Access Pharmaceuticals provides update on MuGard commercial launch in North America

Source: money.cnn.com Author: press release Access Pharmaceuticals, Inc., today provided an update on its North American commercial launch of MuGard, an FDA approved treatment for oral mucositis, a debilitating side effect of radiation treatment and chemotherapy. Access intends to commercially launch MuGard in North America in the first quarter of 2010. Key strategic items pertaining to the launch include: Manufacturing: Access is currently working with its contract liquid manufacturer, Accupac, on initial clinical and stability batches, and expects to have initial commercial quantities available in 1Q 2010. Reimbursement: Access is working with outside regulatory consultants in developing and finalizing its reimbursement strategy as it pertains to third-party payors and Medicare/Medicaid. Clinical: Consistent with strategies employed by its global marketing partners, Access is working with key opinion leaders to develop a strategy for post-approval studies if and as needed. Access believes that its approved label indication and directions for use supports positioning MuGard as a preventative for oral mucositis caused by radiation and chemotherapy treatments, and provides for expansion into treatment of all types of oral wounds including aphthous ulcers, canker sores and traumatic ulcers, such as those caused by oral surgery. Marketing/Sales: Access has signed a deal with iMedicor to support online eMarketing efforts and education of oncologists, radiation oncologist and support staff as it pertains to oral mucositis and MuGard specifically. Access intends to build a hybrid, dedicated salesforce with oncology supportive care experience. Co-Promotion: Access continues to seek potential co-promotion arrangements with pharmaceutical and biotechnology companies in the [...]

2009-11-11T14:29:14-07:00November, 2009|Oral Cancer News|

National Comprehensive Cancer Network receives research grant to evaluate pralatrexate in solid tumors and hematologic malignancies

Source; au.sys-con.com Author: PRNewswire press release The National Comprehensive Cancer Network (NCCN) has been awarded a research grant from Allos Therapeutics, Inc. to support clinical studies of pralatrexate (FOLOTYN(TM), Allos Therapeutics, Inc.) in the treatment of select hematologic malignancies and solid tumors. Pralatrexate was recently approved by the FDA to treat patients with relapsed or refractory peripheral T-cell lymphoma, a type of non-Hodgkin's lymphoma that is relatively uncommon, but particularly aggressive. Clinical trials supported by this grant will focus on evaluating innovative single agent and combination studies of pralatrexate in Burkitt's lymphoma, multiple myeloma, specific indolent lymphomas, ovarian cancer, head and neck cancer, prostate cancer, gastroesophageal cancer, and colorectal cancer. "NCCN is committed to enhancing cancer care by evaluating new agents such as pralatrexate to determine their full potential in treating several types of cancer," says William T. McGivney, Ph.D., Chief Executive Officer, NCCN. "Through this research grant from Allos Therapeutics, Inc., we are pleased to provide NCCN Member Institutions with an opportunity to take part in innovative cancer research with the hope that their work will ultimately benefit patients with cancer." Pralatrexate is a chemotherapy drug classified as an antifolate that works by interfering with the ability of cancer cells to divide, resulting in cell death. It is a targeted therapy that is designed to accumulate preferentially in cancer cells. "Our collaboration represents a unique opportunity to benefit from the research expertise of NCCN and the NCCN Member Institutions, as we explore the potential of investigator initiated clinical studies [...]

2009-11-11T09:03:52-07:00November, 2009|Oral Cancer News|

Intensity-modulated radiation offers treatment advantages over conventional therapy for head and neck cancer

Source: www.docguide.com Author: John Otrompke Patients treated with simultaneously integrated boost treatment using intensity-modulated radiation therapy (IMRT) experience better overall survival, disease-free survival, and local recurrence rates, as well as decreased dermatitis and better postoperative salivary function that those treated with conventional radiation. "IMRT treatment was described as 'boosted' because we use 2 different doses in the same patient, who gets a dose of 2.12 gy to 1 part of their anatomy, while another part gets 1.8 gy," said Sebastien Clavel, MD, University of Montreal, Montreal, Quebec, on November 3 at the American Society of Therapeutic Radiology and Oncology (ASTRO) 51st Annual Meeting. In the study, 249 patients with stage III and IV oropharyngeal carcinoma were treated between 2000 and 2007. Of these, 100 received IMRT, while 149 patients received conventional radiation therapy. After a 33-month median follow-up, 95.4% of those treated with IMRT were still alive, compared with 75.8% of those in the conventional arm. Disease-free survival was 89.3% for the IMRT group, compared with 71.6% in the conventional radiation arm. In addition, local control was 92.4% in the IMRT patients, compared with 85.3% in the conventional group. "With the old technique, the rays were shooting from both sides, whereas with IMRT, the rays come from all directions," said Dr. Clavel. "When using IMRT, we also always give them a 3-mm margin with the skin, both of which result in fewer cases of dermatitis." IMRT patients experienced a 20% decrease in dermatitis grades 3 and 4. "If we are [...]

2009-11-11T08:45:27-07:00November, 2009|Oral Cancer News|

Weekly radiation of more than 10 gy improves local control in head and neck cancer patients

Source: www.docguide.com Author: John Otrompke Patients with head and neck squamous cell carcinoma who receive an average weekly fractionated radiation dose of more than 10 gy experience significantly better local control at 2 years, unless they are receiving chemotherapy at the same time, according to a study presented here at the American Society of Therapeutic Radiology and Oncology (ASTRO) 51st Annual Meeting. "We're not seeing the benefit in those who also receive chemotherapy with the radiation," said Alek F. Dragovic, MD, Radiation Oncology, University of Alabama at Birmingham, Birmingham, Alabama. If they have low-stage cancer, they may not necessarily need chemotherapy along with radiation. Also, patients are often not healthy enough to receive chemotherapy if they can't tolerate the side effects, Dr. Dragovic explained in his presentation on November 3. In the study, 601 patients who received definitive radiotherapy were divided retrospectively into those who received more or less than an average weekly dose of 10 gy. Patients who received the traditional schedule of once per day made up 45.1% of the patient population, those who received concomitant boost radiation, in which patients get treated twice per day during the last 2 weeks of radiotherapy, were 17.6% of the population; while 17.5% were treated with simultaneous integrated boost, 15.1% received radiation twice daily, and other received other schedules. Overall, patients who received on average more than 10 gy per week experienced 77.4% local regional control at 2 years, compared with 71.4% who received less than 10 gy per week. For [...]

2009-11-11T07:50:14-07:00November, 2009|Oral Cancer News|

HPV vaccine clears viral infection and may reduce cancerous lesions

Source: www.newswise.com Author: staff Breakthrough study reports complete and partial remissions following vaccination A new vaccine designed to stimulate an immune response against a cancer-causing human papillomavirus (HPV-16) can eliminate chronic infection by the virus and may cause regression of precancerous genital lesions in women who receive the vaccine. According to a report published in the November 5 issue of the New England Journal of Medicine (2009;361:1838-47), the vaccine successfully induced HPV-specific immune responses in 100% of patients with advanced vulvar intraepithelial neoplasia (VIN3), a life-threatening disease that in the majority of cases results from HPV infection and for which there is as yet no satisfactory standard therapy. Among the women who participated in the study, the majority (79%) experienced measurable regression of their VIN3 lesions within 1 year of vaccination. Nine of the women (47%) experienced complete disappearance of lesions and were still symptom-free two years following vaccination. The virus was undetectable in four of five women whose disease had regressed completely after the first year. According to researchers who conducted the phase II study at the Leiden University Medical Center in Leiden, The Netherlands, spontaneous regression of HPV-16 positive VIN3 lesions is very rare, occurring in less than 1.5% of patients. The induction of HPV-specific T-cell immune responses following vaccination, and the researchers’ observation that stronger vaccine-induced immune responses correlated with better clinical outcome indicate that the vaccine is the most likely cause of the high response rate among the patients treated in the study. Unlike recently approved [...]

2009-11-10T20:37:37-07:00November, 2009|Oral Cancer News|

Report highlights cancer advances

Source: www.medpagetoday.com Author: Charles Bankhead, Staff Writer, MedPage Today As the war on cancer enters its fifth decade, 51 studies stood out as examples of progress that occurred in the past year, as determined by the American Society of Clinical Oncology (ASCO) and reported in "Clinical Cancer Advances 2009." Reflecting input from specialists throughout the field, the ASCO annual report highlights research developments for nine types of cancer, as well as cancer disparities, quality of life and quality of care, and cancer prevention and screening. "As this report demonstrates -- and as history shows -- investment in clinical cancer research pays off," ASCO president Douglas Blayney, MD, of the University of Michigan in Ann Arbor, said in a statement included in the report. "Since 1990, cancer mortality rates have declined by 15%. Today, two-thirds of patients survive at least five years after diagnosis, compared to just half of patients 40 years ago." "Thanks to basic research advances, we are entering an era of personalized cancer medicine, in which treatment is tailored to the unique genetics of the individual," Blayney added. The entire report appears online in the Journal of Clinical Oncology, but here is a summary of developments related to some of the most common cancers. In an attempt to provide context and a diversity of viewpoints, MedPage Today, in collaboration with ABC News, solicited comments from cancer specialists who were not involved in developing the ASCO publication. As appropriate, their views are included with the review of cancer research [...]

2009-11-10T08:08:06-07:00November, 2009|Oral Cancer News|

The oral cancer epidemic in central and eastern Europe

Source: Int J Cancer, October 30, 2009 Author: Werner Garavello et al. To monitor recent trends in oral and pharyngeal cancer mortality in 38 European countries, we analyzed data provided by the World Health Organization over the period 1975-2004. Joinpoint analysis was used to identify significant changes in trends. In the European Union (EU), male mortality rates rose by 2.1% per year between 1975 and 1984, by 1.0% between 1984 and 1993, and declined by 1.3% between 1993 and 2004, to reach an overall age-standardized rate of 6.1/100,000 in 2000-2004. Mortality rates were much lower in women, and the rate in the EU rose by 0.9% per year up to 2000, and levelled off to 1.1/100,000 in 2000-2004. In France and Italy - which had the highest rates in the past - male rates have steadily declined during the last two decades (annual percent change, APC=-4.8% in 1998-2004 in France, and -2.6% in 1986-2003 in Italy). Persisting rises were, however, observed in several central and eastern European countries, with exceedingly high rates in Hungary (21.1/100,000; APC=6.9% in 1975-1993 and 1.4% in 1993-2004) and Slovakia (16.9/100,000; APC=0.14% in 1992-2004). In middle aged (35 to 64) men, oral and pharyngeal cancer mortality rates in Hungary (55.2/100,000) and Slovakia (40.8/100,000) were comparable to lung cancer rates in several major European countries. The highest rates for women were in Hungary (3.3/100,000; APC=4.7% in 1975-2004) and Denmark (1.6/100,000; APC=1.3% in 1975-2001). Oral and pharyngeal cancer mortality essentially reflects the different patterns in tobacco smoking and [...]

2009-11-10T07:56:32-07:00November, 2009|Oral Cancer News|

Does green tea prevent cancer?

Source: www.ivanhoe.com Author: staff Evidence continues to brew about the protective effects of green tea against cancer, but scientists are still not sure the tea leaves reveal the answer. Vassiliki Papadimitrakopoulo, M.D., professor of medicine in the Department of Thoracic/Head and Neck Medical Oncology at the University of Texas M. D. Anderson Cancer Center, and colleagues tested 41 patients who took green tea extract orally for three months at three dose levels. Nearly 60 percent of patients with oral pre-malignant lesions, who were at the highest dose levels, displayed clinical response, compared with less than 20 percent among those taking placebo. Researchers also observed a trend toward improved histology, and a trend toward improvement in a handful of biomarkers that may be important in predicting cancer development. Patients were followed for 27.5 months, and at the end of the study period, 15 developed oral cancer. Although there was no difference in oral cancer development overall between those who took green tea extract and those who did not, patients who presented with mild to moderate dysplasia had a longer time to develop oral cancer if they took green tea extract. Although encouraged by the results, Dr. Papadimitrakopoulo cautioned against any recommendations that green tea could definitely prevent cancer. "This is a phase II study with a very limited number of patients who took what would be the equivalent of drinking eight to 10 cups of green tea every single day," Dr. Papadimitrakopoulo was quoted as saying. "We cannot with certainty claim [...]

2009-11-09T14:03:35-07:00November, 2009|Oral Cancer News|

Hookah myths go up in smoke

Source: Author: Kate Dopazo Students, university health officials discuss misconceptions about smoking hookah When Rajiv Ulpe, a public and community health master’s student, asked students to compare hookah to cigarettes Friday afternoon at a lecture on the campus, most attendees agreed hookah was a much healthier alternative to smoking cigarettes. “I don’t think you can get addicted to hookah,” Nick Patcella, a junior civil engineering major, said. “I think you can get addicted to the social aspect because it’s a fun activity, but not the hookah itself.” “People think it’s a lot less lethal than cigarettes," senior cell biology major Ray Gonzalez, added. "The water takes out more of the impurities.” But Ulpe said these are all common myths associated with hookah — a water pipe used to smoke tobacco through cooled water — adding that according to the Centers for Disease Control and Prevention, a typical hour-long hookah smoking session involves inhaling 100 to 200 times the volume of smoke inhaled in a single cigarette. During the discussion, nine undergraduate students between the ages of 18 and 22 were asked to discuss their attitudes toward hookah and what exactly they know about its effects. “Hookah is more natural than cigarettes and you smoke hookah less than cigarettes,” Patcella said. Ulpe and Public and Community Health professor Nancy Atkinson held the event to learn about students’ knowledge, attitudes and myths surrounding hookah use. The consensus of the group was that most students do not know the consequences of smoking hookah [...]

2009-11-09T13:59:18-07:00November, 2009|Oral Cancer News|

Dentists your first defence in fight against oral cancer

Source: Timescolonist Author: Johnathan Skuba In 2003, an estimated 3,100 Canadians were newly diagnosed with oral cancer. That same year, 1,090 people died of the disease. In the U.S., oral cancer kills roughly one person per hour, 24 hours a day. Of those newly diagnosed, only half will survive five years later, and this terrifying death rate has not declined for decades. Those statistics are frightening, but the good news is that early detection plays a major role in preventing or curing oral cancers. The first line of defence is the dentist. They are specifically trained to recognize even subtle changes in the mouth and take action. Pre-malignant lesions usually manifest as white patches (leukoplakias) that can look like small calluses. They could be benign and nothing but skin thickened by trauma or normal wear and tear of oral tissues. Of greater concern are spots that become ulcers, bleed, rapidly change appearance or that are obviously getting larger. Red patches (erythroplakia) should also be examined as they too could represent cancerous tissue. If any such spots are present and either enlarge or don't improve within 10-14 days, or if they disappear and then recur, patients are advised to see their dentists as soon as possible. Once in the chair, patients will find that dentists do not take chances, especially when the spots appear in areas where normal trauma is unlikely, such as the soft palate of the mouth or under the tongue. When such spots are seen, and particularly when [...]

2009-11-09T12:23:32-07:00November, 2009|OCF In The News, Oral Cancer News|
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