EU grants orphan drug status to BioAlliance Pharma’s clonidine Lauriad

Source: www.pharmabiz.com Author: staff European Commission has granted orphan drug designation to BioAlliance Pharma SA's clonidine Lauriad for prevention of radiotherapy-induced oral mucositis in patients with head and neck cancer. Oral mucositis is a very frequent inflammation of the oral mucosa in head and neck cancer patients treated with radio- and chemotherapy (98,000 new patients estimated per year in Europe). Severe oral mucositis occurs in 60% of these patients and may induce intense oral pain and eating disability requiring artificial nutritional support. In 20 to 30% of cases, patients have to be hospitalized and the disease may result in a modification or a stop of the radiotherapy treatment in more than 10% of them. Radiotherapy-induced oral mucositis has currently no preventive cure. In Europe, the orphan designation is granted for medicinal products in diseases affecting less than 5/10,000 patients. This status permits to benefit from incentives related to the clinical development, thus enabling a faster registration, and an extra protection with a 10- year commercial exclusivity after market authorization. “The European designation for clonidine Lauriad as an orphan drug is key in shortening its development timeline, optimizing costs and reinforcing its future market access. Clonidine Lauriad, currently in Phase II clinical trial, is the second product from our “Orphan Oncology Products” portfolio to be granted orphan status in Europe. The portfolio comprises assets with high commercial potential and will leverage our future growth”, stated COO, Judith Greciet. Dedicated to cancer and supportive care treatment with a focus on resistance targeting [...]

2011-11-06T10:14:20-07:00November, 2011|Oral Cancer News|

ADA updates guidelines for managing ONJ risk patients

Source: www.drbicuspid.com Author: Rabia Mughal, Contributing Editor A patient receiving antiresorptive therapy for the prevention and treatment of osteoporosis has a low risk of developing osteonecrosis of the jaw (ONJ), and benefits of the medication outweigh the risk of ONJ, according to an advisory statement from the ADA. The statement, "Managing the Care of Patients Receiving Antiresorptive Therapy for Prevention and Treatment of Osteoporosis," is based on a literature review by an advisory committee of the ADA Council on Scientific Affairs and updates ADA's 2008 advisory statement (Journal of the American Dental Association, November 2011, Vol. 142:11, pp. 1243-1251). ONJ associated with antiresorptive agents has mostly been referred to as bisphosphonate-associated ONJ, but nonbisphosphonate antiresorptive agents are now available that also could be associated with ONJ, the panel noted. That is why they refer to the condition as antiresorptive agent-induced ONJ (ARONJ). A relatively new condition, bisphosphonate-associated ONJ, has received tremendous media attention because of a flurry of lawsuits against the makers of Fosamax and Zometa alleging that the medications led to ONJ. These lawsuits have been a factor in raising patients' and dentists' awareness of the condition, according to Helen Ristic, PhD, director of scientific information for the ADA's Division of Science and one of the panelists who contributed to the report. "The first calls the ADA received from dentists about ARONJ were in response to advertisements by lawyers and media reports," she said. Still, much about the condition remains a mystery, in part because there has not been [...]

2011-11-06T10:10:08-07:00November, 2011|Oral Cancer News|

Vibrating Gel May Give New Voice to Throat-Cancer Patients

Source: Businessweek.com Nov. 1 (Bloomberg) -- Bob Langer may be the last, best hope for aging rockers. Just ask Roger Daltrey, lead singer for The Who. Langer, the Massachusetts Institute of Technology researcher whose work has created two dozen biotech startups, is developing a gel that can vibrate up to 200 times a second -- replicating the action of human vocal cords -- to rejuvenate the damaged voices of singers such as Daltrey and Aerosmith’s Steven Tyler, both of whom have contributed funding for the project, along with actress Julie Andrews. More than 13,000 people diagnosed each year in the U.S. with throat tumors may end up being helped by the effort of the singers, the scientist and the surgeon who brought them together, Harvard University’s Steven Zeitels. Langer and Zeitels plan to test the gel next year in a cancer patient. “Unless you’ve been touched personally, it’s difficult to see, but there are millions of people who have no voice whatsoever,” said Daltrey, who was operated on for precancerous lesions in his throat two years ago, and couldn’t speak at all for two weeks. The gel will be injected into the vocal cords. Once there, it behaves the same way as the uninjured membrane, responding to breath and muscles tension by vibrating as if it was the real thing, Zeitels said. The research has been funded by the nonprofit patient organization, The Institute of Laryngology and Voice Restoration, where Andrews is an honorary chairwoman. ‘Sound of Music’ The research, [...]

2011-11-01T11:23:12-07:00November, 2011|Oral Cancer News|

The Oral Cancer Foundation Helps Sponsor HPV/Oral Cancer Study

Source: Jada.org An increase in the incidence and survival of oropharyngeal cancer in the United States since 1984 can be attributed to the human papilloma-virus (HPV) infection, say researchers in an article published online Oct. 3 in Journal of Clinical Oncology. The results of previous studies have shown that oropharyngeal cancers can be divided into two separate diseases with distinct causes: HPV-negative cancers, which are associated with tobacco and alcohol use; and HPV-positive cancers, which are linked to certain types of HPV, a sexually transmitted virus. Patients with HPV-positive oropharyngeal cancer tend to be younger than and to have better survival rates than patients with HPV-negative cancer. To determine HPV infection’s role, researchers led by Anil K. Chaturvedi, PhD, National Cancer Institute, National Institutes of Health, Bethesda, Md., tested for HPV infection 271 archived samples of cancerous oropharyngeal tissue collected between 1984 and 2004 at three population-based cancer registries located in Hawaii, Iowa and Los Angeles in the National Cancer Institute’s Surveillance, Epidemiology and End Results Residual Tissue Repositories Program. By using a variety of molecular assays, researchers found that the proportion of oropharyngeal cancers that were HPV-positive—particularly among men—increased over time, from 16.3 percent for cancers diagnosed from 1984 to 1989 to 72.7 percent for cancers diagnosed from 2000 to 2004. They also found that the incidence of HPV-negative oropharyngeal cancers declined by 50 percent between 1988 and 2004, likely due to declines in smoking and tobacco use. According to senior author Maura Gillison, MD, PhD, a professor of [...]

Monitoring Tobacco-Specific N-Nitrosamines and Nicotine in Novel Marlboro and Camel Smokeless Tobacco Products: Findings From Round 1 of the New Product Watch

Source: OxfordJournals.org Abstract Introduction: Information on chemical composition of the new oral “spitless” smokeless tobacco products is scarce, and it is not clear whether there is some variability as a function of purchase place or time due to either unintended or intended manufacturing variations or other conditions. Methods: We analyzed tobacco-specific N-nitrosamines (TSNA) and nicotine in Marlboro Snus, Camel Snus, and dissolvable Camel products Orbs, Sticks, and Strips that were purchased in various regions of the country during the summer of 2010. Results: A total of 117 samples were received from different states representing six regions of the country. Levels of unprotonated nicotine in Marlboro Snus and Camel Snus varied significantly by regions, with the differences between the highest and the lowest average regional levels being relatively small in Marlboro Snus (∼1.3-fold) and large in Camel Snus (∼3-fold). Some regional variations in TSNA levels were also observed. Overall, Camel Snus had significantly higher TSNA levels than Marlboro Snus, and Camel Strips had the lowest TSNA levels among all novel products analyzed here. The amount of unprotonated nicotine in the dissolvable Camel products was comparable to the levels found in Marlboro Snus. Conclusions: Our study demonstrates some regional variations in the levels of nicotine and TSNA in Marlboro and Camel novel smokeless tobacco products. Continued monitoring of this category of products is needed as the existing products are being test marketed and modified, and new products are being introduced. This information is particularly important given its relevance to Food and Drug [...]

Kentucky Cancer Center Urges Smokers to Switch to Smoke-Free Tobacco. But is it Really a Better Option?

Source: Yourlife.USAtoday.com In the smoker-heavy state of Kentucky, a cancer center is suggesting something that most health experts won't and the tobacco industry can't: If you really want to quit, switch to smoke-free tobacco. The James Graham Brown Cancer Center and the University of Louisville are aiming their "Switch and Quit" campaign at the city of Owensboro. It uses print, radio, billboard and other advertising to urge smokers to swap their cigarettes for smokeless tobacco and other products that do not deliver nicotine by smoke. Supporters say smokers who switch are more likely to give up cigarettes than those who use other methods such as nicotine patches, and that smokeless tobacco carries less risk of disease than cigarettes do. "We need something that works better than what we have," said Dr. Donald Miller, an oncologist and director of the James Graham Brown Cancer Center, which supports the effort along with the University of Louisville. "This is as reasonable a scientific hypothesis as anybody has come up with and it needs to be tried." The campaign runs counter to the prevailing opinion of the public health community, which holds that there is no safe way to use tobacco. Federal researchers, however, have begun to at least consider the idea that smokers might be better off going smokeless. The National Cancer Institute at the National Institutes of Health says on its website that the use of all tobacco products "should be strongly discouraged," and that there is "no scientific evidence that using [...]

Packet Helps Smokers Hide Graphic Warnings

Source: tvnz.co.nz Sticky seals in the packets of one brand of cigarettes are helping smokers cover up graphic health warnings. Graphic images of illnesses like gangrene, mouth cancer and lung disease must be printed on every packet of cigarettes to cover 30% of the front and 90% of the back of the pack. ONE News looked at a range of cigarettes from a number of companies. Dunhill was the only product found with a seal inside the packet that can be stuck on the outside. It is labelled "exclusively Dunhill". The sticky 'reloc' seal is just the size to cover health warnings. Michael Colhoun of Action on Smoking and Health says nothing about a tobacco packet is accidental and the sticky seals have been included deliberately. "This seems to be a brand marketing exercise," he said. Fresh-seal stickers are used to cover graphic warning images Manufacturer British American Tobacco says its design is not intended to undermine the law. "We do not condone the practice of using one part of the pack designed for a particular purpose to hide those warnings," the company said. It said the seal is simply for keeping cigarettes fresh. One smoker said the sticker is "sneaky". Some smokers said they will continue using the sticker to hide the images. Quitline says since the graphic images first appeared in 2008, numbers of calls to its helpline have increased. But there are websites and even how-to videos dedicated to showing smokers how to cover the pictures up. This news story was resourced by the Oral Cancer Foundation, [...]

Ethics Being Questioned In Dentistry

Source: Dr.Bicuspid.com Scandals, lawsuits, a growing focus on commercialization and self-promotion, and dentists who prescribe excessive treatments are tarnishing the profession's image, according to a presentation on ethics at the recent ADA annual session in Las Vegas. Most dentists may be surprised that a Google search on ethical scandals among health professions shows that dentistry now gets more hits than medicine, nursing, chiropractics, and pharmacology, according to Ann Boyle, DMD, interim provost and vice chancellor for academic affairs at Southern Illinois University. Some of the public's changing perceptions toward dentistry can undoubtedly be traced to ubiquitous media coverage of scandals and malpractice lawsuits involving medical professionals, Dr. Boyle noted. Gordon Christensen, DDS, MSD, PhD, discussed the decline of dentists' credibility in a 2001 article, noting a Gallup poll showed that their ranking among professions had fallen below nurses, physicians, and veterinarians (Journal of the American Dental Association, August 2001, Vol. 132:8, pp. 1163-1165). Dentists were ranked third among the most trusted professionals in 1995 but slipped to ninth in 2001, according to Gallup poll rankings; they ranked sixth in 2009. Negative influences, according to Dr. Christensen, included commercialization and self-promotion, excessive treatment and fees, providing service only when it's convenient, and refusing to accept responsibility when treatment fails prematurely. “These front-line physicians consider us uncaring, selfish, greedy, and unprofessional.” — Ann Boyle, DMD, Southern Illinois University Dr. Boyle pointed to a 1997 Reader's Digest article about dentists' honesty. In it, the author visited 50 dentists in 28 states to see how [...]

Possible Link Between HPV and Heart Disease

Source: CVTNews.ca We already know HPV, or human papillomavirus, can cause cervical cancer. It's also known to cause some kinds of oral cancer. But could HPV also cause heart disease? An intriguing new study is drawing a link. The study found that women who are known to be infected with cancer-causing strains of the virus may be at increased risk for cardiovascular disease and stroke -- even when they have none of the usual heart disease risk factors. The study authors say their research is one of the first to investigate a potential link between heart disease and HPV, which is one of the most common sexually transmitted infections. The Public Health Agency of Canada estimates that more than 70 per cent of sexually-active Canadian men and women will have a sexually transmitted HPV infection at some point in their lives. They say they began the study because they wanted to know why some people have heart attacks even though they have none of the usual risk factors, like high cholesterol or high blood pressure. About 20 per cent of patients with heart disease lack risk factors, which has left open the possibility that underlying "nontraditional" causes might be involved in the disease. If there is indeed a link between the virus and heart disease, it could have a number of implications. It would mean that doctors would have to monitor patients with HPV to help prevent heart attack and stroke. As well, there is the possibility that the HPV vaccine [...]

HPV Vaccine Recommended for Boys aged 11 to 12 Years

Source: HemOncToday.com The CDC's Advisory Committee on Immunization Practices today approved routine recommendation in favor of administering the quadrivalent HPV vaccine for boys aged 11 to 12 years. Committee members decided that the vaccine (Gardasil, Merck) was safe, efficacious and cost-effective enough to warrant routine usage in this population. The recommendation issued in 2009 was permissive, meaning providers could give the vaccine to boys, but it was not routinely administered. This change would put the HPV vaccine into the regular vaccination schedule. The three-vaccination series can start as early as age 9 years. "The committee recommended that routine vaccination of males aged 11 or 12 years with three doses of quadrivalent vaccine be given to prevent HPV infection and HPV-related disease," Anne Schuchat, MD, director of the CDC's National Center for Immunization and Respiratory Diseases, said in a phone call with reporters. "Boys and young men 13 to 21 years of age who have not already received the vaccine should be vaccinated." Anne Schuchat, MD Insurance companies typically cover HPV vaccine in boys, but that is not necessarily the case for a permissive recommendation, according to Schuchat, who said a routine recommendation for a vaccine usually translates into coverage without co-pays. The committee voted 8-5 with one abstention in favor of recommending vaccination for young men up to age 21 years with permissive recommendation for men aged 22 to 26 years. The committee considered recommending vaccination up to age 26 years, which would have harmonized recommendations for men and women, [...]

Go to Top