FDA accepts priority review for new indication of Erbitux – update

Source: www.rttnews.com Author: staff Imclone Systems Inc. and Bristol-Myers Squibb Co. announced that the supplemental biological license application seeking expanded approval of Erbitux for first-line treatment of patients with recurrent or metastatic squamous cell carcinoma of the head and neck has been accepted for priority review by the U.S. Food and Drug Administration. Priority review implies that the FDA will review the application in six months. Erbitux is marketed by ImClone and Bristol-Myers Squibb in the U.S. and by German drug and chemical maker Merck KGaA outside the U.S. Bristol-Myers holds 61% of the North American sales rights to Erbitux, while Merck KGaA owns 90% of the drug's international distribution rights. Under the existing agreement with Bristol-Myers, ImClone receives a distribution fee based on a flat rate of 39% of net sales of Erbitux in North America. The companies had sought expanded approval for Erbitux based on data from the randomized Phase 3 EXTREME (ERBITUX in first-line Treatment of REcurrent or MEtastatic head and neck cancer) study1 investigating the efficacy of Erbitux in combination with platinum-based chemotherapy in the first-line treatment of patients with recurrent or metastatic squamous cell carcinoma of the head and neck. According to the study, which was conducted by Merck KGaA, Erbitux, in combination with platinum-based chemotherapy, resulted in a statistically significant improvement in median overall survival time compared with chemotherapy alone. If approved, metastatic squamous cell carcinoma will be the third U.S. indication for Erbitux in head and neck cancer. Erbitux was initially approved to [...]

2008-11-06T19:54:40-07:00November, 2008|Oral Cancer News|

VELscope system featured on “The Doctors” television series

Source: www.dentaleconomics.com Author:  staff LED Dental has announced that its VELscope Oral Cancer Screening System was featured on "The Doctors", a television program syndicated throughout the U.S. and Canada by CBS Television Distribution. The VELscope system received exposure in a segment focusing on the link between oral sex and oral cancer. The VELscope system was brought to the attention of "The Doctors" producers by Dr. Bill Dorfman, a frequent guest on the show and the cofounder of Discus Dental. Dr. Dorfman was also the featured dentist on "Extreme Makeover", a reality TV series on ABC. "The producers asked me what new oral cancer detection technologies the public needs to know about, and the first thing that came to mind was the VELscope," said Dr. Dorfman. "Now that we understand that oral cancer can be caused not just by tobacco and heavy drinking, but also by exposure to the sexually-transmitted human papilloma virus, dental practices need to take the lead in giving thorough oral cancer exams to all of their adult patients at least once a year." When Dr. Dorfman first became aware of the link between HPV and oral cancer, he began using an oral cancer screening technology that required rinsing with a vinegar-based solution and the use of messy blue dies. "Neither my patients nor I liked that technology, so I started to search for an alternative that was simpler, faster and less invasive, and that's when I discovered the VELscope system," said Dr. Dorfman. "Plus, in addition to [...]

2008-11-05T08:22:26-07:00November, 2008|Oral Cancer News|

Gardasil Vaccine honoured with International Galien Prize for pharmaceutical research

Source: www.medicalnewstoday.com Author: staff Gardasil®, the four-type (6,11,16,18) human papillomavirus (HPV) vaccine, has been awarded the 2008 International Galien Prize, a prestigious award for recognising and promoting significant advances in pharmaceutical research which is considered the pharmaceutical industry equivalent of the Nobel Prize. "It is gratifying to be part of the transformation of scientific breakthrough into actual benefits for people's health," says Didier Hoch, President of Sanofi Pasteur MSD. "Only 30 years after the discovery that HPV can cause cervical cancer and many other diseases we hold today a vaccine in our hands that can save lives and prevent the suffering of thousands and millions of women. This is unprecedented progress in medical and pharmaceutical research." From 2006 to 2008, Gardasil® has won national Galien Prizes in Belgium, France, Netherlands, Switzerland, the US and the UK (the two HPV vaccines currently licensed for use in the UK were jointly awarded the Galien prize in the palace of Westminster, in September 2008). Additionally, Gardasil® has garnered a number of other prizes, including the 2006 Scrip Award by the British pharmaceutical newsletter Scrip for "Best new biological product" and 2007 Medec Prize by the French general practitioners for "Medicine of the year." During the 1970s, Professor Harald zur Hausen, the Co-Laureate of this year's Nobel Prize in Physiology or Medicine, postulated the role of HPV in causing cervical cancer. He pursued this idea for more than 10 years by searching for different HPV types, which culminated in the discovery in 1983 of [...]

2008-11-04T13:40:33-07:00November, 2008|Oral Cancer News|

Oncolytics reports positive results from phase I/II cancer studies

Source: www.pharmaceutical-business-review.com Author: staff Oncolytics Biotech has announced positive interim results in its Phase I and Phase II UK combination Reolysin and paclitaxel/carboplatin clinical trials for patients with advanced cancers. Four of the responding patients continue on study, while a fifth patient is too early to evaluate for response, the company said. These results appear to confirm preclinical evidence of synergy for Reolysin and platinum/taxane combinations. A US Phase II trial has now been opened in this patient population utilizing this regimen. The Phase I trial has two components. The first is an open-label, dose- escalating, non-randomized study of Reolysin given intravenously to patients with paclitaxel and carboplatin every three weeks. In this portion of the trial, standard dosages of paclitaxel and carboplatin are delivered to patients with escalating dosages of Reolysin intravenously. The second component of the trial includes the enrollment of a further nine patients at the top dose of Reolysin in combination with a standard dosage of paclitaxel and carboplatin. Eligible patients include those who have been diagnosed with advanced or metastatic solid tumors such as melanoma, lung and ovarian that are refractory (have not responded) to standard therapy or for which no curative standard therapy exists. The Phase II trial is a 14-patient, single arm, open-label, dose-targeted, non-randomized trial of Reolysin given intravenously in combination with a standard dosage of paclitaxel and carboplatin. Eligible patients include those with advanced or metastatic head and neck cancers that are refractory to standard therapy or for which no curative [...]

2008-11-04T13:40:52-07:00November, 2008|Oral Cancer News|

Patient perception of risk factors in head and neck cancer

Source: Head Neck, October 28, 2008 Author: Leeor Sommer et al. Background: A previous study at our institution noted that only 15% of newly diagnosed patients with oral cancer could identify smoking or alcohol abuse as major risk factors for the development of their cancer. The objective of this study was to determine the effectiveness of a simple educational intervention in 189 consecutively identified patients with head and neck malignancy. Methods: Patients were interviewed prior to and immediately following reading a written educational pamphlet. The patients were then interviewed 5 weeks later to determine longer-term recall. Recall success was correlated to patient demographic parameters including level of education, occupation, sex, age, and place of residence. Results: Immediate recall success increased, on average, 27% from preintervention knowledge, with the largest increase for the risk factor of alcohol abuse. Five-week postintervention recall success decreased on average 10.5% for all risk factors with the largest decrease being seen for smokeless tobacco use (12%). The immediate and 5-week recall success increases were both statistically significant when compared to the preintervention recall success (p

2008-11-03T09:56:33-07:00November, 2008|Oral Cancer News|

Survival after surgical resection of pulmonary metastases and second primary squamous cell lung carcinomas in head and neck cancer

Source: Head Neck, October 28, 2008 Authors: Thomas W Geurts et al. Background: Patients with head and neck squamous cell carcinoma (HNSCC) are at risk for developing both pulmonary metastasis and second primary lung cancer (SPLC). The objective of this study was to determine survival characteristics of patients with pulmonary lesions after curative treatment for HNSCC. Methods: Lung resection or biopsy specimens of 36 patients, curatively treated for HNSCC between 1978 and 2002, were defined as second primary squamous cell lung cancer or metastasis by loss of heterozygosity (LOH analysis). Twenty-two of them underwent surgical resection. Survival characteristics were estimated using Kaplan-Meier analysis according to the LOH characterization. Results: The number of resected lung lesions ranged from 1 to 3. Median overall survival after lung surgery was 23.1 months for SPLC (n = 14) and 25.1 months for lung metastases (n = 8). Fourteen patients, SPLC (n = 6) and metastases (n = 8), did not undergo surgical resection, and their median overall survival was 3.7 and 4.4 months, respectively. Conclusion: Survival after resection of metachronic lung lesions following curative treatment of HNSSC is similar for lesions characterized as second primary squamous cell lung cancer and those characterized as metastases. Authors: Thomas W Geurts, Alfons J M Balm, Marie-Louise F van Velthuysen, Harm van Tinteren, Jacobus A Burgers, Nico van Zandwijk, and Houke M Klomp Authors' affiliation: Department of ORL, Academic Medical Center, Amsterdam, The Netherlands

2008-11-03T09:49:47-07:00November, 2008|Oral Cancer News|

Mouthwash and oral cancer risk: an update

Source: Oral Oncol, October 24, 2008 Author: Carlo La Vecchia The possible relationship between mouthwash use and oral cancer risk has been the subject of at least 10 case-control studies published over the last three decades. Three of these reported relative risks above unity and seven no consistent association. Only a few studies, moreover, included information on different types of mouthwash, and addressed the issue of alcohol-containing mouthwash. Thus, critical review of published data revealed that a link between mouthwash use, specifically alcohol-containing mouthwash, and oral cancers is not supported by epidemiological evidence. Author's affiliation: Istituto di Ricerche Farmacologiche "Mario Negri" Milano e Istituto di Statistica Medica e Biometria "G.A. Maccacaro", Universit degli Studi di Milano, Via Giuseppe La Masa 19, 20156 Milano, Italy

2008-11-03T09:44:40-07:00November, 2008|Oral Cancer News|

Cranberry and grape seed extracts inhibit the proliferative phenotype of oral squamous cell carcinomas

Source: Evid. Based Complement. Altern. Med., July 23, 2008 Authors: Kourt Chatelain et al. Proanthocyanidins, compounds highly concentrated in dietary fruits, such as cranberries and grapes, demonstrate significant cancer prevention potential against many types of cancer. The objective of this study was to evaluate cranberry and grape seed extracts to quantitate and compare their anti-proliferative effects on the most common type of oral cancer, oral squamous cell carcinoma. Using two well-characterized oral squamous cell carcinoma cell lines, CAL27 and SCC25, assays were performed to evaluate the effects of cranberry and grape seed extract on phenotypic behaviors of these oral cancers. The proliferation of both oral cancer cell lines was significantly inhibited by the administration of cranberry and grape seed extracts, in a dose-dependent manner. In addition, key regulators of apoptosis, caspase-2 and caspase-8, were concomitantly up-regulated by these treatments. However, cranberry and grape seed extracts elicited differential effects on cell adhesion, cell morphology, and cell cycle regulatory pathways. This study represents one of the first comparative investigations of cranberry and grape seed extracts and their anti-proliferative effects on oral cancers. Previous findings using purified proanthocyanidin from grape seed extract demonstrated more prominent growth inhibition, as well as apoptosis-inducing, properties on CAL27 cells. These observations provide evidence that cranberry and grape seed extracts not only inhibit oral cancer proliferation but also that the mechanism of this inhibition may function by triggering key apoptotic regulators in these cell lines. This information will be of benefit to researchers interested in elucidating which dietary [...]

2008-11-03T09:42:11-07:00November, 2008|Oral Cancer News|

Microvascular free tissue transfer for tongue reconstruction after hemiglossectomy: a functional assessment of radial forearm versus anterolateral thigh flap

Source: J Oral Maxillofac Surg, November 1, 2008; 66(11): 2270-5 Authors: JC de Vicente et al. Purpose: The purpose of this study was to evaluate tongue function and donor site morbidity in patients with oral cancer surgically treated and reconstructed with radial or anterolateral thigh free flaps. Patients and Methds: Twenty patients underwent primary reconstruction after hemiglossectomy between January 2002 and June 2004. Ten patients were reconstructed using a free forearm flap and the remaining with an anterolateral thigh flap. Eight patients on each group underwent postoperative radiotherapy (average, 60 Gy). All of them were followed postoperatively to determine after 6 months their functional outcome as it related to speech, deglutition, tongue mobility, and donor site morbidity. The intelligibility, deglutition, and tongue mobility were each scored on a scale ranging from 1 to 7 by an independent investigator. Data were analyzed by the 2-tail Mann-Whitney U test. Results: No differences in mean speech intelligibility, tongue mobility, or deglutition mean scores were seen between radial forearm flap and anterolateral thigh flap (P > .05). In all anterolateral thigh flap-treated cases, the donor site was closed directly and no complications were seen. However, in all forearm flaps donor site closure was carried out with skin grafts and dorsal forearm splinting was applied for 1 week postoperatively. In 4 cases a partial skin graft failure was observed and donor sites healed for second intention. Conclusion: Anterolateral thigh flap, with its versatility in design, long pedicle with a suitable vessel diameter, and low donor [...]

2008-11-03T09:37:01-07:00November, 2008|Oral Cancer News|

Inspiring words from Roger Ebert

Source: New Wanderings of Dr Ben (drben54.blogspot.com) Author: Roger Ebert Blind people develop a more acute sense of hearing. Deaf people can better notice events on the periphery, and comprehend the quick movements of lips and sign language. What about people who lose the ability to speak? We expand other ways of communicating. There are three ways I can "speak." I can print notes. I can type on my laptop, and a built-in voice says them aloud. I can use my own pidgin sign language, combining waving, pointing, shrugging, slapping my forehead, tracing letters on my palm, mime, charades, and more uses of "thumbs up" and "thumbs down" than I ever dreamed of. Another path is open to me in the age of the internet. I can talk with new friends all over the world. Writing has always been second nature to me, as satisfying in a different way as speaking. Maybe because I was an only child with lots of solitary time, I always felt the need to write, and read. I was editor of my grade school, high school and college newspapers. I published the "Washington Street News" with a primitive Hectograph system when I was 9 or 10. I was a full-time newspaper sports writer and reporter (not an intern) when I was 16. I am a quick writer. It flows conversationally. I know I could become fluent in American Sign Language, but the problem is, I need another person who speaks ASL. Selfishly, at this stage [...]

2008-11-03T09:29:45-07:00November, 2008|Oral Cancer News|
Go to Top