BioVex launches Phase 3 study on head and neck cancer treatment

Source: www.masshightech.com Author: James M. Connolly Woburn-based biotech company BioVex Inc. today said that it has launched a Phase 3 study of its OncoVEXGM-CSF as a treatment for patients with locally advanced squamous cell carcinoma of the head and neck. The study will be conducted at sites in the U.S. and U.K., and will enroll 528 previously untreated patients. The goal is to demonstrate a statistically significant increase in two-year, event-free survival for patients treated with chemoradition and with OncoVEXGM-CF. BioVex founder and chief technology officer Robert Coffin said in a press release, “The start of a second pivotal Phase 3 study is part of a broad planned development program for OncoVEX GM-CSF beyond our lead indication of metastatic melanoma.” BioVex has an operational commercial scale manufacturing facility in Woburn. It is developing biologics for the treatment of cancer and prevention of infectious disease. In addition to OncoVEXGM-CSF, the company has a second development program, ImmunoVEXHSV2, a vaccine for genital herpes that displayed complete protection in animal models. That vaccine is currently undergoing clinical testing in the U.K.

2010-12-12T09:57:29-07:00December, 2010|Oral Cancer News|

Tobacco company pays $5M in groundbreaking case

Source: www.ctlawtribune.com Author: Thomas B. Scheffey Kelly June Hill, Executrix, et al. v. U.S. Smokeless Tobacco: The Altria Group, successor to tobacco marketer United States Smokeless Tobacco of Greenwich, has settled for $5 million a lawsuit filed by the estate of a North Carolina man who died of tongue cancer. The worker, Bobby Hill, initially went to an Ashville, N.C., lawyer, who referred his case to Bridgeport’s Koskoff, Koskoff & Bieder. Partners Antonio Ponvert III and Christopher Bernard launched a state court wrongful death action in Connecticut. From the beginning, Ponvert said, Hill and his family wanted to draw attention to the danger of “dipping snuff” and to discourage youngsters from starting its addictive use. “It’s the first time a plaintiff has won a wrongful death chewing tobacco verdict or settlement in the history of the industry,” said Ponvert. Altria, based in Richmond, Va., also owns Philip Morris, and has a corporate policy of not settling any individual consumer cases, he added. Altria Group spokesman Steve Callahan said, “U.S. Smokeless Tobacco is honoring an agreement it made in this case prior to its acquisition by Altria….We have no current intention to settle cases like this in the future.” Historically, the tobacco industry has fiercely defended itself in the courts. And for decades, it denied that tobacco is addictive or a health risk. More recently, it has maintained that people know the risks of tobacco and they should take personal responsibility if they use it. In the industry, a no-settlement rule [...]

2010-12-12T09:51:00-07:00December, 2010|Oral Cancer News|

Electronic nicotine delivery systems: is there a need for regulation?

Source: http://tobaccocontrol.bmj.com/ Author: Anna Trtchounian, Prue Talbot Purpose: Electronic nicotine delivery systems (ENDS) purport to deliver nicotine to the lungs of smokers. Five brands of ENDS were evaluated for design features, accuracy and clarity of labeling and quality of instruction manuals and associated print material supplied with products or on manufacturers' websites. Methods: ENDS were purchased from online vendors and analyzed for various parameters. Results: While the basic design of ENDS was similar across brands, specific design features varied significantly. Fluid contained in cartridge reservoirs readily leaked out of most brands, and it was difficult to assemble or disassemble ENDS without touching nicotine-containing fluid. Two brands had designs that helped lessen this problem. Labeling of cartridges was very poor; labelling of some cartridge wrappers was better than labelling of cartridges. In general, packs of replacement cartridges were better labelled than the wrappers or cartridges, but most packs lacked cartridge content and warning information, and sometimes packs had confusing information. Used cartridges contained fluid, and disposal of nicotine-containing cartridges was not adequately addressed on websites or in manuals. Orders were sometimes filled incorrectly, and safety features did not always function properly. Print and internet material often contained information or made claims for which there is currently no scientific support. Conclusions: Design flaws, lack of adequate labeling and concerns about quality control and health issues indicate that regulators should consider removing ENDS from the market until their safety can be adequately evaluated. Authors affiliation: Department of Cell Biology and Neuroscience, University of [...]

2010-12-11T06:13:33-07:00December, 2010|Oral Cancer News|

When the state paid, people stopped smoking: study

Source: Reuters By: Maggie Fox When Massachusetts started paying for stop-smoking treatments, people not only kicked the habit but also had fewer heart attacks, researchers reported on Tuesday in the first study to show a clear payoff from investing in smoking prevention efforts. Smoking dropped by 10 percent among clients of Medicaid, the state health insurance plan for the poor, and nearly 40 percent of Medicaid patients who smoked used benefits to get nicotine patches or drugs to help them quit, the researchers said. The study -- which suggests states can save money from investing in efforts to cut smoking -- found the yearly rate of hospital admissions for heart attacks fell by 46 percent for Medicaid clients and 49 percent fewer of them were hospitalized for clogged arteries. "The dramatic decline in heart attack hospitalizations for smokers who used the benefit is stunning and demonstrates the effectiveness of tobacco treatment coverage that includes behavioral counseling and medicines approved by the Food and Drug Administration," American Heart Association CEO Nancy Brown, who was not involved in the research, said in a statement. Thomas Land and colleagues at the Massachusetts Tobacco Cessation and Prevention Program, as well as the Harvard Medical School, looked at hospital records for the study, published in the Public Library of Science journal PLoS Medicine. In July 2006, the Massachusetts Medicaid program, called MassHealth, began paying for drugs and other treatments to help smokers quit, including nicotine patches, gum and drugs. "Over 75,000 Medicaid subscribers used the [...]

2010-12-10T12:20:36-07:00December, 2010|Oral Cancer News|

Age is not a limiting factor for brachytherapy for carcinoma of the node negative oral tongue in patients aged eighty or older

Source: 7thspace.com Author: Hideya Yamazaki et al Purpose: To examine the role of brachytherapy for aged patients 80 or more in the trend of rapidly increasing number. Methods: We examined the outcomes for elderly patients with node negative oral tongue cancer (T1-3N0M0) treated with brachytherapy. The 21 patients (2 T1, 14 T2, and 5 T3 cases) ranged in age from 80 to 89 years (median 81), and their cancer was pathologically confirmed. All patients underwent definitive radiation therapy, with low dose rate (LDR) Ra-226 brachytherapy (n=4; median 70Gy), with Ir-192 (n=12; 70Gy), with Au-198 (n=1) or with high dose rate (HDR) Ir-192 brachytherapy (n=4; 60 Gy). Eight patients also underwent external radiotherapy (median 30 Gy). The period of observation ranged from 13 months to 14 years (median 2.5 years). We selected 226 population matched younger counterpart from our medical chart. Results: Definitive radiation therapy was completed for all 21 patients (100%), and acute grade 2-3 mucositis related to the therapy was tolerable for patients with good performance status. Local control (initial complete response) was attained in 19 of 21 patients (90%). The 2-year and 5-year local control rates were both 91%, (100% for T1, 83% for T2 and 80% for T3 tumors after 2 years). The cause-specific survival rate was 83% and the regional control rate 84% at the 2-years follow-up. However, 12 patients died because of intercurrent diseases or senility, resulting in overall survival rates of 55% at 2 years and 34% at 5 years. Conclusion: Age is not [...]

2010-12-10T09:00:06-07:00December, 2010|Oral Cancer News|

Aspirin a day helps to keep cancer at bay, say scientists

Source: www.guardian.co.uk Author: Sarah Boseley Taking a low-dose aspirin every day will reduce your chances of dying from cancer, scientists say today, confirming the over-the-counter pill as the most extraordinary drug yet discovered. Daily aspirin has already been shown to cut the chances of heart attacks and stroke in people who are at risk. The study published today in the Lancet medical journal reveals that it also has a powerful preventive action against a range of cancers – and possibly more of them than there is currently enough evidence to prove. While the doctors who carried out the study say it is not for them to make recommendations, the lead author, 46-year-old Prof Peter Rothwell from Oxford University, says he has been taking aspirin for the last two years. The beneficial dose is 75mg – a quarter of a standard tablet, which is 300mg. Some pharmacies sell low-dose tablets, but at a higher price. Rothwell and his colleagues have already shown that daily aspirin cuts death rates from colorectal cancer by more than a third. For the study published today, they examined all the data they could find from well-conducted trials that had assessed the use of aspirin against a control drug and had recorded deaths from cancer. In eight trials involving more than 25,000 patients, they found there were 21% fewer deaths after five years among those who took a daily aspirin tablet, compared with those who did not. The effect was most noticeable in gastrointestinal cancers, where deaths [...]

2010-12-10T08:21:25-07:00December, 2010|Oral Cancer News|

Smokeless tobacco picking up steam — Products growing in popularity as smokers turn to cheaper and less obtrusive alternatives

Source: Los Angeles Times By: Julie Wernau Ron Carroll prefers to smoke cigars and pipes. But when he can't do that he says he manages to unobtrusively get his nicotine fix by slipping a packet of tobacco, about the size of a teabag, under his upper lip. "I use it all the time — movies, planes," said the Chicagoan, who adds that he likes the fact he can remove the packet as easily as a piece of gum. There's no chewing, spitting or mess, he says. "It's discreet, and you don't look like an addict, he said. "Smoking's definitely more about the flavor; the whole experience,'' Carroll said. "With this, it's just taking the edge off." Cigarette sales by volume have plummeted 17 percent from 2005, partly the result of health warnings and bans on smoking in public places as well as taxation by local and federal governments. And the heat on cigarette smokers is expected to intensify as the federal Food and Drug Administration requires images of corpses and diseased lungs to be featured on cigarette packs in two years. Smokeless tobacco products — which come in shapes ranging from toothpicks to orbs and in flavors from cherry to peach — so far have not met with the same intense scrutiny, although there have been some changes. In June, the FDA increased the size of warning labels on smokeless products. "This product is addictive" and "This product is not a safe alternative to cigarettes,'' say the warnings. Scientists say [...]

2010-12-07T12:42:38-07:00December, 2010|Oral Cancer News|

First wrongful death settlement from chewing tobacco won by plaintiff

NEW HAVEN, Conn. (AP) — A smokeless tobacco company has agreed to pay $5 million to the family of a man who died of mouth cancer in what the family's attorney and an expert called the first wrongful death settlement from chewing tobacco. Attorney Antonio Ponvert III told The Associated Press on Tuesday that U.S. Smokeless Tobacco Co. agreed to pay $5 million to the family of Bobby Hill of Canton, N.C. "This company manufactures and sells a dangerous and defective product that it knows causes addiction, disease and death in consumers who use it as intended," Ponvert said. The company, which makes Copenhagen and Skoal brands and was headquartered in Greenwich, Conn. before it was acquired by Altria last year, confirmed the settlement in a regulatory filing, but declined further comment. Mark Gottlieb, director of the Tobacco Products Liability Project at Northeastern School of Law in Boston, said he believes it's the first case of its kind and predicted more lawsuits involving smokeless tobacco. "I think this is sort of a wakeup call to the plaintiff's bar that there are a lot of victims of smokeless tobacco use out there and it's possible these cases can be successful," Gottlieb said. Past lawsuits against smokeless tobacco makers were not successful and lawyers focused more on cigarette makers due to stronger evidence to back up their claims even though smokeless tobacco is harmful as well, Gottlieb said. "The cigarette is sort of the dirty needle of nicotine delivery," Gottlieb said. Tobacco [...]

2010-12-08T09:15:35-07:00December, 2010|Oral Cancer News|

Time for a national immunization strategy, health officials say

Source: The Globe and Mail As Ottawa and the provinces embark on negotiations to renew the Health Accord in 2014, they should take the opportunity to invest in a truly national vaccination strategy, public health leaders say. “Right now, we have a patchwork of approaches across the country,” Debra Lynkowski, CEO of the Canadian Public Health Association, said in an interview. “It’s time for a harmonized and national approach.” She was speaking on behalf of a coalition of public health officials, government and industry representatives who are calling for a strategy that includes several elements, including: - A national immunization registry where there is a central record of all vaccines individuals have received – currently some provinces have registries but they are not linked; - Creating a single childhood immunization schedule so children get the same vaccines at the same time across Canada – there are now wide variations between jurisdictions and some children miss key vaccines as a result; - Harmonizing vaccine delivery and access to ensure the same vaccines are funded in every province and territory at the same time. Ian Gemmill, past chair of the Canadian Coalition for Immunization Awareness and Promotion, said such a strategy exists on paper but not in practice. “It needs a kick start. Our governments need to make a sustained investment in the health of our children,” he said. The coalition has not put a dollar figure on the initiative but, based on past efforts, at least $100-million a year would be [...]

2010-12-07T12:22:45-07:00December, 2010|Oral Cancer News|

New Discovery May Offer Cure for Human Papillomavirus (HPV)

MONMOUTH JUNCTION, N.J., Nov. 29, 2010 /PRNewswire-FirstCall/ --Tamir Biotechnology, Inc. (Pink Sheets: ACEL) (formerly Alfacell Corporation) announced today that scientists supported by the National Institute of Allergy and Infectious Diseases (NIAID) reported test results confirming two of our lead compounds showed excellent in vitro antiviral activity and no cellular toxicity at dose levels tested for Human Papillomavirus (HPV). Testing was performed using the HPV 11 strain, which along with HPV type 6, is responsible for ninety percent of genital or anal warts. According to the scientist performing the test, the results were among the top one to two percent seen by the researcher for testing of HPV type 11. The report states the following: "Excellent antiviral activity and no cellular toxicity at doses tested." Within the last several months, we have reported significant results for our compounds against Dengue Fever, Yellow Fever, SARS, CMV, and now HPV. We are on the cusp of building an impressive antiviral portfolio that will be targeting viruses where there is currently an unmet need.  Besides the fact that our drugs have shown significant antiviral activity against the viruses mentioned above, equally impressive is the fact that very low concentrations of our drugs were needed in order to show this significant antiviral activity. It is important to realize that Onconase®, our lead compound, has been in clinical studies for other oncology indications and has proven itself to be well tolerated in over 1,000 patients treated to date.  We cannot stress enough how significant our drug [...]

2010-12-06T11:50:03-07:00December, 2010|Oral Cancer News|
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