1/3/2006 Copenhagen, Denmark press release PRNewswire (www.prnewswire.com) Genmab A/S announced today that HuMax-EGFr has been designated a Fast Track Product by the US Food and Drug Administration (FDA). This designation covers patients with head and neck cancer who have previously failed standard therapies. Genmab presented positive results from the Phase I/II study of HuMax-EGFr in May 2005. Fast Track Product status allows the FDA to facilitate the development and expedite the review of a drug if it is intended for the treatment of a serious or life-threatening condition, and if it demonstrates the potential to address unmet medical needs for such a condition. This fast track designation gives Genmab the opportunity to submit a Biologics License Application (BLA) in sequential sections, and have these sections reviewed as they are submitted, thus saving development time. A BLA is the biologic products' equivalent to a New Drug Application and is the final stage before a drug is approved for the market by the FDA. Fast track status also opens the possibility for receiving a priority review or accelerated approval of the BLA where the review time would be halved to just 6 months. "We are very pleased that HuMax-EGFr has been designated a Fast Track product and is now poised to move forward to pivotal studies which we hope to begin this year," said Lisa N. Drakeman, Ph.D., Chief Executive Officer of Genmab. About HuMax-EGFr HuMax-EGFr is a fully human, high-affinity antibody targeted at the Epidermal Growth Factor receptor (EGFr). EGFr is [...]

1/3/2006 Baltimore, MD Britt C Reid, R Gary Rozier Oral Oncol, December 20, 2005 This study investigated whether receiving continuous regular care with the same primary care provider had an independent association with stage at diagnosis for head and neck cancers (HNCA) in a Medicare population. The study database (N=10,662) linked files from the Surveillance, Epidemiology, and End Results Program 1991-2000 for patients with cancers of the oral cavity, pharynx, and larynx with their files from the Center for Medicare and Medicaid Services Program. Continuity of care displayed a statistically significant independent association and dose-response pattern with stage at diagnosis when the provider was an internist but not a general or family physician. An independent statistically significant association between continuity of care with an internist and stage at diagnosis was found for oral cavity tumors (adjusted odds ratio [AOR]=0.85; 95%CI=0.73-0.99), but not pharyngeal tumors (AOR=1.02; 95%CI=0.74-1.41). Laryngeal tumors were borderline statistically significant at p-value=0.07 (AOR=0.84; 95%CI=0.69-1.02). Regular continuous care from the same primary care provider displayed an independent association with early diagnosis of HNCA when the anatomic site was the oral cavity and the provider was an internist, but not when the provider was a general or family physician. Primary care physicians including general/family physicians may represent a relevant group for encouraging increased opportunistic HNCA screening efforts among their patients. Authors affiliation: Department of Health Promotion and Policy, Health Services Research Program, Room 3A-08, School of Dentistry, University of Maryland

1/2/2006 London, England staff Daily Mail (www.dailymail.co.uk) We all know the scary headlines - smoking causes lung disease, stroke, oral cancer and heart disease. That's probably why you want to quit but you've known all those risks for months - if not years - already, so will that alone make a difference? The fact is smoking is responsible for a whole range of conditions - from extra wrinkles to fertility - that you probably didn't even know about. Here we highlight these lesser known facts in our print-and-keep guide. Have it by your side at all times and read any time you think of having a smoke. Hopefully it will give you the resolve you need... Smoking - the lesser known facts -Every cigarette takes 11 minutes off your life. -Smokers in their 40s have as many facial wrinkles as non-smokers in their 60s. -In Britain, one person is diagnosed with lung cancer - the cancer most commonly associated with smoking - every 15 minutes. -114,000 people die every year from smoking. That's 312 every day. -Smoking gives you yellow teeth, bad breath and hollow cheeks from repeated sucking on cigarettes. -Around half of all regular smokers will eventually be killed by their habit. -Female smokers have a 30 per cent lower fertility rate than non-smokers. -Male smokers are 50 per cent more likely to be impotent. -Around 450 children start smoking every day. -Men who smoke around their pregnant partner can significantly harm their unborn child. -Women who smoke [...]

1/2/2006 California Christian Nordqvist Medical News Today (www.medicalnewstoday.com) If you want to lower your chances of developing cancer you should increase your intake of vitamin D, say researchers from the University of California. High vitamin D intake is associated with significantly lower risks of developing cancer of the colon, ovary and breast, say the researchers. The team, led by Dr C Garland, looked at 63 different studies dating from 1966 to 2004. Their conclusion is that the link is too strong to ignore. They even went as far as to say that nothing else protects you from cancer so effectively. You can read about this study in the American Journal of Public Health. The researchers say an enormous number of cancers can be attributed to not enough vitamin D. The best source of vitamin D is sunlight. If you do not have access to sunlight all year round, as is the case in many northern countries, the researchers advise taking a supplement - raising your intake to 1000 IUs (international units) per day.

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 [...]