Drugmaker Merck seeks Gardasil approval for boys

Source: www.forbes.com Author: Linda A. Johnson Drugmaker Merck & Co. has asked federal regulators to approve use in males for its vaccine against the human papillomavirus, which causes cervical and other sexually transmitted cancers. The application was submitted in late December, Merck spokeswoman Amy Rose said Tuesday. It was long planned as part of Whitehouse Station, N.J.-based Merck's strategy to increase the market for Gardasil. It prevents infection with the sexually transmitted virus and thus cancers of the genital organs. Gardasil, launched in 2006 for girls and young women, quickly became one of Merck's top-selling vaccines, thanks to aggressive marketing and attempts to get states to require girls to get the vaccine as a requirement for school attendance. However, it is one of the priciest vaccines on the market, typically costing $360 for a three-dose regimen. Gardasil had 2007 sales of $1.5 billion, but sales began slowing in the second half of 2008, after a government-funded Harvard study concluded it was cost-effective for girls but not for women in their 20s. The U.S. Food and Drug Administration has two months to decide whether the application for use in males meets its standards. Reviews can then take 10 months or more. The application includes research data from a Merck study including about 4,000 males, ages 16 to 26; Gardasil prevented 90 percent of cases of penile cancer and genital warts caused by the four common virus strains targeted by the vaccine. The agency approved use of Gardasil in females ages 9 [...]

HPV-16 oncoprotein vaccine protects against head and neck cancer in mice

Source: www.medscape.com Author: staff Immunization with a vaccine that targets the E6 and E7 oncoproteins of human papillomavirus-16 (HPV-16) prevents mice with HPV-16-positive head and neck squamous cell cancers (HNSCCs) from expressing these two oncoproteins by mounting a potent immune response. The vaccine may become part of a treatment regimen, along with surgery, chemotherapy or radiotherapy, in patients with HPV-16-positive HNSCCs, investigators report in the December issue of the Archives of Otolaryngology, Head and Neck Surgery. Dr. John H. Lee and colleagues at the Veterans Administration Medical Center in Iowa City generated an adenoviral recombinant vaccine expressing HPV-16 E6/E7 oncoproteins (adenovirus 5 (Ad5) E6/E7). Mice inoculated with the vaccine "completely cleared E6/E7-expressing tumor cells implanted 2 weeks after immunization." (Dr. Lee is now at the Sanford School of Medicine, University of South Dakota, Sioux Falls.) "A time course of interferon-gamma response showed that E6/E7-specific interferon-gamma production is significantly increased in the first 2 weeks after administration of the vaccine and is substantially maintained for up to 70 days," the investigators report. "At all dosages of vaccine, mice inoculated with Ad5 E6/E7 completely cleared E6/E7-expressing tumor cells implanted 2 weeks after either intratracheal or submucosal inoculation, with significant E6/E7-specific interferon-gamma production," the team reports. "Inoculated mice cleared E6/E7-expressing tumor 70 days after implantation." "In accord with this, our data show that immunization with HPV-16 E6/E7 is an effective method for protecting a host from E6/E7-expressing HNSCCs via generation of a potent immune response," Dr. Lee and colleagues write. "Therapeutic vaccines may [...]

Oral rinses used for tracking HPV-positive head and neck cancers hold promise for screening

Source: American Association for Cancer Research Author: staff A study published in the journal Clinical Cancer Research, a journal of the American Association for Cancer Research, validates a non-invasive screening method with future potential for detection of human papillomavirus (HPV)-positive head and neck cancers. In the study, researchers at Johns Hopkins University used oral rinses and targeted DNA amplification to track and identify oral HPV infections in patients with HPV16-positive and negative head and neck carcinomas (HNSCC) before and after therapy. Findings showed detection of high-risk HPV infections in patients with HPV16-positive HNSCC for up to five years after therapy, indicating a high rate of persistent infection and reaffirming the connection between high-risk types of HPV and HPV-positive head and neck cancer. “There is no question of cause,” said the study’s co-author Maura Gillison, M.D., Ph.D. associate professor of oncology. “It has now become a question of tracking the infection over time to identify those at risk of developing HPV-positive cancer, and for those who have had it, the risk of recurrence and risk of transmission. This is the first study in which we have been able to track the disease and related oral infections for an extended period of time.” Researchers obtained oral rinse samples from a group of 135 patients with head and neck carcinomas. Tissue analysis showed that 44 of these patients had HPV16-positive tumors. Both the tissue and oral rinse samples were genetically sequenced to specify the HPV variants in each. Patients with HPV16-positive tumors were [...]

2008-12-29T22:53:40-07:00December, 2008|Oral Cancer News|

Wart virus caused 25,000 cancers in 5 years – CDC

Source: www.reuters.com Author: Reporting by Maggie Fox, editing by Will Dunham and Philip Barbara The human wart virus HPV caused 25,000 cases of cancer in the United States between 1998 and 2003, including not only cervical cancer but also anal and mouth cancers, the U.S. Centers for Disease Control and Prevention reported on Monday. The study suggests a broad need for screening both men and women for human papillomavirus, or HPV, another team of researchers, who did a similar survey, said. HPV includes about 100 different viruses, and they are the leading cause of cervical cancer. The viruses, transmitted sexually and by skin-to-skin contact, can also cause anal and penile cancers, as well as cancers of the mouth and throat. HPV also causes common warts. Both Merck and Co. and GlaxoSmithKline make vaccines against some of the strains of HPV most strongly linked with cervical cancer. They are recommended for girls and young women who have not begun sexual activity. "This gives us baseline data to measure the impact of HPV vaccine and cervical cancer screening programs in reducing the incidence of cervical cancer and other HPV-associated cancers and precancers," the CDC's Dr. Mona Saraiya, who led the study, said in a statement. Dr. Maura Gillison of Johns Hopkins University in Baltimore, who has studied the link between HPV and oral cancers, said the findings suggest a wider use of the cervical cancer vaccines may be justified. "Currently available HPV vaccines have the potential to reduce the rates of HPV-associated [...]

2008-12-23T20:01:22-07:00December, 2008|Oral Cancer News|

LSUHSC Public Health contributes to estimate of HPV-related cancers

Source: www.canceraids.org Author: staff Professor Vivien Chen, PhD,. Associate Professor Xiao Cheng Wu, MD, PhD and Assistant Professor Edward Peters, DMD, SM, ScD, at LSU Health Sciences Center New Orleans School of Public Health contributed five papers to the largest most comprehensive assessment of the burden of human papillomavirus (HPV)-associated cancers in the United States to date. The report, “Assessing the Burden of Human Papillomavirus (HPV)-Associated Cancers in the United States (ABHACUS),” is available now online and will be published in the November 15, 2008 supplement to the journal Cancer. The publication reports that 25,000 cases of HPV-associated cancers were diagnosed in 38 states and the District of Columbia from 1998-2003. These include cancers of the cervix, vagina, vulva, penis, anus, oral cavity and oropharynx. Human papillomaviruses comprise about 100 different types, more than 30 of which are sexually transmitted. As the data were collected prior to the development of the HPV vaccine, they will provide baseline incidence rates to determine the effectiveness of the vaccine as well as cervical cancer screening programs in reducing the incidence of HPV-associated cancers and precancers. The most comprehensive analysis studied data from the National Cancer Institute’s Surveillance, Epidemiology and End Results (SEER) cancer registries, including the Louisiana Tumor Registry at LSU Health Sciences Center New Orleans, and the Centers for Disease Control’s National Program of Cancer Registries. The papers on which the LSUHSC public health faculty are co-authors are Incidence of in situ and invasive vulvar cancer in the US, 1998-2003 (p 2865-2872), [...]

2008-11-16T11:40:36-07:00November, 2008|Oral Cancer News|

Doctors warn of HPV link to developing oral cancer

Source: Tampa Bay Online (www2.tbo.com) Author: staff Ten years ago, most of Brian Nussenbaum's oral cancer patients were men older than 60 who used tobacco and drank heavily. Today, his patients look different, as does the risky behavior that seems to be leading to their cancer. Nussenbaum, an ear, nose and throat doctor at Washington University in St. Louis, estimates 70 percent of his cancer patients have tumors on the back of their tongues and tonsils caused by human papillomavirus-16. Most of those patients are between ages 45 and 55. About half are women. And experts suspect that all of them - men and women - got the HPV from oral sex. "We know now that 98 percent of cervical cancer is caused by HPV, and mostly HPV-16," he says. "But no one talks about how you can also get mouth cancer from it." Researchers at Johns Hopkins Kimmel Cancer Center reported a link between HPV and these specific throat cancers in 2000. The increase in HPV oral cancer stems from a shift in sexual behaviors, combined with a dramatic decrease in the number of tonsillectomies performed. Cancer from the HPV virus often develops on the tonsils. In a Johns Hopkins study, researchers concluded that people with HPV infections were 32 times more likely to develop oral cancer than those without HPV. These findings have ramifications for anyone who is sexually active. Parents have another reason to think hard about whether they want their adolescent daughters, and perhaps even sons, [...]

2008-11-16T08:03:40-07:00November, 2008|Oral Cancer News|

HPV virus helps cervical and head and neck cancers resist treatment and grow and spread

Source: www.sciencedaily.com Author: staff The human papillomavirus (HPV) allows infected cervical and head and neck cancer cells to maintain internal molecular conditions that make the cancers resistant to therapy and more likely to grow and spread, resulting in a poor prognosis for patients, researchers with UCLA's Jonsson Cancer Center found. Virtually all human cancers experience a state called intratumoral hypoxia, or a low amount of oxygen within the tumor. In the UCLA study, researchers showed that the HPV-positive cancers adapted to and took advantage of the hypoxic environment by expressing a protein that activates a cell signaling pathway that helps the cancers survive, grow and spread. The study is published in the Nov. 4, 2008 issue of the journal Cancer Cell. The research, done on cells in culture and in animal models, may lead to the development of new therapies that target the cell signaling pathway, thereby interrupting ability of the cancer cells to thrive, said Dr. Matthew Rettig, senior author of the study and a researcher at UCLA's Jonsson Comprehensive Cancer Center. "There is potential for therapeutic intervention based on this finding," said Rettig, an associate professor of urology and medicine. The finding is crucial because 90 to 98 percent of cervical cancers are caused by HPV. Cervical cancer is the second most common cancer in women worldwide, with more than 500,000 cases diagnosed annually. In all, 200,000 women die from cervical cancer every year. In oral cavity and pharynx cancers, the HPV virus is linked to about 20 [...]

2008-11-15T09:51:58-07:00November, 2008|Oral Cancer News|

HPV virus helps cervical and head and neck cancer grow and spread

Source: www.newswise.com Author: staff The human papillomavirus (HPV) allows infected cervical and head and neck cancer cells to maintain internal molecular conditions that make the cancers resistant to therapy and more likely to grow and spread, resulting in a poor prognosis for patients, researchers with UCLA’s Jonsson Cancer Center found. Virtually all human cancers experience a state called intratumoral hypoxia, or a low amount of oxygen within the tumor. In the UCLA study, researchers showed that the HPV-positive cancers adapted to and took advantage of the hypoxic environment by expressing a protein that activates a cell signaling pathway that helps the cancers survive, grow and spread. The study is published in the Nov. 4, 2008 issue of the journal Cancer Cell. The research, done on cells in culture and in animal models, may lead to the development of new therapies that target the cell signaling pathway, thereby interrupting ability of the cancer cells to thrive, said Dr. Matthew Rettig, senior author of the study and a researcher at UCLA’s Jonsson Comprehensive Cancer Center. “There is potential for therapeutic intervention based on this finding,” said Rettig, an associate professor of urology and medicine. The finding is crucial because 90 to 98 percent of cervical cancers are caused by HPV. Cervical cancer is the second most common cancer in women worldwide, with more than 500,000 cases diagnosed annually. In all, 200,000 women die from cervical cancer every year. In oral cavity and pharynx cancers, the HPV virus is linked to about 20 [...]

2008-11-03T13:08:17-07:00November, 2008|Oral Cancer News|

Cervical cancer vaccine called safe

Source: www.washingtonpost.com Author: staff Gardasil, the two-year-old vaccine that's designed to prevent cervical cancer, is safe, U.S. officials said Wednesday. The U.S. Centers for Disease Control and Prevention's Immunization Safety Office said a study of 370,000 doses given to girls and young women over the past two years found no evidence that the vaccine causes an increased risk of blood clots or other serious conditions, Bloomberg News reported. The CDC, which recommends the vaccine for girls starting at ages 11 and 12, based its findings on statistics from the Vaccine Safety Datalink, which uses medical data to test hypotheses about vaccine safety, the news service said. "There were no associations found that suggested an elevated risk," said John Iskander, acting director for the Immunization Safety Office, toldBloomberg. Critics of the vaccine, including some groups that worry that the inoculation could promote promiscuity, have contended that Gardasil may not be safe and could give women a false sense of security about sexually transmitted diseases. Gardasil protects against four types of genital human papillomavirus, HPV, which is spread through sexual contact and can cause cervical cancer in women. The U.S. study covered 190,000 girls and young women who received at least one dose of the vaccine's three-shot regimen. The CDC researchers compared medical data on those girls who got the vaccine with data for girls and young women who received other vaccines or none. "The results are really reassuring," said Dr. Paul Offit, chief of the infectious diseases division at Children's Hospital [...]

Green card applicants mandated to get HPV vaccine

Source: www.therapeuticsdaily.com Author: staff A new requirement that girls as young as 11 be vaccinated against a sexually transmitted virus before they can become legal U.S. residents is unfair, immigration advocates say. The federal rule added Gardasil to the list of vaccinations that female immigrants ages 11 to 26 must get before they can obtain "green cards." The series of three shots over six months protects against the strains of the human papillomavirus blamed for most cases of cervical cancer and genital warts. But the vaccine is one of the most expensive on the market and controversial. "This is a huge economic, social and cultural barrier to immigrants who are coming into America," said Tuyet Duong, senior staff attorney for the Immigration and Immigrant Rights Program at the Asian American Justice Center. At a cost of $400, Gardasil places an added burden on green card applicants already paying more than $1,000 in form fees and hundreds of dollars for mandatory medical exams, advocates say. The mandate potentially affects tens of thousands of women and girls annually. More than 200,000 women and girls ages 10 to 29 were granted legal permanent resident status each of the past two years. Past efforts to require the vaccine for American girls has stirred emotional debate and complaints that such mandates intrude on family decisions about sex education. In Texas, lawmakers last year fought off an order by Gov. Rick Perry requiring the shots for sixth grade girls amid questions about vaccine's safety, efficacy and [...]

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