5/10/2005 Austin, TX press release Pharmalive.com Introgen Therapeutics, Inc. is highlighted in the May 2005 issue of Nature Biotechnology in a feature story titled, "Gene Therapy: cursed or inching towards credibility?" The feature, written by Malorye A. Branca, charts the successes and challenges of developing gene based therapies. David G. Nance, Introgen’s President and Chief Executive Officer, is quoted in the Nature Biotechnology article about the advancements in the United States in moving gene therapy products closer to approval. Introgen has recently applied for Accelerated Approval with the FDA as part of its product licensing process for ADVEXIN®, currently in two Phase 3 studies for head and neck cancer. "As the gene therapy field continues its advances, I am reminded of the similarities with development and commercialization of monoclonal antibody therapies," said Mr. Nance. "After much initial promise, monoclonal antibody therapies fell out of favor. Over time, however, the powerful technology was translated into products that are now an important part of standard medical care. I have no doubt that gene therapies will translate into important products, and will define an era in which medicines can be used to treat disease at the fundamental, molecular level. The Nature Biotechnology article chronicles part of the journey, illustrates how far we have come, and heralds the arrival of gene therapy as a commercial product." Introgen’s most advanced product development efforts have focused on gene therapy product candidates, such as the p53 tumor suppressor gene, that are clinically delivered to tumors using specially [...]

5/8/2005 Japan T Ikebe et al. Int J Oral Maxillofac Surg, April 30, 2005 Oral mucositis is a dose-limiting toxic effect of radiotherapy and chemotherapy on oral cancer. The purpose of the present study is to assess the relationship between tumor response and oral mucositis in preoperative radiochemotherapy for oral cancer retrospectively. Fifty-four cases of oral squamous cell carcinoma were treated with concurrent radiochemotherapy prior to surgery. When oral mucositis was evaluated with the WHO scale, severe oral mucositis (Grades 3 and 4) developed in 22 cases (41%). A more than 50% reduction in tumor size was clinically observed in 38 cases (70%). From histopathological analysis of the surgical specimens all tumor cells observed appeared to be non-viable in 16 cases (29%). The cases with Grade 1, Grade 2, Grade 3 and Grade 4 oral mucositis included 33%, 62%, 85% and 89% of clinical good-response cases and 0%, 24%, 31% and 55% of histopathological good-response cases, respectively. This retrospective study suggests that severe oral mucositis promises a good response of oral squamous cell carcinoma to radiochemotherapy. Authors: T Ikebe, K Seki, S Nakamura, Y Takenoshita, H Nakayama, M Shinohara, and K Shirasuna Authors Affiliation: Department of Oral and Maxillofacial Surgery, Sensory and Motor Organ Sciences, Faculty of Medical and Pharmaceutical Sciences, Kumamoto University, 1-1-1 Honjyo, Kumamoto 860-8556, Japan; Section of Oral and Maxillofacial Surgery, Faculty of Dental Science, Kyushu University, Fukuoka 812-8582, Japan

5/6/2005 Hokinsville, KY Karen Campbell Kentucky New Era Rick Bender started using tobacco when he was 12. At 26, he was diagnosed with mouth cancer. He lost half of his jaw and a third of his tongue. He was given two years to live. "I am lucky to be alive today," said the Cadiz resident. "I want to use my second chance to tell as many people as I can about the dangers of tobacco of all kinds." Bender travels to schools around the country spreading his message. He also takes his "No Snuff" campaign to corporations. He speaks to professional baseball players about the importance of being role models and has been part of public service announcements on MTV. The underlying theme of his presentation tells of the dangers of spit tobacco, but he stresses that tobacco is tobacco and in any form it kills. "It does not matter, roll it in a cigarette, stuff it in a pipe or just (put) a pinch between your cheek and gum. It is all the same and it will kill you," Bender told the children. In 45 minutes he told North Drive Middle School students his story -- how he got started, what happened because of his use and the effects he lives with today. But he also talked to them about other people's stories and showed them slides of warning signs www.sfa.univ-savoie.fr. As he spoke to sixth-graders about operations, physical effects that never go away, and being given two years [...]

5/6/2005 Toronto, Canada based on press release CancerConsultants Oncology Center (patient.cancerconsultants.com) According to a recently completed clinical trial, a vaccine that is injected directly into the site(s) of cancer produces promising results in patients with head and neck cancer who have stopped responding to standard therapies. Approximately 40,000 people in the United States are diagnosed with head and neck cancer every year. Cancers of the head and neck comprise several types of cancer, including the nasal cavity and sinuses, oral cavity, nasopharynx, oropharynx, and other sites located in the head and neck area. Once the cancer stops responding to standard therapeutic approaches, which typically consists of chemotherapy and/or radiation therapy, it is referred to as “refractory”. Patients with refractory head and neck cancer currently have very limited effective treatment options, with overall survival being dismal in this group of patients. There are currently no treatment modalities that have demonstrated an improvement in survival in the treatment of refractory head and neck cancer. Several clinical trials are underway to evaluate novel therapeutic approaches for the treatment of this disease. A novel vaccine Proxinium™ recently completed an early-phase clinical trial in the evaluation of advanced head and neck cancer. Proxinium™ is comprised of a monoclonal antibody, which is a protein that is targeted against and binds to a specific component of a cell. The monoclonal antibody portion of Proxinium™ is targeted against EpCAM, a molecule that is often highly expressed in head and neck cancer cells. Proxinium™ also contains the toxin produced [...]

5/5/2005 Tzu-Chen Yen, MD, PhD et al. Journal of Nuclear Medicine Vol. 46 No. 5 775-781 This prospective, nonrandomized, case-control study evaluated the impact of 18F-FDG PET in staging untreated squamous cell carcinoma of the buccal mucosa (BSCC) and compared the results with CT/MRI and histopathology. Methods: Between January 2002 and April 2004, 102 untreated BSCC patients with cM0 (no evidence of distant metastatic focus on chest radiograph, liver ultrasonograph, and bone scan) were enrolled with either conventional work-up (CWU, n = 51) or PET (CWU+PET, n = 51). All were monitored for at least 6 mo. The comparative diagnostic efficacies of PET and CT/MRI were evaluated using the area under the receiver-operating-characteristic curve (AUC). The primary endpoint was the percentage reduction in futile surgery (preoperative detection of distant metastatic lesions). The secondary endpoint was the 2-y cumulative recurrence rate among study participants (with PET) compared with that of comparable control subjects (without PET). Results: Significant benefits of PET compared with those of CT/MRI for BSCC patients were in the detection of locoregional (AUC, 0.973 vs. 0.928; P = 0.026), regional (AUC, 0.939 vs. 0.837; P = 0.026), and level II (AUC, 0.974 vs. 0.717; P = 0.02) lymph nodes. Two percent (1/51) of the patients experienced a reduction in futile surgery in the CWU+PET group compared with 0% (0/51) in the CWU group. However, no statistical difference was found in the 2-y locoregional control rate between the CWU and the CWU+PET groups. Conclusion: The role of 18F-FDG PET for [...]

5/3/2005 Asbury Park, NJ Kathleen Doheny Asbury Park Press (www.app.com) The day may come when patients will spit in the doctor's office, and no one will be offended. That's because researchers have designed a test based on human saliva that may detect oral, breast and other cancers in their very early stages. How soon before such tests are reality? "My prediction for oral cancer tests is a year to a year-and-a-half," said senior investigator Dr. David T. Wong, a professor and associate dean of research at the UCLA School of Dentistry and the Jonsson Comprehensive Cancer Center, in Los Angeles. For breast cancer testing, he said, it will be longer, because that research is not as far along. A spokesman from the American Cancer Society, who is familiar with the research, said that more study is needed before the tests can be expected to be in widespread use, however. In the study, genetic "biomarkers" isolated in saliva predicted oral cancer in about nine out of 10 cases. A biomarker, Wong said, is a kind of genetic "fingerprint" for the disease. "These 'fingerprints' occur in a totally noninvasive fluid, saliva," he said. Wong's team isolated the genetic material, called messenger RNA, from saliva to evaluate whether it might have diagnostic value for detecting cancer in its earliest stages. The scientists looked for patterns or changes in this mRNA that might predict cancer. Overall, the researchers collected saliva and blood samples from 32 patients with oral cancer, 40 patients with breast cancer, [...]

5/3/2005 Orlando, FL George Diaz Orlando Sentinel (www.orlandosentinel.com) Baseball's dirty habit is back in vogue as big-leaguers struggle with addiction to chewing tobacco. Johnny Damon got in his Porsche this spring with no particular purpose other than making the obligatory journey from Orlando to Fort Myers to begin spring training. As the miles clicked off, he put a wad of chewing tobacco in his mouth to relax. Growing closer to his destination, he began thinking about the dangers of chewing, consequences that could escalate from unsightly stains on his teeth to cancerous lesions. By the time he stepped out of his car and walked into the Boston Red Sox clubhouse, Damon decided he would quit. "Better for my health. Better for the color of my teeth," Damon, an outfielder, said recently during a three-game trip to Tampa. "I did the cold-turkey thing. It's worked so far, but we've got a long ways to go." Chewing tobacco is a baseball ritual that spans generations. Interspersed with sunflower seeds and chewing gum, it appears as a friendly companion to the 162-game grind of taking infield, batting practice and nine innings of baseball. Players say the nicotine buzz is soothing. In reality, it can kill. The Oral Cancer Foundation estimates that 30,000 Americans will be diagnosed with oral or pharyngeal cancer this year, causing more than 8,000 deaths (killing roughly one person per hour, 24 hours per day). Of those 30,000 cases, only half will be alive in five years. Lung, colorectal, breast [...]

5/3/2005 Bethesda, MD Sarah L. Zielinski Journal of the National Cancer Institute, Vol. 97, No. 9, 617, May 4, 2005 More than one-half of adults surveyed nationwide had seen or heard celebrity endorsements of cancer screening tests, and more than one-fourth of those who had seen or heard an endorsement reported that it made them more likely to undergo the promoted screening test, according to a new study in the May 4 issue of the Journal of the National Cancer Institute. Celebrity endorsements of cancer screening are becoming increasingly common. High-profile people, such as former New York City Mayor Rudolph Giuliani and journalist Katie Couric, endorse screening tests through stories about their own cancer diagnoses or when they become involved in promotional campaigns for specific tests. However, little is known about how these endorsements affect the public. To examine the extent to which adults of screening age had seen, heard, or were influenced by celebrity endorsements of various types of cancer screening—screening mammography, prostate-specific antigen (PSA) testing, and sigmoidoscopy or colonoscopy—Robin J. Larson, M.D., of the Department of Veteran Affairs Medical Center in White River Junction, Vt., and colleagues at Dartmouth Medical School conducted a telephone survey of American adults from December 2001 through July 2002. Almost three-quarters (73%) of women age 40 and older (the age group potentially eligible for breast cancer screening) reported that they had seen or heard celebrities talk about mammograms, and, of these women, 25% said that it made them more likely to undergo screening [...]

5/2/2005 Lowell, MA Nancye Tuttle Lowell Sun Lowell General Hospital (LGH) program, ‘What About Me...?,' helps kids whose family members have cancer deal with their feelings Brendan McDonough and his dad Dick love baseball and always had fun playing catch together. But that all changed 15 months ago, when Dick was diagnosed with brain cancer. Now, says Brendan, he realizes that what he misses most since his dad got sick is just going outside to play ball with him. “All he can do now is watch TV,” says the Chelmsford 11-year-old. Brendan talks easily about his feelings, sharing them with new friends he has made in “What About Me...?,” a support group at Lowell General Hospital's Cancer Center for adolescents between the ages of 11 and 17 whose families have been touched by cancer. Before joining the group, says his mother Suzanne, Brendan didn't talk much about his father's illness. But now he's more willing to share his feelings. So, too, is Nicholas Janeczko, 11, of Lowell, whose father Mark has bone cancer following colon cancer. “It helps the kids, since they need someone else to talk to besides us,” Mark Janeczko says. Brendan's sister, Kelly, 8, and Nicholas' brother, Bryan, 7, participate in “What About Me...? Jr.,” for youngsters from ages 7 to 10. Kelly has become friendly with Samantha Benoit, another 8-year-old from Chelmsford, whose father is in remission from mouth cancer. Brendan, Kelly, Samantha, Bryan and Nicholas were at the hospital last Tuesday, along with Kyle Gilman, [...]

4/30/2005 St. Simons Island, Ga. Kim J. Masters, M.D. Am J Psychiatry 162:1023, May 2005 Letter to the editor: Dry mouth (xerostomia) is a frequent complication of psychoactive medications with antimuscarinic and anticholinergic side effects. The lack of saliva is annoying to patients, impairs their ability to masticate and digest food, and is a potential source of dental morbidity, including increased risk for caries and oral infection. Pilocarpine is a cholinergic muscarinic agonist. It has been used to treat xerostomia induced in cancer patients by head and neck radiotherapy (1). It has recently been found to be effective in doses of 20 mg/day in a randomized, placebo-controlled dose-adjustment study in the treatment of dry mouth and dry eyes in patients with Sjogren’s syndrome (2). It has been used to treat dry mouth as a complication of opioid treatment (3). Toxicity has been infrequently reported (4). However, it is contraindicated in patients with angle-closure glaucoma. We have empirically used pilocarpine in doses of 10–30 mg/day, divided into dosing of two or three times a day. We have used it with our acute psychiatric inpatients, ages 20–69, who complained of dry mouth after they had been started on psychoactive medication. These included atypical antipsychotic agents, particularly clozapine and olanzapine; anticholinergic agents, primarily benztropine; and antidepressants, particularly tricyclic antidepressants and mirtazapine. Substantial relief of dry mouth was achieved in most patients. Side effects were mainly sweating and increased urination. We did not observe any adverse impact on psychiatric symptoms. The patients were generally [...]