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OSI Pharmaceuticals Announces Acceptance Of Tarceva Supplemental New Drug Application For Review By The U.S. Food And Drug Administration
OSI Pharmaceuticals, Inc. (NASDAQ: OSIP) announced that the U.S. Food and Drug Administration (FDA) has accepted for filing and review the supplemental New Drug Application (sNDA) for the use of Tarceva® (erlotinib) as a first-line maintenance treatment for patients with advanced non-small cell lung cancer (NSCLC) who have not progressed following first-line treatment with platinum-based chemotherapy. Based upon the March 17th receipt of filing the FDA Prescription Drug Fee Act (PDUFA) review date will be on or about January 18, 2010.
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Spiration Presents Results Of Two Analyses Of Methods For Evaluating Effectiveness Of Bronchial Valve Treatment For Severe Emphysema
Spiration, Inc., a developer of novel medical devices designed to benefit patients with severe and chronic conditions of the lung, presented results of two analyses of methods used for evaluating U.S. Pilot Study effectiveness of bronchial valve treatment for severe emphysema at the annual American Thoracic Society (ATS) International conference taking place in San Diego May 15 to 22, 2009.
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In New U-M Lab-On-A-Chip Device, Music Is The Engine
Music, rather than electromechanical valves, can drive experimental samples through a lab-on-a-chip in a new system developed at the University of Michigan. This development could significantly simplify the process of conducting experiments in microfluidic devices.
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GTx-758, An Oral LH Inhibitor For First Line Treatment Of Advanced Prostate Cancer, Advances Into Second Phase I Clinical Trial

GTx, Inc. (Nasdaq: GTXI), announced the initiation of a Phase I multiple ascending dose clinical trial evaluating GTx-758, an oral LH inhibitor for first line treatment of advanced prostate cancer. A Phase I single ascending dose clinical trial in 96 subjects was successfully completed in June. In the completed Phase I single ascending dose clinical trial, GTx-758 was well tolerated. GTx-758 demonstrated a pharmacokinetic profile compatible with once daily oral dosing and systemic exposures increasing with dose. The ongoing Phase I multiple ascending dose clinical trial is an open label, single center study of five dose groups of GTx-758, with ten healthy male subjects per group each receiving doses for 10 days. The study will evaluate the safety, tolerability and pharmacokinetic profile of GTx-758. In addition, testosterone and other hormones will be measured to assess the activity of GTx-758 on hormones secreted by the pituitary, hypothalamus, and adrenal glands. "In this clinical trial, we expect to establish proof of the ability of GTx-758 to reduce testosterone, which is the endpoint required for primary androgen deprivation therapy clinical trials," said GTx CEO Mitchell S. Steiner, MD. GTx expects to complete this Phase I multiple ascending dose clinical trial in the fourth quarter. About GTx-758 GTx-758 is an oral LH inhibitor which GTx is developing for the treatment of advanced prostate cancer. Preclinical in vitro and in vivo data suggest GTx-758 rapidly suppresses secretion of LH, thereby inhibiting production of androgens by the testes. GTx believes GTx-758 has the potential to reduce testosterone, a primary growth factor of prostate cancer, without causing bone loss and hot flashes. Prostate cancer is the second most common type of cancer diagnosed in men in the U.S. An estimated 186,000 new cases of prostate cancer were diagnosed in the U.S. in 2008. Approximately 700,000 men with prostate cancer are being treated with androgen deprivation therapy (ADT) and an estimated 100,000 initiate ADT each year. Annual US sales of drugs for ADT exceeded $1.7 billion in 2008. GTx, Inc.


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