Gene therapy finds welcoming environment in China

3/1/2006 Beijing, China Hepeng Jia [email protected] Are China's regulations too lax? China in November became the first country to have approved two drugs based on gene therapy. The approvals have fueled quick growth in the field, but they may be a sign that China's drug regulation is too lax, experts caution. China's State Food and Drug Administration in October 2003 approved Gendicine to treat head and neck cancers. The drug uses an adenovirus to deliver the tumor suppressor gene p53 into tumor cells. Ins November 2005, the agency approved Shanghai Sunway Biotech's H101, also an adenovirus, which targets cancer cells that lack p53. More than 50% of all cancers have abnormal expression of p53 (Oncology 13, 148–154; 1999). In the West, the approach to gene therapy has been cautious since the death in 1999 of 18-year-old Jesse Gelsinger in a gene therapy trial at the University of Pennsylvania. More recently, French researchers used the technique to treat ten children with the so-called 'bubble boy' disease, but that trial was put on hold in 2003 after two of the children developed leukemia. In China, however, both the government and the public have embraced the technology. The success of the two approved products has boosted the number of gene therapy trials in China from 5 in late 2003 to 19 in 2006. "The huge numbers of highly cooperative patients, the low cost for research and clinical trials and the positive support from the government has enabled China to lead the world in [...]

2009-04-12T09:23:29-07:00March, 2006|Archive|

Subcutaneous Amifostine Feasible During Radiotherapy for Head and Neck Cancer

3/1/2006 New York, NY staff Cancerpage.com The use of subcutaneous amifostine to reduce the toxic effects of radiation therapy and chemotherapy is feasible in patients with head and neck cancer, Swiss physicians report. However, nausea and vomiting and hypotension are relatively common adverse events associated with the drug. Amifostine (Ethyol; Essex-Chemie AG, Lucerne, Switzerland) is an organic thiophosphate that protects normal tissues from free radicals produced by radiation therapy or chemotherapy. It is FDA approved as an intravenously administered drug, but subcutaneous administration is believed to have less toxic effects. Dr. Mahmut Ozsahin and colleagues at Centre Hospitalier Universitaire Vaudois in Lausanne retrospectively evaluated 33 consecutive patients treated with accelerated concomitant-boost radiation therapy, 26 of whom also received cisplatin alone or cisplatin plus fluorouracil. The parotid glands were included in the planning radiation therapy volume. According to their report in the Archives of Otolaryngology Head and Neck Surgery for February, the patients received a 200-mg dose of the oral anti-emetic dolasetron mesylate 1 to 2 hours prior to amifostine treatment. Amifostine 500 mg was injected subcutaneously into the abdomen 15 to 30 minutes prior to radiation therapy. Fifteen patients appeared to be tolerant to amifostine, whereas 11 discontinued its use because of nausea and vomiting and 6 discontinued because of hypotension. Acute effects of treatment included grades 1 to 3 dysphagia, mucositis and skin erythema. Late toxic effects included grade 2 or higher xerostomia in 8 of 19 patients who received at least 20 amifostine injections and in 9 of [...]

2009-04-12T09:22:52-07:00March, 2006|Archive|

FDA Approves First Head & Neck Cancer Treatment in 45 Years Data Shows Treatment with Erbitux Extends Survival

3/1/2006 Washington, D.C. press release US Food and Drug Administration (www.fda.gov) The Food and Drug Administration (FDA) today announced the approval of Erbitux (cetuximab) for use in combination with radiation therapy to treat patients with squamous cell cancer of the head and neck (SCCHN) that can not be removed by surgery (unresectable SCCHN). This is the first drug approved for head and neck cancer that has shown a survival benefit in this population. Erbitux was also approved today for use alone (monotherapy) to treat patients whose head and neck cancer has spread (metastasized) despite the use of standard chemotherapy. "Patients suffering from all forms of cancer have a common goal – to treat the disease and prolong life," said Steven Galson, MD, Director of FDA's Center for Drug Evaluation and Research. "We consider this approval an important advance in the treatment of head and neck cancer because it has been shown to help some patients live longer. The approval of Erbitux monotherapy to shrink tumors in patients with metastatic disease who no longer respond to other forms of treatment is also important. Patients need as many effective treatment options as possible." Erbitux, which received a priority review, is the first drug approved to treat head and neck cancer since methotrexate became available in the 1950s. Approval of Erbitux in combination with radiation therapy was based on a study that showed it prolonged survival by 20 months compared to treatment with radiation alone. Approval of Erbitux monotherapy was based on evidence [...]

2009-04-12T09:22:02-07:00March, 2006|Archive|
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