Drug companies attempting cervical cancer breakthrough
Tuesday, January 11, 2005
Researchers and drug companies believe they are on the verge of a breakthrough against cervical cancer, a disease that kills more than a quarter million women a year despite significant progress made against it in recent decades.
Two new vaccines against the human papillomavirus, which causes nearly all cervical cancer, are well along in development, and the University of Alabama at Birmingham is participating in human trials being conducted worldwide for both of them
“I think we’re very, very close.” Dr. Warner Huh, an OB/GYN and researcher at the medical center, said Monday during a news conference to promote recruitment for a new study. “This research is really groundbreaking.”
The human papillomavirus, HPV, is the most common sexually transmitted disease, and in some women it leads to cervical cancer. HPV infections produce no noticeable symptoms in either men or women.
For decades, U.S. doctors have used routine Pap tests to fight cervical cancer. The test, which was introduced in the 1940s, detects precancerous and cancerous conditions, allowing early treatment. The approach has driven down cervical cancer rates in the United States.
But Pap tests are inconvenient and expensive, considering nearly 50 million U.S. women undergo the procedure annually. And such an approach is impossible in developing nations, where there’s little medical care and cervical cancer still rages.
So two drug companies – GlaxoSmithKline and Merck – have produced HPV vaccines that have shown promise in studies. Both vaccines are targeted at strains of HPV that produce about 75 percent of cervical cancer cases.
“The vaccines are incredibly, incredibly effective,” Huh said. “They may really change the frontier and how patients are managed from the moment they are born.”
UAB is enrolling 200 women ages 19 to 25 as part of a large, four-year trial of the GlaxoSmithKline vaccine. It is the final step toward approval of the vaccine by the Food and Drug Administration.
Half the women in the trial will get the vaccine, and half will get an FDA-approved vaccine against hepatitis A, the type that is transmitted in food. The HPV vaccine requires three injections, Huh said.
The Merck vaccine, which also is being tested at UAB, is competing against the GlaxoSmithKline product. It is aimed at the same strains of HPV, but it also includes protection against HPV strains that cause genital warts. Two studies are under way at UAB, but test subjects are no longer being recruited.
Dr. Sharmila Makhija, another OB/GYN and researcher at the medical center, said Merck is slightly leading the race for an HPV vaccine, and its product could be approved by the FDA soon.
“I think they were shooting for this year, but it may be the beginning of next year,” she said.
In the United States the vaccines could lead to fewer cases of cervical cancer and fewer deaths from the disease. It might allow women to wait longer between Pap tests, although that kind of progress probably is decades away, Makhija said.
Internationally, the impact of the vaccines likely would be greater.
For instance, Makhija is working on HPV vaccine research in India, where UAB is developing a cooperative agreement with Tata Memorial Hospital in Bombay. Cervical cancer is the leading cause of cancer-related death in India and the third-leading cause of death overall for women.
The Merck product could be used to vaccinate girls in India between 8 and 12 years old, before they become sexually active, Makhija said.
“We’d have to vaccinate them very early on,” she said. “The reason is these women get married very early there, 14 or 15.”
There are cultural barriers, she said. Some parents in India are insulted by the suggestion that their children should be vaccinated against a sexually transmitted disease, she said.
But the younger generation of women in India – and the United States – likely could be big benefactors of HPV vaccines, Makhija said.
Meanwhile, the drug companies appear to be looking at the vaccines as potential blockbusters that could reap giant profits similar to those produced by drugs such as Viagra or Lipitor.
“They’re pretty quiet about things,” Makhija said, “but that’s the feeling I get.”
The HPV vaccine trials are being conducted through the UAB Comprehensive Cancer Center. For more information about the GlaxoSmithKline study, call 975-7223. dparks@bhamnews.com