11/5/2006 Plainsboro, NJ press release PrimeZone.com Integra LifeSciences Holdings Corporation today announced that its subsidiary Integra Radionics launched its latest radiosurgery software, XKnife(TM) version RT 4.0, at the annual meeting of the American Society for Therapeutic Radiology and Oncology (ASTRO). XKnife(TM) version RT 4.0 software is the tenth major release of the Integra Radionics radiosurgical treatment planning software, which was originally developed in collaboration with Harvard Medical School for the precise treatment of brain tumors. Through continued collaborations with institutions worldwide, the software has evolved into a system capable of precisely treating tumors in the brain, head and neck, lung, prostate, and spine. In addition to the three-dimensional treatment planning software, the XKnife(TM) system includes stereotactic localizers and immobilizers, radiosurgical collimators, a miniature multileaf collimator, and quality assurance instrumentation. Over 350 XKnife(TM) radiosurgery systems have been installed worldwide. Unlike conventional surgery, XKnife(TM) radiosurgery is completely non-invasive and does not require a surgical incision. This eliminates the discomfort and complications associated with standard surgery. Cancerous or other diseased tissue can be treated with focused radiation beams from a linear accelerator (linac) that are precisely guided using CT, MRI, and PET images. Surrounding normal tissue is spared and patients are typically able to leave the hospital immediately after their approximate thirty minute single treatment. To date, over 45,000 patients have undergone XKnife(TM) radiosurgery. The latest XKnife(TM) software offers the benefit of improved treatment planning efficiencies, enhanced quality assurance (QA), and increased synergies with new radiotherapy technologies. Shorter planning time is a product [...]

11/3/2006 New Rochelle, NY press release Genetic Engineering News (www.genengnews.com) Introgen Therapeutics obtained a worldwide, exclusive license to a family of patent applications regarding a combination therapy using Advexin® with inhibitors of epidermal growth factor receptors (EGFr). The family of patents was licensed from The University of Texas System M.D. Anderson Cancer Center. Advexin is Introgen’s p53 tumor suppressor therapy for potential use in head and neck cancer. The company plans to use it in combination with such drugs like Erbitux™ (ImClone Systems), Vectibix™ (Amgen), Tarceva™ (OSI Pharmaceuticals), and Iressa™ (AstraZeneca). "The regulatory implications of the combination of Advexin and EGFr inhibitors are significant," points out Max W. Talbott, Ph.D., Introgen's senior vp of worldwide commercial development. "In discussions with regulatory authorities, due to the unique efficacy mechanism of Advexin and its minimal toxicity, we have been encouraged to consider development of combination therapeutic approaches utilizing Advexin and the inhibitors." This technology is based on the discovery by scientists at M.D. Anderson Cancer Center that p53 and mda7 therapies can work synergistically with EGFr inhibitors to arrest tumor growth. Introgen reports that preclinical studies have shown that this double-barrel therapeutic approach results in an unexpectedly greater level of cancer cell death than when either therapy is used alone. "The results of our preclinical work, coupled with the recent agreement with M. D. Anderson Cancer Center for the EGFr technology, should have a positive impact on Advexin and follow-on product development plans both in the United States as well as in [...]

11/2/2006 New York, NY staff Forbes.com The editors of the New England Journal of Medicine this week added another chapter to the story of disgraced Norwegian researcher Dr. Jon Sudbo, as they formally retracted two reports on oral cancer his team published in the journal in 2001 and 2004. By his own admission -- issued through his lawyer earlier this year --much of Sudbo's published data was fabricated. A recent report from an investigative commission formed by Sudbo's former employers, the Rikshospitalet-Radiumhospitalet Medical Center and the University of Oslo, has since confirmed the fraud. The NEJM editors based their retraction largely on the report's findings. "Given the weight of evidence offered in the commission's report and the requests of most of the authors of the articles, we retract both articles," NEJM editors Dr. Gregory Curfman, Dr. Jeffrey Drazen and Stephen Morrissey wrote in the Nov. 2 issue of the journal. They noted that all of the two studies' authors, with the exception of Sudbo, have agreed with the Oslo commission's findings and the journal's subsequent retraction of the article. Sudbo's various co-authors have been cleared of any wrongdoing. Both articles focused on patients (typically long-term tobacco users) who were at high risk of oral cancer due to the presence of precancerous white growths in their mouths or on their tongues known as oral leukoplakia. Sudbo's April 1, 2004, NEJM article suggested that a cellular aberration called "aneuploidy" -- the presence of disordered cells marked by overabundant DNA -- might predict [...]

11/2/2006 Memphis, TN staff CancerConsultants.com According to the results of two studies published in the International Journal of Radiation Oncology, Biology, Physics, treatment of head and neck cancer with intensity-modulated radiation therapy is less likely to result in dry mouth (xerostomia) than treatment with conventional radiation therapy. Head and neck cancers originate in the throat, larynx (voice box), pharynx, salivary glands, or oral cavity (lip, mouth, tongue). Most head and neck cancers involve squamous cells, which are cells that line the mouth, throat, or other structures. 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. For head and neck cancer patients treated with radiation therapy, xerostomia is a potential side effect of treatment. Xerostomia refers to a condition of an abnormally dry mouth. Patients with severe xerostomia have very limited or virtually no saliva production. This results in difficulty eating, speaking, and swallowing. These symptoms make xerostomia extremely uncomfortable, and patients who suffer from the condition have a drastically reduced quality of life. Xerostomia can last long after treatment is completed. Intensity modulated radiation therapy (IMRT) is a newer approach to radiation therapy that allows for the more precise delivery of radiation to cancer cells, while sparing healthy surrounding tissue. Two studies recently evaluated parotid gland function among head and neck cancer patients treated with IMRT or conventional radiation therapy. The parotid glands [...]

11/2/2006 New York, NY David Douglas CancerPage.com The development of hypothyroidism appears to have a beneficial effect in patients with head and neck cancer, researchers report in the October issue of the Archives of Otolaryngology--Head and Neck Surgery. Dr. Marc Nelson and colleagues at the Cleveland Clinic Foundation, Ohio note that there are reports of improved survival in hypothyroid patients with various cancers and thyroid hormones appear to have a role in neoplasia. To determine whether this might be the case in advanced-stage head and neck squamous cell carcinoma, the researchers studied 155 patients who had undergone radiation therapy with or without chemotherapy and surgery where indicated. In total 55 of the patients developed hypothyroidism, as indicated by a thyrotropin level greater than 5.5 mIU/L. Despite treatment for hypothyroidism, these patients had improved survival, lower recurrence rates and increased recurrence-free survival. After adjusting for the time of detection, hypothyroidism was still associated with improved survival but this did not reach statistical significance (hazard ratio = 0.62, p = 0.12). The researchers conclude that prospective studies would be needed to test the hypothesis that "maintaining patients at a clinically tolerable level of hypothyroidism may have a beneficial effect in regard to their neoplastic disease." In fact, senior investigator Dr. Marshall Strome told Reuters Health that "at this time it is my practice to leave those patients who are hypothyroid and asymptomatic, mildly hypothyroid. I believe that time and prospective controlled trials will prove the concept." Source: Arch Otolaryngol Head Neck Surg [...]

11/1/2006 Quebec, Canada press release Biology Net News (www.biologynews.net) New research here suggests that hormones produced as during periods of stress may increase the growth rate of a particularly nasty kind of cancer. The study showed that an increase in norepinephrine, a stress hormone, can stimulate tumor cells to produce two compounds. These compounds can break down of the tissue around the tumor cells and allow the cells to more easily move into the bloodstream. From there, they can travel to another location in the body to form additional tumors, a process called metastasis. The research also suggests the same hormone can also stimulate the tumor cells to release another compound that can aid in the growth of new blood vessels that feed cancer cells, hastening the growth and spread of the disease. The work was reported in the latest issue of the journal Cancer Research. "This opens up an entirely new way of looking at stress and cancer that's different from current interpretations," explained Ronald Glaser, a professor of molecular virology, immunology and medical genetics, and director of the Institute for Behavioral Medicine Research at Ohio State University . Glaser and Eric Yang, a research scientist in the same institute, focused on the role of these three compounds. Two of them, both matrix metalloproteinases -- MMP-2 and MMP-9 -- play a role in breaking down the scaffolding that cells attach to in order to maintain their shape. The third compound, vascular endothelial growth factor (VEGF), is important in the [...]

11/1/2006 Pittsburgh, PA Anita Srikameswaran Post-Gazette.com State health authorities are today launching a media campaign intended to get teenagers to chew on a few grim realities about smokeless tobacco. According to Pennsylvania Health Secretary Dr. Calvin B. Johnson, manufacturers are on the verge of introducing new products with fruit flavors and chew that can be swallowed instead of spat, which could entice youngsters into the addictive habit. "With these kinds of things on the horizon, we really wanted to get ahead of the curve and ... be aggressive about putting other information out there," Dr. Johnson said. A person who uses eight to 10 dips per day gets about the same amount of nicotine as a person who smokes 30 to 40 cigarettes daily. "That's a two-pack-a-day person," the health secretary explained. "That's considered a heavy smoker." Rather than lecture young people about the down-the-road risks of oral cancer, the campaign's television spots, radio ads and Web components will focus on the early, unpleasant consequences of using spit tobacco, including foul breath and stained teeth. After all, "what kid wants to try to get a prom date with teeth missing from their mouth?" Dr. Johnson pointed out. "Those immediate things, such as discoloration, bad breath and loss of teeth, seem to have more of a persuasive effect on the kids." According to the health department, 11.5 percent of high school students in Pennsylvania are smokeless tobacco users. The practice is more common among white males and in rural areas. Pediatric [...]

10/26/2006 USA staff www.pharmaceutical-business-review.com Danish biotech firm Genmab has initiated a phase I/II study of HuMax-EGFr in combination with chemo-radiation as first line treatment of head and neck cancer. The study will include a total of 36 patients with advanced squamous cell carcinoma of the head and neck. The objective of the study is to investigate the safety and efficacy of HuMax-EGFr in combination with chemo-radiation as first line treatment of patients with advanced head and neck cancer. "We welcome the expansion of the HuMax-EGFr program, which we hope will benefit earlier stage patients," said Lisa Drakeman, CEO of Genmab. The study consists of an initial dose-escalation part and a subsequent parallel group design. In the dose-escalation part of the study, three dose levels of HuMax-EGFr will be tested in combination with conventional fractionated radiotherapy and cisplatin. The safety of the dose levels will then be evaluated before dosing is continued at the next level. In the following parallel group design part of the study, HuMax-EGFr will be tested in combination with cisplatin and three different regimes of accelerated radiotherapy.

10/30/2006 Seoul, Korea staff EurekAlert.com Researchers have shown that targeted overexpression of heat shock protein 25 prevents radiation-induced damage to salivary glands, a common consequence of treatment for head and neck cancer. The related report by Lee et al., "Radioprotective effect of HSP25 on submandibular glands of rats," appears in the November issue of The American Journal of Pathology. Patients with head and neck cancer often receive radiation therapy as part of their treatment. However, the salivary glands, which frequently reside within the irradiation field, can become damaged at the same time. The resulting salivary dysfunction may involve dry mouth, oral infections, dental caries, and difficulty eating, some of which persist long after treatment ends, even permanently. Dr. Yun-Sil Lee and colleagues examined whether salivary glands could be protected by heat shock proteins (HSPs), which are expressed by cells in an effort to counteract environmental stressors such as heat, hypoxia, and ionizing radiation. Using adenoviral vectors, the researchers specifically overexpressed HSP25 and HSP70i in submandibular salivary glands of rats. Rat salivary glands were then irradiated and monitored for radiation-induced changes. In treated rats, HSP25 protected salivary gland function by maintaining gland weight, salivary flow rate, and salivary fluid composition, whereas HSP70i significantly protected only salivary flow rate. When specific damage to the glands was assessed, HSP25 and HSP70i both greatly diminished scarring, nuclear damage, and cell death (apoptosis), but HSP70i was slightly less effective. Finally, HSP25 and HSP70i preserved expression of aquaporin 5, which is important for water transport in [...]

10/30/2006 web resource, no city listed Yael Waknine Medscape.com On October 13, the French regulatory authority Agence Francaise de Sécurité Sanitaire des Produits de Santé (AFSSAPS) approved miconazole Lauriad 50-mg bioadhesive buccal tablets (Loramyc, made by BioAlliance Pharma SA) for the treatment of oropharyngeal candidiasis in immunodepressed patients, particularly those with head and neck cancers who have undergone radiotherapy and those infected with HIV. Miconazole Lauriad is designed with proprietary technology (Lauriad) that ensures an early and extended release of the active component at the site of infection, maintaining therapeutic levels of the drug (saliva concentration > 1 µg/mL) while reducing the risk for drug interactions and systemic effects. In contrast with other topical treatments such as gels, rinses, or lozenges that require multiple daily dosing, the product is applied once daily on the upper gum. According to a company news release, approval of miconazole Lauriad was based on data from 2 European phase 3 clinical trials. The first of these was conducted in 25 HIV-positive patients at 11 clinical sites in France. Results showed clear evidence of efficacy (success rates at day 7 and 15 were 89.5% and 94.7%, respectively) and the study was therefore terminated early. The second study was a comparative, multicenter, randomized study in 306 French and North African patients with head and neck cancer treated by radiotherapy and presenting with candidiasis and low saliva levels (dry mouth). Results at day 14 confirmed the noninferiority of the miconazole Lauriad 50-mg tablet applied once daily compared with [...]