2009 – Page 19 – Oral Cancer News

BioVex Agrees SPA With the FDA for a Pivotal Phase III Study With OncoVEX (GM-CSF) in Head and Neck Cancer

Source: PR Newswire Author: Staff WOBURN, Mass., Sept. 15 /PRNewswire/ -- BioVex Inc, a biotechnology company developing clinical stage treatments for cancer and the prevention of infectious disease, announced today that the U.S. Food and Drug Administration (FDA) has approved the design of a single, pivotal, Phase III clinical trial evaluating its lead product, OncoVEX (GM-CSF), for the first-line treatment of patients with squamous cell cancer of the head and neck. The study is the second the Company has agreed with the FDA under the Special Protocol Assessment (SPA) procedure and highlights the broad potential utility of BioVex's first-in-class cancer destroying virus technology. The first SPA was in melanoma under which BioVex is currently conducting a pivotal Phase III trial. Patients with head and neck cancer often present with locally advanced, bulky disease that is too large, or too close, to vital organs to remove surgically. These patients typically undergo combination radiation and chemotherapy treatment, in some cases with additional surgery. Patients who present with tumor-containing lymph nodes are particularly difficult to treat and approximately half of these patients relapse within two years. Philip Astley-Sparke, President & CEO, for BioVex said: "The announcement of our second SPA governing a Phase III study demonstrates the breadth of the commercial opportunity with OncoVEX (GM-CSF). In addition to treating metastatic disease as is the intention in our ongoing Phase 3 study in melanoma, following multiple systemic responses in Phase II, OncoVEX (GM-CSF) also has considerable potential utility in treating discrete solid tumor masses [...]

Charlotte Parker2009-09-16T16:29:05-07:00September, 2009|Oral Cancer News|

Where cancer progress is rare, one man says no

Source: nytimes.com Author: Gardiner Harris Politicians and researchers have predicted for nearly four decades that a cure for cancer is near, but cancer death rates have hardly budged and most new cancer drugs cost a fortune while giving patients few, if any, added weeks of life. For this collective failure, the man atop the nation’s regulatory agency for new cancer drugs increasingly — and supporters say unfairly — gets the blame: Dr. Richard Pazdur. Patient advocates have called Dr. Pazdur, director of the Food and Drug Administration’s cancer drug office, a murderer, conservative pundits have vilified him as an obstructionist bureaucrat, and guards are now posted at the agency’s public cancer advisory meetings to protect him and other committee members. “The industry is not producing that many good drugs, so now they’re looking for scapegoats in Rick Pazdur and the F.D.A.,” said Ira S. Loss, who follows the drug industry for Washington Analysis, a service for investors. In 10 years at the Food and Drug Administration, Dr. Pazdur, 57, has helped to loosen approval standards for cancer medicines and made it easier for dying patients to get experimental drugs. But he demands that drug makers prove with near certainty that their products are beneficial, a requirement that he repeated at a public advisory hearing on Sept. 1 in the slow, loud tones of someone disciplining a dog. After he spoke, the committee of experts voted to reject both drugs. Critics say that Dr. Pazdur’s resolve has cost thousands of lives [...]

Oral Cancer Foundation News Team - A2009-09-16T05:02:16-07:00September, 2009|Oral Cancer News|

Going up in smoke

Source: www.abs-cbnnews.com (Philippines) Author: Adel Gabot Who would have thought graphic, disturbing pictures, like those showing a dead fetus lying amidst cigarette butts, or gangrenous feet, or ugly, bleeding mouth sores, or throats bulging with massive red tumors or black lung tissue would be so widely distributed, and even legally mandated? I’m talking about cigarette packaging, of course. Those of you smokers who travel have seen these pictures on cigarette packs abroad. In Singapore, Thailand, Malaysia, Australia, New Zealand, Brazil, everywhere. These caring and enlightened governments have long ago made it a law that cigarettes packaging must carry graphic images of diseases and the effects of tobacco on our health, in an aggressive effort to scare people off smoking. The more graphic the pictures, the better to convince people to kick the habit. Canada, which started doing this in 2000 with a picture of mouth cancer, is now contemplating upping the ante by putting the actual deathbed photos of anti-smoking activist Barb Tarbox, as she looked, emaciated, and withered just before her recent death from cancer. Their research has shown that the photos elicit an even more intense response from smokers than the usual diseased body parts. More recently, the United States, which had limited health warnings on cigarette packaging to a short, small text-only message from the Surgeon General on the side of the box, is now about to implement similar graphic pictorial warnings on 50% of the front and back of the pack. President Barack Obama, who is [...]

Oral Cancer Foundation News Team - A2009-09-16T04:52:36-07:00September, 2009|Oral Cancer News|

UCLA awarded Government grant to extended oral cancer research

Source: Privatemdlabs.com Author: Brendan Missett Funding made available from the Obama Administration's stimulus plan will assist the UCLA School of Dentistry in cancer research. The National Institutes of Health awarded more than $5 million to UCLA which will be used toward the construction of a state-of-the-art complex designed to expand the School of Dentistry's research on the detection and treatment of oral cancer. The building will be called the Yip Center for Oral/Head & Neck Oncology Research. In the past three years, the school was awarded close to $30 million in grants for oral cancer research. Construction plans for the complex, which is named after philanthropists Felix and Mildred Yip, have already begun. The construction is expected to conclude in 2013. No-Hee Park, dean of the UCLA School of Dentistry, commented, "This visionary funding will enable the dental school to become a nexus of multidisciplinary, collaborative research." She added that she hopes the school will become the "premier" oral cancer research program in the country. According to the Oral Cancer Foundation, oral cancer kills about one person every hour, and only half of oral cancer patients survive for more than 5 years after their diagnosis. The National Cancer Institute recommends oral cancer testing to detect the disease at an early, treatable stage.

Charlotte Parker2009-09-15T15:44:10-07:00September, 2009|OCF In The News, Oral Cancer News|

BioVex agrees SPA with the FDA for a pivotal phase III study with OncoVEX (GM-CSF) in head and neck cancer

Source: news.prnewswire.com Author: press release BioVex Inc, a biotechnology company developing clinical stage treatments for cancer and the prevention of infectious disease, announced today that the U.S. Food and Drug Administration (FDA) has approved the design of a single, pivotal, Phase III clinical trial evaluating its lead product, OncoVEX (GM-CSF), for the first-line treatment of patients with squamous cell cancer of the head and neck. The study is the second the Company has agreed with the FDA under the Special Protocol Assessment (SPA) procedure and highlights the broad potential utility of BioVex's first-in-class cancer destroying virus technology. The first SPA was in melanoma under which BioVex is currently conducting a pivotal Phase III trial. Patients with head and neck cancer often present with locally advanced, bulky disease that is too large, or too close, to vital organs to remove surgically. These patients typically undergo combination radiation and chemotherapy treatment, in some cases with additional surgery. Patients who present with tumor-containing lymph nodes are particularly difficult to treat and approximately half of these patients relapse within two years. Philip Astley-Sparke, President & CEO, for BioVex said: "The announcement of our second SPA governing a Phase III study demonstrates the breadth of the commercial opportunity with OncoVEX . In addition to treating metastatic disease as is the intention in our ongoing Phase 3 study in melanoma, following multiple systemic responses in Phase II, OncoVEX also has considerable potential utility in treating discrete solid tumor masses across multiple indications including those that are [...]

Oral Cancer Foundation News Team - A2009-09-15T14:20:04-07:00September, 2009|Oral Cancer News|

Some question benefit of costly treatments

Source: Indystar.com Author: John Russell Cancer doctors say thousands of dollars may buy little time When a cancer patient is facing a steep, painful decline, the high cost of drugs may seem worth every penny. But some cancer specialists are starting to wonder about the cost-effectiveness of some treatments and are raising pointed questions about Eli Lilly and Co.'s newest cancer drug, Erbitux. Treating a lung-cancer patient with Erbitux costs $80,000 for an 11-week regimen, according to a study published in the June issue of the Journal of the National Cancer Institute. Yet such treatment prolongs survival by 1.2 months, the study found. "Many Americans would not regard a 1.2-month survival advantage as significant progress," wrote the authors, Tito Fojo, an oncologist with the National Cancer Institute, and Christine Grady, a bioethicist at theNational Institutes of Health. The study's findings raise the question: How can the U.S. control ever-growing health costs, particularly at the end of life? When Lilly announced its acquisition of Erbitux last year, the drug maker said it planned to become "an oncology powerhouse." The Indianapolis-based company has two other cancer drugs, Gemzar and Alimta, each with sales of more than $1 billion last year. Some cancer specialists say the widespread use of expensive treatments is questionable. "Erbitux, which costs $10,000 a month for treatment, can lead to what might be described as a marginal benefit," said Dr. Paul Helft, an oncologist at theIndiana University Simon Cancer Center. Some oncologists use various lengths of treatment depending on the [...]

Charlotte Parker2009-09-14T09:56:42-07:00September, 2009|Oral Cancer News|

Hills attorney boasts ‘largest jury verdict’

Source: www.hometownlife.com Author: Stacy Jenkins It may be the largest jury verdict award for a dental malpractice lawsuit, but Michigan's tort laws prevent the $15 million award from becoming a reality. Farmington Hills attorney Robert Gittleman said he is “thrilled” by the $15 million verdict reached Aug. 27 by an Oakland County Circuit Court jury because “it sends a strong message.” But the tort laws, he says, are “ludicrous and unfair.” Under Michigan's tort laws, his client will receive $500,000 instead of the $15 million the jury thought she deserves. “It's not tort reform, it's tort deform,” he said. “It's an oppressive law that messes up the jury (process) because the jury speaks, then the judge has to (rule) something else.” Gittleman represented Herta Hopton, 61, of Novi, in the jury trial in Circuit Court Judge Steven Andrews' courtroom in August. Hopton, who was referred to board-certified oral surgeon Warren Vallerand, in Novi, had pain in her lower right jaw in 2005. She visited her general dentist at that time, and again in February 2006 when three lower teeth became loose in the area of the jaw pain. She was referred to a periodontist, who recommended the teeth be pulled and a bridge be inserted. A white lesion in her mouth at that time was considered to be “aspirin burn,” according to court documents. The lesion cleared up, but another surfaced in May 2006. Hopton was then referred to oral surgeon Vallerand for lesion evaluation and a possible biopsy. “His [...]

Oral Cancer Foundation News Team - A2009-09-14T06:58:22-07:00September, 2009|Oral Cancer News|

Hookah hang-ups: smoking shisha may not be has harmless as perceived

Source: Author: Angel Allen It’s a beautiful evening and you’re puffing smoke rings with your friends, but while the fruit punch taste you inhale may be sweet and relaxing, officials say it comes with the cloudy possibility of future illness. Hookahs are single or multiple stemmed water pipes used to smoke tobacco. They continue to be a popular fixture around the UA campus. But health officials say many students remain ignorant of the ill health effects of shisha, the flavored tobacco smoked in hookahs. A May report issued by the Journal of Adolescent Health said hookah use is growing among college students, despite growing consensus that it may be as dangerous as cigarettes. Hirbod Jalili, a Pima Community College computer sciences student from Iran, said he grew up smoking hookah, starting at age 14. In Iran, “there’s no age for it, anyone can do it. It’s a tradition,” he said. Usually families and friends smoke together as a relaxing hobby, Jalili said. Tea and dates are often served along with the hookah as complementary items. Hacène Chaouch, an optical engineering graduate student from Algeria, said, “We know it’s harmful and it’s not the reason we get together, but it’s something to do when we are together. It’s social.” Local café Espresso Art, 944 E. University Blvd., offers hookah smoking starting from noon outside and 6 p.m. inside until closing at midnight each evening. Owner Danny Mannheim said he enjoys offering an international feel to his café. Mannheim said his café [...]

Oral Cancer Foundation News Team - A2009-09-13T05:06:29-07:00September, 2009|Oral Cancer News|

Early postoperative Taxol® may improve outcomes in high-risk head and neck cancer

Source: professional.cancerconsultants.com Author: staff Researchers involved in the RTOG 0024 study have reported that the administration of early adjuvant Taxol® (paclitaxel) followed by concurrent chemoradiotherapy may improve local control and improve disease-free survival in patients with high-risk head and neck carcinoma. The details of this study appeared in the Journal of Clinical Oncology early online on August 31, 2009.[1] There have been several randomized and non-randomized clinical trials that suggest that the concomitant administration of platinum-based chemotherapy and radiotherapy (RT) is superior to RT alone for the treatment of patients with advanced head and neck cancer for local and regional control. Most, but not all, have also shown a survival advantage for combined treatment. An intergroup trial with participation of RTOG, ECOG, and SWOG compared post-operative radiotherapy alone or with concurrent Platinol® (cisplatin) for patients with high-risk head and neck cancer. This study showed that the addition of adjuvant Platinol decreased local recurrences but had no significant impact on metastatic disease or overall survival. An EORTC trial showed that the addition of Platinol to RT improved progression-free and overall survival by 10% and improved overall survival by the same degree. The current study (RTOG 0024) sought to improve the results of adjuvant chemoradiotherapy in high-risk head and neck cancer patients by administering Taxol postoperatively on weeks 2, 3, and 4 prior to RT. Taxol and Platinol were administered concomitantly with RT after week 4. This study was compared to the previous RTOG trial 9501, which administered Platinol alone with RT. [...]

Oral Cancer Foundation News Team - A2009-09-13T04:51:10-07:00September, 2009|Oral Cancer News|

FDA Panel OKs HPV Vaccine Gardasil for Boys

Source: WebMD Author: Miranda Hitti Sept. 9, 2009 -- An FDA advisory committee voted to recommend approval of the vaccine Gardasil for males ages 9 to 26 to prevent genital warts. Gardasil targets four strains of human papillomavirus, commonly called HPV. Males can carry HPV and transmit it sexually to their partners. HPV can cause genital warts and penile and anal cancer in men. Each year, about 200 out of 100,000 males are newly diagnosed with genital warts, according to background information cited by the FDA. Penile cancer and anal cancer are much rarer. Gardasil already has FDA approval for use in females ages 9 to 26. In females, HPV can cause cervical cancer. The FDA advisory committee ruled 7 to 0, with one abstaining vote, that Gardasil's clinical trial data support the vaccine's effectiveness at preventing genital warts in males ages 9 to 26. And in a 7 to 1 vote, the advisory committee ruled that the data show Gardasil to be safe for males in that age range. The FDA advisory committeereviewed three studies of Gardasil that together included more than 5,000 males ages 9 to 26 in various countries including the U.S. Participants got a total of three shots of Gardasil or a placebo spread over six months. They also got checkups and tests to check for HPV infection. Gardasil was 89% effective in preventing genital warts. The vaccine was less effective in participants who had already been exposed to HPV. No serious side effects were seen, [...]

Charlotte Parker2009-09-11T10:42:14-07:00September, 2009|Oral Cancer News|