June 8, 2006
(LOUISVILLE, KY) – Two members of the team that invented the world’s first 100 percent effective cervical cancer vaccine today praised the U.S. Food and Drug Administration’s approval of the drug. The vaccine neutralizes the human papillomavirus (HPV)—the major cause of cervical cancer. However, today’s FDA approval of the vaccine is only the first step of eliminating the second leading cancer killer of women worldwide, and the number one killer in underdeveloped countries.
Researchers Alfred Bennett “Ben” Jenson, MD and Shin-je Ghim, PhD, now working at the University of Louisville‘s James Graham Brown Cancer Center, are developing a second generation, more affordable version of the vaccine. The team’s third step in their mission of curing the women of the world of cervical cancer is to also create a therapeutic treatment that could be given to women who already have cervical cancer and cure them.
Step One: Preventing Cervical Cancer
Jenson and Ghim were on the original team that developed the vaccine, while working at Georgetown University. The vaccine is engineered to protect women against the two strains of HPV that cause 75 percent of all cervical cancer cases. Two pharmaceutical companies, Merck and GlaxoSmithKline, have developed it for market. It is Merck’s vaccine, Gardasil, which received FDA approval today after making headlines last fall when the vaccine proved 100 percent effective in preventing HPV among the women tested. Jenson and Ghim hold four crucial patents behind both the GlaxoSmithKline and Merck vaccines.
Although Merck has not released the price of the vaccine, speculation is that it will be expensive. While that will probably not be prohibitive for most American women, the cost may have implications for women in underdeveloped countries and underserved women in the United States.
Step Two: Access for All
With availability to all women in the forefront of their minds, now the research team is developing a less expensive, but equally powerful, version of the vaccine. To do that, they are actually growing the vaccine in tobacco plants, an irony for the Kentucky-based researchers and the state’s most vilified crop.
“To work with a plant, or an acre or two of plants, just requires air, water and sun,” Jenson says.
“We hope that this will be an effective, much less costly vaccine,” says Ghim.
“The decision to use tobacco as the host was an easy one,” Jenson adds. “More is known about the tobacco plant genetically than any other plant, and it is being used in a number of creative ways.”
Last step: Find a Cure
Because the vaccine prevents the virus that causes cervical cancer, it is only effective if a woman has not yet been infected with HPV, or before she is sexually active. This would require administration between the ages of 9 and 13. That would still leave a segment of the population left unvaccinated that could develop cervical cancer. It will also take at least a couple of decades to see the impact the vaccine has had on cervical cancer deaths.
Therefore Jenson and Ghim are continuing their crusade against cervical cancer. Their final step and ultimate goal is clear: to create a therapeutic treatment to cure women who already have cervical cancer.
Jenson and Ghim say that the resources available through the Brown Cancer Center’s Molecular Targeting Research Program will hopefully make this third phase of their research a reality.
The James Graham Brown Cancer Center is part of the University of Louisville’s Health Sciences Center and UofL Health Care. As the region’s leading academic, research, and teaching medical center, our patients benefit from the latest medical advances, often long before they become available in non-teaching settings. The Brown Cancer Center is affiliated with the National Cancer Institute and the Kentucky Cancer Program. It is the only cancer center in the region to use a unified approach to cancer care, with multidisciplinary teams of physicians working together to guide patients through diagnosis, treatment and recovery.
- Alfred Bennett “Ben” Jenson, MD and Shin-je Ghim, PhD are part of the original team that created the world’s first preventative cancer vaccine, which prevents cervical cancer (U.S. patent # 6,887,478).
- While working at Georgetown University, Jenson’s research team invented the vaccine that neutralizes the human papillomavirus (HPV)—the major cause of cervical cancer. The team also showed the efficacy of the vaccine in preclinical trials. Jenson and his team hold several U.S. patents on both the preclinical and human vaccine.
- Their work is the basis of the vaccine that is now being developed by Merck and GlaxoSmithKline.
- Merck's vaccine, Gardasil, received FDA approval on June 8, 2006. The vaccine is the world's first 100% effective, cervical cancer vaccine.
- GlaxoSmithKline's vaccine is due out within the next year.
- As the minds behind the cure of the world’s first preventative cancer vaccine, Jenson and Ghim’s goal is to rid the world of cervical cancer.
- Step one in this process was creation of the first vaccine. Steps two and three of their groundbreaking research are taking place at the University of Louisville’s James Graham Brown Cancer Center.
- The team’s second phase is creation of a less expensive, but equally powerful version of the original vaccine so that all women—in Kentucky, across the United States and around the world—regardless of health insurance or access to medical care can be protected against HPV and prevent cervical cancer.
- Utilizing Kentucky’s resources, Jenson and Ghim are working on developing a second-generation vaccine. By using the tobacco mosaic virus, the vaccine can then be grown in genetically modified tobacco plants—providing an alternative use for a plant linked to the leading cancer killer nationally and in Kentucky, lung cancer.
- This process costs approximately $2 per dose versus the $100 per dose of the original vaccine, thus making it more affordable for women in underdeveloped regions and in third world countries.
- The team’s third step in their mission of curing the women of the world of cervical cancer is to create a therapeutic treatment that could be given to women who already have cervical cancer and cure them. Jenson and Ghim say that the resources available through the Brown Cancer Center’s Molecular Targeting Research Program will hopefully make this third phase of their research a reality.
Cervical Cancer & the Human Papillomavirus (HPV)
Cervical Cancer is the number two cancer killer of women worldwide, and the number one killer in underdeveloped countries.
The human papillomavirus (HPV) is now recognized as the major cause of cervical cancer.
There are more than 100 types of HPV, and more than 30 of those are sexually transmitted.
Of those 30, strains HPV-16 and 18 are responsible for 75% of cervical cancer cases.
Data gathered by the Kentucky Cancer Registry and the National Cancer Institute (NCI) shows that in 1998, Kentucky’s invasive cervical cancer incidence was 49% higher than the national rate.
In areas, like Kentucky, where women face various socioeconomic disparities, the cervical cancer rates are higher than the national or world average.
Even though routine screening with the Pap test has greatly reduce the cervical cancer toll in the United States (70% since it was introduced in 1941), many women are still diagnosed with cervical cancer in the U.S. every year.
Every year, approximately 15,000 women in the U.S. are diagnosed with cervical cancer and there are about 5,000 deaths.
Worldwide, approximately 500,000 women are diagnosed with cervical cancer annually, with nearly a quarter of a million deaths.
A lot of these cases occur in women who have never had a Pap test or have not had one in the past five years.
In 2002, 17% of Kentucky women surveyed did not have a Pap test in the past three years. Nationally, it’s 16% (Center for Disease Control and Prevention).
Access to medical care and/or consistent health care coverage contributes to this factor.
Partnering with the Brown Cancer Center’s Gynecologic Oncology Group
, Jenson and Ghim are also working on an effective HPV at home self-test that women can administer themselves. This would help women around the world who do not have access to the Pap test.
The James Graham Brown Cancer Center