7/4/2008 web-based article Matthew Dennis cancerdrugnewsblog.blogspot.com Introgen Therapeutics has submitted a BLA to the FDA, while simultaneously Gendux Molecular (Introgen) has submitted an MAA to the EMEA, both seeking marketing approval for Advexin (INGN 201), the company's targeted p53 tumour suppressor gene therapy, to treat recurrent, refractory head and neck cancer. INGN 201 represents the first in a new class of tumour suppressor cancer therapy and is the first of its kind to be submitted for regulatory approval in the US and Europe. Introgen has requested priority review from the FDA for INGN 201, meaning that the treatment could be on the market in early 2009. INGN 201 therapy harnesses the body's natural tumour suppression mechanisms to fight cancer, without the toxicities associated with conventional cancer treatments. Abnormalities in protective tumour suppressor p53 pathways are associated with the majority of all solid cancers. Designed to restore patients' ability to fight cancer, INGN 201 delivers large doses of the normal p53 gene to target abnormal p53 function present in tumour cells, which triggers natural tumour suppression mechanisms in cancer without harming normal cells. According to Dr Jack Roth, inventor of Advexin and professor at the University of Texas MD Anderson Cancer Center: "This is an important milestone in the clinical application of gene therapy for cancer patients. With the use of p53 biomarkers, Advexin will provide more effective and less toxic treatment for head and neck cancer patients who have limited treatment options." The submissions are based on pivotal Phase II [...]

7/4/2008 Ottawa, Ontario, Canada Sarah Schmidt Canada.com Graphic health warnings on cigarette packages are failing to move the majority of smokers to quit, a new government survey has found. Over the last five years, the percentage of smokers who say the warnings are ineffective at getting them to try to kick the habit has increased, according to the newly released Health Canada poll. More than half - 57 per cent - say they are unmoved by these graphic warnings, up five points from five years earlier. Among potential quitters - smokers who are seriously thinking of quitting - the percentage who characterize the campaign as not very effective or not at all effective in getting them to try to quit has also increased in this period, to 43 per cent from 40 per cent. Only 14 per cent of smokers and 20 per cent of potential quitters said the health warnings are very effective at getting them to try to quit smoking, also down from five years ago, when 18 per cent of smokers and 25 per cent of potential quitters described the campaign in these terms. Health Canada commissions the annual Environics poll to track the effectiveness of health warning messages on cigarette packages. In 2001, Canada became the first country in the world to require tobacco companies to put photos of cancerous lungs, diseased hearts and mouth cancer among others on cigarette packages with text messages such as "Cigarettes Cause Lung Cancer" and "Cigarettes Cause Strokes." The photos [...]

7/3/2008 Salt Lake City, UT press release The Earth Times (www.earthtimes.com) BSD Medical Corp. today announced the addition of seven new BSD-500 hyperthermia systems purchased by major cancer treatment center in the United States. The most recent purchase by the Massey Cancer Center at Virginia Commonwealth University located in Richmond, Virginia joins in a number of recent hyperthermia system sales in the United States. Other notable cancer care hospitals that have also purchased or installed BSD hyperthermia systems this year include: 1 Cleveland Clinic Taussig Cancer Institute in Cleveland, Ohio 2 William Beaumont Hospital in Grosse Pointe, Michigan 3 Robert H. Lurie Comprehensive Cancer Center at Northwestern University in Chicago, Illinois 4 Banner Good Samaritan Medical Center in Phoenix, Arizona 5 Cancer Treatment Centers of America (CTCA) in Tulsa, Oklahoma 6 Spectrum Health Blodgett Hospital in Grand Rapids, Michigan These prestigious cancer treatment centers have a long-standing tradition of offering world-class cancer care and treatment in the United States. The addition of hyperthermia therapy to each institution as an adjuvant to traditional cancer treatment demonstrates leadership in cancer awareness, diagnosis and management. The BSD-500 systems purchased by these cancer institutions are employed to treat various types of cancer. Hyperthermia is used to make cancer cells more sensitive to radiation as well as destroy cancer cells directly. In Phase III clinical trials where hyperthermia was combined with radiation, hyperthermia improved 2-year local control of melanoma from 28% to 46%, complete response for recurrent breast cancer from 23% to 68% and the [...]

7/3/2008 web-based article staff MedicalNewsToday.com GlaxoSmithKline on Monday said it does not expect to receive FDA approval for its human papillomavirus vaccine Cervarix until late 2009, Reuters reports. GSK said it has decided to wait until results from a Phase III trial of the vaccine are available before seeking U.S. approval. The study results likely will be submitted to FDA in the first half of 2009, with an FDA decision expected no more than six months later. GSK is competing with Merck for HPV vaccination contracts around the world (Hirschler, Reuters, 6/30). Cervarix and Merck's FDA-approved vaccine Gardasil in clinical trials have been shown to be 100% effective in preventing infection with HPV strains 16 and 18, which together cause about 70% of cervical cancer cases (Daily Women's Health Policy Report, 6/20). Both vaccines are designed to be given to girls and young women but have different properties (Reuters, 6/30). According to Reuters, Cervarix uses a "novel adjuvant," or additive, that GSK says makes it longer lasting. Cervarix has been approved in 67 countries, including Australia, European Union countries and Mexico (Debreczeni, Dow Jones, 6/30). FDA in December 2007 requested additional information about the vaccine before issuing a decision on GSK's application for Cervarix (Deighton, Thomson Financial/Forbes, 6/30). GSK CEO Jean-Pierre Garnier in February said that the company will provide FDA with the requested information by the third quarter of 2008 (Daily Women's Health Policy Report, 4/11). The company said it decided to wait until the results from the Phase [...]

7/1/2008 Austin, TX staff Biocompare (news.biocompare.com) Mechanical engineering Assistant Professor Adela Ben-Yakar at The University of Texas at Austin has developed a laser "microscalpel" that destroys a single cell while leaving nearby cells intact, which could improve the precision of surgeries for cancer, epilepsy and other diseases. "You can remove a cell with high precision in 3-D without damaging the cells above and below it," Ben-Yakar says. "And you can see, with the same precision, what you are doing to guide your microsurgery." Femtosecond lasers produce extremely brief, high-energy light pulses that sear a targeted cell so quickly and accurately the lasers' heat has no time to escape and damage nearby healthy cells. As a result, the medical community envisions the lasers' use for more accurate destruction of many types of unhealthy material. These include small tumors of the vocal cords, cancer cells left behind after the removal of solid tumors, individual cancer cells scattered throughout brain or other tissue and plaque in arteries. A commercially available femtosecond laser system and microscope was developed recently for LASIK and other eye surgeries, but the system's bulk limits its usefulness. Ben-Yakar's laboratory has overcome technological challenges to create a microscope system that can deliver femtosecond laser pulses up to 250 microns deep inside tissue. The system includes a tiny, flexible probe that focuses light pulses to a spot size smaller than human cells. Ben-Yakar's experimental system and its use to destroy a single cell within layers of breast cancer cells grown in [...]

7/1/2008 Chicago, IL D. Robert McCaffree, MD Chicago Tribune (www.chicagotribune.com) I read with interest the open letter from Dr. Brad Rodu to Sen. Obama in the June 22 Perspective section ("Quitting ins't that easy"). In this open letter, Dr.Rodu advocated the use of smokeless and spit tobacco (which I will refer to only as spit tobacco) to reduce the cravings of nicotine addiction and reduce the harm from cigarettes. He minimized the risk from spit tobacco in his comments. As a physician who has spent my professional career helping those with nicotine addiction, I would like to offer an alternative view. Using spit tobacco for smoking cessation is an area of controversy among anti-tobacco advocates. Many of us who have cared for patients with their tongues or half their jaws removed because of spit tobacco would not advocate its use. Moreover, UST, Philip Morris, RJ Reynolds and other producers of spit and smokeless tobacco are marketing flavored packets designed to attract and addict young people. And many spit tobacco products deliver more nicotine than cigarettes. While I support using a variety of techniques for smoking cessation for my patients, I would suggest that a safer method than spit tobacco is using approved nicotine replacement such as patches, gum and lozenges. In fact, the most recent update of the CDC Guidelines for Smoking Cessation doesn't recommend use of spit tobacco but does recommend the use of combinations of nicotine replacements, such as patches plus gum, finding that the results were as [...]

7/1/2008 Washingon, D.C. Matt Schudel Washington Post (www.washingpost.com) Clay S. Felker, the pioneering editor who founded New York magazine and helped launch the new journalism of the 1960s, with its novelistic techniques and strong point of view, died July 1 at his Manhattan home at 82. He had battled throat cancer in recent years. "He had beaten cancer three times," his wife, writer Gail Sheehy, said yesterday. "He died at home in his sleep." By defining the form of the modern city magazine and encouraging writers to address modern life in a bold, vividly descriptive style, Mr. Felker was one of the most influential journalists of his time. His first triumphs came in the mid-1960s, when he was editor of New York, originally the Sunday magazine of the New York Herald Tribune newspaper. He gave writers such as Tom Wolfe and Jimmy Breslin the freedom to roam the city and write as they pleased, making the colorful supplement "the hippest Sunday reading in town," as Newsweek put it. When the newspaper folded in 1967, Mr. Felker used his severance pay to buy the magazine's name and secured more than $1 million in financing to rebuild New York as a glossy weekly publication. When it debuted on April 8, 1968, it was not an immediate success, but Mr. Felker soon found an innovative formula that would inspire imitators around the world. He combined in-depth articles on politics, crime and finance with lighter features on shopping, restaurants, reviews and listings that made [...]

6/30/2008 Cardiff, Wales press release www.foxbusiness.com At the third annual conference on Advanced Digital Technology for Head and Neck Reconstruction today, SensAble Technologies, Inc, a leading provider of touch-enabled modeling solutions and haptic devices, and Majenta Solutions, an Authorized Reseller in the UK, showcased innovative uses of the FreeForm 3D modeling system for quickly creating patient-specific cranial and maxillofacial implants and prostheses. These include: - Orbital (eye socket) soft-tissue implants created by Morriston Hospital in South Wales - Surgical guides and soft-tissue, extra-oral prosthetics for eyes, ears and noses created by the University of Wales Institute - Cardiff's National Centre for Product Design & Development Research (PDR) - Custom titanium dental onlays to correct mandibular asymmetry made by the University of Sheffield's School of Clinical Dentistry Patients with cancer, trauma and congenital conditions often need custom implants with irregular or organic shapes. Traditionally medical teams carved wax, clay or gypsum models of patient-specific implants and prostheses - a time-consuming process requiring multiple iterations. Today teams are sculpting the same complex forms digitally with SensAble's FreeForm 3D modeling system and delivering them faster, with more accuracy and reducing the number of patient fittings. "FreeForm saved us at least 30 percent of the time it would have taken us to create our soft-tissue orbital implant versus working in wax," said Peter Evans, consultant in maxillofacial prosthetics at Morriston Hospital. "We see such potential in FreeForm that we formed a collaboration called CARTIS to further explore how digital 3D design can aid in [...]

6/30/2008 Cardiff, Wales Madeleine Brindley Wales Online (www.walesonline.co.uk) THE leader of the team which carried out the world’s first face transplant will lecture at a major international medical conference to be held in Cardiff. Professor Bernard Devauchelle, from Amiens, France, made international headlines in 2005 when his team carried out the world’s first face transplant on a 40-year-old French woman, Isabelle Dinoire, who had been mauled by a dog. He will be among a number of prominent speakers at the International Conference on Advanced and Digital Technology in Head and Neck Reconstruction, which is being held in the UK for the first time. The conference, which runs until tomorrow, will look at the ways new technologies have advanced the field of reconstruction of the face. The conference has been organised by surgeons at Abertawe Bro Morgannwg University NHS Trust and from the University Hospital of Wales, in Cardiff. It comes as a series of major new developments have been made in the discipline at Morriston Hospital, in Swansea. The hospital is the first in Wales to install a £30,000 3D facial soft tissue scanner which can to link with other CT and MRI scanners to build up as complete a picture as possible of a patient’s face and aid surgeons in planning treatment. An operating theatre at Morriston has also been equipped with an electronic medical images system, allowing a complex software system to be operated as surgery is under way. This gives surgeons extra information to help fine-tune and [...]

6/30/2008 web-based article Bhuvanesh Singh and David G. Pfister Journal of Clinical Oncology, Vol 26, No 19 (July 1), 2008: pp. 3114-3116 Integrated chemotherapy and radiation therapy have become the standard of care for most patients with advanced stage laryngopharyngeal cancers. The concurrent administration of these two modalities is the approach recommended by most experts at present.1 This strategy achieves higher rates of locoregional control compared to when chemotherapy is given as induction treatment before, or as an adjuvant after, radiation therapy.2-6 However, the benefits from concomitant chemoradiotherapy treatment are tempered by higher rates of treatment-related sequelae, especially in the short term. This issue is of particular concern in patients that fail to respond and who have to endure the adverse effects of treatment. Based on observations that response to chemotherapy predicts radiation response, initial combined modality trials used response to induction chemotherapy to select patients for subsequent organ preservation treatment with definitive radiation, reserving laryngectomy for chemoresistant patients.5,6 However, with a shift to concomitant administration of chemotherapy and radiation therapy, the opportunity for treatment selection based on initial response was lost.3 To maximize the potential value of induction chemotherapy in terms of patient selection while minimizing the delay in the start of concomitant treatment, Urba et al has promulgated an approach in larynx cancer in which one cycle of neoadjuvant chemotherapy is delivered to select patients for subsequent concomitant chemoradiotherapy.7 Their published work suggests that this approach offers advantages for survival improvement over historical controls. The group recently expanded [...]