12/30/2005 London, UK Stig Bengmark, MD, Ph. D. Journal of Parenteral and Enteral Nutrition, Vol. 30, No. 1, 2006 45-51 Background: The world suffers a tsunami of chronic diseases, and a typhoon of acute illnesses, many of which are associated with the inappropriate or exaggerated activation of genes involved in inflammation. Finding therapeutic agents which can modulate the inflammatory reaction is the highest priority in medical research today. Drugs developed by the pharmaceutical industry have thus far been associated with toxicity and side effects, which is why natural substances are of increasing interest. Methods: A literature search (PubMed) showed almost 1500 papers dealing with curcumin, most from recent years. All available abstracts were read. Approximately 300 full papers were reviewed. Results: Curcumin, a component of turmeric, has been shown to be non-toxic, to have antioxidant activity, and to inhibit such mediators of inflammation as NFB, cyclooxygenase-2 (COX-2), lipooxygenase (LOX), and inducible nitric oxide synthase (iNOS). Significant preventive and/or curative effects have been observed in experimental animal models of a number of diseases, including arteriosclerosis, cancer, diabetes, respiratory, hepatic, pancreatic, intestinal and gastric diseases, neurodegenerative and eye diseases. Conclusions: Turmeric, an approved food additive, or its component curcumin, has shown surprisingly beneficial effects in experimental studies of acute and chronic diseases characterized by an exaggerated inflammatory reaction. There is ample evidence to support its clinical use, both as a prevention and a treatment. Several natural substances have greater antioxidant effects than conventional vitamins, including various polyphenols, flavonoids and curcumenoids. Natural substances [...]

12/27/2005 New York, NY Gina Kolata New York Times (www.nytimes.com) Jay Weinstein found out that he had chronic myelogenous leukemia in 1996, two weeks before his marriage. He was a New York City firefighter, and he thought his health was great. He learned that there was little hope for a cure. The one treatment that could save him was a bone marrow transplant, but that required a donor, and he did not have one. By 1999, his disease was nearing its final, fatal phase. He might have just weeks to live. Then, Mr. Weinstein had a stroke of luck. He managed to become one of the last patients to enroll in a preliminary study at the Oregon Health & Science University, testing an experimental drug. Mr. Weinstein is alive today and still taking the drug, now on the market as Gleevec. Its maker, Novartis, supplies it to him free because he participated in the clinical trial. Dr. Brian Druker, a Howard Hughes investigator at the university's Cancer Institute, who led the Gleevec study, sees Mr. Weinstein as a pioneer in a new frontier of science. His treatment was based not on blasting cancer cells with harsh chemotherapy or radiation but instead on using a sort of molecular razor to cut them out. That, Dr. Druker and others say, is the first fruit of a new understanding of cancer as a genetic disease. But if cancer is a genetic disease, it is like no other in medicine. With cancer, a person [...]

12/27/2005 Switzerland staff PharmaTimes (www.pharmatimes.com) Merck & Co has been granted approval in Switzerland to expand the uses of its Erbitux (cetuximab) product to include the treatment of patients with head and neck cancer. The approval by Swissmedic is the first in the world for this indication and means that Erbitux can be used alongside radiotherapy for patients with locally advanced squamous cell carcinoma of the head and neck (SCCHN) which has not yet spread to other parts of the body. The drug is already approved to treat metastatic colorectal cancer. The market for head and neck cancer treatments is underserved at present, with radiotherapy and older, more toxic chemotherapy drugs the only treatment options available. Analysts at Credit Suisse First Boston said earlier this year that adding the head and neck cancer indication to Erbitux could boost peak sales of the drug into the $1.5 billion dollar range. In Europe alone, around 100,800 people are diagnosed with head and neck cancer and almost 40,000 die from the disease every year, according to Merck. The registration is based upon results from a Phase III study which showed that Erbitux combined with radiotherapy improved median survival by 19.7 months compared with radiation alone. Erbitux was originated by biotechnology firm ImClone Systems and is sold in the USA by Bristol-Myers Squibb. ImClone filed for approval of Erbitux in head and neck cancer in the USA in August, and an application in the European Union is also under review.

12/27/2005 Austin, TX press release Chron.com (www.chron.com) Introgen Therapeutics, Inc. today announced its proposal to the U.S. Food and Drug Administration (FDA) to request permission to accelerate the initiation of an interim analysis of its randomized, controlled phase 3 ADVEXIN clinical trial data ahead of schedule. Introgen plans to begin the safety analysis of its randomized, controlled phase 3 clinical trial investigating ADVEXIN monotherapy for the control of recurrent, squamous cell carcinoma of the head and neck (SCCHN). The analysis of the phase 3 trial data is being initiated before the protocol-specified number of survival events has occurred. As part of Introgen's ongoing interactions with the FDA, the company also plans to submit additional information regarding the characteristics of patients most likely to benefit from ADVEXIN therapy based upon the drug's known molecular mechanisms of action and further analyses of ADVEXIN's phase 2 clinical trial data in head and neck cancer. Correlating the mechanisms of drug action with disease and patient characteristics facilitates selection of appropriate clinical trial endpoints and defines target patient populations most likely to obtain medical benefit. Introgen's senior vice president of Worldwide Commercialization, Dr. Max Talbott stated, "FDA has suggested that Introgen consider performing interim efficacy analyses of the Phase 3 clinical trial data in head and neck cancer. We are developing a plan for these analyses that is consistent with the FDA initiatives to expedite drug approvals based upon the identification of target patient populations most likely to benefit from therapy. We have compiled significant [...]

12/27/2005 New York, NY press release BusinessWire.com (home.businesswire.com) ImClone Systems Incorporated today issued the following statement regarding the approval by Swissmedic, the Swiss agency for therapeutic products, of ERBITUX(R) (Cetuximab), an IgG1 monoclonal antibody, in combination with radiation in the treatment of patients with previously untreated, advanced squamous cell carcinoma of the head and neck: "This approval gives doctors in Switzerland a first-of-its-kind treatment option in a tumor type that has seen no new modalities of treatment in thirty years. Swissmedic's decision is further validation of ERBITUX's role in neutralizing the EGF receptor, an important mediator of a tumor's survival and a receptor overexpressed in virtually all head and neck cancers. ImClone Systems and Merck KGaA will continue to study ERBITUX in head and neck cancer, including in combination with chemoradiation, and are optimistic about ERBITUX's future promise." Merck KGaA of Darmstadt, Germany, received the approval for ERBITUX from Swissmedic based on a phase III trial (IMCL-9815) that included 424 patients with advanced squamous cell carcinoma of the oropharynx (area of the throat at the back of the mouth), larynx (voice box) or hypopharynx (cavity at the back of the mouth that opens into the esophagus) that had spread through the head and neck region. Patients were randomized to receive radiation plus weekly ERBITUX therapy (n=211) or radiation alone (n=213) for six to seven weeks. This study and other ERBITUX study data are included in regulatory applications in various countries, including a supplemental Biologics License Application (sBLA) that was recently [...]

12/26/2005 Australia Elizabeth Gosch The Australian (www.theaustralian.news.com.au) Tobacco companies are side-stepping a recent agreement with the consumer watchdog by replacing the banned words "light" and "mild" with suggestive colours and numbers on cigarette packs. Anti-smoking groups accused tobacco companies yesterday of using dirty tricks to get around their agreement with the Australian Competition and Consumer Commission to remove the words "light" and "mild" from cigarette packets. A $9million television, print and radio advertising campaign warning consumers that low-tar cigarettes are not a healthier alternative began yesterday. The campaign is funded by fines levied on three of the country's major tobacco companies by the ACCC. "The television advertisements are very effective. They make it clear that any cigarette pack which is coloured differently or has numbers on it should not create the impression that those cigarettes are less harmful or less toxic," ACCC chairman Graeme Samuel said. From March, smokers will get another strong disincentive with graphic images of mouth cancer, gangrene and open heart surgery replacing written warnings on cigarette packs. The series of 14 colour photos includes images of a stroke-damaged brain, a blind eye and cancerous lungs. Earlier this year, the ACCC found Philip Morris, British American Tobacco and Imperial had been using misleading advertising. The companies agreed to remove the "light", "mild" and related descriptions and numbers from packaging, stop making health representations relating to those terms and contribute $9million in funding for a consumer education campaign. Action on Smoking and Health Australia chief executive Anne Jones [...]

12/24/2005 Houston, TX Renee Twombly Medical News Today (www.medicalnewstoday.com) It's a question that has emerged in the past 20 years, given advances in screening and early diagnosis, rapid developments in genetics and molecular biology, and progress in the treatment of early disease and in next-generation targeted therapies. And finding answers is one of the top goals of The University of Texas M. D. Anderson Cancer Center, which has one of the largest cancer prevention research programs in the world. M. D. Anderson was among the first to begin dedicated prevention research efforts in the late 1970s. A decade ago, nine faculty were working on 23 projects - a pursuit that was regarded as trend-setting at the time. The cancer center's focus on prevention has grown so much in recent years that the 48 faculty, involved in 140-plus research projects and clinical programs valued at more than $20 million in 2005 alone, just moved into the new Cancer Prevention Building. In addition to housing faculty offices, the building's Cancer Prevention Center and new Behavioral Research and Treatment Center provide advanced early detection and risk-reduction services and state-of-the-art biobehavioral and psychosocial research venues. These two centers involve only a sliver of the basic and applied research under way. In short, the researchers, physicians, nurses, employees and volunteers that staff this building aim to bring about a future that may some day be free of cancer. They also are the first to say that attaining this goal will not be easy; that prevention [...]

12/22/2005 Piscataway, NJ press release NPI Center (www.npicenter.com) Sabinsa Corporation's Curcumin C3 Complex(R) was named as the curcumin ingredient of choice by M.D. Anderson Cancer Center at the University of Texas. M.D. Anderson Cancer Center is currently conducting numerous studies to determine the effects of curcumin, an extract of turmeric root, in fighting against several types of cancers. "Although there are numerous companies that supply curcumin, consumers need to be careful that they are buying the genuine product, which is why we recommend Sabinsa Corporation," stated Dr. Bharat Aggarwal, professor of cancer research, M.D. Anderson Cancer Center. "A 'supercurcumin' is also available from Sabinsa that contains Bioperine(R), a standardized pepper extract, which enhances curcumin's effectiveness." According to researchers at M.D. Anderson Cancer Center, curcumin blocks a key biological pathway needed for development of melanoma and other cancers. Curcumin shuts down nuclear factor-kappa B (NF-kB), a powerful master switch known to regulate expression of more than 300 genes that promote an abnormal inflammatory response that leads to a variety of disorders, including arthritis and cancer. "We strive to provide safe and effective standardized ingredients of the highest quality to our customers around the world. It is gratifying to see the growing interest in research involving our patented Curcumin C3 Complex," stated Todd Norton, president, Sabinsa Corporation. Curcumin and its derivatives demethoxycurcumin and bisdemethoxycurcumin are collectively known as curcuminoids, and are recognized as one of the most promising food derived compounds in fighting cancer. Sabinsa Corporation provides an extract of turmeric standardized [...]

12/20/2005 Denmark JB Thomsen et al. Acta Radiol, October 1, 2005; 46(6): 569-75 Purpose: To validate lymphatic mapping combined with sentinel lymph node biopsy as a staging procedure, and to evaluate the possible clinical implications of added oblique lymphoscintigraphy and/or tomography and test the intra- and interobserver reproducibility of lymphoscintigraphy. Material and Methods: Forty patients (17 F and 23 M, aged 32-90) with 24 T1 and 16 T2 squamous cell carcinoma of the oral cavity. Planar lymphoscintigraphy, emission and transmission tomography were performed. Detection and excision of the sentinel nodes were guided by a gamma probe. The sentinel nodes were step-sectioning and stained with hematoxylin and eosin and cytokeratin (CK 1). Histology and follow-up were used as "gold standard". Tumor location, number of sentinel lymph nodes, metastasis, and recurrences were registered. Two observers evaluated the lymphoscintigraphic images to assess the inter-rater agreement. Results: Eleven (28%) patients were upstaged. The sentinel lymph node identification rate was 97.5%. Sentinel lymph node biopsy significantly differentiated between patients with or without lymph node metastasis (P = 0.001). Lymphatic mapping revealed 124 hotspots and 144 hot lymph nodes were removed by sentinel lymph node biopsy. Three patients developed a lymph node recurrence close to the primary tumor site during follow-up. Added oblique lymphoscintigraphic images and/or tomography revealed extra hotspots in 15/40 (38%) patients. In 4/40 (10%), extra contralateral hotspots were detected. Conclusion: Sentinel lymph node biopsy upstaged 28% of the patients. Sentinel lymph nodes close to the primary tumor were difficult to find. Added oblique [...]

12/20/2005 Charleston, SC Z. Rumboldt et al. Curr Treat Options Oncol, January 1, 2006; 7(1): 23-34 The goals of imaging in head and neck cancer are to establish tumor extent and size, to assess nodal disease, to evaluate for perineural tumor spread, and to distinguish recurrent tumor from post-treatment changes. MRI is the preferred modality for assessment of nasopharyngeal, sinonasal, and parotid tumors, because of better contrast resolution, high frequency of perineural spread, and less prominent motion artifacts. MRI is the best modality to delineate the extent of intraorbital and intracranial extension of malignant tumors. Tumors of the oropharynx, larynx, and hypopharynx are frequently primarily imaged with CT, which is less affected by breathing and swallowing artifacts. MRI is also the initial study of choice for tumors confined to the oral tongue, and possibly also for other oral cavity locations because MRI is superior in detection of tumor spread into the bone marrow. There is no clear advantage of CT or MRI for evaluation of nodal disease. Positron emission tomography (PET) is very sensitive for metastatic lymph nodes that are at least 8 mm in size and is the technique of choice in dubious cases. Imaging-guided biopsies are performed whenever needed. For imaging of treated head and neck cancer, PET scans have been found to generally offer higher sensitivity than MRI or CT. Combined PET/CT may be the modality of choice because it almost completely eliminates the false-positive and false-negative PET findings. Patients with head and neck cancer who are [...]