Kepivance (palifermin) Receives Positive Regulatory Opinion for Approval in Europe

7/29/2005 Thousand Oaks, CA press release Business Wire (www.businesswire.com) Amgen today announced that the European Committee for Medicinal Products for Human Use (CHMP), which is the scientific advisory panel to the European Medicines Agency (EMEA), has issued a positive opinion to approve marketing authorization for Kepivance(TM) (palifermin) in the European Union (EU). The CHMP opinion recommends authorization of palifermin to decrease the incidence, duration and severity of oral mucositis (mouth sores) in patients with hematologic (blood) cancers undergoing myeloablative therapy associated with a high incidence of severe oral mucositis, and requiring autologus bone marrow transplant. "Before palifermin, the best we could hope for in managing oral mucositis was to control the patient's pain with narcotics and oral rinses," said Jean-Luc Harousseau, M.D., head of the department of clinical hematology in the University Hospital of Nantes and former palifermin investigator. "With the potential approval of palifermin, physicians may be able to help protect transplant patients with hematologic malignancies from severe oral mucositis and may decrease their pain and discomfort." In patients with oral mucositis, the cells lining the mouth and throat are damaged by the chemotherapy drugs and/or radiation used in cancer treatment. Oral mucositis can be extremely painful and can have a devastating impact on patients. In fact, oral mucositis has been rated as the most debilitating side effect by patients with blood cancers undergoing bone marrow transplantation. Patients suffering from these debilitating mouth sores may require longer hospitalization, high doses of narcotics, such as morphine, and intravenous feeding to [...]

2009-04-02T15:32:53-07:00July, 2005|Archive|

Molecular Targeting With Cancer Vaccines

7/29/2005 Seattle, WA Mary L. Disis Journal of Clinical Oncology, Vol 23, No 22 (August 1), 2005: pp. 4840-4841 The last decade has resulted in the identification of a multitude of tumor-associated antigens and the initiation of clinical trials to determine whether cancer patients can be vaccinated. In this issue of the Journal of Clinical Oncology, Carbone et al1 present an extensive analysis of the immunogenicity and potential clinical efficacy of vaccinating advanced-stage cancer patients against specific K-ras and p53 mutations present in their tumors. This report provides long-term follow-up after vaccination over a period of several years, so the length of time between initiation and publication of the trial allows evaluation of the data in the context of the evolution of more refined methods of vaccination. The authors also present data detailing the pitfalls of the clinical application of targeted therapy, which includes the need to evaluate large numbers of patients to find the few patients who may derive therapeutic benefit. Finally, the authors demonstrate an intriguing association between the development of an antigen-specific immune response and prolonged survival. The vaccination strategy used in the trial was to incubate mutated K-ras and p53 peptide sequences with peripheral-blood mononuclear cells obtained from each patient. Presumably, antigen-presenting cells present in the peripheral blood would uptake K-ras and p53 peptides, process the peptides, and present the fragments in the context of class I major histocompatibility complex molecules, resulting in the stimulation of antigen-specific cytotoxic CD8+ T cells. It has only been in [...]

2009-04-02T15:31:39-07:00July, 2005|Archive|

Tapping a Cure for Dry Mouth

7/27/2005 Tampa, FL Tania Hershman Business 2.0 (www.business2.com) What do you get when you cross a dentist with an engineer? A high-tech remedy for dry mouth. Granted, it's not much of a punch line, but it's also no joke. In fact, the dental implant developed by Saliwell Medical Systems -- an Israeli startup founded by dentist Andy Wolff and engineer Benzi Beiski -- could unlock a $2 billion market. Triggered by radiation therapy, blood-pressure medication, and autoimmune diseases, dry mouth, or xerostomia, interferes with swallowing, sleeping, and speech. But drugs to treat it often have debilitating side effects. Saliwell's implant, the Crown, is equipped with electrodes, sensors, and a 16-bit microprocessor. If the sensors detect dryness, the electrodes stimulate the lingual nerve to jump-start saliva flow. The company hopes to have the Crown on the market by 2006. If it does, Wolff and Beiski will pocket nearly all of the profits, thanks to the clever strategy they used to launch the company. Rather than relying on venture funding, the duo landed a $2 million European Union grant for medical R&D, which meant they didn't have to give up any equity -- a deal sweet enough to make any entrepreneur salivate.

2009-04-02T15:31:00-07:00July, 2005|Archive|

The role of the dental professional

7/26/2005 Patti DeGrangi, RDH, BS RDH Magazine, September 2005 Humble beginnings often wind their way down unexpected paths toward unthink-able destinations. Ribbons we wear, rib-bons on our cars, and wristbands have become not only methods to bring aware-ness of various cancers and causes; they have become a fad of nearly epic proportions. Discovering the history of the ribbon craze is tricky, with different groups and individuals taking credit. Some give credit to the black armbands worn in Victorian times or the yellow ribbons from the Tony Orlando song. But whatever the origination, these symbols can bring attention, understanding, and most importantly, funding to organizations and individuals struggling with disease. For several years, oral cancer awareness and screening has had a part in each program I give, for some very specific and personal reasons. Using my skills and intuition as a dental hygienist, I saw a suspicious area on a client. The client denied it, saying she wasn’t a smoker. The lesion was on the palate. The client said it was from eating taco chips. There was something about it that just didn’t resonate for me. I had to talk her into allowing a brush biopsy. The biopsy came back showing atypical cells; the scalpel biopsy showed early squamous cell carcinoma. The client was my sister. The good news was that we found it so early that the very early scalpel biopsy has thus far, after six years, seemed to have removed everything and there has been no recurrence. CDx Labs [...]

2008-07-09T20:54:18-07:00July, 2005|OCF In The News|

The role of the dental professional

7/26/2005 Patti DeGrangi, RDH, BS RDH September 2005 Humble beginnings often wind their way down unexpected paths toward unthink-able destinations. Ribbons we wear, rib-bons on our cars, and wristbands have become not only methods to bring aware-ness of various cancers and causes; they have become a fad of nearly epic proportions. Discovering the history of the ribbon craze is tricky, with different groups and individuals taking credit. Some give credit to the black armbands worn in Victorian times or the yellow ribbons from the Tony Orlando song. But whatever the origination, these symbols can bring attention, understanding, and most importantly, funding to organizations and individuals struggling with disease. For several years, oral cancer awareness and screening has had a part in each program I give, for some very specific and personal reasons. Using my skills and intuition as a dental hygienist, I saw a suspicious area on a client. The client denied it, saying she wasn’t a smoker. The lesion was on the palate. The client said it was from eating taco chips. There was something about it that just didn’t resonate for me. I had to talk her into allowing a brush biopsy. The biopsy came back showing atypical cells; the scalpel biopsy showed early squamous cell carcinoma. The client was my sister. The good news was that we found it so early that the very early scalpel biopsy has thus far, after six years, seemed to have removed everything and there has been no recurrence. CDx Labs (www.oralcdx.com) [...]

2009-04-02T15:30:28-07:00July, 2005|Archive|

Many Cancer Survivors Make Healthy Changes

7/26/2005 Jennifer Warner WebMD (www.webmd.com) Male, Older, and Less-Educated Patients Less Likely to Change Lifestyle After Cancer Cancer survivors often make healthy lifestyle changes after their cancer treatment, but a new study suggests many may not go far enough in adopting healthy habits. Researchers found up to 60% of cancer survivors follow a healthier diet after diagnosis and treatment, yet less than half are eating the recommended five or more servings of fruits and vegetables per day. The study also showed that about 70% of breast and prostate cancer survivors remain overweight or obese. There are almost 10 million cancer survivors in the U.S., and that number is expected to grow thanks to improvements in cancer diagnosis and treatment. For example, only about 50% of people diagnosed with cancer in 1971 were expected to be alive after five years, compared with 64% of those diagnosed with cancer today. Researchers say adopting healthy lifestyle changes is especially important for cancer survivors because they are at increased risk for second cancers as well as other diseases, such as osteoporosis, obesity, heart disease, and diabetes. A Healthier Life After Cancer? In their study, researchers reviewed 100 studies on cancer survivors to examine the impact of cancer diagnosis and treatment on lifestyle and behavior changes. The results appear in the Aug. 20 issue of the Journal of Clinical Oncology. Overall, they found that many cancer survivors adopt healthier behaviors, such as: 30%-60% eat a healthier diet. 46%-96% of smokers with tobacco-related cancers (lung, head, [...]

2009-04-02T15:19:44-07:00July, 2005|Archive|

What to Do With a Patient Who Smokes

7/26/2005 San Francisco, CA Steven A. Schroeder, MD JAMA. 2005;294:482-487 Despite the reality that smoking remains the most important preventable cause of death and disability, most clinicians underperform in helping smokers quit. Of the 46 million current smokers in the United States, 70% say they would like to quit, but only a small fraction are able to do so on their own because nicotine is so highly addictive. One third to one half of all smokers die prematurely. Reasons clinicians avoid helping smokers quit include time constraints, lack of expertise, lack of financial incentives, respect for a smoker’s privacy, fear that a negative message might lose customers, pessimism because most smokers are unable to quit, stigma, and clinicians being smokers. The gold standard for cessation treatment is the 5 A's (ask, advise, assess, assist, and arrange). Yet, only a minority of physicians know about these, and fewer put them to use. Acceptable shortcuts are asking, advising, and referring to a telephone "quit line" or an internal referral system. Successful treatment combines counseling with pharmacotherapy (nicotine replacement therapy with or without psychotropic medication such as bupropion). Nicotine replacement therapy comes in long-acting (patch) or short-acting (gum, lozenge, nasal spray, or inhaler) forms. Ways to counter clinicians’ pessimism about cessation include the knowledge that most smokers require multiple quit attempts before they succeed, that rigorous studies show long-term quit rates of 14% to 20%, with 1 report as high as 35%, that cessation rates for users of telephone quit lines and integrated [...]

2009-04-02T15:19:04-07:00July, 2005|Archive|

Combination Scanner and Detecting Spread, Recurrence of Head, Neck Cancer

7/26/2005 Chapel Hill, NC staff Newswise (www.newswise.com) A highly powerful scanner combining two state-of-the-art technologies – computed tomography (CT) and positron emission tomography (PET) – may detect the spread of head and neck cancer more accurately than other widely used imaging examinations. These findings, based on new research from the University of North Carolina at Chapel Hill School of Medicine, appear in the July issue of the medical journal The Laryngoscope. The whole-body PET/CT also is highly accurate for detecting head and neck cancer recurrence, the researchers said. “PET/CT is very helpful in determining where we should pinpoint our biopsies for recurrent disease,” said Dr. Carol Shores, assistant professor of otolaryngology/head and neck surgery at UNC and the report’s senior author. Shores is a member of the UNC Lineberger Comprehensive Cancer Center. “We can pick up cancer where we thought none existed. The new scans are so precise that in some cases cancer had been detected that probably would not have been through any other noninvasive imaging exam.” Since its development in 2000, PET/CT imaging has enabled collection of both anatomical and biological information during a single examination. The PET component picks up the metabolic signal of actively growing cancer cells in the body, and the CT provides a detailed picture of the internal anatomy that reveals the size and shape of abnormal cancerous growths. “Alone, each test has its limitations, but when the results of the scans are integrated they provide the most complete information on cancer location and [...]

2009-04-02T15:17:30-07:00July, 2005|Archive|

Cancer survivors initiate diet, exercise, and other beneficial lifestyle changes following a cancer diagnosis

7/25/2005 Durham, NC staff News-Mediacl.net (www.news-medical.net) An analysis of more than 100 studies of cancer survivors shows that many survivors initiate diet, exercise, and other beneficial lifestyle changes following a cancer diagnosis, but that those who are male, older, and less educated are less likely to adopt such changes. The term "cancer survivor" refers to a person who has been diagnosed with cancer. The review, which will be published online July 25 in the Journal of Clinical Oncology (JCO), says that a cancer diagnosis often prompts immediate changes in health behavior, including significant modifications in diet and physical activity. Using the MEDLINE and PubMed databases, lead author Wendy Demark-Wahnefried, PhD, RD, LDN, of Duke University Medical Center, and colleagues from the National Cancer Institute and Brown University identified and reviewed more than 100 studies of cancer survivors published since 1996. Researchers found that many survivors adopt healthier behaviors, such as following a healthier diet (30-60% of survivors), quitting smoking (46-96% of smokers with tobacco-related cancers, such as lung or head and neck), abstaining from alcohol (47-59% of those with head and neck cancers, which are closely linked to alcohol use), and regular physical activity (with up to 70% of survivors reporting 30 minutes of exercise a day, at least 5 days a week). Many of these changes should be beneficial because cancer survivors are a vulnerable population, at increased risk for second cancers, osteoporosis, obesity, cardiovascular disease, and diabetes. However, researchers noted that not all cancer patients adopted healthier behaviors, [...]

2009-04-02T15:16:55-07:00July, 2005|Archive|

Pathology Diagnosis: Do You Need a Second Opinion?

7/24/2005 Raleigh, NC staff Cancer Wire (July 2005 Edition) John, age eight, was diagnosed with an Anaplastic Astrocytoma (AA) which is an aggressive and often fatal brain tumor. He underwent brain surgery followed by high-dose chemotherapy and radiation therapy (equivalent to about 50,000 dental x-rays). These treatments are highly toxic to the developing brain of a child and, if he were to survive, his IQ and cognitive abilities would be seriously compromised. The family moved to a different state and took John to the local children’s hospital for follow-up care. There, the doctors reviewed John’s pathology slides. They discovered that John’s tumor was not an AA, but was benign. This diagnosis was subsequently confirmed by two other hospitals. John never needed chemotherapy or radiation therapy. Today, John’s IQ decreases at a rate of about 6 points a year as he suffers from the side-effects of a treatment he never needed. Pathology is the medical specialty that deals with the examination of tissues and cells under the microscope in order to arrive at a diagnosis. When it comes to cancer, a pathological diagnosis is the gold standard that indicates the presence or absence of cancer, the type of cancer, and its classification. Because therapeutic decisions are based on the presumed reliability of the pathology diagnosis, a misdiagnosis can result in unnecessary, harmful and aggressive therapy (like John’s story) or inadequate treatment. Unfortunately, medical studies over the last two decades have demonstrated that this gold standard is not consistently reliable. In fact, [...]

2009-04-02T15:16:21-07:00July, 2005|Archive|
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