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Major Medical Groups Back Comp Effectiveness Legislation
"Major medical organizations are urging health committees in the House and Senate to make comparative-effectiveness research a key component of healthcare reform," Modern HealthCare reports. The Senate Health, Education, Labor and Pension Committee"s bill "plans for a new federal center on health outcomes research was seen by some GOP members as a possible means to ration healthcare." But "a letter, co-signed by the American Medical Association and more than 60 other groups, countered that comparative-effectiveness research would not lead to "cookbook" medicine or rationing of expensive forms of care" (Lubell, 6/26).

Campaign Reminds Doctors Of 14 August Deadline For Licensing Decision - General Medical Council (GMC), UK
Doctors are being reminded to contact the GMC with their licensing decision through an advertising campaign launched yesterday, 1 August. Adverts will appear in the medical trade press throughout the first half of August as a final push to encourage doctors to respond to the GMC.
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Based On New Study, Tobacco Control Researchers Call On FDA To Require Complete Disclosure From Tobacco Companies Of Changes Made To Cigarettes
As President Obama prepares to sign a bill giving the Food and Drug Administration (FDA) oversight of the tobacco industry, a new study from Harvard School of Public Health (HSPH) researchers shows that tobacco manufacturers have continually changed the ingredients and the design of their cigarettes over time, even if those changes have exceeded acceptable product variance guidelines. The result, say the researchers, is that consumers who buy the same brand of product are not made aware of how that product has been altered and what effect those alterations might have on their levels of addiction or harm.
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Ascenta Therapeutics Announces Multiple Presentations On AT-101 At 2009 ASCO Annual Meeting

Ascenta Therapeutics announced that eleven presentations or publications on pre-clinical and clinical studies of AT-101, an oral, pan-Bcl-2 inhibitor, in several major tumor types will be made during the 2009 American Society of Clinical Oncology (ASCO) Annual Meeting, May 29-June 2, in Orlando, Florida. Prostate Cancer MacVicar G, et al. An open-label, multicenter, phase I/II study of AT-101 in combination with docetaxel (D) and prednisone (P) in men with castrate resistant prostate cancer (CRPC). Abstract #5062; Poster Board #17; Poster Discussion, May 31, 8:00 a.m.-12:00 p.m. Poiesz B, et al. Preliminary report of an open-label, multicenter, phase I/II study of AT-101 in combination with docetaxel (D) and prednisone (P) in men with docetaxel refractory prostate cancer. Abstract #5145; Poster Board #J13; GU General Poster Session, May 31, 2:00 p.m.-6:00 p.m. Glioma Fiveash J, et al. NABT-0702: A phase II study of AT-101 in recurrent glioblastoma multiforme (GBM). Abstract #2010; Poster Board #2; Poster Discussion, May 30, 8:00 a.m.-12:00 p.m. Lung Cancer Heist R, et al. A phase I/II study of AT-101 in combination with topotecan (T) in patients with relapsed or refractory small cell lung cancer (SCLC) after prior platinum containing first line chemotherapy. Abstract #8106; Poster Board #R14; Lung Cancer - Metastatic, May 30, 2:00 p.m.-6:00 p.m. Ready N, et al. AT-101 or placebo (P) with docetaxel (D) in second line NSCLC with gene signature biomarker development. Abstract #3577; Poster Board #J19; Developmental Therapeutics, May 30, 8:00 a.m.-12:00 p.m. Min P, et al. Small molecule pan-bcl-2 inhibitor AT-101 induces apoptosis in NSCLC by upregulating noxa and enhances antitumor activity of docetaxel or targeted kinase inhibitors. Abstract #e14591; Publication only. Non-Hodgkin"s Lymphoma Kingsley E, et al. An open-label, multicenter, phase II study of AT-101 in combination with rituximab (R) in patients with untreated, grade I-II, follicular Non-Hodgkin"s Lymphoma (FL). Abstract #8582; Poster Board #S11; Lymphoma and Plasma Cell Disorders, May 30, 8:00 a.m.-12:00 p.m. Advanced Cancers Leal TB, et al. A phase I study of AT-101 in combination with cisplatin (P) and etoposide (E) in patients with advanced solid tumors and extensive-stage small cell lung cancer (ES-SCLC). Abstract #e13502; Publication only. Saleh M, et al. Extended phase I trial of the oral pan-Bcl-2 inhibitor AT-101 by multiple dosing schedules in patients with advanced cancers. Abstract #e14537; Publication only. Mechanism of Action/Pharmacokinetics Wang S, et al. AT-101 induces transcriptional up-regulation of Noxa and Puma and overcomes Mcl-1-mediated cancer cell resistance to apoptosis. Abstract # e14611; Publication only. Pitot H, et al. Analysis of a phase I pharmacokinetic (PK)/food effect study of AT-101 in patients with advanced solid tumors. Abstract #2557; Poster Board #B18; Developmental Therapeutics, May 30, 8:00 a.m.-12:00 p.m. About AT-101 AT-101 is an orally-active, pan-Bcl-2 inhibitor (including Bcl-2, Bcl-xL, Bcl-w, and Mcl-1 inhibition) that has been shown to induce apoptosis directly by operating as a BH3 mimetic and indirectly as an independent upregulator of Noxa and Puma. By blocking the binding of Bcl-2 family members with proapoptotic proteins and upregulating specific proapoptotic factors, AT-101 lowers the threshold for cancer cells to undergo apoptosis in various tumor types. In Phase I and Phase II trials, AT-101 has demonstrated single-agent cytoreductive activity in several cancers, including chronic lymphocytic leukemia (CLL), non-Hodgkins lymphoma (NHL), and prostate cancer. Phase II combination trials are ongoing in several cancers, including hormone-refractory prostate cancer and non-small cell lung cancer (with Taxotere(R)), B-cell malignancies (with Rituxan(R)), small cell lung cancer (with Hycamtin(R)), glioma (with Temodar(R), +/- chemoradiotherapy [XRT]) and esophageal cancer (with docetaxel, 5-fluorouracil and XRT). About Ascenta Therapeutics Ascenta Therapeutics, Inc. is a privately-held, clinical-stage biopharmaceutical company that discovers and develops new medicines for the treatment of cancer. The company is headquartered in Malvern, Pennsylvania, and has a preclinical research facility in Shanghai, China. Its technology, licensed from both the National Institutes of Health and the laboratory of Dr. Shaomeng Wang at the University of Michigan, is focused on discovering molecules that restore the natural potential for cancer cells to undergo cell death (apoptosis). Ascenta"s lead agent, AT-101, is an orally-active small molecule pan Bcl-2 inhibitor (Bcl-2, Bcl-xL, and Mcl-1) currently in Phase 2 clinical trials in castrate resistant prostate cancer. The Company"s preclinical pipeline includes the oral multi-IAP antagonist AT-406, and an HDM2-p53 inhibitor program. Ascenta Therapeutics


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