5/18/2005 Orlando, FL & Darmstadt, Germany PharmaLive (www.medadnews.com) Merck KGaA of Darmstadt, Germany, today announced its continued investment in innovative therapies in oncology, supported by data presented at the 41st annual meeting of the American Society of Clinical Oncology (ASCO). Merck KGaA, known for the first-in-class EGFR-targeted monoclonal antibody, Erbitux® (cetuximab) that works by blocking the epidermal growth factor receptor (EGFR) to inhibit tumor growth and spread, has ongoing active development programs with additional novel therapies that may offer new hope to people with cancer. “These are exciting times in oncology,” said Dr. Bernhard Ehmer, Vice President, Business Area Oncology, Merck KGaA. “With a better understanding of the growth and spread of tumors, we are able to develop treatments that target the cancer cells and give physicians and their patients additional options with which to fight cancer. We are particularly excited by Erbitux not only in the treatment of colorectal cancer but also in its potential in head and neck cancer and by BLP25 Liposome Vaccine (L-BLP25), which is showing impressive results in the treatment of non-small cell lung cancer. Furthermore, our humanized EGFR-targeting monoclonal antibody matuzumab is showing potential in several types of cancer.” Erbitux Consistent findings in clinical trials supports the use of Erbitux in different treatment settings, and several presentations at ASCO focused on the results of studies of Erbitux in the treatment of various stages of colorectal cancer, squamous cell carcinoma of the head and neck (SCCHN) and non-small cell lung cancer (NSCLC). Study results presented [...]

5/17/2005 Paris, France press release Business Wire (www.businesswire.com) BioAlliance Pharma, a biopharmaceutical company focused on the field of drug resistance, announced today that a randomized Phase III trial evaluating the Company's miconazole Lauriad(R) 50mg Bioadhesive Buccal Tablets in head and neck cancer patients suffering from oropharyngeal candidiasis following radiotherapy, demonstrated efficacy with 10 times less drug and on a more convenient schedule than the miconazole oral gel comparator. These results suggest definite potential for better compliance in treating oropharyngeal candidiasis in patients with altered mucosa and xerostomia. The study (Abstract #5527) of 306 patients conducted at 36 clinical sites in France and North Africa was presented at the 41st Annual Meeting of the American Society of Clinical Oncology (ASCO) in Orlando, Florida. "These results represent an important medical advance for the local treatment of oropharyngeal candidiasis," said Dominique Costantini, M.D., president and CEO of BioAlliance Pharma. "Our goal is to provide physicians with an effective option for local treatment of this fungal infection that obviates the need to prescribe systemic therapies due to its enhanced potential for improved patient compliance and avoidance of systemic drug-drug interaction and development of drug resistance." Study Objectives The main objective was to demonstrate that the efficacy of the miconazole Lauriad(R) 50mg Bioadhesive Buccal Tablet administered once daily for 14 days, was not inferior to that of miconazole oral gel 500mg delivered in 4 divided doses for 14 days. Secondary objectives were to compare other efficacy criteria at days 7 and 14, and the safety [...]

5/17/2005 New York, NY Nicholas Bakalar New York Times (www.nytimes.com) Infectious disease used to be a simple matter: this germ causes that illness. Doctors just had to find the germ, kill it, and cure the disease. But the old rules no longer apply. A report issued last month by the American Academy of Microbiology paints a much more complex picture of infectious disease. Germs, scientists are learning, are probably the cause of many illnesses that were never thought to be infectious, and determining exactly how a germ contributes to disease is no longer simple. The old rules date to 1883, when the German bacteriologist Robert Koch laid down three laws - now called Koch's postulates - that infectious disease specialists have used ever since to determine whether an organism causes a disease: The suspected germ must be consistently associated with the disease; it must be isolated from the sick person and cultured in the laboratory; and experimental inoculation with the organism must cause the symptoms of the disease to appear. In 1905, a fourth rule was added: The organism must be isolated again from the experimental infection. Using Koch's postulates as a starting point, scientists figured out the cause, prevention and treatment for one infectious disease after another. In the mid-20th century, some experts began to believe that infectious disease might be permanently conquered. But microbes have been found to metamorphose into new and more destructive forms, to jump from animals to humans, to hide where they are hard to [...]

5/17/2005 Mumbai, India Anand Giridharadas International Herald Tribune Asia-Pacific The way some tell it, there is nothing paan won't do. They say it is a stimulant, breath freshener and strengthener of gums. It raises sperm count and lowers blood pressure. It releases oxytocin, the love hormone, and blood chemicals believed by ancient Hindus to rouse motherly affection There is more. Paan ingredients are said to hone memory, ease depression and forestall aging. It is a cancer therapy that doubles as lipstick. Not bad for an egg-sized snack consisting of a betel-nut leaf draped around a polychrome blend of slaked lime, shredded betel nuts, tree-bark extract and rose-petal preserves. Every night in this vast subcontinent and across India's global diaspora, tens, maybe hundreds, of millions of Indians pop a paan. At its simplest, it offers both digestive penance for the sins of a too-heavy meal and a chemical boost to keep drooping eyelids aloft till bedtime. It is something like an antacid tablet and an shot of espresso rolled into one "There is an old relationship of man with stimulants: He has sought to be stimulated from anything which is organic around him, like tea leaves and coffee," said Mahesh Bhatt, a top Bollywood film director and a paan chewer. "That is an essential need that paan fulfills in the paan-chewing population of this country - that it gives them a kick. It is oral pleasure." But increasingly, despite that kick and ancient healers' view of it as a cure-all, paan [...]

5/17/2005 Toronto, Ontario, Canada press release Newswire Canada (www.newsire.ca) Viventia Biotech Inc. today announced that it disclosed updated clinical data for its anti-cancer therapeutic, Proxinium(TM) (VB4-845), in two poster presentations on Saturday, May 14th given at the 2005 American Society of Clinical Oncology's (ASCO) annual meeting in Orlando, Florida being held from May 13-17, 2005. Dr. Nick Glover, President and CEO of Viventia Biotech, commented: "In these poster presentations, we provided an update on previously disclosed clinical data demonstrating that Proxinium(TM) has a good safety profile and beyond this, that the drug can produce very encouraging efficacy results including a demonstrable survival benefit in patients with refractory head & neck cancer." The first poster presented by the Company (Abstract No. 5569) entitled "A Phase I study of VB4-845 in patients with advanced, recurrent head & neck cancer on a weekly dosing scheme," disclosed updated results from an exploratory Phase I efficacy trial using direct intratumoral injection of Proxinium(TM) as a monotherapy. A total of 20 patients were enrolled in the study and 18 were considered evaluable at the end of the trial. VB4-845 administered on a weekly basis for 4 weeks was safe and well tolerated. The maximum tolerated dose (MTD) on this schedule was determined to be 930 (micro) g/day. Preliminary results from this study were previously described in a press release dated March 29th, 2005. Although this study was primarily designed to evaluate safety and tolerability, clinical observations indicated that VB4-845 demonstrated promising anti-tumor responses against Ep-CAM-positive SCCHN [...]

5/17/2005 Toronto, Ontario, Canada press release Newswire Canada (www.newswire.ca) Patients being treated with high dose radiation for head and neck cancer in the morning have a lower risk of developing debilitating side effects than patients who receive treatment in the late afternoon, suggests new research by oncologists at the Toronto Sunnybrook Regional Cancer Centre, the comprehensive cancer program at Sunnybrook and Women's College Health Sciences Centre. Funded by the Canadian Cancer Society and the Canadian Institutes of Health Research, the clinical trial found a condition called mucositis was much less common in patients who received high-dose radiation treatment early in the day compared to the end of the afternoon. Mucositis is damage to the lining of the mouth and throat that is sometimes so severe that treatment must be stopped. The research presented yesterday at the American Society of Clinical Oncology Annual Meeting, is the first to show a link between circadian rhythms and the development of mucositis due to radiotherapy. The study is based on research lead by medical oncologist Dr. Georg Bjarnason from Sunnybrook & Women's who is internationally known for his research on circadian rhythms and cancer. "In a previous study on healthy volunteers, we discovered a variation in the cell division cycle of cells in the mouth over a 24-hour period. In the morning, the cells in the lining of the mouth are in a phase of cell division that is relatively resistant to radiotherapy, whereas in the afternoon these cells are in a phase that [...]

5/17/2005 Orlando, FL press release EurekAlert (www.eurekalert.com) Study shows RADPLAT treatment shows promise against tough-to-treat cancer Researchers studying an innovative treatment for advanced head-and-neck cancer, combining chemotherapy and radiation, report that about half of patients were still alive four years after treatment. Radiation Therapy Oncology Group physicians announced results from their phase II study at the American Society of Clinical Oncology annual meeting on May 14. The treatment, called RADPLAT, combines radiation and a platinum-based chemotherapy drug called cisplatin. What makes the treatment unique is that instead of providing chemotherapy intravenously, oncologists inject cisplatin through tiny catheters directly into the arteries that feed the tumor, sending the drug exactly where it is needed. "Our results were extremely encouraging," says study presenter Parvesh Kumar, M.D., professor and chair of radiation oncology at the Keck School of Medicine of the University of Southern California and USC/Norris Comprehensive Cancer Center. "The benefits seen in patients with advanced, inoperable disease were comparable to benefits seen with the same therapy in patients with earlier-stage disease. "Based on these favorable results, we should certainly consider a bigger phase III clinical trial for this technique in a wider, broader group of patients." Physicians at 11 university medical centers recruited 67 patients for the study, and performed the treatment in 61 patients. Patients had stage IV-T4 disease: Tumors were large and inoperable. Squamous cell carcinoma is difficult to treat successfully in this advanced stage. Tumor sites ranged from the mouth to the larynx. The oncologists inserted catheters into [...]

5/17/2005 Orlando, FL press release Business Wire (www.businesswire.com) OSI Pharmaceuticals provided a second informational update summarizing highlights from presentations on Tarceva(TM) (erlotinib) made at the 41st Annual Meeting of the American Society of Clinical Oncology (ASCO) being held from May 14-17 in Orlando, Fla. The presentations included data from two separate single-arm Phase II studies of monotherapy Tarceva in chemotherapy-naive or front-line non-small cell lung cancer patients. Both studies indicated encouraging indications of anti-tumor activity for monotherapy Tarceva in this setting. Another presentation based on data from the BR.21 study concluded that patients on Tarceva had slower deterioration of their disease-related symptoms of cough, dyspnea and pain and that these differences were clinically and statistically significant. Encouraging indications of anti-tumor activity were also reported in several Phase II studies outside of NSCLC including combination therapy data for Tarceva with Avastin in renal cell carcinoma, Tarceva with chemotherapy in head and neck cancer and monotherapy use of Tarceva in colorectal and hepatocellular cancer. Highlights included: Phase II Study of Combination Cisplatin, Docetaxel and Erlotinib in Patients with Metastatic/Recurrent Head and Neck Squamous Cell Carcinoma (HNSCC) - E.S. Kim (Abstract #5546) Encouraging preliminary data was presented from an ongoing Phase II trial combining Tarceva with cisplatinum and docetaxel in HNSCC. Results were reported for the 22 patients evaluable for response. Complete response was reported in 3 patients (13 percent), partial response was reported in 14 patients (64 percent) and 4 patients (18 percent) were reported having stable disease. Responses were documented using [...]

5/16/2005 Chicago, IL Reuters staff Reuters Alert Net (www.alertnet.org) Statin drugs commonly used to lower cholesterol and fight heart disease appear to cut the risk of pancreatic and throat cancer by more than half, a study said on Monday. It was the latest in a number of reports to attribute anti-cancer properties to statins, and comes after Saturday's release in Florida of a study involving 40,000 women that found the drugs lowered the risk of breast cancer by 51 percent. Earlier reports also have ascribed a protective effect to statins for prostate and colon cancers, though why they may limit tumor growth in both humans and test animals has not been clear. The latest finding "suggests that these compounds may have health benefits that extend well beyond the heart and may affect the entire body," said John Johanson, a physician at the University of Illinois. He made the comment in a report released at an annual meeting of gastrointestinal experts, where Monday's study from U.S. Veterans Administration doctors was presented. The study involved nearly half a million U.S. veterans, mostly men, under treatment from 1998 to 2004. One part of the study found that statins were associated with a 56 percent reduced incidence of esophageal cancer, after age, gender, smoking and alcohol use were taken into account. A second part of the study found a 59 percent reduced risk of pancreatic cancer after taking into account the same factors. "The results should be interpreted with caution," the study said, because [...]

5/15/2005 Atlanta, GA Medical News Staff Medical News Today (www.medicalnewstoday.com) Binding gold nanoparticles to a specific antibody for cancer cells could make cancer detection much easier, suggests research at the Georgia Institute of Technology and the University of California at San Francisco (UCSF). The report is published online as an ASAP article in the journal Nano Letters. “Gold nanoparticles are very good at scattering and absorbing light,” said Mostafa El-Sayed, director of the Laser Dyanamics Laboratory and chemistry professor at Georgia Tech. “We wanted to see if we could harness that scattering property in a living cell to make cancer detection easier. So far, the results are extremely promising.” Many cancer cells have a protein, known as Epidermal Growth Factor Receptor (EFGR), all over their surface, while healthy cells typically do not express the protein as strongly. By conjugating, or binding, the gold nanoparticles to an antibody for EFGR, suitably named anti-EFGR, researchers were able to get the nanoparticles to attach themselves to the cancer cells. “If you add this conjugated nanoparticle solution to healthy cells and cancerous cells and you look at the image, you can tell with a simple microscope that the whole cancer cell is shining,” said El-Sayed. “The healthy cell doesn't bind to the nanoparticles specifically, so you don't see where the cells are. With this technique, if you see a well defined cell glowing, that's cancer.” In the study, researchers found that the gold nanoparticles have 600 percent greater affinity for cancer cells than for [...]