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PolyMedix Receives Regulatory Clearance To Initiate Second Phase I Clinical Study Of Novel Systemic Antibiotic Compound
PolyMedix, Inc., an emerging biotechnology company developing acute care products for infectious diseases and acute cardiovascular disorders, has received a notice of no objection from Health Canada for the Company"s Clinical Trial Application ("CTA") for its defensin mimetic antibiotic compound, PMX-30063. This notice of no objection allows for the initiation of the second human clinical study in Canada. PMX-30063 is a defensin mimetic antibiotic compound, the first of an entirely new class of antibiotic drugs that is believed to work in such a way that makes bacterial resistance unlikely to develop.
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ABRAXANE Approved For Advanced Breast Cancer Patient Treatment In Quebec
Abraxis BioScience, Inc. (NASDAQ:ABII), an integrated biotechnology company, announced the listing of ABRAXANE® for Injectable Suspension (paclitaxel protein-bound particles for injectable suspension) (albumin-bound) 100 mg in Quebec for the treatment of metastatic breast cancer with a recommendation from the Quebec Conseil du Mç©dicament and approval from the Quebec Ministry of Health. ABRAXANE is approved and commercially available in Canada for the treatment of metastatic breast cancer, including first-line disease. The listing of ABRAXANE in Quebec offers an important new treatment option to Quebec women with advanced breast cancer.
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Important Questions Raised About Genetic Research Based Only On Blood Samples; New Treatment In Vascular Disease Foreseen At The Same Time
Research by a group of Montreal scientists calls into question one of the most basic assumptions of human genetics: that when it comes to DNA, every cell in the body is essentially identical to every other cell. Their results appear in the July issue of the journal Human Mutation.
Diagnostics

QRxPharma Initiates Comparative Phase 2 Proof-of-Concept Study For MoxDuo(TM) IV Pain Therapy

QRxPharma Limited (Pink Sheets: QRXPY; ASX: QRX) announced the initiation of a Phase 2 comparative proof-of-concept study to evaluate the efficacy and safety of MoxDuo(TM) IV (intravenous morphine and oxycodone) versus IV morphine alone for the treatment of moderate to severe post-operative pain in patients following hip replacement surgery. Data from this study will serve as a significant predictor of MoxDuo(TM) IV"s clinical benefits and provide guidance for the design of further clinical trials leading to submission of an NDA to the US Food and Drug Administration (FDA) within the next three years. "QRxPharma"s goal is to bring to market complementary analgesic options for pain specialists, delivering greater patient tolerability and efficacy than current standards of care. MoxDuo(TM) IV is one of three Dual-Opioid(TM) products that also include immediate-release (IR) and controlled release (CR) oral formulations," said Dr. John Holaday, Managing Director and Chief Executive Officer, QRxPharma. QRxPharma"s MoxDuo(TM) products are the only combination opioids in commercial development. Extensive clinical studies have shown Dual-Opioids(TM) to provide better pain relief with significantly fewer side effects. This double blind, active controlled study will determine: (1) whether MoxDuo(TM) IV has fewer opioid-related adverse events than morphine alone at equianalgesic doses and (2) whether the maximum analgesic effect of MoxDuo(TM) IV is superior to morphine alone. The study is being conducted at the Cologne-Merheim Medical Center, a part of Witten/Herdecke University, and Cologne University Hospital, both in Cologne, Germany. "I am pleased to be conducting this study of MoxDuo(TM) IV with QRxPharma," said Professor Dr. Edmund Neugebauer, Chair of Surgical Research at the Institute of Research in Operative Medicine. "I am optimistic that MoxDuo(TM) IV will enable doctors to provide better pain relief with fewer side effects, getting patients on their feet earlier than with existing opioid pain medications." Following hip replacement surgery, 40 subjects will be randomised into MoxDuo(TM) IV or morphine IV groups over a two-part, 48-hour treatment period. In Part 1, rapid dosing will be used by the physician to achieve maximal reductions in pain. In Part 2, patients will manage their own pain relief on an "as needed" basis using self-administered PCA (patient controlled analgesia). The MoxDuo(TM) IV and morphine groups will be compared for clinically significant differences in analgesia and/or side effects. "Preliminary Phase 3 data demonstrate that the Company"s MoxDuo(TM) IR oral formulation consistently yields superior pain relief with a lower frequency of side effects than morphine and oxycodone alone. We believe our intravenous formulation will demonstrate similar benefits as seen with orally administered MoxDuo(TM) IR," said Dr. Holaday. "Specifically, the absence of sedation as well as reduced nausea and vomiting may permit accelerated patient recovery while providing superior pain relief. This will enable physical therapy to begin sooner, saving time and money for both patient and payer." QRxPharma expects the study to be completed before the end of 2009. Forward Looking Statements This press release contains forward-looking statements that involve risks and uncertainties. The forward-looking statements contained herein represent the judgment of QRxPharma as of the date of this release. These forward-looking statements are not guarantees for future performance. Actual results could differ materially from those currently anticipated due to a number of factors including risks relating to the stage of products under development; uncertainties relating to clinical trials; dependence on third parties; future capital needs; and risks relating to the commercialisation of the Company"s proposed products. About QRxPharma QRxPharma (ASX: QRX and OTCQX: QRXPY) is a clinical-stage specialty pharmaceutical company focused on the development and commercialisation of new treatments for pain management and central nervous system (CNS) disorders. Based on a development strategy which focuses on enhancing and expanding the clinical utility of currently marketed compounds, the Company"s product portfolio includes both late and early stage clinical drug candidates with the potential for reduced risk, abbreviated development paths, and improved patient outcomes. The Company intends to directly commercialise its products in the US and seek strategic partnerships abroad. QRxPharma"s lead compound, MoxDuo(TM) IR , successfully completed a Phase 3 study and met primary and secondary endpoints. The Company"s preclinical and clinical pipeline includes other technologies in the fields of pain management, neurodegenerative disease and venomics. QRxPharma Limited


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