11/11/2005 Toronto, Ontario, Canada press release prnewswire.com Viventia Biotech Inc. today announced that the U.S. Food and Drug Administration (FDA) has designated the Company's lead drug, Proxinium(TM), as a Fast Track Product for the treatment of patients with recurrent squamous cell carcinoma of the head and neck (SCCHN). The Fast Track program facilitates the development and expedites the review of new therapeutics that are intended to treat serious or life threatening diseases and demonstrate the potential to address unmet medical needs. The Fast Track Program is intended to accelerate the filing of an NDA. The FDA will provide input into product development plans and may accept portions of the marketing application prior to the completion of the final registration package. Also most, but not all, drugs that are designated for the Fast Track Program are given priority review once the NDA is filed. The targeted date for drugs entitled to priority review is 6 months compared to the target of 10 months as set by the Food and Drug Modernization Act. "Recurrent, refractory head and neck cancer is a devastating and aggressive disease for which there are limited treatment options," said Dr. Nick Glover, President and CEO of Viventia. "We look forward to working with the FDA to further advance our clinical strategy for Proxinium(TM), which has shown promising early-stage efficacy results in patients with this form of cancer." About Proxinium(TM) Proxinium(TM) combines a powerful cytotoxic protein payload with the highly precise tumour-targeting characteristics of a monoclonal antibody. A single [...]

11/11/2005 New York, NY Megan Rauscher Yahoo News (news.yahoo.com) Smokeless oral tobacco products such as moist snuff and hard snuff lozenges are not a safe alternative to cigarettes for people trying to kick the habit, as these products contain high levels of cancer-causing compounds. Instead, the best aids appear to be medicinal nicotine replacement products such as the nicotine patch or gum as these products contain only trace amounts of cancer-causing compounds, according to research presented at a cancer prevention conference in Baltimore this month. Dr. Stephen Hecht and colleagues from the University of Minnesota Cancer Center in Minneapolis compared the levels of cancer-causing nitrosamines in popular smokeless tobacco products and medicinal nicotine products such as the nicotine patch, nicotine gum, and nicotine lozenges. The results "clearly showed that the levels of cancer-causing nitrosamines are far higher in smokeless tobacco products than they are in medicinal nicotine products," Hecht said during a press briefing. Nitrosamine levels were highest in oral snuff tobacco products made in the US, following by Swedish 'snus' (another type of smokeless tobacco), whereas the lowest levels were found in hard snuff lozenges. The snuff lozenges actually did "quite well in our study -- it does appear to have lower levels of carcinogenic nitrosamines" than most of the other smokeless tobacco products, Hecht said. By contrast, only trace amounts of these cancer-causing nitrosamines were found in the nicotine patch and gum. While smokeless tobacco has "demonstrably less carcinogens and toxins than cigarette smoke," said Hecht, smokeless tobacco [...]

11/10/2005 Birmingham, England Emma Brady Birmingham Post (icbirmingham.icnetwork.co.uk) It's hard to pick up, but Muriel Bishop is frightened. As the 78-year-old waits for the anaesthetist to arrive, she admits she is a little worried about her eight-hour operation at Queen Elizabeth Hospital, in Edgbaston. The retired book-keeper, from Wylde Green, is having surgery to remove her tongue which is being weighed down by a golfball-sized tumour. It is being replaced with a prosthetic tongue. Ulcers were first spotted on her tongue in 1984 which were later diagnosed as cancer and Mrs Bishop underwent a course of radiotherapy. But years of smoking had already left their legacy and the symptoms eventually returned, resulting in difficulty eating and drinking. "At the moment I can't swallow very well and I'm hoping that when this is over I shall be able to get back to normal," said Mrs Bishop. "I'd had a biopsy and then a few weeks ago I realised my tongue felt different, it was all ulcerated, so I went to see my consultant, Sat Parmar, and he recommended this procedure. "Obviously I'm scared but I've every faith in the doctors here, and I'm sure Mr Parmar will do a great job." Mrs Bishop's case is fairly advanced but the number of mouth and other oral cancers is rising. Linked to excessive drinking and smoking, health bosses are keen to raise public awareness about this form of cancer, which accounts for a sixth of all cancers in Britain. Mr Parmar, an oral [...]

11/8/2005 New York, NY Steven Reinberg Forbes (www.forbes.com) Aspirin and other non-steroidal anti-inflammatory drugs (NSAIDs) may help prevent esophageal cancer from developing in patients with Barrett's esophagus, researchers report. Barrett's esophagus is a precancerous condition in which the esophagus changes so that some of its lining is replaced by tissue similar to that normally found in the intestine. People with Barrett's esophagus are 50 times more likely to develop a type of throat cancer called esophageal adenocarcinoma, the most rapidly increasing cancer in the United States. "We observed that people who had Barrett's esophagus who were taking aspirin and other NSAIDs were about a third less likely to go on to get esophageal cancer, compared with people who never took NSAIDs regularly," said study author Dr. Thomas L. Vaughan, head of the epidemiology program at Fred Hutchinson Cancer Research Center in Seattle. Besides aspirin, the NSAID group of pain relievers include ibuprofen, naproxen and the Cox-2 painkillers Vioxx, Bextra and Celebrex -- of which only Celebrex remains on U.S. drugstore shelves. Reporting in the Nov. 7 online edition of The Lancet Oncology, Vaughan and his colleagues collected data on 350 people diagnosed with Barrett's esophagus. For more than five years, Vaughan's team looked at whether NSAID use correlated with the development of esophageal adenocarcinoma in these patients. They found that people taking NSAIDs were at a 68 percent lower risk of developing esophageal adenocarcinoma, compared with people who didn't use the drugs. Among people who had taken NSAIDs in the [...]

11/8/2005 Austin, TX staff MedGadget (medgadget.com) Introgen Therapeutics has announced an alliance with Colgate-Palmolive to develop and potentially market oral health care products. The terms of the alliance call for the development of specialized formulations of Introgen's molecular therapies targeted at pre-cancerous conditions of the oral cavity and oral cancer. According to the press release, the research and development activities in the alliance will be conducted by Introgen and will focus on oral formulations of Introgen's molecular therapeutics employing tumor suppressor genes such as p53, mda-7, and FUS1. Introgen has already conducted a phase 1 clinical study using INGN 234, a mouthwash formulation delivering the p53 tumor suppressor for oral cancer prevention in patients diagnosed with leukoplakia, a pre-cancerous condition that can lead to oral cancer. Leukoplakia has an incidence of approximately 3 percent of the adult population. "We are enthusiastic about the opportunity to apply Introgen's molecular agents to develop oral care products with Colgate-Palmolive," stated David G. Nance, Chief Executive Officer of Introgen. "We believe future commercial applications of therapeutic genes will include topical formulations such as those developed for oral use under the alliance with Colgate. The tissues lining the oral cavity may be particularly well suited and accessible targets for molecular therapies that can arrest abnormal cell growth without harming normal cells. We believe that repair of damaged cells and safe elimination of malignant or pre-malignant cells from the mouth could represent important therapies for dentists, oral health professionals and oncology specialists to prevent and treat [...]

11/8/2005 Spain Ricardo Hitt et al. Journal of Clinical Oncology, 10.1200/JCO.2004.00.1990 Purpose: To compare the antitumor activity and toxicity of the two induction chemotherapy treatments of paclitaxel, cisplatin, and fluorouracil (FU; PCF) versus standard cisplatin and FU (CF), both followed by chemoradiotherapy (CRT), in locally advanced head and neck cancer (HNC). Patients and Methods: Eligibility criteria included biopsy-proven, previously untreated, stage III or IV locally advanced HNC. Patients received either CF (cisplatin 100 mg/m2 on day 1 plus FU 1 mg/m2 continuous infusion on days 1 through 5) or PCF (paclitaxel 175 mg/m2 on day 1, cisplatin 100 mg/m2 on day 2, and FU 500 mg/m2 continuous infusion on days 2 through 6); both regimens were administered for three cycles every 21 days. Patients with complete response (CR) or partial response of greater than 80% in primary tumor received additional CRT (cisplatin 100 mg/m2 on days 1, 22, and 43 plus 70 Gy). Results: A total of 382 eligible patients were randomly assigned to CF (n = 193) or PCF (n = 189). The CR rate was 14% in the CF arm v 33% in the PCF arm (P < .001). Median time to treatment failure was 12 months in the CF arm compared with 20 months in the PCF arm (log-rank test, P = .006; Tarone-Ware, P = .003). PCF patients had a trend to longer overall survival (OS; 37 months in CF arm v 43 months in PCF arm; log-rank test, P = .06; Tarone-Ware, P = .03). [...]

11/8/2005 Chapel Hill, NC staff Science Daily (www.sciencedaily.com) A highly powerful scanner combining two state-of-the-art technologies might detect the spread of head and neck cancer more accurately than other imaging. Researchers say combining computed tomography and positron emission tomography might be more effective than other widely used imaging examinations. The findings are based on research conducted at the University of North Carolina at Chapel Hill School of Medicine, "PET/CT is very helpful in determining where we should pinpoint our biopsies for recurrent disease," said Dr. Carol Shores, assistant professor of otolaryngology at UNC and the report's senior author. "We can pick up cancer where we thought none existed. "The new scans are so precise that, in some cases, cancer had been detected that probably would not have been through any other noninvasive imaging exam," she added The study is detailed in the July issue of medical journal The Laryngoscope.

11/7/2005 New York, NY Andrew Pollack New York Times (www.nytimes.com) Brush your teeth and rinse with gene therapy. That could be the future of oral health care as envisioned by Colgate-Palmolive and Introgen Therapeutics, an Austin, Tex., biotechnology company. The companies announced an alliance Friday to incorporate gene therapy - an exotic, experimental and so far largely unsuccessful form of medicine - into mouthwashes, gels and similar products to treat and prevent oral cancers. Gene therapy involves putting genes into cells in the body, often to replace native genes that are malfunctioning. The technique has rarely worked in the 15 years it has been tried, largely because of the difficulty of getting enough functioning genes into cells. Introgen's method puts so-called tumor suppressor genes into cancerous cells to stop the growth of tumors. The company's most advanced drug, which is in late-stage clinical trials, is a treatment for head and neck cancer that it hopes will be the first gene therapy approved in the United States. In that treatment, viruses containing the desired gene are injected directly into tumors. Working with Colgate, Introgen will try to put the tumor suppressor genes into an oral product to treat leukoplakia, a precancerous condition characterized by lesions on the cheeks, gums or tongue. In some cases the lesions turn cancerous, usually after many years. Dr. Robert E. Sobol, Introgen's senior vice president for medical and scientific affairs, said an initial product would probably be a prescription drug that would require approval by the [...]

11/7/2005 Thriuvananthapuram, India John Mary The Peninsula (www.thepeninsulaqatar.com) The Regional Cancer Centre at Thriuvananthapuram, whose studies suggest that a 5-minute oral cancer screening can check about 40,000 deaths worldwide, is launching clinical trials to test the efficacy of turmeric in preventing oral cancers. Oncologist K Ramadas at the RCC said that although turmeric was widely believed to be a broad spectrum anti-cancer agent, there have been very few studies to establish its therapeutic efficacy in treating pre-cancer lesions. The RCC and the Rajiv Gandhi Centre for Biotechnology (RGCB) will be funded by the Federal Department of Biotechnology in initiating multi-centric clinical trails at RCC, Amrita Institute of Medical Sciences, Kochi, and Tata Hospital, Mumbai, over the next three years. Trials are intended to check out the preventive action of curcumin on white patches in the mouth (leuokplakia) that can turn cancerous. RGCB director Dr Radhakrishna Pillai, one of the two principal investigators of the project, said laboratory studies and studies on animals had been encouraging. Dr Ramadas said the major handicap experienced so far in anti-cancer treatment had been the low absorption rate of curcumin. Only a minuscule fraction of curcumin passed through the liver. The bulk of it would get metabolised in the liver, leaving little to reach the tumour site. Hence, the focus of the clinical trails would be to try using curcumin lozenges and patches to treat lesions. Turmeric holds a high place in ayurvedic medicine as a "cleanser of the body" and today science is finding [...]

11/7/2005 Washington, DC staff Wall Street Journal Online (online.wsj.com) The 10 million cancer survivors in the U.S. require customized follow-up for years that too few now receive, says a major study that calls for oncologists to create a "survivorship plan" to guide every patient's future health care. Half of all men and one-third of women in the U.S. will develop cancer in their lifetimes. Thanks to advances in early detection and treatment, the number who survive has more than tripled over the past three decades. When active treatment ends, these people's special needs may be just beginning, said the study, released Monday. Yet, the legacy of physical, psychological and social consequences has largely been ignored by doctors, researchers, even patient-advocacy groups, leaving survivors too often unaware of simmering health risks or struggling to manage them on their own, said the report by the Institute of Medicine. "Successful cancer care doesn't end when patients walk out the door after completion of their initial treatments," said Sheldon Greenfield of the University of California, Irvine, who led the study for the institute, an arm of the National Academy of Sciences. Yet, "you fall off a cliff when your treatment ends," said report co-author Ellen Stovall, president of the National Coalition for Cancer Survivorship, who speaks from personal experience as a two-time survivor. Busy oncologists' priority is to treat patients and they may have little time for the survivor, while physicians who don't specialize in cancer care may not know what special needs survivors [...]