SciClone announces topline results from Phase 2 clinical trial of SCV-07 for prevention of oral mucositis

Source: CNNMoney.com Author: press release SciClone Pharmaceuticals, Inc. today announced topline results from the company's phase 2 clinical trial of SCV-07 for the prevention of severe oral mucositis (OM) (World Health Organization, WHO scale, grades 3 to 4) -- a painful, debilitating, and costly toxicity caused by chemoradiotherapy regimens used to treat head and neck cancer. This proof of concept study was intended to provide an estimate of SCV-07's treatment effect and guide further studies of SCV-07 in addressing this serious unmet medical need. Patients receiving the study's higher dose (0.1 mg/kg) of SCV-07 showed a trend towards delay to onset of severe OM, the study's primary endpoint. Patients in the low dose treatment arm (0.02 mg/kg) appeared to do worse than placebo, suggesting that the treatment effect is sensitive to dose. Additionally, SCV-07 was safe and well tolerated with no drug-related serious adverse events reported, indicating that there is potential to administer higher doses of SCV-07 in future clinical studies. Additional data analysis showed a more pronounced clinical benefit for patients in the high dose treatment arm when evaluating the delay to onset of ulcerative OM (WHO scale, grades 2 to 4), an expanded measure of OM. In this analysis, the low dose treatment arm appeared similar or slightly better than placebo. "We are encouraged that the trial provides an indication of a biological signal, in the high dose arm, for the pre-specified primary endpoint of the study," said Stephen T. Sonis, DMD, DMSc, Senior Physician, Brigham and Women's [...]

Research argues HPV vaccine should extend to boys

Source: RadioAustralia.net Author: Staff It is already available free to young girls in countries like Nauru, Vanuatu, Tuvalu and Cook Islands, but researchers are now saying the human papilloma virus, or HPV, vaccine Gardasil should also be offered to males. It follows new Australian research showing that the virus which causes cervical cancer in women is now a leading cause of oral cancer in men. It says 60 per cent of throat and tonsil cancers are caused by the virus. Presenter: Lindy Kerin Speaker: Barbara Rowe, associate professor in research with University of Sydney; Luke Connolly, director of Australian Centre for Economic Research; Dr Jonathan Clark, head and neck surgeon with Royal Prince Alfred and Liverpool Hospitals, New South Wales LINDY KERIN: For the past two years Australia has been rolling out the cervical cancer vaccine Gardasil to young women. It immunises them against the human papilloma virus, or HPV as it's known. Now there's growing evidence that the same virus is responsible for an increasing number of mouth and throat cancers in men. Barbara Rowe is an associate professor in research at the University of Sydney. BARBARA ROWE: We've tested just over 300 cancers of the oropharynx, and the oropharynx includes the tonsil and the base of tongue and part of the pharangyl wall. And we've tested those for the human papilloma virus type-16 and type-18, which the major cause of cervical cancer in women. And we found a sizeable proportion are associated with those types. In fact probably [...]

2010-04-01T17:14:59-07:00April, 2010|Oral Cancer News|

Oral sex and HPV related cancers – a threat for both sexes

Source: Examiner.com Author: Charles Simmins An editorial in the British Medical Journal on March 25 links the increasing incidence of oropharyngeal squamous cell carcinoma to infections by human papillomavirus (HPV) that patients caught through oral sex. HPV infection is known to be related to cancers of the cervix, as well as vulvar, vaginal, and male anal cancers. The United States has seen a 22% increase in this oral cancer from 1999 to 2006 and the United Kingdom a 51% increase from 1989 to 2006. The editorial reports that biopsies of these cancers in the United States are showing a 50% to 100% increase in HPV findings over a decade. The authors point to recent studies that show the risks of developing oropharyngeal carcinoma are increased in those patients with six or more lifetime sexual partners, four or more lifetime oral sex partners and, for men, an earlier age at first sexual intercourse. The implications of these findings suggest reconsideration of some basic healthcare issues. In an e-mail exchange with William Bonnez, M.D., Associate Professor of Medicine at the University of Rochester, he pointed out that no screening tools exist for HPV related cancers other than the Pap smear for cervical cancer. The authors of the editorial report that HPV oropharyngeal squamous cell carcinoma appears to have a more favorable prognosis than the non-HPV variety, and that those affected are usually younger. They point out that this means the patients will be dealing with the illness and its effects for a longer period [...]

2010-04-01T19:39:12-07:00April, 2010|Oral Cancer News|

Sharp rise in HPV-related oropharyngeal carcinoma — a legacy of the “sexual revolution”?

Source: MedScape Today Author: Zosia Chustecka March 30, 2010 — The incidence of oropharyngeal carcinoma related to human papillomavirus (HPV) has been increasing in recent years, and there is speculation that this is the result of the "sexual revolution" of the 1960s. This increase in the incidence of HPV-related oropharyngeal cancer has important public health implications, British experts warn in an editorial published online March 25 in the British Medical Journal. HPV-related oropharyngeal carcinoma appears to be a new and distinct disease entity, with better survival than the classic non-HPV-related disease, they point out. "These patients are typically younger and employed, and — because outcomes seem to be more favorable than for patients with non-HPV-related carcinoma — they will live longer with the functional and psychological sequelae of their treatment. Consequently, they need prolonged support from health, social, and other services, and may require help returning to work," write the authors, headed by Hisham Mehanna, BMedSc, MB ChB, FRCS, director of the Institute of Head and Neck Studies and Education at University Hospital in Coventry, United Kingdom. However, currently, there is no good evidence to support managing patients with HPV-related head and neck cancer differently from those whose tumors are not HPV-related, the researchers write. Several studies are being planned to evaluate different treatment options, and Dr. Mehanna and colleagues urge clinicians to offer all patients with oropharyngeal cancer the opportunity to enroll in a clinical trial. However, until data from those trials are available, "we suggest that clinicians should not change their [...]

2010-04-01T19:38:46-07:00April, 2010|Oral Cancer News|

Adjuvant radiotherapy helpful in early, node-positive oral cancer

Source: www.acr.org Author: David Douglas Postoperative radiotherapy significantly improves survival in patients with early T stage oral cavity squamous cell carcinoma and a single positive lymph node, researchers report in the March issue of Archives of Otolaryngology: Head and Neck Surgery. "Even for small primary tumors of the oral cavity, the presence of a single positive lymph node may be an indication to offer radiation despite the relatively early stage of these tumors," lead author Dr. Mark G. Shrime told Reuters Health by email. "This is especially true in T2 tumors of the tongue and the floor of mouth." Dr. Shrime of Boston University Medical Center and colleagues examined data on more than 1500 patients who had surgery between 1983 and 2004. Patients who had postoperative radiotherapy had significantly better 5-year overall survival (54.2% versus 41.4%). The largest advantage was in patients with T2 primary tumors (48.8% versus 32.5%). The difference in patients with T1 tumors (63.4% versus 56.5%) was not statistically significant. Also, the authors report, adjuvant radiotherapy was particularly effective in T2 tumors of the tongue (improving 5-year survival from 37.9% to 52.3%) and floor of the mouth (boosting survival from 17.7% to 39.9%). For all other sites, adjuvant radiotherapy was not associated with improved overall 5-year survival. The 5-year cause-specific survival rate was 64.3% in patients treated with surgery alone, versus 72.1% in patients who also had radiotherapy. While the results appear encouraging, the researchers call for "further analysis with either large multi-institutional series or more detailed [...]

Rise in mouth cancer linked to STI’s, primarily HPV16

Source: www.nhs.uk Author: staff The Daily Telegraph reported that a “rise in mouth cancer may be due to sexually transmitted infection”. The newspaper said that there has been a 50% increase in the number of mouth cancers in the last 20 years, and the increase appears to be in those cases related to the human papilloma virus (HPV). The story is based on an editorial in the British Medical Journal by cancer specialists, which highlighted an increase in the numbers of a specific type of throat cancer in the UK. The specialists also discussed studies from other countries that show an increase in the proportion of HPV-related throat cancers. The editorial reported on a very small number of studies, but it shows that there may be a need to investigate the incidence of HPV-related throat cancers in the UK, to track these cases and to see if HPV-related cancers should be treated differently to non-HPV-related throat cancers. There is insufficient evidence at the moment to suggest that the HPV vaccination, currently available for teenage girls, should also be given to boys. Where did the story come from? This editorial was written by Hisham Mehanna, director of the Institute of Head and Neck Studies and Education at University Hospital, Coventry, and colleagues at the University of Liverpool, Université Catholique de Louvain and the University of Texas. The editorial was commissioned and published by the British Medical Journal and was not externally peer reviewed. What was the editorial about? This editorial was [...]

Study evaluating clinical performance of Cervista(R) HPV HR presented at AOGIN

Source: www.prnewswire.com Author: press release Hologic, Inc. (Hologic or the Company), a leading developer, manufacturer and supplier of premium diagnostics, medical imaging systems and surgical products dedicated to serving the healthcare needs of women, today announced that interim data from the first large-scale independent evaluation of clinical performance of Cervista® HPV HR compared to Hybrid Capture 2 (hc2), were presented at the 4th Biennial Meeting of AOGIN (Asia-Oceanic Research Organization in Genital Infection and Neoplasia) in New Delhi, India on March 26-28, 2010. Cervista HPV HR is a diagnostic test for the detection of 14 high-risk human papillomavirus (HPV) types. The study, SHENCCAST II, is a major cervical cancer screening trial including more than 10,000 women that is being conducted in China to evaluate the performance of HPV assays, among other endpoints. A preliminary analysis of data from 5,043 patients showed the Cervista HPV HR test performed as follows: Overall HPV positivity for this cohort was 12.2 percent for the Cervista HPV HR test and 14.6 percent with the hc2 test. For histologically confirmed CIN 2 or more severe lesions, the Cervista HPV HR test showed a sensitivity of 90.7 percent and a specificity of 90.2 percent. For the hc2 test, sensitivity and specificity were 94.7 percent and 87.9 percent, respectively. While the Cervista HPV HR test demonstrated improved specificity and the hc2 test yielded higher sensitivity, a statistical analysis of overall test accuracy that plots sensitivity and specificity found the two methods were clinically equivalent (area under the ROC [...]

Oropharyngeal carcinoma related to human papillomavirus

Source: BMJ 2010;340:c1439 Author: Staff Incidence is increasing rapidly, with implications for prognosis and policy Head and neck cancer is the sixth most common cancer, with about 640,000 new cases each year worldwide. Despite an overall marginal decline in the incidence of most head and neck cancers in recent years,1 the incidence of oropharyngeal squamous cell carcinoma has increased greatly, especially in the developed world. In the United States, the incidence of oropharyngeal squamous cell carcinoma increased by 22% from 1.53 per 100,000 to 1.87 per 100,000 between 1999 and 2006, after showing no change between 1975 and 1999. 1 The United Kingdom has seen a 51% increase in oral and oropharyngeal squamous cell carcinoma in men from seven per 100,000 to 11 per 100,000 between 1989 and 2006. 2 The increase in incidence of oropharyngeal squamous cell carcinoma seems to be accounted for by a rise in human papillomavirus (HPV) related oropharyngeal carcinoma. A recent retrospective study showed a progressive proportional increase in the detection of HPV in biopsies taken to diagnose oropharyngeal squamous cell carcinoma in the Swedish county of Stockholm over the past three decades (23.3% in 1970s, 29% in 1980s, 57% in 1990s, 68% between 2000 and 2002, 77% between 2003 and 2005, and 93% between 2006 and 2007).3 Similarly, HPV related oropharyngeal carcinoma has been reported in 60-80% of recent oropharyngeal biopsy samples in studies conducted in the US, compared with 40% in the previous decade.4 More research is needed to establish the incidence of HPV related oropharyngeal carcinoma in African, Asian, and South American countries. HPV related oropharyngeal carcinoma seems to be a new and distinct [...]

2010-03-26T16:16:09-07:00March, 2010|Oral Cancer News|

HPV-related cancer leap to have big impact on health services

Source: www.dentistry.co.uk Author: staff The rapid rise in cases of squamous cell carcinoma related to human papillomavirus (HPV) infection has serious implications for health services around the world, warn researchers. They suggest that sexual transmission of HPV might be the reason for the rise. Head and neck cancer is the sixth most common cancer, with about 640,000 new cases each year worldwide. Despite an overall marginal decline in most head and neck cancers in recent years, the level of oropharyngeal squamous cell carcinoma (OSCC) has increased greatly, especially in the developed world. In the US, cases increased by 22% between 1999 and 2006, after showing no change between 1975 and 1999, while the UK has seen a 51% increase in oral and oropharyngeal cancer in men between 1989 and 2006. This increase seems to be accounted for by a rise in HPV-related tumours, say the authors, led by Hisham Mehanna at the Institute of Head and Neck Studies and Education, University Hospital, Coventry. A recent study showed a 70% increase in the detection of HPV in biopsies taken to diagnose oropharyngeal carcinoma in Stockholm since the 1970s. HPV-related oropharyngeal carcinoma has also been reported in 60-80% of recent biopsy samples in studies conducted in the US, compared with 40% in the previous decade. HPV-related oropharyngeal carcinoma seems to be a new and distinct disease entity, explain the authors. It has a better prognosis than non-HPV related oropharyngeal carcinoma, particularly in non-smokers, but the reason for this improved survival is not [...]

Time-released muco-adhesive patch more effective than oral rinse for xerostomia

Source: www.news-medical.net/news Author: press release A newly developed time-released muco-adhesive patch for treating oral health conditions, including the widespread condition of dry mouth (xerostomia), has been shown to be more effective than a leading oral rinse, according to a newly-published study. As increasing segments of the population consume more medications (one of the leading causes of dry mouth), the results of this study could potentially help provide relief for millions of Americans. Chronic dry mouth impacts the quality of life and for some, can be debilitating. Published in the March 2010 issue of Quintessence International, the study found that chronic dry mouth sufferers can now get a statistically significant reduction of mouth dryness from a new time-released muco-adhesive patch (OraMoist Dry Mouth Patch), compared with the leading oral rinse which has been on the market for nearly two decades. Overall, patients with xerostomia treated with the muco-adhesive patch reported a statistically significant reduction in mouth dryness sensation with elevated salivary flow rate (150%) after just 30 minutes, which was considered clinically outstanding by the study authors, since the product does not contain any cholinergic agonist, a drug often used to treat dry mouth. OraMoist, a new time-released, non-drug formula, not only outperformed the mouthwash, one of the most often used delivery formats for treating dry mouth, but unlike dry mouth sprays, rinses or gels, which need to be applied frequently – sometimes every 20 minutes – OraMoist works to increase moisture and help restore a healthy oral environment for hours [...]

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