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Pluristem Therapeutics Receives European Regulatory Approval For Placental-Derived Stem Cell Clinical Trial
Pluristem Therapeutics Inc. (NasdaqCM:PSTI) (DAX: PJT), a bio-therapeutics company dedicated to the commercialization of unrelated donor-patient (allogeneic) cell therapy products for a variety of disorders, announced today that the Paul Ehrlich Institute (PEI), the German competent authority in the European Union, has approved the Company"s Clinical Trial Application (CTA) and granted approval to begin clinical trials with its placental-derived adherent stromal cell product, termed PLX-PAD, for the treatment of critical limb ischemia (CLI), the end-stage of peripheral artery disease (PAD). In addition, Pluristem has already received approval from the Ethics Committee and, as previously announced, the US Food & Drug Administration (FDA) had cleared the Company"s Investigational New Drug (IND) application to initiate a similar trial in the United States. Both approvals of the CTA and IND clear the way for the world"s "first-in-man" clinical trial using PLX-PAD.
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Among Men Living With Early, Untreated Prostate Cancer, Study Finds Acceptable Levels Of Anxiety
Men with early stages of prostate cancer who delay radical treatment in favor of an approach of "expectant management" do not have high levels of anxiety and distress. That is the conclusion of a new study published in the September 1, 2009 issue of Cancer, a peer-reviewed journal of the American Cancer Society. The study"s results suggest that living with untreated cancer is not upsetting for many patients with early prostate cancer.
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Alzheimer's Society Comment On New Research Into Heart Rhythm Disorder As A Risk Factor For Dementia
Researchers at the Intermountain Medical Center have conducted research into the link between atrial fibrillation, a fairly common heart rhythm disorder, and dementia. The study of more than 37,000 shows that patients with atrial fibrillation were 44% more likely to develop dementia than patients without the disorder.
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Baucus: 'Effectiveness' Part Of Health-Care Bill, Could Reduce Health Costs

"Senate Finance Chairman Max Baucus, D-Mont., said Tuesday he expects Senate health-care legislation will include provisions encouraging doctors to compare drugs and therapies for their effectiveness," Dow Jones Newswires reports. At a conference at the Brookings Institution, "Baucus said he plans to re-introduce legislation with Sen. Kent Conrad, D-N.D., that further boosts" comparative effectiveness research. The research, which "saw $1.1 billion from the federal stimulus package earlier this year," lets "doctors and patients to utilize publicly-available information on medical treatments, has emerged as something of a political lightning rod this year. Some conservative Republicans are suggesting it would result in rationing of health care." But Baucus "sought to dispel that notion Tuesday, saying that the research would not be used solely to cut costs" (Yoest, 6/9). Kaiser Health News adds that "Baucus says lawmakers can ease critics" fears by ensuring that research is "patient focused," that physicians play a significant role and that decisions are based on clinical evidence about what works best, not solely on cost." The Baucus-Conrad bill from last year "would have created a public-private comparative effectiveness institute to set national research priorities and contract with government agencies and private groups to conduct the evaluations" (Appleby, 6/9). BusinessWeek reports that "whenever researchers compare drugs or treatments to see which works best, somebody"s ox gets gored. Such "comparative effectiveness" studies have already cast doubt on expensive new blood pressure and schizophrenia drugs, as well as spinal fusions and other surgeries." The process of educating patients about the alternatives to expensive procedures "leads patients to choose conservative options more often," providing an opportunity to potentially "trim hundreds of billions of dollars from the nation"s $2.4 trillion health-care bill." And patients "do as well or better than if they had opted for the procedures." But "sharing of evidence is rare" in the American health care system, and "financial incentives" for doctors and hospitals are "heavily skewed toward doing more surgeries and other procedures, not fewer." One study showed that "misconceptions" about the effectiveness of the procedures also "skew even the scientific view of the disease," which also causes doctors to opt for the procedures even when there is no evidence they will help (Carey, 6/9). This information was reprinted from kaiserhealthnews.org with kind permission from the Henry J. Kaiser Family Foundation. You can view the entire Kaiser Daily Health Policy Report, search the archives and sign up for email delivery at kaiserhealthnews.org. © Henry J. Kaiser Family Foundation. All rights reserved.


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