4/29/2006 London, UK Tom Neilson Pharmaceutical Business Review Online (www.pharmaceutical-business-review.com) AstraZeneca is to pay $200 million for rights to co-promote in the US Abraxane, a breast cancer drug developed by Abraxis BioScience. Meanwhile, the Anglo-Swedish pharmaceutical company's branded anesthetic and analgesic products have been acquired by Abraxis for $350 million. Abraxane, approved by the FDA in January 2005, achieved sales of $134 million in its first 11 months on the market. The drug is currently in various stages of development for the treatment of a number of other cancers including first-line metastatic breast and non-small cell lung, adjuvant breast, neo-adjuvant breast, malignant melanoma, ovarian, prostate, pancreatic, gastric, and head and neck cancers. The anesthetic and analgesic products acquired by Abraxis encompass over 100 dosage forms and include the leading branded anesthetic agent, Diprivan, and a proprietary Naropin, as well as a comprehensive suite of local anesthetics including EMLA (eutectic mixture of lidocaine and prilocaine), Xylocaine, Polocaine, Nesacaine, Sensorcaine, and Astramorph. "This deal gives AstraZeneca access to the key US chemotherapy market. Abraxane brings significant benefits to cancer patients over existing therapies and complements and extends our oncology product portfolio in the US," said Tony Zook, president and CEO of AstraZeneca US. "At the same time Abraxis BioScience is acquiring a strong anesthetic and analgesic portfolio which enhances their market leading injectable drug portfolio in the US."
4/29/2006 Mumbai, India staff MoneyControl.com Scientists in this brand new facility built by Biocon are an excited lot. That’s because Biocon's collaborator, CIMAB has just received the marketing approval for a revolutionary treatment for head and neck cancer. The fast track approvals are obtained for select countries like Columbia, China, Cuba and Argentina. The intravenous injectible drug coded H-R3 is a high-end biotech discovery that effectively blocks the epidermal growth factor receptors, a substance that is responsible for the growth of cancer cells. With almost 600 patients clearing the safety and efficacy data, this drug may see quick acceptance among patients with head and neck cancer. With more marketing approvals for the drug expected from European regulatory agencies soon, Biocon chairperson Kiran Mazumdar Shaw expects due marketing permissions from India too. The pricing, she says, will be affordable to the Indian population. Biocon scientists say that the drug has significant advantages over its rivals in terms of localisation on points, where the cancer cell density is high. However, with global majors like Genentech working on more sophisticated monoclonal antibodies, this appears to be an exciting opportunities. Biocon may soon become the first ever Indian company to have its own molecule in the global market.
Phase III Trial of an Emulsion Containing Trolamine for the Prevention of Radiation Dermatitis in Patients With Advanced Squamous Cell Carcinoma of the Head and Neck: Results of Radiation Therapy Oncology Group Trial 99-13
4/29/2006 Alexandria, VA Elizabeth A. Elliott et al. Journal of Clinical Oncology, Vol 24, No 13 (May 1), 2006: pp. 2092-2097 Purpose: This multicentered phase III trial was designed to compare an emulsion containing trolamine against the usual supportive care within each participating institution for patients with head and neck cancer undergoing radiation therapy. Patients and Methods: Patients with biopsy-proven squamous cell carcinoma of the oral cavity, oropharynx, hypopharynx, or larynx were randomly assigned to one of the following treatments: prophylactic trolamine emulsion, interventional trolamine emulsion, or declared institutional preference. The primary outcome was the reduction in grade 2 or higher skin toxicity, as per National Cancer Institute Common Toxicity Criteria version 2.0. Secondary outcomes included patient-reported quality of life (QOL). Results: From October 2000 to April 2002, 547 patients from 51 institutions were entered onto the trial. The average age was 59 years. Patients were predominately male (79%) and most continued to use tobacco products (52%). The rates of grade 2 or higher radiation dermatitis were 79%, 77%, and 79% in the prophylactic, interventional, and institutional preference arms of the study, respectively. No significant differences in QOL were found. Conclusion: The results of this trial demonstrate no advantage for the use of trolamine in reducing the incidence of grade 2 or higher radiation dermatitis or improving patient-reported QOL. The use of 15 different local standards of care highlights the need to continue research that will result in evidence-based recommendations to reduce the burden of radiation dermatitis. Authors: Elizabeth A. [...]
4/27/2006 San Mateo, CA staff ProgressiveU (www.progressiveu.org) The American Cancer Society says that every year in the United States, an estimated 3,700 women die of cervical cancer. Around the world, it is nearer to 270,000. According to the national Cancer Institute, Human Papillomaviruses (HPV's) "are the major cause of cervical cancer." In addition to this, they may cause other cancers. HPVs are now recognized as the major cause of cervical cancer. Studies also suggest that HPVs may play a role in cancers of the anus, vulva, vagina and some cancers of the oropharynx (the middle part of the throat that includes the soft palate, the base of the tongue and the tonsils). The National Cancer Institute also says that there is no cure for HPV infection - but that soon will not be true. You see, they have come out with a vaccine to eliminate HPV. The tests are nearly complete, and we may see the HPV vaccine on the market soon. From myDNA: The human papillomavirus (HPV)vaccine, Cervarix, has passed another hurdle. The latest study shows the medication protects women against HPV strains that cause up to 70 percent of all cervical cancers for at least a four-year period. [...] Cervarix protects against four strains of HPV that cause nearly all cervical cancers. It was found to be 100 percent effective against HPV strains 16 and 18, nearly 100 percent effective agianst HPV 45, and 50 percent effective against HPV 31. This vaccine can cut the number of cervical [...]
4/27/2006 New York, NY staff ABC News Health (www.abcnews.go.com) After Bruce Paltrow died in 2002, his wife, Blythe Danner, began fighting to raise awareness about head and neck cancer, which is diagnosed in 40,000 Americans every year and kills 11,000. "It means a lot to get the word out," Danner said. "It's a very unrecognized cancer." Paltrow was first diagnosed with cancer in the fall of 1998. He had been hoarse for months but had refused to go to the doctor. By the time he went, the cancer was in stage IV. "Because it was hidden way back in [his] throat, it was hard to detect," Danner said. "Stage I or II, he'd still be with us, I think." Regular dental checkups are important to early detection, because dentists often see the first signs of the disease, like unusual white spots on the gums or jaws. There are particular warning signs of head and neck cancer: Persistent sore throat and hoarseness Lingering pain in the mouth An unhealed lump on the mouth or neck Ear pain on one side only Sinuses that don't clear Paltrow underwent six weeks of radiation therapy, and he went into remission for four years. Then, in October 2002, he flew to Italy for his daughter Gwyneth Paltrow's 30th birthday. Friends discovered him in his room after the celebration throwing up blood. Gwyneth forced him to go to the hospital, where doctors discovered that his cancer had returned. He died before any other family member could [...]
18F-FDG PET/CT for Detecting Nodal Metastases in Patients with Oral Cancer Staged N0 by Clinical Examination and CT/MRI
4/27/2006 New York, NY Heiko Schöder et al. Journal of Nuclear Medicine Vol. 47 No. 5 755-762 Introduction: 18F-FDG PET has a high accuracy in staging head and neck cancer, but its role in patients with clinically and radiographically negative necks (N0) is less clear. In particular, the value of combined PET/CT has not been determined in this group of patients. Methods: In a prospective study, 31 patients with oral cancer and no evidence of lymph node metastases by clinical examination or CT/MRI underwent 18F-FDG PET/CT before elective neck dissection. PET/CT findings were recorded by neck side (left or right) and lymph node level. PET/CT findings were compared with histopathology of dissected nodes, which was the standard of reference. Results: Elective neck dissections (26 unilateral, 5 bilateral; a total of 36 neck sides), involving 142 nodal levels, were performed. Only 13 of 765 dissected lymph nodes harbored metastases. Histopathology revealed nodal metastases in 9 of 36 neck sides and 9 of 142 nodal levels. PET was TP in 6 nodal levels (6 neck sides), false-negative in 3 levels (3 neck sides), true-negative in 127 levels (23 neck sides), and false-positive in 6 levels (4 neck sides). The 3 false-negative findings occurred in metastases smaller than 3 mm or because of inability to distinguish between primary tumor and adjacent metastasis. TP and false-positive nodes exhibited similar standardized uptakes (4.8 ± 1.1 vs. 4.2 ± 1.0; P = not significant). Sensitivity and specificity were 67% and 85% on the basis of neck [...]
4/27/2006 Louisville, KY Laura Ungar The Courier-Journal (courier-journal.com) University of Louisville researcher leads campaign An apple a day may be a good thing, but a University of Louisville researcher argues that berries could be the real key to staving off cancer. Ramesh Gupta is leading a research effort that has shown certain berries may help protect against two of the nation's most deadly cancers: breast cancer and lung cancer. "We've been told we need to eat more fruits and vegetables," said Gupta, who is based at the James Graham Brown Cancer Center. "But berries certainly seem to come to the top of the list. " Gupta, who presented his breast-cancer findings to the American Association of Cancer Researchers in Washington, D.C., this month, found that eating antioxidant-rich blueberries and black raspberries reduced the size of breast tumors by 60 percent to 70 percent among rats exposed to estrogen. His lung-cancer research, given at an earlier meeting of the association, showed that a mixture of four berries -- strawberries, blueberries, black raspberries and blackberries -- reduced the incidence and number of lung tumors by 30 percent to 35 percent in mice exposed to cigarette smoke. He is planning human tests in the next two years. The research provides hope to people such as 71-year-old Harvey Plaschke of Louisville, whose wife, Amparo, died of lung cancer three years ago, at age 68. A nonsmoker, she had suffered pneumonia twice since 2000, then developed a persistent cough. She died shortly before their 40th [...]
Cytokinetics Announces Clinical Trials Data to be Presented at the 2006 Annual Meeting of The American Society of Clinical Oncology
4/25/2006 San Francisco, CA press release prnewsire.com Cytokinetics, Incorporated announced today that five abstracts summarizing data from clinical trials conducted by GlaxoSmithKline (GSK) or the National Cancer Institute (NCI) evaluating ispinesib (SB-715992) or SB- 743921 will be presented at the 2006 Annual Meeting of the American Society of Clinical Oncology (ASCO) in Atlanta, Georgia. Ispinesib and SB-743921 are both novel, chemically distinct, small molecule inhibitors of kinesin spindle protein (KSP), a mitotic kinesin essential for proper cell division. Both drug candidates have arisen from a broad strategic collaboration between Cytokinetics and GSK to discover, develop and commercialize novel small molecule therapeutics targeting human mitotic kinesins for applications in the treatment of cancer and other diseases. Abstract: A Phase II Study of SB-715992 (Ispinesib) in Patients with Recurrent and/or Metastatic Head and Neck Squamous Cell Carcinoma (RMHNSC). Abstract will be published in the ASCO 2006 Annual Meeting Proceedings. About Ispinesib Ispinesib is a novel small molecule inhibitor of Kinesin Spindle Protein (KSP), a mitotic kinesin protein essential for proper cell division. Ispinesib is the first drug candidate in clinical development that has arisen from a broad strategic collaboration between Cytokinetics and GSK to discover, develop and commercialize novel small molecule therapeutics targeting human mitotic kinesins for applications in the treatment of cancer and other diseases. GSK is conducting a broad clinical trials program for ispinesib designed to study this drug candidate in multiple tumor types, combination regimens and dosing schedules. GSK is currently evaluating ispinesib in two Phase II clinical trials [...]
4/24/2006 Watertown, MA NN Maser et al. Cancer Epidemiol. Biomarkers Prev., April 1, 2006; 15(4): 774-81 Recent case-control studies indicate that alcohol increases the risk of oral premalignant lesions (OPL) among tobacco users, but the independent association between alcohol and OPL remains unclear. We prospectively evaluated the association between alcohol consumption and the incidence of OPL. Participants were 41,458 men in the Health Professionals Follow-up Study. Alcohol consumption was assessed every 4 years using validated food frequency questionnaires. We confirmed clinically or histopathologically diagnosed OPL events occurring between 1986 and 2002 by medical record review (193 cases). Multivariate-adjusted relative risks of OPL were calculated from Cox proportional hazards models. With detailed control for tobacco and other variables, multivariate relative risks (95% confidence intervals) were 1.7 (0.9-3.2) for drinkers of 0.1 to 14.9 g/d, 2.9 (1.5-5.6) for 15 to 29.9 g/d, and 2.5 (1.3-5.1) for >/=30 g/d, compared with nondrinkers. Approximately one additional drink per day (12.5 g) was associated with a 22% increase in risk (P < 0.001). The associations did not vary by beverage type, frequency, or consumption with meals. Results were similar when restricted to cases of oral epithelial dysplasia. Alcohol increased OPL risk in never-users of tobacco as well as in past or current users. An interaction between alcohol and tobacco was apparent by their more-than-additive joint effects. Alcohol is an independent risk factor for OPL, regardless of beverage type or drinking pattern. Recommendations to reduce alcohol intake have the potential to reduce incidence of OPL in [...]
4/22/2006 San Francisco, CA press release EurekAlert (www.eurekalert.com Researchers at the San Francisco VA Medical Center report that they have found a potential molecular cause for the aggressive growth and spread of human head and neck squamous cell carcinoma, a highly malignant form of cancer with a very high death rate. The discovery could potentially lead to new treatments as well, say the researchers. Their key finding is the triple interaction between three players: CD44, a surface receptor molecule that plays an important role in a variety of cellular functions; hyaluronan (HA), a complex carbohydrate found in the connective tissues between cells; and LARG, a signal activator found in tumor cells. That interaction apparently initiates two molecular pathways that simultaneously cause tumor cell growth and tumor cell migration, says lead author Lilly Bourguignon, PhD, a research career scientist at SFVAMC and a professor of medicine at the University of California, San Francisco. The study results are reported in the current on-line "In Press" section of the Journal of Biological Chemistry. Working with human cancer cells in culture, Bourguignon and her team found that HA mediates the interaction between CD44 and LARG in a way that stimulates a molecular pathway called RhoA. Through a series of complex steps, the RhoA pathway causes the tumor cell's cytoskeleton – the structure that maintains the cell's shape – to reorganize in a way that causes tumor cells to migrate to other sites in the body, resulting in cancer metastasis. At the same time, the [...]