10/23/2006 United Kingdom press release Medical News Today (www.medicalnewstoday.com) In its September meeting 2006, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMEA) gave a positive opinion to include the use of docetaxel in combination with the current standard treatment - cisplatin and 5 - fluorouracil - for the induction treatment of patients with inoperable locally advanced squamous cell carcinoma of the head and neck. On October 18, the US Food and Drug Administration (FDA) gave its approval to the new treatment as well. According to Steven Galson, M.D., director of FDA's Center for Drug Evaluation and Research, it will “provide prescribers with a new treatment option that has been shown to help slow the spread of the disease and prolong patients' survival.” This drug - label extension of Taxotere (docetaxel) was possible due to the EORTC 24971 phase III, open label randomized trial, involving 358 patients, evaluating the benefit derived from docetaxel - based combination in inoperable locally advanced head and neck cancer. Patients treated with the regimen prior to surgery or radiation had significantly longer median overall survival compared to a standard treatment of cisplatin and 5-fluorouracil; with a 28 percent risk reduction of the, 18.6 vs 14.5 months (p=0.0128). Patients receiving the docetaxel-based regimen also had a significantly longer time-to-disease progression of 11.4 months, compared with 8.3 months (P=0.015) for the patients receiving standard therapy. These results have been associated to an improvement of the safety profile. ”Very few treatment options [...]

10/23/2006 Stockholm, Sweden Anthony S. Gunnell et al. Cancer Epidemiology Biomarkers & Prevention, 10.1158/1055-9965.EPI-06-0399 Background: A majority of studies have implicated the involvement of cigarette smoking in cervical cancer development, although its mechanism of action remains unclear. We conducted a large population-based case-control study to address the potential interaction between smoking and human papillomavirus type 16 (HPV-16) in development of cervical cancer in situ (CIS). Methods: Information on risk factors for CIS was collected via interview, and archival cervical smears were tested for HPV-16 DNA presence in cases (n = 375) and controls (n = 363). Adjusted odds ratios (OR) for the effects of smoking, HPV-16 presence/absence, and load at first smear (taken, on average, 9 years before diagnosis) were calculated. Results: The risk for CIS among current smokers who were HPV-16 positive at time of first smear was >14-fold [adjusted OR, 14.4; confidence interval (95% CI), 5.6-36.8] compared with HPV-16-negative current smokers. In contrast, the risk for CIS among HPV-16-positive nonsmokers was only 6-fold (adjusted OR, 5.6; 95% CI, 2.7-11.5), compared with HPV-16-negative nonsmokers. HPV-16-positive smokers with high viral load at time of first smear exhibited a high risk for CIS (adjusted OR, 27.0; 95% CI, 6.5-114.2) compared with HPV-16-negative smokers. Within nonsmokers, however, high HPV-16 load contributed only a 6-fold increased risk compared with HPV-16-negative nonsmokers (adjusted OR, 5.9; 95% CI, 2.4-14.6). Interaction was observed (P = 0.03) between duration of smoking and HPV-16 presence in CIS development. Conclusion: Results suggest a synergistic effect between smoking and both [...]

10/21/2006 Cleveland, OH M Nelson et al. Arch Otolaryngol Head Neck Surg, October 1, 2006; 132(10): 1041- Objective: To determine if the development of hypothyroidism has an effect on the outcome of advanced-stage head and neck squamous cell carcinoma. Design: Retrospective database analysis. Setting: Tertiary care center. Patients: The study population comprised 155 patients with advanced-stage head and neck squamous cell carcinoma. Interventions: Patients underwent radiation therapy alone or in combination with chemotherapy and surgery when indicated. MAIN Outcome Measures: Kaplan-Meier analysis was used to assess survival, not adjusting for timing of the detection of hypothyroidism. The following 2 analyses were then performed to adjust for the timing of detection: (1) hypothyroidism was assessed as a time-varying covariate in a Cox proportional hazards model and (2) a landmark analysis was conducted at 9, 12, 15, 18, 21, and 24 months using the Kaplan-Meier method. Results: Of the 155 patients, 59 developed hypothyroidism, defined as a thyrotropin level greater than 5.5 mIU/L (institutional value). An unadjusted Kaplan-Meier analysis indicated that patients who develop hypothyroidism have significantly better survival than patients who do not (P<.001, log-rank test). After adjusting for the timing of hypothyroidism, a Cox proportional hazards analysis indicated that survival was better, but not statistically significant, for patients who developed hypothyroidism (hazard ratio, 0.62; P=.12); results from a landmark analysis supported this finding (P values ranged from .11 to .19). Conclusions: Development of hypothyroidism may be associated with improved survival and increased recurrence-free survival. Larger, prospective studies appear warranted to [...]

10/20/2006 Baltimore, MD Nancy Nairi Maserejian et al. American Journal of Epidemiology 2006 164(6):556-566 The authors prospectively evaluated fruit and vegetable consumption and the incidence of oral premalignant lesions among 42,311 US men in the Health Professionals Follow-up Study. Diet was assessed every 4 years by food frequency questionnaires. The authors confirmed 207 cases of clinically or histopathologically diagnosed oral premalignant lesions occurring between 1986 and 2002. Multivariate-adjusted relative risks were calculated from proportional hazards models. Significant inverse associations were observed with citrus fruits, citrus fruit juice, and vitamin-C-rich fruits and vegetables, indicating 30–40% lower risks with greater intakes (e.g., citrus fruit juice quintile 5 vs. quintile 1 relative risk = 0.65, 95% confidence interval: 0.42, 0.99). Inverse associations with fruits did not vary by smoking status and were stronger in analyses of baseline consumption, with a 10-year lag time to disease follow-up (quintile 5 vs. quintile 1 relative risk = 0.41, 95% confidence interval: 0.20, 0.82; p = 0.01). No associations were observed with total vegetables or with ß-carotene-rich or lycopene-rich fruits and vegetables. For current smokers, green leafy vegetables (ptrend = 0.05) and ß-carotene-rich fruits and vegetables (ptrend = 0.02) showed significant linear trends of increased risk (one additional serving/day relative risk = 1.7). The risk of oral premalignant lesions was significantly reduced with higher consumption of fruits, particularly citrus fruits and juices, while no consistent associations were apparent for vegetables. Authors: Nancy Nairi Maserejian1,2,3, Edward Giovannucci1,4,5, Bernard Rosner4, Athanasios Zavras2 and Kaumudi Joshipura1,2,6 Authors' affiliations: 1 Department [...]

10/20/2006 Rockville, MD Patricia Shehan All Headline News (www.allheadlinenews.com) On Wednesday, the Food and Drug Administration (FDA) approved a new form of drug treatment for patients who have inoperable, locally advanced squamous cell carcinoma of the head and neck (SCCHN). The approved drug, Taxotere Injection Concentrate (docetaxel; Sanofi-Aventis, Paris, France), is to be used in combination with chemotherapy drugs (cisplatin and fluorouracil) before radiothermy treatment. Taxotere was studied in a random trial of 358 patients. One group was given Taxotere in combination with the chemotherapy drugs. The other group received only the chemotherapy drugs. The results comparing the additional use of Taxotere showed a longer survival time (18.6 months versus 14.2 months) and a longer time to progression of disease or death (11.4 months versus 8.3 months) than the group who only received the chemotherapy drugs. Patients with SCCHN represent approximately 3 percent of all new diagnosed cases of cancer in the U.S. According to the Director of FDA's Center for Drug Evaluation and Research, Steven Galson, M.D., "Today's approval will provide prescribers with a new treatment option that has been shown to help slow the spread of the disease and prolong patients' survival." There were some of the usual adverse side effects experienced when comparing the study patients on Taxotere with those who were not on the drug treatment.

10/20/2006 Austin, TX press release PRnewswire.com Introgen Therapeutics, Inc today reported updated data from several clinical studies which demonstrate the activity of Advexin p53 therapy in patients with cancers of the head and neck, lung, breast and esophagus. Additional results showing utility of Advexin in the inherited cancer known as Li-Fraumeni Syndrome were also reported. Evaluation of molecular and clinical biomarkers was able to predict patient populations most likely to benefit from Advexin therapy. Data were presented over the weekend at the annual meeting of the International Society for Cell and Gene Therapy in Chiba City, Japan by Sunil Chada, Ph.D., Introgen's associate vice president of Clinical Research and Development. The international meeting joined hundreds of clinicians and researchers to discuss the progress of novel cancer treatments. Dr. Chada commented, "Advexin shrinks tumors, halts tumor growth, and improves symptoms in patients with multiple types of cancer. Patients with tumors having abnormal p53 were shown to have improved outcomes following Advexin therapy. These observations are consistent with the presence of p53 abnormalities in the majority of cancers. Aberrant p53 is the molecular target of Advexin therapy." Dr. Robert E. Sobol, Introgen's senior vice-president of Medical and Scientific Affairs, stated, "We have advanced our analyses of Advexin efficacy in recurrent, squamous cell carcinoma of the head and neck. These patients have limited effective treatment options. The Advexin tumor response rate defined by a 30 percent reduction in tumor size was 10.3 percent for the overall population and 26.5 percent for the clinical [...]

10/18/2006 Los Angeles, CA press release UCLA News (www.newsroom.ucla.edu) The UCLA School of Dentistry has received two research awards from the National Institutes of Health which, combined with the school's ongoing NIH-funded saliva research studies, are building UCLA's reputation as a center for excellence in oral fluid research. A major five-year, $12.5-million UO1 grant from the National Institute of Dental and Craniofacial Research, an arm of the NIH, will fuel the development of a functional prototype of the Oral Fluid NanoSensor Test (OFNASET), a handheld clinical device for point-of-care saliva diagnostics. In addition, a five-year, $2.5-million NIH RO1 grant will support efforts to identify the diagnostic signatures of Sjögren's Syndrome in the saliva of individuals affected by that auto-immune disease. "The UCLA School of Dentistry is proud to provide leadership in the national effort to investigate and innovate in the promising area of saliva diagnostics," said Dr. No-Hee Park, dean of the School of Dentistry. David Wong, a professor in the division of oral biology and medicine and the associate dean of research at the UCLA School of Dentistry, the director of the UCLA Dental Research Institute and a member of UCLA's Jonsson Cancer Center, is the principal investigator for both grants. Predating the new awards, the School of Dentistry's current saliva research studies supported by the NIH include the Human Salivary Proteome Project, the UCLA Collaborative Oral Fluid Diagnostic Research Center, and the Genomics and Proteomics for Progressing Oral Precancer study. Earlier this year, as a product of those [...]

10/18/2006 Orlando, FL staff wftv.com Throat and neck cancer surgeries can leave patients with serious side effects such as scars and speech problems. But with the help of a robot, two surgeons are the first in the world to treat these types of cancers without making even one incision. John McCauley had tongue cancer surgery 20 years ago. And she recently had to have it again. "The recovery from my first surgery for tongue cancer was… very raw. It was a raw area, it was tender, and it was quite painfull to be honest," she said. But the second time, a robot did much of the work. In the past, surgeons cut across the throat to remove the tumor. But the robot operates in the mouth so the incisions are small and are made on the inside of the body. "Now, we do remove the entire tumor but we don't have to do things such as wide incisions on the neck or breaking or splitting the jaw bone and moving the tongue aside," said Dr. Bert O'Malley Jr., a head & neck surgeon. "The robot allows me to move my hands on the joysticks of the robotic console, and it's as if my hands were made this small, and I could get them right into the mouth to do the operation," he said. Two surgeons partner on each operation. One operates the console, one is by the patient's side. Patients lose less blood and can actually talk and swallow more [...]

10/18/2006 New Rochelle, NY press release Genetic Engineering News (www.genengnews.com) Rexahn Pharmaceuticals (OTCBB:RXHN.OB), a clinical stage biopharmaceutical company dedicated to the discovery, development, and commercialization of innovative treatments for cancer, disorders of the central nervous system and unmet medical needs, today announced the conclusion of the Phase I clinical trials of its leading oncology candidate, RX-0201. RX-0201 is a first-in-class signal inhibitor that directly blocks the production of Akt, a protein kinase that plays a key role in cancer progression. Akt is over-activated in a significant number of cancers, such as breast, colorectal, gastric, head and neck, ovarian, pancreatic, prostate, and thyroid cancers. Akt's transformation ability, as well as its role in cancer progression, makes it a highly attractive and unique target in the treatment of cancer. The clinical trial of RX-0201, which took place at Georgetown University and the University of Alabama, was an open-label, dose-escalation study intended primarily to determine the safety and tolerability of the drug in patients with advanced cancer. The trial has demonstrated that the dose limiting toxicity of RX-0201 occurs at 315 mg/m2 dose in the form of fatigue. No other serious adverse reactions such as hematological toxicities were observed in this study. The Company expects to file a complete final report of Phase I results with the FDA in early 2007. Of the clinical trial, Dr. Chang Ahn, Chairman and CEO of Rexahn, said, "We are very pleased that RX-0201 has successfully concluded Phase I. As a company that is focused on developing [...]

10/18/2006 Orlando, FL staff wftv.com Background: The American Cancer Society estimates about 30,990 new cases of oral cavity and oropharyngeal cancer will be diagnosed in the United States in 2006. More than 7,000 people will die of these cancers this year. Oral cancer is cancer that starts in the mouth, while oropharyngeal cancer is cancer that develops in the part of the throat just behind the mouth, called the oropharynx. The treatment options for people with oral and oropharyngeal cancers are surgery, radiation therapy, and chemotherapy either alone or in combination, depending on the stage of the tumor. Depending on where the cancer developed, surgeons may need to cut through the outside of the throat to get to the tumor. Gregory Weinstein, M.D., and Bert O'Malley, M.D., are co-directors of The Center for Head and Neck Cancer at the University of Pennsylvania. "Traditional approaches are incisions in the neck and into the throat to get exposure to the cancer," says Dr. Weinstein. "Sometimes it can be involved in splitting the jaw and opening up the tissues widely to get exposure to the lesions." A New Approach: Now, Drs. Weinstein and O'Malley are partnering on a new way to approach these kinds of cancers: through the mouth using robotic surgery equipment. "We haven't done a full objective analysis, but our experience suggests that patients do better in speech and swallowing after the surgery," says Dr. O'Malley. "We remove the entire tumor, but we don't have to do things such as live [...]