Cervarix – Page 7 – Oral Cancer News

HPV vaccine clears viral infection and may reduce cancerous lesions

Source: www.newswise.com Author: staff Breakthrough study reports complete and partial remissions following vaccination A new vaccine designed to stimulate an immune response against a cancer-causing human papillomavirus (HPV-16) can eliminate chronic infection by the virus and may cause regression of precancerous genital lesions in women who receive the vaccine. According to a report published in the November 5 issue of the New England Journal of Medicine (2009;361:1838-47), the vaccine successfully induced HPV-specific immune responses in 100% of patients with advanced vulvar intraepithelial neoplasia (VIN3), a life-threatening disease that in the majority of cases results from HPV infection and for which there is as yet no satisfactory standard therapy. Among the women who participated in the study, the majority (79%) experienced measurable regression of their VIN3 lesions within 1 year of vaccination. Nine of the women (47%) experienced complete disappearance of lesions and were still symptom-free two years following vaccination. The virus was undetectable in four of five women whose disease had regressed completely after the first year. According to researchers who conducted the phase II study at the Leiden University Medical Center in Leiden, The Netherlands, spontaneous regression of HPV-16 positive VIN3 lesions is very rare, occurring in less than 1.5% of patients. The induction of HPV-specific T-cell immune responses following vaccination, and the researchers’ observation that stronger vaccine-induced immune responses correlated with better clinical outcome indicate that the vaccine is the most likely cause of the high response rate among the patients treated in the study. Unlike recently approved [...]

Oral Cancer Foundation News Team - A2009-11-10T20:37:37-07:00November, 2009|Oral Cancer News|

US advisers decline to push Gardasil for boys

Source: Reuters.com Author: Maggie Fox * Committee advises that doctors free to use vaccine * Says needs more evidence of cost benefit * Did not consider value in preventing cancer (Updates throughout, adds quotes, share price) WASHINGTON, Oct 21 (Reuters) - U.S. vaccine advisers declined to press for the use of Merck & Co's (MRK.N) Gardasil in boys and men, opting instead on Wednesday to simply advise doctors they are free to use it. Despite some impassioned pleas from patients and doctors alike, the Advisory Committee on Immunization Practices voted almost unanimously for "permissive" use of the vaccine for boys. It protects against the human papillomavirus, or HPV, which causes a variety of cancers and genital warts. But the committee did recommend including Gardasil for eligible boys aged 9 to 18 in the Vaccines For Children program, a government-funded system that provides vaccines to children eligible for the state-federal Medicaid health insurance plan and other uninsured children. Merck's shares were down 1.7 percent at $33.16 in afternoon trading on the New York Stock Exchange. The U.S. Centers for Disease Control and Prevention currently recommends Gardasil for girls 11 and 12 years old and women 13 to 26 who have not been vaccinated. Earlier this month, the U.S. Food and Drug Administration approved Gardasil for preventing genital warts in boys and men ages 9 through 26. The main reason the vaccine was approved was to prevent cervical cancer, which kills 4,000 women a year in the United States alone. But various [...]

Charlotte Parker2009-10-21T14:45:00-07:00October, 2009|OCF In The News, Oral Cancer News|

FDA approves two HPV vaccines: Cervarix for girls, Gardasil for boys

Sources: www.cancer.gov/ncicancerbulletin Author: news bulletin The FDA has approved a second vaccine to prevent cervical cancer and cervical precancers, the vaccine’s manufacturer, GlaxoSmithKline, announced last week. The approval is based on data from a large clinical trial showing that the vaccine, Cervarix, prevented precancerous lesions in 93 percent of those who received the full vaccine sequence of three injections over 6 months. Cervarix is a bivalent vaccine, meaning it is specifically designed to protect against two human papillomavirus (HPV) types, HPV 16 and 18, which together are responsible for three-quarters of cervical cancers in North America. Clinical trial data also indicate that Cervarix offers more modest protection against precancerous lesions associated with HPV 31, GSK explained in a statement, as well as other tumor-causing (or oncogenic) HPV types. The company expects the vaccine to be available in the United States by the end of the year. The FDA last week also approved the HPV vaccine Gardasil for the prevention of genital warts in boys. Gardasil is already approved and is being actively used in girls and young women for the prevention of cervical cancer. Gardasil is a quadrivalent vaccine that is designed to specifically protect against infections with four HPV types: 16, 18, 6, and 11. HPV types 6 and 11, which are not considered to be oncogenic, cause genital warts. The agency’s approval of Gardasil for boys aged 9 to 26 is based on data from a randomized clinical trial of more than 4,000 males aged 16 to 26, [...]

Oral Cancer Foundation News Team - A2009-10-21T04:44:55-07:00October, 2009|Oral Cancer News|

Wart virus makes for less deadly cancer

Source: www.montrealgazette.com Author: Maggie Fox A wart virus best known for causing cervical cancer may make for a less-deadly kind of head and neck cancer, researchers reported on Thursday. People whose head and neck tumours carried the human papillomavirus virus, or HPV, were 59 percent less likely to die than people whose tumours were not caused by the virus, the researchers said. "A patient who has this actually has a better prognosis than patients with HPV-negative tumours," Dr. Richard Schilsky, president of the American Society of Clinical Oncology and a cancer specialist at the University of Chicago, said in an interview. He said it may be clear now that there are two kinds of head and neck cancers -- those caused by HPV and those linked to other causes, such as smoking and drinking. Not only can patients be treated differently, perhaps waiting longer for toxic chemotherapy if they have an HPV-positive tumour, but there may be ways to prevent these tumours, Schilsky said. Two vaccines -- Cervarix, made by GlaxoSmithKline, and Gardasil, made by Merck & Co Inc -- prevent HPV-16 infection. "There is every reason to think that vaccination with the HPV vaccine will prevent these," Schilsky said. Dr. Maura Gillison and colleagues at Johns Hopkins University in Baltimore studied 317 head and neck cancer patients whose tumours could be tested for HPV. The phase III study confirms earlier work Gillison's lab did linking HPV and these tumours. They said 87 percent of patients with tumours that tested [...]

Oral Cancer Foundation News Team - A2009-10-16T15:43:55-07:00October, 2009|Oral Cancer News|

FDA approves GlaxoSmithKline’s Cervarix

Source: Philadelphia Business Journal Author: John George The Food and Drug Administration granted marketing approval Friday to Cervarix, the cervical cancer vaccine developed by GlaxoSmithKline. The London pharmaceutical company, which has major operations in the Philadelphia region, said the vaccine will be on the market before the end of the year. The FDA approved the drug for use in women and girls ages 10 to 25. GlaxoSmithKline (NYSE:GSK) will have a challenge taking market share away from Merck & Co. Inc. (NYSE:MRK), which launched its cervical cancer vaccine Gardasil in 2006. Gardasil had worldwide sales of $1.4 billion for Merck last year. Cervarix, which was previously approved in markets outside the United States including Europe, Japan and Australia, had sales of more than $200 million in 2007.

Charlotte Parker2009-10-16T10:56:58-07:00October, 2009|Oral Cancer News|

Giving Gardasil to boys not worth the cost?

Source: HealthDay.com Author: Steven Reinberg But other experts dispute finding, and say young men need protection from STDs THURSDAY, Oct. 8 (HealthDay News) -- The cost of giving boys the human papillomavirus (HPV) vaccine would outweigh any health benefit, researchers say. Last month, a U.S. Food and Drug Administration panel recommended expanding use of the Gardasil vaccine to males aged 9 to 26 to protect them from genital warts, but the cost effectiveness of such a program was unclear at the time. But researchers from the Harvard School of Public Health conducted such an analysis comparing a girls-only vaccination program with a co-ed vaccination program. Currently, Gardasil is approved for girls aged 9 and over to protect them from cervical cancer. "This study found that while vaccine coverage and efficacy are high in girls, including boys in an HPV vaccination program generally exceeds what the U.S. typically considers good value for money," said lead researcher Jane Kim, an assistant professor of health decision science. The report is published in the Oct. 9 online edition of the British Medical Journal. Vaccination was considered a good value if cost-effectiveness ratios ranged from $50,000 to $100,000 per quality-adjusted life year, meaning the cost of the vaccine vs. the number of added years someone would gain by getting the vaccine. Assuming 75 percent coverage and lifelong protection, the researchers found routine vaccination of 12-year-old girls was a good value at less than $50,000 per quality-adjusted life year. However, adding preadolescent boys increased the cost-effectiveness ratio [...]

Charlotte Parker2009-10-12T11:54:27-07:00October, 2009|Oral Cancer News|

37% of U.S. teen girls got HPV vaccine

Source: www.medscape.com Author: Daniel J. DeNoon More than one in three U.S. teen girls has had at least one shot of Gardasil, a CDC survey shows, but only 18% of girls got the three shots needed for protection. The survey includes girls vaccinated through 2008, two years after Gardasil's approval. A second HPV vaccine, GlaxoSmithKline's Cervarix, is expected to be approved this year. Gardasil, from Merck, protects against the four strains of the sexually transmitted human papillomavirus (HPV) that cause most cases of cervical cancer and genital warts. But other HPV strains also cause these diseases, so even vaccinated women still need regular Pap exams. Gardasil's acceptance varied widely by state. More than half of all teen girls aged 13 to 17 had at least one shot of the HPV vaccine in six states: Arizona, Massachusetts, New Hampshire, New York, Rhode Island, and Vermont. Fewer than one in five girls got the vaccine in three states: Georgia, Mississippi, and South Carolina. Coverage was highest in Rhode Island (54.7%) and New Hampshire (54.4%) and lowest in Mississippi (15.8%) and Georgia (18.5%). Cervical cancer is more common in women of Hispanic descent and in people living below the poverty level. Perhaps because the Vaccines for Children (VFC) program provides the expensive vaccine to uninsured children, girls in these groups had higher rates of coverage than other girls. The CDC reported results of the survey in today's issue of Morbidity and Mortality Weekly Report. Source: MMWR, Sept. 17, 2009; vol 58: pp 997-1001.

Oral Cancer Foundation News Team - A2009-09-25T12:57:21-07:00September, 2009|Oral Cancer News|

Three clinical studies give GSK’s cancer vaccine an edge

Source: EH News Bureau Author: Staff GlaxoSmithKline Pharmaceuticals Limited (GSK) recently shared the results of three recently published clinical studies, conducted for its cervical cancer vaccine—Cervarix. Said Dr Hasit Joshipura, Vice President, South Asia and Managing Director, GSK India, "The findings confirmed that the vaccine offers protection against five of the most common cancer-causing virus types, generates significantly higher immune response compared to the other available vaccine Gardasil and provides high and sustained antibody levels for at least 7.3 years till date." The clinical studies involved 18,644 women and was published in The Lancet. The study confirmed that Cervarix is not only highly effective at protecting against the two most common cervical cancer-causing human papillomavirus (HPV) types, 16 and 18, but also provides additional cross-protection against HPV types 31, 33 and 45, the three most common cancer-causing virus types beyond 16 and 18. This additional efficacy could translate into approximately 11-16 per cent extra protection against cervical cancer over and above the protection afforded by efficacy against HPV 16 and 18 alone. In India, the same five HPV types are responsible for almost 90 per cent cervical cancer cases. "These results amply demonstrate that preventive vaccination is one of the most effective methods of primary prevention of HPV infection, the necessary cause of cervical cancer. In tandem with screening tests, it is perfectly positioned to lend a decisive edge against this deadly cancer. Extending the scope of protection beyond types 16 and 18 will allow prevention of the vast majority [...]

Charlotte Parker2009-08-21T04:48:45-07:00August, 2009|Oral Cancer News|

HPV vaccine debate shifts to boys

Source: Buffalo News Author: Henry L. Davis New questions arise as cancer tied to HPV is rising in men Parents who face the dilemma of whether to protect their young daughters with a vaccine aimed at a sexually transmitted infection that causes cervical cancer now face a new question: Should they do the same for their sons? As evidence mounts of a rising number of other cancers linked to the human papillomavirus, or HPV, a debate has intensified over whether to give the vaccine to males. Advocates say vaccinating boys and men can prevent them from passing on the virus to their sexual partners. Critics still question the long-term safety and effectiveness of Merck & Co.’s Gardasil, despite studies indicating that its risks and lasting power are within the range of other vaccines. But a newer wrinkle in the debate is the discovery in recent years that oral HPV infections — most likely acquired from oral sex with multiple partners—significantly increase the risk of head and neck cancers. The rate of oral cancers is rising so steadily, especially in men, that, if the trend continues, there may be more oral cancers in the United States caused by HPV in 10 years than by tobacco or alcohol, a major study concluded last year. “We should be investing our care and dollars in preventing HPV infection instead of treating the cancers,” said Dr. Thom Loree of Roswell Park Cancer Institute. Physicians at the cancer center have begun publicly touting the benefits of [...]

Charlotte Parker2009-07-15T13:04:17-07:00July, 2009|Oral Cancer News|

‘Poor knowledge’ on cervical cancer

Source: The Press Association Author: Staff More than one in three girls does not know the causes of cervical cancer despite the "Jade Goody effect", a new poll suggests. A total of 38% of girls said they were unaware of the causes even though Goody - a former Big Brother star - raised the profile of the disease. Goody died in March aged 27 after a battle with the cancer, which had spread around her body. Anecdotal evidence from across the NHS suggests the number of women attending cervical screening has shot up as a result of her story. The poll of girls aged 12 to 18 was carried out for GlaxoSmithKline, which makes the Cervarix vaccine to protect against Human papillomavirus (HPV), which causes most cases of cervical cancer. Of the 255 girls questioned, 5% thought "sexual promiscuity" caused cervical cancer. Another 11% said "a type of virus" caused it but only 6% knew the HPV virus did. When the findings were compared with a survey of 139 girls aged 16 to 18 carried out before Goody was diagnosed, 40% said they did not know what caused the disease and 6% pointed to HPV. This could suggest that knowledge about HPV has not increased despite Goody's diagnosis. The more recent survey also found that 40% of girls thought a family history of the disease was a major factor in getting cervical cancer. Girls aged 12 to 13 are currently being vaccinated against HPV as part of an NHS campaign. [...]

Charlotte Parker2009-06-08T17:11:12-07:00June, 2009|Oral Cancer News|