12/5/2001 Phoenix PR Newswire Zila Professional Pharmaceuticals, a division of Zila, Inc. (Nasdaq: ZILA), announced the acquisition of world marketing rights (excluding the Pacific Rim) for the ViziLite(TM) chemiluminescent light technology, which is cleared by the U.S. Food & Drug Administration (FDA) for marketing in the United States. Using the ViziLite Test Kit in combination with a conventional visual oral mucosal examination, healthcare providers can improve the identification, evaluation and monitoring of oral mucosal abnormalities in those at increased risk for oral cancer. The American Cancer Society publication "Cancer Facts & Figures 2001" advises that the risk factors for oral cancer are cigarette, cigar or pipe smoking; use of smokeless tobacco; and excessive consumption of alcohol. Some 25 percent of oral cancer occurs in people with no known risk factors. The transaction with Trylon Corporation of Torrance, California, involves up to 2,000,000 shares of restricted Zila common stock plus royalties (10 percent in the first five years, and 5 percent in the next five years) on ViziLite product sales. Trylon continues to market a similar technology, the PapSure(R) screening test, for cervical health. That technology received FDA clearance based on a 13,000-patient clinical study involving 55 sites. Subsequently, in November 2001, the FDA granted clearance for oral application of the ViziLite Test Kit based on evidence of substantial equivalence as demonstrated by testing at the University of California/San Francisco and the University of the Pacific. Dr. Ralph Green, Vice President and General Manager of Zila Professional Pharmaceuticals, noted, "Zila is [...]

11/29/2001 New York ADA News Releases The use of gene-transfer technology to repair salivary-gland tissue, allowing a pathway for saliva to flow in patients undergoing radiation therapy for head and neck cancer is possible in principle, disclosed Bruce J. Baum, DMD, PhD. Dr. Baum, who is chief of the Gene Therapy and Therapeutics Branch, National Institute of Dental and Craniofacial Research, National Institutes of Health, Bethesda, Md., spoke about the breakthrough study to attendees at the American Dental Association's National Media Conference, held here today. "We hypothesized that the major impediment to saliva flow from these irradiated, nonsecreting cells was the absence of a pathway for water in their membranes," he explained. "Our strategy was to transfer a gene for a water channel protein into the radiation-surviving cells that would function as the pathway." Each year in the United States, the salivary glands of some 40,000 individuals are exposed to ionizing radiation (IR) during therapy for head and neck cancer. They experience irreversible salivary gland damage. In addition, patients with dry mouth or Sjogren's syndrome (SS), (an autoimmune disorder characterized by progressive destruction of the lacrimal and salivary glands) also suffer the loss of salivary secretory tissue. Many patients receiving IR or those with SS experience complete gland destruction. The primary function of salivary glands is to make saliva, the oral fluid that provides the major lubrication and protection for the mouth and upper gastrointestinal tract. In the absence of saliva, patients have difficulty swallowing food, develop mucosal infections like [...]

11/23/2001 Reuters Health Infection with Helicobacter pylori may increase the risk of developing larynx cancer, researchers from Turkey report. Dr. Erdinc Aygenc of Ankara Numune Hospital and colleagues screened 26 laryngeal cancer patients and 32 cancer-free subjects for H. pylori infection. About 73% of patients with laryngeal cancer had H. pylori infection, the investigators found, while 41% of those without cancer were infected with the bacterium. "This study suggests that H. pylori may be an initiator or promoter organism of [larynx cancer], but we cannot say that H. pylori is absolutely the causative agent," the authors write in the November issue of the journal Otolaryngology-Head and Neck Surgery. For example, they suggest, H. pylori may make laryngeal cells more susceptible to the effects tobacco and alcohol, which are associated with an increase risk of laryngeal cancer. According to the CDC, recent studies have shown an association between long-term H. pylori infection and the development of gastric cancer. Cancer of the larynx is acommon type of cancer to occur in the head and neck. It is believed to have the same risk factors as oral cancer. Approximately 10,000 Americans will be diagnosed with the disease and roughly 4000 people will die from it in 2001. Otolaryngol Head Neck Surg 2001;125:520-521.

11/13/2001 Reuters Health Survivors of head and neck cancer generally report more morbidity, including more sexual dysfunction, than survivors of prostate cancer, but age and marital status appear to influence morbidity in both patient groups, according a study reported at the American Society for Therapeutic Radiation and Oncology annual meeting in San Francisco. Dr. Charles Scott, lead author and statistician for the American College of Radiology, told Reuters Health the findings suggest "cancer survivors are often ill-prepared for the types of impairments that may accompany aggressive treatment." For example, Dr. Scott said that head and neck cancer survivors 65 years of age or older are more likely to have speech impairments, but that "younger survivors are more likely to complain about speech impairment. This is probably because younger survivors are more likely to be employed, which makes communication more important." Dr. Scott identified head and neck and prostate cancer survivors from the Radiation Therapy Oncology Group database. There were 460 survivors, 276 of whom agreed to participate in a survey that included questions on quality of life, mood, sexual function, alcohol and tobacco use, and mental status. Twenty-one percent of the patients had head and neck cancers and 79% were prostate cancer patients. The average age of prostate cancer survivors was 75 years, while the average age for the head and neck cancer survivors was 65 years. Twelve percent of the head and neck cancer patients were African American, as were 16% of the prostate cancer patients. Older head and [...]

11/6/2001 MGI PHARMA, INC, Press release MGI PHARMA, INC., (Nasdaq:MOGN) today announced that the Radiation Therapy Oncology Group (RTOG) presented final results on data regarding the Company's Salagen(R) Tablets product at this year's American Society for Therapeutic Radiology and Oncology (ASTRO) meeting held in San Francisco on November 4-8, 2001. The resulting data were discussed by Dr. Charles W. Scarantino, lead investigator of the RTOG study on Salagen Tablets, in his presentation entitled: "A Phase 3 study on the concurrent use of pilocarpine to reduce hyposalivation and mucositis associated with radiation therapy in head an neck cancer patients - final results of RTOG 97-09." Study Data The RTOG presented data showing that use of Salagen(R) Tablets (pilocarpine hydrochloride), MGI's approved product to treat the symptoms of radiation-induced dry mouth, gave a statistically significant improvement of salivary flow versus placebo in head and neck cancer patients receiving curative radiation therapy. This Phase 3 trial, with 244 eligible patients, showed the pilocarpine group, who received active drug during radiation therapy and up to six months post therapy, had significantly better salivary flow than did the placebo group at end of radiation therapy, and at three-month and six-month follow-up visits. Based on these findings, RTOG concluded that these results provide new support for the use of Salagen Tablets during radiation treatment. One of the main side effects of radiation therapy for head and neck cancer patients is dry mouth, a condition that can be permanent, according to Dr. Scarantino, a radiation oncologist with [...]

10/31/2001 Lisbon, Portugal Peter Hofland, PhD Reuters Health Temoporfin-mediated photodynamic therapy represents a major advance in the treatment of head and neck cancer, yielding complete response rates comparable with those published for surgery or radiotherapy, according to phase II data reported here last week during ECCO 11, the European Cancer Conference. Temoporfin-mediated photodynamic therapy (Foscan PDT) is an "effective and well-tolerated treatment" and can be administered without surgery, said Dr. Colin Hopper, a consultant surgeon of the National Medical Laser Centre in London, UK. Dr. Hopper presented the results of a prospective non-randomised phase II study, conducted in 15 centers in 6 countries. The trial examined response rates to Foscan PDT in 114 patients with primary (Tis, T1 and T2) squamous cell carcinoma of the lip, oral cavity, oropharynx or hypopharynx. Patients with Karnofsky status greater than or equal to 70 received Foscan (0.15 mg/kg IV), followed 4 days later by a single nonthermal illumination of the tumor with red light (20 J/cm?, irradiance 100 mW/cm? , wavelength 652 nm). The initial response was determined after 12 weeks. After 2 years of follow-up, 85% of patients had a complete response (elimination of the tumor) with Foscan PDT alone, and another 6% achieved a complete response with Foscan PDT followed by other adjunctive therapy, including surgery or radiotherapy, giving an overall response rate of 91%. Dr. Hopper reported that in 59% of all cases a complete response rate was biopsy-confirmed. The 1- and 2-year overall survival rates were 90% and 81% [...]

10/31/2001 See end of article Yale School of Medicine Yale School of Medicine researchers have found that a diet high in cholesterol, animal protein and vitamin B12 is linked to risk of a specific type of cancer of the stomach and esophagus that has been increasing rapidly. The researchers also found that plant-based nutrients such as dietary fiber, dietary beta-carotene, folic acid, vitamin C and vitamin B6 were associated with lower risk of these kinds of cancers. They further found that regular use of vitamin C supplements was associated with a 40 percent reduction in the risk of cancer in the middle and lower parts of the stomach. The rate of a specific type of esophageal and stomach cancer, known as adenocarcinoma of the esophagus and gastric cardia, has increased by 300 percent since the mid-1970s, according to lead author Susan Mayne, associate professor in the Department of Epidemiology and Public Health at Yale School of Medicine, and associate director of the Yale Cancer Center. To identify reasons for this rapid increase, the United States National Cancer Institute launched a large study at three centers, including Yale, the University of Washington and Columbia University. The researchers interviewed patients throughout Connecticut, New Jersey and western Washington State and compared the nutrient intake of 1,095 people with stomach or esophageal cancer to that of 687 healthy people in a control group. The team also looked at the participants' use of nutrient supplements. Their results are published in the October issue of Cancer [...]

10/30/2001 Ohio Ohio State University A cup of black raspberries a day may help keep esophageal cancer at bay. Researchers found evidence in rats that black raspberries may both prevent the onset of esophageal cancer as well as inhibit precancerous growth already underway. "Black raspberries are loaded with nutrients and phytochemicals that may prevent the development of cancer," said Gary Stoner, a study co-author and a professor of public health at Ohio State University. Stoner, who has also found similar anti-carcinogenic effects with strawberries, said the study results suggest that a daily diet of about 1.4 to 2 cups of fresh berries may be ideal for staving off certain types of cancer. "Although this level is larger than a standard serving size of fruit, it is behaviorally possible," he said. "The National Cancer Institute recommends that every American eat at least four to six helpings of fruit and vegetables each day. We suggest that one of these helpings be berries of some sort." The research appears in the journal Cancer Research. Esophageal cancer is the sixth-leading cause of cancer-related deaths worldwide. The outlook is bleak for those diagnosed with the disease, five-year survival rates range from 8 to 12 percent. In the current study, the researchers looked at black raspberries' ability to halt the onset of cancer, as well as the fruit's ability to inhibit the progression of precancerous cells to cancer. They conducted experiments on two groups of rats. Some of the rats from each group were injected with [...]

10/25/2001 Jennifer Huget The Washington Post It's not every day a dentist gets to play Star Wars. But that's not why more than 30,000 dentists in the United States are deploying OralCDx, a new diagnostic tool that incorporates technology developed as part of the Strategic Defense Initiative. OralCDx, launched nationwide last year, offers dentists a better shot at catching oral cancer lesions while there's time to treat them. About 8,000 Americans die of oral cancer each year. Nearly 30,000 new cases are diagnosed annually, and only 53 percent of all oral cancer victims are still alive five years after diagnosis. But among those in whom the disease -- which is most common among tobacco users and heavy drinkers and is more common among men, people over 40 and African Americans -- is caught early, five-year survival rates soar to 88 percent. The problem has been that early stage oral cancer lesions look like benign mouth lesions, even to vigilant dentists. By the time a lesion becomes obviously, visibly cancerous, successful treatment is difficult. In the past, dentists have had to make tough choices: Should they perform traditional scalpel biopsies (or refer patients to oral surgeons for the procedure) on all of the estimated 5 percent to 15 percent of their patients who have oral lesions? At up to $300 per procedure, plus lab analysis fees of up to several hundred dollars, scalpel biopsy is costly. Plus, the procedure requires the uncomfortable surgical removal of chunks of tissue, and only a [...]

5/16/2001 San Francisco, CA Daniel Q. Haney Associated Press A gene-therapy mouthwash shows promise of warding off oral cancer by killing ominous growths before they turn malignant. The idea is to attack these pre-malignant patches by unleashing viruses programmed to kill cells with cancer-causing genes. The first study of this approach is still under way, but doctors said yesterday that it appears to work in at least some patients, making ominous patches in their mouths disappear completely. In the past 20 years, scientists have learned that all cancer arises from genetic defects that accumulate during a lifetime, causing cells to grow rampantly and spread in the body. With this insight came the belief that it might be possible to target these bad genes to stop cancer. This was once one of the hottest ideas in cancer research. But enthusiasm cooled as scientists hit roadblocks. One was reaching and killing every cancer cell. Even reaching 80 percent of the cells is not good enough, because the rest keep growing. So researchers decided that the mouth might be an excellent target for gene therapy, since the problem can be so easily reached. "The advantage is that it's where we can see it," said Dr. Ezra Cohen of the University of Chicago. "We can get to it, and the therapy does not get absorbed into the body." White or red patches in the mouth, so-called dysplastic lesions, frequently are a forerunner of malignancy and are common in smokers and heavy drinkers. These cells [...]