Therapeutics News and Research

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COMPARE trial results demonstrate higher efficacy of XIENCE V stent system

Late-breaking data presented today from the COMPARE trial demonstrated that Abbott's market-leading XIENCE V(R) Everolimus Eluting Coronary Stent System demonstrated significantly better outcomes in key safety and efficacy measures compared to the TAXUS(R) Liberte Paclitaxel-Eluting Coronary Stent System (TAXUS).

24 Sep 2009

CEL-SCI Corporation engages a CRO for clinical trial of its investigational LEAPS-H1N1 treatment

CEL-SCI Corporation (NYSE AMEX: CVM), a developer of vaccines and therapeutics for the treatment of infectious diseases and a late-stage oncology company, announced today that it has hired a full-service Clinical Research Organization (CRO) with an office in the Washington, D.C./Baltimore area to support its conduct of the upcoming clinical trial of its investigational LEAPS-H1N1 treatment.

24 Sep 2009

Study reveals that AIR Inhaled Insulin is inferior to SC insulin

The commercial failure of Exubera- (Pfizer, New York, NY), the first inhaled insulin product to come to market, led other companies such as Eli Lilly-Alkermes to halt studies of similar drug delivery in development intended to compete for a share of the lucrative diabetes market. Does this signal defeat for efforts to deliver insulin via the lungs? The science and circumstances behind the Lilly-Alkermes decision to discontinue trials of the AIR- inhaled insulin product are explored in a special supplement to Diabetes Technology & Therapeutics, a peer-reviewed journal published by Mary Ann Liebert, Inc. (www.liebertpub.com). The supplement is available free online at www.liebertpub.com/dia

24 Sep 2009

Computational models form basis to design the device for recreating kidney function

Researchers from Mount Sinai School of Medicine and two other academic institutions have received federal funding to systematically assemble functional human kidney tissue from tissue modeled on a computer. If successful, the research-which ties together several emerging technologies including virtual tissue modeling and nanofabrication-could lead to a more predictable way for researchers to engineer tissue outside the body and, consequently, to screen for new drugs.

24 Sep 2009

Z-Medica launches the QuikClot Interventional hemostatic bandage for use during catheterization procedures

Z-Medica Corporation, a medical device company developing innovative hemostatic agents, today announced the availability of the QuikClot® Interventional™ hemostatic bandage, on display at booth #1338 at the 21st annual Transcatheter Cardiovascular Therapeutics (TCT) scientific symposium, sponsored by the Cardiovascular Research Foundation.

From Medica Corporation 24 Sep 2009

Aegera Therapeutics raises $7 Million for additional working capital

Aegera Therapeutics, a clinical stage biotechnology company focussed on developing targeted therapeutics for oncology and pain, announced today the full drawdown of a $7 Million debt facility provided by Investissement Quebec.

24 Sep 2009

Morphotek receives NIAID grant to develop human mAb therapies against staphylococcal-derived pathogens

Morphotek(R), Inc., a subsidiary of Eisai Corporation of North America, announced today that it was awarded $843,289 in funding from the National Institutes of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health, to support the development of human monoclonal antibody (mAb) therapies against staphylococcal-derived toxin(s).

23 Sep 2009

ImmunoCellular Therapeutics completes humanization of its ICT-37 and ICT-109 antibody candidates

ImmunoCellular Therapeutics, Ltd. (OTCBB: IMUC), a clinical-stage biotechnology company that is developing immune based therapies for the treatment of brain and other cancers, announced today that it has completed humanization of ICT-37 and ICT-109.

23 Sep 2009

FDA accepts Sangamo's IND for repeat-dosing in Phase 1 clinical trial of SB-728-T ZFN-based therapeutic

Sangamo BioSciences, Inc. (Nasdaq: SGMO) announced today that the US Food and Drug Administration (FDA) has reviewed and accepted an Investigational New Drug (IND) application to initiate an open-label, repeat-dosing Phase 1 clinical trial (SB-728-T-902) of the company's ZFN-based therapeutic, SB-728-T. A single dose Phase 1 clinical study of SB-728-T was initiated in February 2009 and is ongoing at the University of Pennsylvania.

23 Sep 2009

Pluristem commences dosing in Phase I clinical trial for the treatment of critical limb ischemia

Pluristem Therapeutics Inc. (NasdaqCM: PSTI; DAX: PJT) today announced the dosing of the first patient in the U.S. with its placenta-derived stem cell product, PLX-PAD, the Company’s leading candidate, in a Phase I clinical trial for the treatment of critical limb ischemia (CLI), the end-stage of peripheral artery disease (PAD).

23 Sep 2009

Next Generation CV-3D workstation and software package for Infinix-i X-ray systems

To improve the ability of physicians to provide superior patient care during interventional procedures, Toshiba America Medical Systems, Inc. has introduced its Next Generation CV-3DTM workstation and software package available on the InfinixTM-i X-ray product line.

23 Sep 2009

New TAXUS Liberté Stent demonstrates superior results for treating long lesions

Angiotech Pharmaceuticals, Inc. (NASDAQ: ANPI, TSX: ANP) today announced that its corporate partner, Boston Scientific Corporation (NYSE: BSX), has released comprehensive data from the TAXUS ATLAS clinical program, a series of global, prospective, single-arm trials evaluating the TAXUS(R) Liberté(R) Paclitaxel-Eluting Stent System in a variety of lesions and patient groups. Three-year results from the TAXUS ATLAS Small Vessel and Long Lesion Trials continue to show significant advantages for the newer TAXUS Liberté Stent when compared to the first-generation TAXUS(R) Express(R) Stent.

23 Sep 2009

St. Jude Medical's cardiovascular healthcare portfolio to be presented at TCT meeting

St. Jude Medical, Inc. (NYSE:STJ) today announced it will display products and technologies from the company’s portfolio of solutions for cardiovascular healthcare professionals at the 21st annual Transcatheter Cardiovascular Therapeutics meeting in San Francisco. The featured products reflect the company’s continued commitment to developing comprehensive, high-performance solutions which advance the practice of interventional cardiology by improving efficiencies and giving physicians more control.

23 Sep 2009

Genous Bio-engineered R stent for STEMI implantation exhibits safety

OrbusNeich announced today that interim data from a prospective registry showed good safety in a broad population of patients that underwent primary percutaneous coronary intervention (PCI) and implantation of the company's Genous Bio-engineered R stent for ST-elevation myocardial infarction (STEMI).

23 Sep 2009

Breakthrough in the successful treatment of AMI

Medical device pioneer Stentys announced today the results on 20 patients participating in the Company’s ‘APPOSITION I’ clinical study—the world’s first to treat patients with acute myocardial infarction (AMI) via a self-expanding stent. These data were disclosed today by the study’s principal investigator, Christian Spaulding, M.D., Ph.D., to an audience of cardiologists during a Stentys-hosted satellite meeting at the Transcatheter Cardiovascular Therapeutics (“TCT”) 2009 annual scientific meeting.

23 Sep 2009

Leading oncology experts to discuss management of hematological malignancies

Oncology experts from leading cancer organizations from around the country, including the John Theurer Cancer Center, MD Anderson Cancer Center, the Mayo Clinic, Dana Farber Cancer Institute and the National Cancer Institute, will discuss trends in patient care, novel therapies through clinical trials and emerging concepts in the management of hematological malignancies.

23 Sep 2009

Medtronic's transcatheter valves to be presented at TCT 2009

With the promise of percutaneous treatments for patients with diseased heart valves growing, Medtronic, Inc., announced today that more presentations than ever before – at least 25 – on the company’s portfolio of unique transcatheter valves will be presented at Transcatheter Cardiovascular Therapeutics (TCT) 2009, the world’s premier annual meeting for interventional cardiologists.

23 Sep 2009

Results of OASIS clinical trial reported by Cardiovascular Systems

Two-year follow-up of patients in the first-ever prospective, multi-center clinical trial evaluating a plaque removal product show promising results after treatment with the Diamondback 360® PAD System, a minimally invasive catheter system that removes hardened plaque to restore blood flow in arteries.

23 Sep 2009

Nasdaq issues Repros Therapeutics a second delisting notice

Repros Therapeutics (NasdaqGM:RPRX) today announced that on September 15, 2009, the Company received a second letter from The Nasdaq Stock Market advising that, in addition to the deficiencies previously disclosed on August 17, 2009, the Company’s market value of publicly held shares was below the minimum $15,000,000 requirement for continued listing on the Nasdaq Global Market by Listing Rule 5450(b)(2)(C) or 5450(b)(3)(C).

22 Sep 2009

Researchers to present results of HORIZONS-AMI trial at TCT scientific symposium

Two subset analyses from the landmark HORIZONS-AMI trial show that the anticoagulant bivalirudin lowers major bleeding and cardiac death versus the combination of heparin and a GP IIb/IIIa inhibitor in patients with ST-segment myocardial infarction (STEMI) who have disease of the left anterior descending artery (LAD), while in STEMI patients at highest risk for death, bivalirudin also confers the greatest mortality benefit.

22 Sep 2009

Therapeutics News and Research

COMPARE trial results demonstrate higher efficacy of XIENCE V stent system

CEL-SCI Corporation engages a CRO for clinical trial of its investigational LEAPS-H1N1 treatment

Study reveals that AIR Inhaled Insulin is inferior to SC insulin

Computational models form basis to design the device for recreating kidney function

Z-Medica launches the QuikClot Interventional hemostatic bandage for use during catheterization procedures

Aegera Therapeutics raises $7 Million for additional working capital

Morphotek receives NIAID grant to develop human mAb therapies against staphylococcal-derived pathogens

ImmunoCellular Therapeutics completes humanization of its ICT-37 and ICT-109 antibody candidates

FDA accepts Sangamo's IND for repeat-dosing in Phase 1 clinical trial of SB-728-T ZFN-based therapeutic

Pluristem commences dosing in Phase I clinical trial for the treatment of critical limb ischemia

Next Generation CV-3D workstation and software package for Infinix-i X-ray systems

New TAXUS Liberté Stent demonstrates superior results for treating long lesions

St. Jude Medical's cardiovascular healthcare portfolio to be presented at TCT meeting

Genous Bio-engineered R stent for STEMI implantation exhibits safety

Breakthrough in the successful treatment of AMI

Leading oncology experts to discuss management of hematological malignancies

Medtronic's transcatheter valves to be presented at TCT 2009

Results of OASIS clinical trial reported by Cardiovascular Systems

Nasdaq issues Repros Therapeutics a second delisting notice

Researchers to present results of HORIZONS-AMI trial at TCT scientific symposium

Achieving and maintaining ISO 27001 and BS 10012 certifications

Expanding research and clinical options for children with cancer

Examining how pain could play a direct protective role in the gut

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