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Bush to announce expanded bank bailout details- The Bush administration plans to spend an initial $250 billion of the $700 billion bailout buying stock in private banks, greatly expanding protections for the U.S. financial system out of deep concern for the faltering economy, industry and government officials said Monday night. President Bush planned to announce the details Tuesday morning.
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McCain: Lewis' remarks on campaign tone are unfair- John McCain said Monday that it was unfair for Rep. John Lewis to compare the negative tone of the Republican presidential campaign to the atmosphere a segregationist fostered in the 1960s.
- Democratic U.S. Rep. Tim Mahoney, married with a child, declined to say Monday whether he had carried on an affair with a former aide and paid to keep her quiet, then called for an investigation by the House ethics committee into his own conduct.
2nd out-of-state teen dropped at Omaha hospital- A Michigan mother drove roughly 12 hours to Omaha, so she could abandon her 13-year-old son at a hospital under the state's unique safe-haven law, Nebraska officials said Monday.
Johnston speaks about Bristol Palin, Obama, baby- Levi Johnston, who's having a baby with Gov. Sarah Palin's daughter, can't believe all the things he's hearing. No, he wasn't held against his will on the campaign trail. No, he's not being forced into a shotgun wedding with 17-year-old Bristol Palin.
Wildfires force frantic evacuations near LA; 2 die- Two huge wildfires driven by strong Santa Ana winds burned into neighborhoods near Los Angeles on Monday, forcing frantic evacuations on smoke- and traffic-choked highways, destroying homes and causing at least two deaths.
Therapy helps hard-to-transplant get a new kidney- Nearly one in three patients who need a kidney transplant may never get one because their bodies are abnormally primed to attack a donated organ. Now doctors are trying new ways to outwit the immune system and save more of those so-called "highly sensitized" patients - often with kidneys donated by living donors, considered the optimal kind.
Janet Jackson cancels more concerts- The doctor has again ordered Janet Jackson to postpone a return to her "Rock Witchu" tour.
Rays bash Red Sox 9-1 to take 2-1 series lead- B.J. Upton, Evan Longoria and the rest of the Tampa Bay Rays are bashing their way through their first trip to the playoffs. Upton and Longoria homered off a suddenly shaky Jon Lester, and the power-packed Rays cleared the Green Monster four times to beat the Boston Red Sox 9-1 Monday for a 2-1 lead in the AL championship series.
Eisai Provides Preliminary Efficacy Update On EORTC Phase III Trial of Dacogen(R) Versus Supportive Care in Patients With Myelodysplastic Syndromes
WOODCLIFF LAKE, N.J.
(Map)
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Subsequent to database lock and the completion of data analysis, comprehensive results of the study, including secondary efficacy endpoints and safety data, will be presented by EORTC at an upcoming scientific forum.
Current Development
Eisai plans to submit a supplemental New Drug Application (sNDA) with the U.S. Food and Drug Administration by the end of the fiscal year for a five-day regimen for Dacogen. The sNDA will be based on a North American, multi-center, open-label, single arm Phase II trial (DACO-020) in which patients received Dacogen every day for five days. The regimen was repeated every four weeks with no limit on the number of treatment cycles that patients could receive as long as they received clinical benefit or until their disease progressed. Median survival at the time of data analysis was 19.4 months and the one-year survival rate for patients treated with Dacogen was 66 percent. An overall complete response rate of 32 percent (International Working Group 2006 Criteria) was achieved with the outpatient administration of Dacogen, confirming previously reported response rates in the outpatient setting. The safety profile of this dosing regimen was consistent with what has been previously reported.
Eisai is committed to a clinical development program to optimize the utility of Dacogen for all patients with MDS. Recent studies of hypomethylating agents have suggested that treatment of patients should continue for as long as they receive clinical benefit or until their disease progresses. To advance the understanding of optimal treatment for MDS and related conditions, there are currently more than 30 ongoing trials with Dacogen either as a single agent or in combination with other therapies, including a Phase III survival study in older patients with acute myelogenous leukemia (AML).
Study Design
EORTC-06011: This Phase III open-label, randomized, multi-center, controlled trial evaluated overall survival of patients receiving Dacogen plus BSC versus BSC only. The study involved 233 elderly patients, greater than or equal to 60 years of age, with predominantly high-risk or Intermediate-2 type MDS.
Patients included in the trial had primary or secondary MDS with or without previous therapy with growth factors, immunosuppressive agents or hydroxyurea. In order to participate in the study, patients had to have bone marrow blast counts between 11 and 30 percent. Patients with blast counts below 10 percent were required to have had poor-risk cytogenetics in order to be eligible for randomization.
DACO-020: This is a multi-center, open-label, single arm Phase II study of Dacogen in 99 patients with de novo or secondary MDS. Dacogen was administered daily for five days repeated every four weeks. Patients were greater than or equal to 18 years of age with MDS (de novo or secondary) of any FAB subtype and with an International Prognostic Scoring System score of greater than or equal to 0.5. In order to be included in the cytogenetic analysis, patients must have had abnormal cytogenetics at baseline and adequate cytogenetics data available for at least one post-baseline visit.
About MDS
Myelodysplastic syndromes, or MDS, are a group of diseases of the bone
marrow characterized by the production of poorly functioning and immature
blood cells. People with MDS may experience a variety of symptoms and
complications, including anemia, bleeding, infection, fatigue and weakness.
Those patients with high-risk MDS may experience bone marrow failure, which
may lead to death from bleeding and infection. Over time, MDS can progress to
acute leukemia, or AML. The Aplastic Anemia and MDS International Foundation
currently estimates that up to 30,000 new cases of MDS are diagnosed annually
in
About Dacogen(R)
Dacogen(R) (decitabine) for Injection was approved by the U.S. Food and
Drug Administration on
Dacogen may cause fetal harm when administered to a pregnant woman. Women of childbearing potential should be advised to avoid becoming pregnant while using Dacogen. Men should be advised not to father a child while receiving treatment with Dacogen and for two months afterwards. The most commonly occurring adverse reactions with Dacogen include neutropenia (90%), thrombocytopenia (89%), anemia (82%), pyrexia (53%), fatigue (48%), nausea (42%), cough (40%), petechiae (39%), constipation (35%), and diarrhea (34%).
Please visit www.dacogen.com for full prescribing information.
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