FDA approves Strativa Pharmaceuticals’s Oravig(TM) buccal tablets for treatment of oropharyngeal candidiasis

Source: www.biospace.com Author: press release Strativa Pharmaceuticals today announced that the U.S. Food and Drug Administration (FDA) has approved Oravig (miconazole) buccal tablets for the treatment of oropharyngeal candidiasis (OPC), more commonly known as thrush, in adults and children age 16 and older. Oravig is the first and only local, oral prescription formulation of miconazole – an antifungal medication – approved for this use in the U.S. Oravig, which adheres to the gum, utilizes innovative buccal tablet technology enabling once-daily dosing that delivers miconazole directly at the local site of infection throughout the day with minimal systemic absorption. Oravig is easy-to-use and provides patients with a flavorless, odorless and convenient treatment option that does not interfere with daily activities such as eating and drinking. Oravig will be offered in a 50 mg dosage strength and is expected to be available in retail pharmacies in the third quarter of 2010. "The FDA approval of Oravig underscores Strativa's commitment to improving patients' overall treatment experience by bringing to market new products that fulfill patient needs," said John A. MacPhee, President, Strativa Pharmaceuticals. "Oravig offers patients suffering from thrush a proven effective treatment in a discreet and convenient once-daily formulation." The FDA approval was based on two pivotal Phase III clinical trials. The first study demonstrated that Oravig completely resolved signs and symptoms of OPC at rates similar to Mycelex® Troche (clotrimazole) administered five times per day in HIV-positive patients. This randomized, double-blind, double-dummy trial was conducted in 577 HIV-positive patients in 28 [...]

Instant screening device is the best defense for detecting deadly oral cancer

Source: worldental.org Author: staff Every year, over 34,000 Americans develop oral cancer. Many die, and many others must undergo surgery that leaves them permanently disfigured. In the March 2010 issue of Esquire magazine, film critic Roger Ebert shared his story about his battle with the oral cancer disease. After multiple surgeries, he lost his lower jaw, along with his ability to speak and eat solid food. Ebert brings publicity to a disease that hasn’t received much. Oral cancer can be a serious diagnosis, mainly because it usually goes undetected until it has reached an advanced stage and has spread throughout the body. People in their 60s who use tobacco and/or alcohol were once thought to be most at risk of getting oral cancer, but new evidence suggests a more disturbing cause. Oral cancer is now linked to the human papillomavirus (HPV), the same virus that causes cervical cancer. This means that oral cancer can be spread via oral sex, which puts sexually active younger adults in a higher-risk category. Dentists are usually the first to diagnose oral cancer, but 75 percent do not check their patients for signs of the disease. What’s more, the early signs of oral cancer are invisible to the naked eye, so even those who look for it may not spot it. Luckily, there is a technology to detect the earliest signs of oral cancer. It’s called the VELscope, and it’s being used in approximately 500 dental practices throughout the United States. Dr. Michael Koczarski of [...]

Study suggests VELscope can help reduce recurrence of oral cancer

Source: www.dentaleconomics.com Author: staff LED Dental has announced a recent study suggests that its VELscope screening system can help surgeons reduce the recurrence rate for oral cancer following surgery. The article, "Tracing the 'At-Risk' Oral Mucosa Field with Autofluorescence: Steps Toward Clinical Impact," was just published in the journal, Cancer Prevention Research. The article was was authored by Catherine F. Poh, Calum E. MacAulay, and Miriam Rosin of the BC Cancer Agency and Lewei Zhang of the University of British Columbia. The study was prompted by numerous previous studies that showed oral cancer recurs in a significant percentage of patients following oral cancer surgery. The study examined the experience of 60 oral cancer surgery patients between 2004 and 2008. Their cancerous lesions were treated with surgical excision alone with a minimum follow-up time of 12 months. For 38 of the 60 patients, the surgeon used a surgical margin that was 10 mm beyond the tumor edge defined by the VELscope exam. Because the VELscope system utilizes fluorescence visualization, or FV, technology, these patients are described in the article as having had FV-guided surgery. The remaining 22 patients--the control group--did not have FV-guided surgery. Instead, the surgeon used a surgical margin that was 10 mm beyond the tumor edge defined by the standard white-light exam. White light exams rely on visual inspection with the naked eye, whereas the VELscope system allows clinicians to discover cancerous and precancerous tissue that might not be apparent to the naked eye. Four years into the [...]

2010-02-18T22:37:36-07:00February, 2010|Oral Cancer News|

Emory couples cancer drug with green tea extract to help fight cancers of the head and neck

Source: www.examiner.com Author: Kristina Bjoran Clinical researchers at the Emory University Winship Cancer Institute have discovered that pairing a popular cancer-fighting drug with green tea extract may help reduce the risks for neck and head cancers. The lead investigator in the trial is Dr. Dong Moon Shin, and he and his team have been working to combine the drug Erlotinib with an extract of green tea to observe the effects. Elrotinib is a drug that has been long used as an effective way to treat certain types of lung and pancreatic cancers. Neck and head cancers are more common than many know. The American Cancer Society touts that almost 50,000 Americans will be diagnosed with one of the two cancers this year alone, so this new trial at Emory may provide hope for those with pre-cancerous lesions related to the cancers. The chemical of interest in the green tea extract is called polyphenon E (PPE), and the lab experiments show that combing PPE with Elrontinib can potentially prevent the development of the cancers by targeting specific cellular activity in the pre-cancerous areas. Shin and his team are focusing on the lesions of the head and neck. Cancers of the head and neck have relatively low survival rates, and have not seen much of an increase over the past few decades. As the sixth most common type of cancer, this new study provides hope to those in need of a new, effective treatment.

2009-12-25T11:02:51-07:00December, 2009|Oral Cancer News|

Autofluorescence-guided surveillance for oral cancer

Source: cancerpreventionresearch.aacrjournals.org Authors: Vijayvel Jayaprakash et al. Early detection of oral premalignant lesions (OPL) and oral cancers (OC) is critical for improved survival. We evaluated if the addition of autofluorescence visualization (AFV) to conventional white-light examination (WLE) improved the ability to detect OPLs/OCs. Sixty high-risk patients, with suspicious oral lesions or recently diagnosed untreated OPLs/OCs, underwent sequential surveillance with WLE and AFV. Biopsies were obtained from all suspicious areas identified on both examinations (n = 189) and one normal-looking control area per person (n = 60). Sensitivity, specificity, and predictive values were calculated for WLE, AFV, and WLE + AFV. Estimates were calculated separately for lesions classified by histopathologic grades as low-grade lesions, high-grade lesions (HGL), and OCs. Sequential surveillance with WLE + AFV provided a greater sensitivity than WLE in detecting low-grade lesions (75% versus 44%), HGLs (100% versus 71%), and OCs (100% versus 80%). The specificity in detecting OPLs/OCs decreased from 70% with WLE to 38% with WLE + AFV. Thirteen of the 76 additional biopsies (17%) obtained based on AFV findings were HGLs/OCs. Five patients (8%) were diagnosed with a HGL/OC only because of the addition of AFV to WLE. In seven patients, additional HGL/OC foci or wider OC margins were detected on AFV. Additionally, AFV aided in the detection of metachronous HGL/OC in 6 of 26 patients (23%) with a history of previously treated head and neck cancer. Overall, the addition of AFV to WLE improved the ability to detect HGLs/OCs. In spite of the lower [...]

2009-11-05T13:17:24-07:00November, 2009|Oral Cancer News|

Trimira offers online library of oral cancer images

Source: www.dentalofficemag.com Author: staff Trimira LLC, manufacturers of the Identafi 3000 Oral Cancer Screening Device, have developed the Trimira Clinical Image Library. The library is a comprehensive online catalog of clinical photographs taken by leading scientists and researchers. The images show a diverse array of lesions in various locations in the oral cavity. Access to the library is free and available at Trimira. A demo version can be accessed by anyone at http://www.trimira.net/library. The full library is available only to registered Trimira customers. Photographs in the Trimira Clinical Image Library were taken under the three proprietary multispectral lights produced by the Identafi 3000, providing visualization of the lesions. Images are categorized by location in the mouth, type of dysplasia, and appearance under each light wavelength. Trimira plans to increase the number and diversity of photographs in the coming months. The Trimira Identafi 3000 is a small, cordless, affordable handheld device that helps clinicians effectively detect early cancers not visible to the naked eye. The device uses a three-wavelength optical fluorescence and reflectance technology patented by Trimira LLC of Houston. The Identafi 3000 was developed in collaboration with scientists at M.D. Anderson Cancer Center, Rice University, and British Columbia Cancer Research Center, and is now available through dealers nationwide.

New oral cancer tests: crucial or wasteful?

Source: nytimes.com Author: Laurie Tarkan Though relatively rare, it is one of the easiest cancers to spot and diagnose. And if treated early, it is usually curable. So why do experts find oral cancer so vexing? Despite the many advances against cancer in recent decades, the statistics on this form of it remain discouraging: more than 60 percent of cases are diagnosed in the late stages, and the five-year survival rate is a disappointing 59 percent. Moreover, oral cancer is increasing in people traditionally at low risk, a phenomenon partly attributed to the rise of the cancer-causing human papillomavirus, or HPV, which can be transmitted through oral sex. Now some dentists — whose visual examinations have long been a first line of defense against oral cancer — are using screening devices that they say may help identify cancers and premalignant lesions. But these new tests have set off a debate over cost and effectiveness. Experts are divided on whether they will reduce mortality from oral cancer or simply lead to a wave of expensive and unnecessary biopsies. An estimated 35,300 Americans learned they had oral cancer last year, and about 7,600 died from the disease. For survivors, oral cancer can be painful and disfiguring, and can destroy the ability to taste and enjoy food. Smokers and heavy drinkers are considered at highest risk for the disease, but 25 percent of those who receive a diagnosis are neither. Still, the lifetime risk of oral cancer — about 1 in 99 — [...]

Survival after surgical resection of pulmonary metastases and second primary squamous cell lung carcinomas in head and neck cancer

Source: Head Neck, October 28, 2008 Authors: Thomas W Geurts et al. Background: Patients with head and neck squamous cell carcinoma (HNSCC) are at risk for developing both pulmonary metastasis and second primary lung cancer (SPLC). The objective of this study was to determine survival characteristics of patients with pulmonary lesions after curative treatment for HNSCC. Methods: Lung resection or biopsy specimens of 36 patients, curatively treated for HNSCC between 1978 and 2002, were defined as second primary squamous cell lung cancer or metastasis by loss of heterozygosity (LOH analysis). Twenty-two of them underwent surgical resection. Survival characteristics were estimated using Kaplan-Meier analysis according to the LOH characterization. Results: The number of resected lung lesions ranged from 1 to 3. Median overall survival after lung surgery was 23.1 months for SPLC (n = 14) and 25.1 months for lung metastases (n = 8). Fourteen patients, SPLC (n = 6) and metastases (n = 8), did not undergo surgical resection, and their median overall survival was 3.7 and 4.4 months, respectively. Conclusion: Survival after resection of metachronic lung lesions following curative treatment of HNSSC is similar for lesions characterized as second primary squamous cell lung cancer and those characterized as metastases. Authors: Thomas W Geurts, Alfons J M Balm, Marie-Louise F van Velthuysen, Harm van Tinteren, Jacobus A Burgers, Nico van Zandwijk, and Houke M Klomp Authors' affiliation: Department of ORL, Academic Medical Center, Amsterdam, The Netherlands

2008-11-03T09:49:47-07:00November, 2008|Oral Cancer News|

Laser treatment for oral cancer

Source: abclocal.go.com Author: Leslie Toldo A quick zap from a painless laser could stop a deadly form of cancer. HealthFirst reporter Leslie Toldo tells us about this oral cancer breakthrough. Oral cancer has a high death rate compared to some other cancers, and the survival rate isn't improving. But this new treatment could stop it before it starts. They're often detected in a routine dental or doctor's exam -- red or white lesions called leukoplakia that can turn into serious, even deadly oral cancers. "I do happen to know people that have died of this kind of cancer, and so we watch it very closely," said oral cancer survivor Mike Hagerman. Hagerman, a former smoker, is a two-time oral cancer survivor. His leukoplakia is back. This time, he's part of a study testing a new photodynamic laser treatment designed to eliminate precancerous cells. Dr. Stuart Wong is a medical oncologist. "When the laser fires onto the lesion, it emits light at a very specific frequency that causes free oxygen radicals that destroy the lesion." Tested on the hand or used in the mouth on actual lesions, researchers say the laser doesn't hurt. it's a preventive measure that doctor say could save lives. "There is some emerging data that the better we can kill off these early precancerous lesions, that that might translate later down the road many, many years to a decreasing in the development of cancers and that's the goal," Wong noted. Oral cancer has a five-year survival rate [...]

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