plus 3, Global Phase III Study Results Show Eribulin Meets Primary Endpoint of ... - Yahoo Finance |
- Global Phase III Study Results Show Eribulin Meets Primary Endpoint of ... - Yahoo Finance
- Just pretend we're not here: Photographers go hungry as Michelle Obama ... - Daily Mail
- Studies demonstrate that investigational cancer vaccines show ... - News-Medical.Net
- October 2009 - Watertown Daily Times
Global Phase III Study Results Show Eribulin Meets Primary Endpoint of ... - Yahoo Finance Posted: 30 Oct 2009 10:54 AM PDT WOODCLIFF LAKE, N.J., Oct. 30 /PRNewswire/ -- Eisai Inc. today announced preliminary results from a recently completed Phase III study with eribulin mesylate (E7389), discovered and developed by the company, in patients with locally advanced or metastatic breast cancer. This global Phase III study, known as "EMBRACE," (Eisai Metastatic Breast Cancer Study Assessing Physician's Choice Versus E7389), was an open-label, randomized, parallel two-arm, multi-center study of 762 women with locally recurrent or metastatic breast cancer previously treated with at least two and a maximum of five prior chemotherapy regimens, including an anthracycline and a taxane. The patients were treated either with eribulin (administered intravenously over two to five minutes on days 1 and 8 every 21 days) or with treatment of physician's choice. Treatment of physician's choice is defined as any single agent chemotherapy, hormonal treatment or biological therapy approved for the treatment of cancer; or palliative treatment or radiotherapy administered according to local practice. Preliminary results from the study demonstrated a statistically significant improvement in overall survival, the primary endpoint, in eribulin-treated patients compared with the physician's choice of therapy. The safety profile of eribulin in this Phase III study was consistent with the adverse events seen in previous Phase II clinical studies and the most common adverse event reported was myelosuppression. Eribulin is a new chemical compound discovered and developed by Eisai. It is a synthetic analogue of halichondrin B, a naturally-derived compound that was first isolated from a marine sponge. While taxanes inhibit cell division by stabilizing microtubules, eribulin is a microtubule dynamics inhibitor that arrests the cell cycle through inhibition of the growth of microtubules without interfering with microtubule shortening. While early detection by breast cancer screening and the development of innovative anti-cancer drugs have contributed to the decline in breast cancer mortality around the world, breast cancer remains one of the leading causes of cancer death in women. Although advances are being made every year in the treatment of breast cancer, women with locally advanced or metastatic breast cancer have limited treatment options and the development of more effective treatment or anti-cancer drugs is critically important. It is believed that more than one million women are newly diagnosed with breast cancer each year around the world. Eisai will complete a more detailed analysis of the data prior to submitting marketing authorization applications for eribulin to health authorities in Japan, the United States, and Europe for locally advanced and metastatic breast cancer by the end of the fiscal year 2009. Eisai is currently conducting clinical trials of this compound in-house to evaluate the efficacy and safety not only in breast cancer, but also in non-small cell lung cancer (NSCLC), hormone refractory prostate cancer, and sarcoma. Eisai also includes eribulin as one of the compounds in the co-development projects based on the strategic collaboration agreement with Quintiles and will proceed with joint clinical development of this compound for NSCLC as well as bladder cancer. Eisai defines oncology as a therapeutic area of focus and is committed to developing novel anti-cancer agents and treatments for supportive care. With these efforts, Eisai will make further contributions to addressing the diversified needs of and improving benefits to patients and families affected by cancer as well as healthcare professionals. For more information about eribulin, U.S. health care professionals and patients may call 1-877-220-3921. Eisai Inc. Eisai Inc. is a wholly-owned subsidiary of Eisai Corporation of North America. Established in 1995 and ranked among the top-20 U.S. pharmaceutical companies (based on retail sales), the company began marketing its first product in the United States in 1997 and has rapidly grown to become a fully integrated pharmaceutical business with fiscal year 2008 (year ended March 31, 2009) sales of approximately $3.7 billion. Eisai Inc.'s areas of commercial focus include neurology, gastrointestinal disorders and oncology/critical care. The company serves as the U.S. pharmaceutical operation of Eisai Co., Ltd., a research-based human health care (hhc) company that discovers, develops and markets products throughout the world. Headquartered in Woodcliff Lake, New Jersey, Eisai Inc. has several R&D facilities in Massachusetts, New Jersey and North Carolina, as well as manufacturing facilities in Maryland and North Carolina. For more information about Eisai, please visit www.eisai.com. *On October 1, 2009, Eisai Research Institute of Boston, Inc. (established in 1987) and Eisai Medical Research Inc. (established in 2002) were merged into Eisai Inc. Eisai Co., Ltd. Eisai Co., Ltd. is a research-based human health care (hhc) company that discovers, develops and markets products throughout the world. Through a global network of research facilities, manufacturing sites and marketing subsidiaries, Eisai actively participates in all aspects of the worldwide health care system. Eisai employs approximately 11,000 employees worldwide. Eisai concentrates its R&D activities in three key areas:
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Just pretend we're not here: Photographers go hungry as Michelle Obama ... - Daily Mail Posted: 30 Oct 2009 06:07 AM PDT By Mail Foreign Service The amount of sweet potatoes harvested at the White House yesterday could feed an army, Michelle Obama observed. Sadly, there was none to spare for the horde of photographers on hand to document the efforts of the First Lady and 30 schoolchildren as they pulled 223 pounds of vegetables from the garden on the South Lawn. Don't mind us: Michelle Obama, left, speaks to a crowd of schoolchildren as they settle down at picnic tables for a peaceful afternoon... under the watchful eye of the White House press corps, inches away Autumn harvest: The First Lady helps schoolchildren pull 223 pounds of produce from the garden on the South Lawn of the White House yesterday Cupboards at a soup kitchen near the White House will be spilling over for several days after a donation of the fresh produce harvested yesterday from Mrs Obama's vegetable garden. The First Lady invited about 30 fifth-graders from two District of Columbia public elementary schools to help with the project. One of the schools, Bancroft Elementary, has helped with the garden since it began, preparing the soil, planting the crops and harvesting in the spring. 'Are you guys ready to do some work? Are you ready to work really hard? Are you ready to get dirty?' she asked them. "All right, let's go!' The First Lady struck some difficult poses as she helped the pupils pulls vegetables from the ground No you can't (eat my vegetables): Mrs Obama eyes an earthworm suspiciously during the harvest The students were divided into groups of three and paired with an adult who showed them what to do. All told, they spent about a half-hour jabbing and digging at the plot on the South Lawn with pitchforks and other tools. They filled one wheelbarrow with huge sweet potatoes, and filled baskets and bowls with carrots, fennel, lettuce, tomatoes, broccoli, turnips, eggplant, peppers, tomatillos and greens, for a total of 223 pounds, Mrs Obama's office said later in the day. Most of the produce is being given to Miriam's Kitchen, a nearby soup kitchen, for the next days' meals. Mrs Obama helped serve lunch there earlier this year. Well done: Mrs Obama high fives a student from Washington's Bancroft Elementary School as they harvest vegetables from the garden
The First Lady appears puzzled as she examines some carrots Before yesterday, the garden already had produced more than 740 pounds of food, Mrs Obama said, bringing the total for the year to more than 960 pounds. Some has been served at White House events. The first lady and her group first tackled sweet potatoes before moving on to carrots and big bulbs of fennel. At one point, she held up one of the larger orange-coloured spuds and said: 'This can feed an army.' Spud-tastic: The size of the sweet potatoes harvested yesterday certainly was impressive
Mrs Obama puts a guiding hand on the wheelbarrow full of sweet potatoes as two children from the school cart them off The First Lady also high fived the students, practically did the splits as she yanked vegetables from the ground, and carefully examined a large earthworm she had found. Before the harvesting began, she said she and daughters, Malia, 11, and Sasha, 8, already had helped themselves to some sweet potatoes. The harvest was the second for the garden. More than 70 pounds of lettuce and 12 pounds of peas came out of a springtime harvest of the 1,100-square-foot, L-shaped plot.
As if the watching press corps weren't enough: Mrs Obama pauses from the work to pose for a mobile phone picture with some of the students
This could feed an army: Mrs Obama, centre, poses with the schoolchildren and the 223 pounds of produce they harvested yesterday After that, fall crops were planted, leading to yesterday's event. Mrs Obama started the garden in March, saying she wanted to use it to talk about the importance of eating a nutritious diet and show what good, fresh food tastes like. She said it cost about $180 to prepare the soil and plant the seeds and seedlings. Share this article:This content has passed through fivefilters.org. |
Studies demonstrate that investigational cancer vaccines show ... - News-Medical.Net Posted: 30 Oct 2009 02:47 AM PDT Results of two phase 1 studies demonstrate that the novel, investigational cancer vaccines MKC1106-MT and MKC1106-PP are well-tolerated and show encouraging immune response rates and objective tumor response in advanced melanoma, prostate cancer and other solid malignancies, setting the stage for phase 2 studies. The data are being presented at the International Society for Biological Therapy of Cancer 2009 Annual Meeting. MKC1106-MT is an active immunotherapeutic product consisting of three components, a DNA plasmid and two synthetic peptides, each of which is administered separately by the unique route of intranodal injection and together are designed to target two tumor-specific antigens that are commonly expressed by melanoma tumor cells. MKC1106-PP is a similar agent that is designed to target two specific tumor antigens commonly expressed by various solid tumor cells. "MKC1106-MT and MKC1106-PP met the primary end-points of both trials and, in addition, showed early evidence of clinical benefit, which marks an important step forward for MannKind's oncology portfolio," said Peter Richardson, MRCP, Corporate Vice President and Chief Scientific Officer, MannKind Corporation. "These encouraging results set the stage to move into phase 2 trials with these innovative, targeted therapies, which represent the cornerstone of our cancer immunotherapy program." This content has passed through fivefilters.org. |
October 2009 - Watertown Daily Times Posted: 30 Oct 2009 11:01 AM PDT
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Talk about an exercise in PR - those photographers just happened to be walking past !
- Capricorn, Johannesburg, South Africa, 30/10/2009 13:56
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