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 [...]

12/19/2005 Philadelphia, PA Warren R. Froelich Medical News Today (www.medicalnewstoday.com) A vast code, invisible to the DNA sequencing effort that constituted the Human Genome Project, is rapidly being shown to play a direct role in human health. This "epigenome" - from the Greek epi, meaning "in addition to" - consists of chemical "amendments" that dangle like charms on a bracelet from the linear string of letters that spell out the genetic code. Now, an international group of 40 leading cancer scientists says the time is ripe to undertake a large-scale international "Human Epigenome Project" designed to map the chemical modifications to DNA that comprise the epigenetic code. Their proposal, "A Blueprint for a Human Epigenome Project" -- published in the December 15, 2005 issue of Cancer Research -- summarizes the findings of an AACR-sponsored workshop held June 15-18, 2005, in Lansdowne, Va. "Definition of the human epigenome and its application to developing diagnostic, prognostic and therapeutic tools will likely produce some of the earliest translational research benefits flowing from large-scale genome initiatives to the bedside," said Frank Rauscher, III, Ph.D., editor-in-chief of Cancer Research. "It is time to create a concerted international effort to unlock the epigenomic information stored in our genome and use it for the benefit of human health," he added. The new report spells out the needs, guidelines and expectations of a Human Epigenome Project (HEP), and describes the developing technologies that make the project currently feasible. "One of the most exciting points to emerge from the [...]

12/17/2005 Thiruvananthapuram, India staff New India Press (www.newindpress.com) The research team of the Regional Cancer Centre (RCC) and the Rajiv Gandhi Centre for Biotechnology, headed by Dr Ramdas and Dr M Radhakrishna Pillai, has developed a mouthwash for patients suffering from oral cancer. “Oral cancer patients suffer a lot after radiation treatment. The mouth gets burned and saliva formation comes down making the mouth dry. There will also be a lot of inflammation,'' said Dr Radhakrishna Pillai. The patients will have difficulty in swallowing and they have to suffer a lot of pain. “There have also been instances when we had to stop the radiation in between. This mouthwash that we have developed is meant for such patients. It will definitely reduce their agony,'' said Dr Pillai. One major advantage of this mouthwash is that it is inexpensive. While cancer-supporting care is very expensive, this mouthwash costs less than 1 Rupee. The mouthwash is non-toxic as it is herbal in origin. Developed from three plants, the combination mouthwash is awaiting a global patent for which the application has already been filed through the Council for Scientific and Industrial Research (CSIR). The formal clinical trials, randomised as well as multilocation trials, will begin as soon as the patent is granted. “Once it is available in the market, the cost of supporting care for oral cancer will drastically come down,'' said Dr Pillai. The mouthwash helps in controlling bacterial infection as well as blister-formation in the mouth. Saliva formation has also been [...]

12/16/2005 Houston, TX staff Newswise (www.newswise.com) Can most types of cancers be prevented? 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 [...]