Scandinavian Formulas: FDA Issues OTC Drug Status for a New Saliva-Stimulating Lozenge

9/1/2005 Sellersville, PA press release biz.yahoo.com Scandinavian Formulas, Inc., announced today that the U.S. Food & Drug Administration (FDA) has issued over-the-counter (OTC) drug status for its product SalivaSure®, a saliva- stimulating lozenge for relief of dry mouth. Dry mouth (xerostomia), which can be extremely debilitating, can be caused by many factors including physiologic, radiation therapy (of the head and neck), and the adverse effects of prescription and OTC drugs, such as antihistamines, antidepressants, anxiolytics, diuretics, and decongestants, to name a few. Saliva -- a vital part of oral health -- provides enzymes to help with the digestion of food and produces a constant flushing of the oral cavity, which keeps the mouth relatively clean and helps to protect it against infection. When the mouth lacks saliva, not only does it produce an unpleasant feeling, but it also causes bacteria to breed, resulting in tooth decay and bad breath. In addition, consuming food and liquids becomes increasingly difficult and the sense of taste is altered. SalivaSure® works by the unique fruit acid formulation that stimulates the taste buds and activates the production of saliva. A combination of sodium citrate and calcium phosphate acts as a buffer to protect the tooth enamel. In addition, the sweetener xylitol is known to reduce plaque formation and help minimize the development of dental caries, which protect tooth enamel for long-term use. What's more, SalivaSure® does not interact with prescription medications and is safe for people with diabetes. The lozenge brings instant relief on contact. [...]

2009-04-04T09:27:38-07:00September, 2005|Archive|

Dye imaging ID’s oral lesions likely to become cancer

9/1/2005 Philadelphia, PA staff EurekAlert (www.eurekalert.org) A team of Canadian scientists may have discovered a way to use a simple dye as a litmus test to identify abnormal areas of the mouth that may become cancers. According to a study published in the September 1 issue of "Cancer Research", the scientists found that lesions that took up the dye known as toluidine blue were six times more likely to become oral cancers. The team also discovered that the dye-staining lesions contained molecular alterations that are linked to high risk of oral cancers -- even at early stages. "In oral cavity lesions, tissue that stained positive with toluidine blue were more likely to advance to cancer than lesions that did not stain with the dye," said Miriam Rosin, Ph.D., Director of the BC Cancer Agency's British Columbia Oral Cancer Prevention Program and Professor, Simon Fraser University. Rosin is the senior author on the study, funded by the National Institute of Dental and Craniofacial Research, of the National Institutes of Health. Toluidine blue is an accepted indicator of oral cancers, Rosin said. The current studies, however, demonstrate that the dye accurately predicts which pre-malignant lesions are likely to advance toward disease. Those lesions appear as white or, less frequently, red patches. "The vast majority of those white patches are often from minor inflammation and irritation," Rosin said. Some, however, are inclined to become cancer--and are the ones targeted by this simple imaging technology. In the study of 100 patients, Rosin and her [...]

2009-04-04T09:27:12-07:00September, 2005|Archive|

Oral cancer knowledge and experience: a survey of South Carolina medical students in 2002

9/1/2005 South Carolina SG Reed et al. J Cancer Educ, September 1, 2005; 20(3): 136-42 Background: Compared to the U.S. states and District of Columbia, the adult population in South Carolina ranks in the high five in oral cavity and pharynx cancer mortality rate and top ten for incidence rate. Previous studies revealed a lack of knowledge related to the diagnosis of oral cancer among health professionals in the USA. This study assessed the oral cancer knowledge and experience of medical students in an academic setting. Methods: This IRB approved cross-sectional survey used a self-administered pilot-tested questionnaire and the census of the Medical University of South Carolina medical students. Data were summarized by frequencies and chi-square comparisons of pre-clinical (first and second year) and clinical (third and fourth year) students. Results: The overall response rate was 79% (450/571 students), range 61-91% by year. Significant (p < 0.001) differences were found between pre-clinical and clinical students for knowledge of risk factors, signs and symptoms of oral cancer, and tobacco cessation techniques; with clinical students more knowledgeable but at less than 78% accuracy. All students were in high agreement of the role and responsibility of physicians in tobacco cessation, and in medical history taking. Four students had seen or been instructed on how to perform an oral biopsy. Most (75%) of fourth year students felt adequately trained to palpate neck lymph nodes. However, less than 7% of all students perceived they were adequately trained to examine patients for oral cancers. Conclusions: Results [...]

2009-04-05T10:20:28-07:00September, 2005|Archive|

The probability for a Pap test to be abnormal is directly proportional to HPV viral load: results from a Swiss study comparing HPV testing and liquid-based cytology to detect cervical cancer precursors in 13 842 women

9/1/2005 G Bigras and F de Marval British Journal of Cancer (2005) 93, 575-581 The probability for a Pap test to be abnormal is directly proportional to HPV viral load: results from a Swiss study comparing HPV testing and liquid-based cytology to detect cervical cancer precursors in 13 842 women. In a study involving 13,842 women and 113 gynaecologists, liquid-based cytology and HPV testing for detecting cervical cancer were compared. A total of 1334 women were found to be positive for one or both tests and were invited for colposcopy with biopsy. A total of 1031 satisfactory biopsies on 1031 women were thereafter collected using a systematic biopsy protocol, which was random in the colposcopically normal-appearing cervix or directed in the abnormal one. In all, 502 women with negative tests were also biopsied. A total of 82 histologic high-grade squamous intraepithelial lesion (HSIL) were reported in biopsies, all from the group with one or both tests positive. Sensitivity and specificity to detect histologic HSIL were 59 and 97% for cytology, and 97 and 92% for HPV. In total, 14% of reviewed negative cytological preparations associated with histologic HSIL contained no morphologically abnormal cells despite a positive HPV test. This suggested a theoretical limit for cytology sensitivity. HPV viral load analysis of the 1143 HPV-positive samples showed a direct relationship between abnormal Pap test frequency and HPV viral load. Thus, not only does the HPV testing have a greater sensitivity than cytology but the probability of the latter being positive can [...]

2009-04-04T09:25:01-07:00September, 2005|Archive|

Advocate Good Samaritan Hospital in Chicagoland First to Offer Tomotherapy for Cancer Treatment

8/30/2005 Downers Grove, IL press release U.S. Newswire (releases.usnewswire.com) Advocate Good Samaritan Hospital's Cancer Care Center is offering the only Tomotherapy Unit in the Chicago/Metropolitan Area. This cutting edge technology is the most precise radiation therapy available for cancer patients and is currently available at only one other site in Northern Illinois (Zion, Ill.) Tomotherapy is a way to create precision with radiation by combining imaging for patient positioning with advanced intensity modulated radiation therapy (IMRT). What does this mean to each patient? More accurate treatment, fewer side effects and decreased time commitments for patients. "Tomotherapy marries a CT (computerized tomography) scan with a radiation treatment machine, advancing accuracy of treatment", explains Michael Stutz, M.D. "Because we are imaging the tumor prior to each radiation treatment, we can ensure that our treatments are on target every day." William Hartsell, M.D. explains: "Tomotherapy is ideal to treat tumors that are next to important normal structures that should be spared from the radiation--such as treating prostate cancer to spare the rectum and bladder; head and neck cancer to spare the salivary glands; and brain cancer to spare as much normal brain as possible." The media is invited to a press conference on September 6, from 10 a.m. to 11 a.m. William Hartsell, M.D., Michael Stutz, M.D., Director of the Cancer Care Center, Paula Timmerman, a radiology technician and possibly a patient about to undergo treatment will be available for questions and comments. Media will also be able to view the new equipment.

2009-04-03T04:53:24-07:00August, 2005|Archive|

Addition of Erbitux® to Radiation Improves Survival in Head and Neck Cancer

8/30/2005 staff CancerConsultants (cancerconsultants.com) A recent phase III trial indicates that the addition of the targeted agent Erbitux (cetuximab) to radiation therapy improves survival in patients with advanced head and neck cancer. Approximately 40,000 people in the United States are diagnosed with head and neck cancer every year. Cancers of the head and neck comprise several types of cancer; these include the nasal cavity and sinuses, oral cavity, nasopharynx, oropharynx and other sites throughout the head and neck area. According to the American Cancer Society, 11,000 people died from head and neck cancer in 2004. Standard treatment for head and neck cancer is largely determined by the stage, or extent to which the cancer has spread, as well as the specific locations within the head or neck area where the cancer has spread. The patient’s overall medical condition is also a deciding factor. Treatment typically consists of radiation therapy, chemotherapy with surgery or surgery alone. Once head and neck cancer has spread from its site of origin, long-term outcomes are generally suboptimal. In addition, treatment for head and neck cancer often results in a compromised quality of life. Research and development of newl therapeutic approaches that will improve long-term outcomes and quality of life for patients with this disease continues. The epidermal growth factor receptor (EGFR) pathway is involved in this research. This biologic pathway plays a role in cellular replication and is often over expressed in cancer. Erbitux, a monoclonal antibody (or protein), has been produced in a laboratory [...]

2009-04-03T04:52:54-07:00August, 2005|Archive|

Predicting Response of Head and Neck Cancer to Accelerated Radiation Therapy

8/30/2005 staff CancerConsultants (cancerconsultants.com) According to a study published in the Journal of Clinical Oncology, patients with head and neck cancers are more likely to benefit from accelerated radiation therapy if a high proportion of their cancer cells have receptors for epidermal growth factor, a growth factor that plays a role in cell proliferation and survival. Approximately 40,000 people in the United States are diagnosed with head and neck cancer every year. Cancers of the head and neck include cancers of the nasal cavity and sinuses, mouth, and throat. According to the American Cancer Society, 11,000 people died from head and neck cancer in 2004. Standard treatment for head and neck cancer is largely determined by the stage (extent to which the cancer has spread) and by the specific locations within the head or neck area where the cancer has spread. Among head and neck cancer patients receiving radiation therapy, one reason for treatment failure is the accelerated regrowth of cancer cells that can occur during fractionated radiation therapy (radiation therapy that is split into smaller doses and administered over the course of several days). To overcome this problem, researchers have investigated accelerated radiation therapy schedules. According to these schedules, higher daily doses of radiation are given over fewer days. Some patients may be more likely than others to benefit from these accelerated schedules. One factor that may influence patient response to different radiation therapy approaches is the presence of epidermal growth factor receptors (EGFR) on cancer cells. Epidermal growth [...]

2009-04-03T04:52:16-07:00August, 2005|Archive|

Merck KGaA Submits Erbitux Head, Neck Cancer Data for Approval

8/30/2005 Frankfurt, Germany press release Bloomberg News (bloomberg.com) Merck KGaA, which owns non-U.S. rights to ImClone Systems Inc.'s Erbitux cancer treatment, submitted to regulators new data on the drug's ability to treat head-and-neck cancers, aimed at boosting its sales in Europe. It submitted its application to the European Medicines Agency and the Swiss regulator Swissmedic, the Darmstadt, Germany-based drugmaker said today in an e-mailed statement. ImClone and its marketing partner Bristol-Myers Squibb Co. have applied to the U.S. Food and Drug Administration to extend the drug's use in the U.S. Merck KGaA Chief Executive Bernhard Scheuble, who negotiated European rights to the drug from ImClone in 1998 for $60 million, aims to widen its use beyond colon cancer, for which it's approved in Europe and the U.S. Merck's sales from Erbitux came to 94 million euros ($115.5 million) during the first half of the year, compared with the 77 million euros it generated in all of 2004, its first year on the market. Erbitux is approved for patients whose bowel cancer has spread and who aren't benefiting from other treatments. The drug was approved in Europe and the U.S. on the basis of phase II clinical data that showed its ability to shrink tumors. Three phases of studies are generally required for regulatory approval. Difficult to Treat The additional sales potential from head-and-neck cancers, which are notoriously difficult to treat, is lower than for other cancer types, Groschke said in an Aug. 29 telephone interview. ``This indication is significantly smaller [...]

2009-04-03T04:51:43-07:00August, 2005|Archive|

Study Could Help Tailor Treatment for Head and Neck Cancer Patients

8/29/2005 Denmark staff The Lancet Oncology, August, 2005 reported by Newswise.com Danish scientists have identified which head and neck cancer patients will benefit from additional drug treatment during radiotherapy, in a paper published online today by The Lancet Oncology. Tumours that have low concentrations of oxygen (hypoxia) are resistant to radiotherapy. A drug called nimorazole (a hypoxia radiosensitiser) can improve the outcome of radiotherapy for patients with these types of tumours. However, at the moment there is no way to identify people with tumours that lack oxygen, who need this additional drug treatment, from those that only need radiotherapy. Researchers knew that the concentration of a protein called osteopontin was associated with tumours that lacked oxygen. Jens Overgaard (Aarhus University Hospital, Denmark) and colleagues assessed whether blood concentration of osteopontin could predict patients’ responses to nimorazole. The investigators measured the concentration of osteopontin in 320patients on a trial comparing nimorazole and radiotherapy with placebo and radiotherapy. Patients were grouped into high, intermediate, and low concentrations of osteopontin and the team recorded their outcome. They found that patients with high concentrations of the protein assigned placebo had a poorer prognosis than those with high concentrations on nimorazole. Professor Overgaard states: “. . . high plasma concentration of osteopontin predicted clinically relevant, modifiable hypoxia-induced resistance to radiotherapy, and this finding might help to identify patients who will benefit from treatment with a hypoxia modifier such as nimorazole during radiotherapy. By contrast, use of nimorazole was not effective in patients with low or [...]

2009-04-03T04:51:13-07:00August, 2005|Archive|

Time to spit out today’s cancerous role models

8/29/2005 editorial Heraldnet (www.heraldnet.com) Perhaps country singer Gretchen Wilson is confused by her status as a role model; it doesn't mean she should model how to roll a wad of chewing tobacco into her lower lip. For her recent tobacco promotion, the country singer is now joining an ever-expanding group of not-so-worthy pop idols. Wilson, 32, a role model among teenage females who frequent her concerts, has been flashing a can of chewing tobacco to the crowd during her recent performances of new song "Skoal Ring," a song simply about the wonders of chew. Glamorizing chewing tobacco to an audience of impressionable young fans goes a long way to undermine every anti-tobacco campaign created to convince youths to avoid the cancer-causing habit. On stage, Wilson's gestures with her small can of tobacco may seem innocent and playful, but they can be detrimental. The female population has been a growing victim of lung cancer for decades. About 21 percent of U.S. females are smokers, according to the Center for Disease Control and Prevention, far from the U.S. goal of cutting the number of smokers to 12.5 percent by 2010. Lung cancer rates increased 600 percent among women in the second half of the 20th century, and deaths from lung cancer now significantly outnumbers deaths from breast cancer. Smokeless tobacco, a more glamorized, if shocking, form of ingesting tobacco, will only continue this trend. This stiff-lower-lip form of tobacco ingestion dramatically increases a person's chance of getting oral cancer. Unfortunately, Wilson isn't [...]

2009-04-03T04:50:42-07:00August, 2005|Archive|
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