing carrageenan were more effective than any other product tested.
In a second 2007 study titled "Genital Transmission of HPV in a Mouse Model is Potentiated by Nonoxynol-9 and Inhibited by Carrageenan," the research team of Jeffrey Roberts, Christopher Buck, Cynthia Thompson, Rhonda Kines, Marcelino Bernardo, Peter L. Choyke, Douglas R. Lowy & John T. Schiller performed in vivo testing with mice.
They report that the common spermicide Nonoxynol-9 increased the likelihood of HPV infection significantly. They also found that carrageenan in general, and Divine 9 specifically, virtually eliminated HPV infection in the mice. Finally, they reported that when a carrageenan based product is combined with Nonoxynol-9, the likelihood of HPV infection is once again reduced significantly.
(1) Holmes KK, Levine R, Weaver M (2004) Effectiveness of condoms in preventing sexually transmitted infections. Bulletin of the World Health Organization 82: 454–461.