US FDA approval for expanded use of Erbitux

Source: www.pharmabiz.com Author: staff The US Food and Drug Administration (FDA) has approved Erbitux (cetuximab), in combination with platinum-based chemotherapy with 5-fluorouracil (CT), for the first-line treatment of recurrent locoregional or metastatic squamous cell carcinoma of the head and neck (SCCHN). The approval, which is based on data from the landmark EXTREME (ErbituX in first-line Treatment of REcurrent or MEtastatic head & neck cancer) trial, makes Erbitux plus CT the first treatment regimen approved in 30 years with extended overall survival in patients with recurrent locoregional or metastatic SCCHN. Erbitux (cetuximab) is a monoclonal antibody (IgG1 Mab) designed to inhibit the function of a molecular structure expressed on the surface of normal and tumour cells called the epidermal growth factor receptor (EGFR, HER1, c-ErbB-1). In vitro assays and in vivo animal studies have shown that binding of ERBITU Erbitux GFR blocks phosphorylation and activation of receptor-associated kinases, resulting in induction of apoptosis (cell death), inhibition of cell growth, and decreased matrix metalloproteinase and vascular endothelial growth factor production. In vitro, Erbitux can mediate antibody-dependent cellular cytotoxicity (ADCC) against certain human tumor types. In vitro assays and in vivo animal studies have shown that Erbitux inhibits the growth and survival of tumour cells that express the EGFR. No anti-tumour effects of Erbitux were observed in human tumour xenografts lacking EGFR expression. EXTREME, which was previously published in the New England Journal of Medicine, was a phase III open label, randomized, multi-centre, controlled trial. This study was conducted outside the US by [...]

2011-11-09T06:24:41-07:00November, 2011|Oral Cancer News|

FDA Approves Cetuximab for Metastatic Head and Neck Cancer

Source: MedScape News Today The US Food and Drug Administration (FDA) has approved cetuximab (Erbitux, Bristol-Myers Squibb ) for use in combination with chemotherapy for the treatment of metastatic head and neck cancer. Data show that when combined with cisplatin-based chemotherapy, cetuximab improved overall survival, compared with chemotherapy alone. According to the researchers, this is the first time in 3 decades — since cisplatin was first used in head and neck cancer — that any regimen has improved on its success. The improved survival that was seen after cetuximab was added to the regimen (at a median of 2.7 months) is "therefore notable." Cetuximab was approved in the United States in 2004 for the treatment of epidermal growth-factor receptor–positive late-stage colon cancer in patients who no longer responded to chemotherapy. In 2006, it was approved for use in combination with radiation therapy for the treatment of locally or regionally advanced squamous cell carcinoma of the head and neck. This latest approval expands on that to cover metastatic head and neck cancer. The ability of cetuximab "to extend the lives of patients with head and neck cancer is an important tool for oncologists, who often rely on a multitreatment approach for patients," said Richard Pazdur, MD, director of the Office of Hematology and Oncology Drug Products in the FDA's Center for Drug Evaluation and Research, in a statement." Given the aggressive nature of head and neck cancers that cannot be treated with surgery and radiation, it is important that patients have [...]

2011-11-08T12:00:48-07:00November, 2011|Oral Cancer News|

EU grants orphan drug status to BioAlliance Pharma’s clonidine Lauriad

Source: www.pharmabiz.com Author: staff European Commission has granted orphan drug designation to BioAlliance Pharma SA's clonidine Lauriad for prevention of radiotherapy-induced oral mucositis in patients with head and neck cancer. Oral mucositis is a very frequent inflammation of the oral mucosa in head and neck cancer patients treated with radio- and chemotherapy (98,000 new patients estimated per year in Europe). Severe oral mucositis occurs in 60% of these patients and may induce intense oral pain and eating disability requiring artificial nutritional support. In 20 to 30% of cases, patients have to be hospitalized and the disease may result in a modification or a stop of the radiotherapy treatment in more than 10% of them. Radiotherapy-induced oral mucositis has currently no preventive cure. In Europe, the orphan designation is granted for medicinal products in diseases affecting less than 5/10,000 patients. This status permits to benefit from incentives related to the clinical development, thus enabling a faster registration, and an extra protection with a 10- year commercial exclusivity after market authorization. “The European designation for clonidine Lauriad as an orphan drug is key in shortening its development timeline, optimizing costs and reinforcing its future market access. Clonidine Lauriad, currently in Phase II clinical trial, is the second product from our “Orphan Oncology Products” portfolio to be granted orphan status in Europe. The portfolio comprises assets with high commercial potential and will leverage our future growth”, stated COO, Judith Greciet. Dedicated to cancer and supportive care treatment with a focus on resistance targeting [...]

2011-11-06T10:14:20-07:00November, 2011|Oral Cancer News|

Proper dental care for cancer patients: why it is important

Source: newcanaan.patch.com Author: Alan B. Sheiner DDS Common side effects from radiation therapy are not stressed enough in dental schools, but they can be managed and even prevented. A few weeks ago, I was contacted by a retired physician with whom I had not spoken for a number of years since he retired from practice to become a “gentleman farmer” in the country. While I was happy to hear from him, his news was not so good. He was calling because he had been treated for base of tongue cancer and his teeth were “coming apart”. His cancer treatment consisted of chemotherapy and radiation therapy. Unfortunately, he somehow “slipped through the cracks” and his oral cavity was now suffering from some of the side effects of the cancer therapy – fortunately he is currently cancer free. The oral cavity, one of the most complex and visible organ systems in the body, is invariably compromised as a result of treatment for head and neck cancer. Whether the malignancy is to be treated by surgery, radiation therapy, chemotherapy or a combination of these modalities, the function, if not also the form, of the oral cavity will be impacted. Aside from the obvious physical changes after cancer surgery to the head and neck region, there are issues which usually accompany radiation therapy to the head and neck region. There may be side effects from cancer therapy, some of which can be devastating, but preventable or manageable with proper precautions and care. The most [...]

Primary component in turmeric kicks off cancer-killing mechanisms in human saliva

Source: Eurekalert.org Curcumin, the main component in the spice turmeric, suppresses a cell signaling pathway that drives the growth of head and neck cancer, according to a pilot study using human saliva by researchers at UCLA's Jonsson Comprehensive Cancer Center. The inhibition of the cell signaling pathway also correlated with reduced expression of a number of pro-inflammatory cytokines, or signaling molecules, in the saliva that promote cancer growth, said Dr. Marilene Wang, a professor of head and neck surgery, senior author of the study and a Jonsson Cancer Center researcher. "This study shows that curcumin can work in the mouths of patients with head and neck malignancies and reduce activities that promote cancer growth," Wang said. "And it not only affected the cancer by inhibiting a critical cell signaling pathway, it also affected the saliva itself by reducing pro-inflammatory cytokines within the saliva." The study appears Sept. 15 in Clinical Cancer Research, a peer-reviewed journal of the American Association of Cancer Research. Turmeric is a naturally occurring spice widely used in South Asian and Middle Eastern cooking and has long been known to have medicinal properties, attributed to its anti-inflammatory effects. Previous studies have shown it can suppress the growth of certain cancers. In India, women for years have been using turmeric as an anti-aging agent rubbed into their skin, to treat cramps during menstruation and as a poultice on the skin to promote wound healing. A 2005 study by Wang and her team first showed that curcumin suppressed the [...]

2011-09-13T11:02:22-07:00September, 2011|Oral Cancer News|

New Study Shows that Fatty Acids Reduces Effectiveness of Chemotherapy

Source: Medicalexpress.com Researchers at University Medical Center Utrecht, the Netherlands, have discovered a substance that has an adverse effect on nearly all types of chemotherapy - making cancer cells insensitive to the treatment. Chemotherapy often loses effectiveness over time. It is often unclear how or why this happens. It now appears that chemotherapy is made ineffective by two types of fatty acid that are made by stem cells in the blood. Under the influence of cisplatin chemotherapy, the stem cells secrete these fatty acids that induce resistance to a broad spectrum of chemotherapies. These substances are referred to by researchers as 'PIFAs' which stands for platinum-induced fatty acids. Cisplatin is a type of chemotherapy that is widely used for the treatment of cancer, including cancer of the lungs and ovaries. Tumors under the skin The researchers studied the effect of PIFA's in mice and human cells. The mice studied had tumors under the skin. Under normal conditions, the tumors would decrease in size following the administration of chemotherapy. In the study, after administering the fatty acids to the mice, the tumors were found to be insensitive to chemotherapy. The fatty acids were isolated from the medium in which chemotherapy exposed stem cells were grown. But also stem cells in the blood of patients produce the fatty acids that desensitize tumors to chemotherapy. The fatty acids are also found in commercially-produced fish oil supplements containing omega-3 and omega-6 fatty acids as well as in some algae extracts. In the experiments conducted [...]

2011-09-13T10:50:40-07:00September, 2011|Oral Cancer News|

Chemotherapy breakthrough could dramatically reduce side-effects

Source: www.guardian.co.uk Author: Alok Jha, science correspondent The Guardian, Scientists have developed 'smart-bomb chemotherapy' which can isolate and destroy tumours without damaging healthy cells. Cancer researchers have developed a "smart bomb" treatment that can target tumours with drugs while leaving healthy body cells intact. The technique means that patients will suffer fewer side-effects from the toxic drugs used in chemotherapy. The side-effects of cancer therapy – including hair loss, nausea and suppression of the immune system – can be debilitating. In many cases, the effects of the drugs can contribute to the ultimate cause of death. In experiments on mice, Laurence Patterson of the University of Bradford found that he could localise a cancer drug to the site of tumours and thereby limit its toxic impact in the body. All the animals, which had been implanted with human cancer cells responded to the targeted treatment and saw their tumours shrink. In half the animals, the tumours disappeared altogether. Professor Patterson will present his work at the British Science Festival in Bradford on Monday. "We've got a sort of smart bomb that will only be active in the tumour and will not cause damage to normal tissue," he said. "It's a new cancer treatment that could be effective against pretty much all types of tumour – we've looked at colon, prostate, breast, lung and sarcoma so far, and all have responded very well to this treatment." The drug is based on a modified version of an existing drug called colchicine [see [...]

2011-09-12T20:07:02-07:00September, 2011|Oral Cancer News|

Fighting cancer with scorpions?

Source: www.foxnews.com Author: Chris Kilham In the fight against cancer, scientists and medical researchers around the world are developing new medicines from seemingly unlikely natural substances. Recent reported developments involve the use of a bacteria found in soil, a poison from a highly toxic scorpion, and the virus that causes herpes. All three demonstrate novel properties that may save lives in cases of otherwise hard to treat killer cancers. The use of bacteria for health and therapeutic purposes is in fact quite common. Various beneficial bacteria within the human digestive tract support digestion and elimination, help to detoxify the body, reduce the risk of some types of disease, and help to maintain overall health. These bacteria are widely available in supplements, and in various “live, active” yogurts. But ever since Edward Jenner developed the first vaccine (for cow pox) in 1796, bacteria have also played central roles in the development of vaccines against several diseases, including against tuberculosis, and even for plague, as in the case of Yersinia pestis. A team from North Carolina State University is developing an oral vaccine against deadly Anthrax poisoning, using Lactobacillus acidophilus, a common beneficial bacteria used to culture yogurt. Recent findings from Britain’s University of Nottingham show another ingenious use for bacteria, in the treatment of cancers. A team of scientists led by Professor Nigel Minton has reported that the bacteria Clostridium sporogenes a species widespread in nature, can be used as a vehicle to deliver anovel enzyme that activates a cancer drug [...]

2011-09-09T05:49:57-07:00September, 2011|Oral Cancer News|

New Research Proves Cancer-Fighting Virus can Kill Tumor Cells Without Harming Healthy Tissue

LOS ANGELES (Reuters) - Researchers have shown for the first time that a single intravenous infusion of a genetically engineered virus can home in on cancer, killing tumor cells in patients without harming healthy tissue. Scientists have been intrigued for decades with the idea of using viruses to alert the immune system to seek and destroy cancerous cells. That interest has taken off in recent years as advances in genetic engineering allow them to customize viruses that target tumors. The field received a boost in January when biotech giant Amgen Inc agreed to pay up to $1 billion for BioVex, the developer of experimental cancer-fighting virus OncoVex. But the only "oncolytic virus" so far approved by a regulatory agency is for treatment of head and neck cancer in China. In a study published in the journal Nature on Wednesday, scientists at institutions including the University of Ottawa and privately held biotech company Jennerex Inc said a small, early-stage trial of experimental viral therapy JX-954 found that it consistently infected tumors with only minimal and temporary side effects. The experimental virus will next be tested in a mid-stage trial of patients with liver cancer. "With chemotherapy you get drastic side effects," said Dr. John Bell, chief scientific officer at Jennerex and senior scientist at the Ottawa Hospital Research Institute. "Patients on this treatment only had 24-hour flu symptoms, and nothing after that." The trial, which involved 23 patients with various types of advanced cancer, was designed to assess the safety of [...]

2011-09-01T10:59:03-07:00September, 2011|Oral Cancer News|

New Study for Cancer Patients to Help Improve the Body’s Ability to Fight Illness

Source: Sign On San Diego A Santa Monica research center will test an experimental therapeutic filtering device being developed by Aethlon Medical on blood taken from cancer patients, the San Diego company said Wednesday. The study will target exosomes, bubbles of protein and RNA molecules excreted by cancerous cells that can block immune system cells from fighting the illness. By removing exosomes from circulating blood, Aethlon officials hope their device will improve the body's ability to fight cancer and the effectiveness of treatments such as chemotherapy. Blood taken from 25 patients with non-small cell lung cancer, prostate cancer, melanoma, sarcoma, and head and neck cancer will be circulated through the Hemopurifier device. In clinical use, blood would be filltered directly from the patient and returned to the body in a similar way to kidney dialysis. However, in the newly announced pre-clinical trial blood will not be returned to patients, Aethlon Chairman and Chief Executive Officer James Joyce said. "If we validate that our Hemopurifier is efficient in capturing exosomes, its possible that we could transition towards a human treatment study to evaluate exosome clearance from the entire circulatory system," he said. The test will be conducted by the Sarcoma Oncology Center, a nonprofit independent research institute focused on cancer therapy development. "This clinical histological study is a critical validation step in Aethlon's Hemopurifier strategy for cancer," said Dr. Sant Chawla, the trial's chief investigator. "The concept of 'subtractive therapy', eliminating a major mechanism of tumor progression and resistance to drugs, [...]

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