Clinical Trial News and Research

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Bypass surgery: New method of growing arteries could lead to non-invasive option for treatment

A new method of growing arteries could lead to a "biological bypass"-or a non-invasive way to treat coronary artery disease, Yale School of Medicine researchers report with their colleagues in the April issue of Journal of Clinical Investigation.

9 Mar 2010

Restructuring results in reduction of Exelixis’ workforce by 40% and increases financial strength

Exelixis, Inc. today announced a restructuring as a consequence of its continued strategy to focus resources on the development of its key late-stage compounds. As its first priority, the company will aggressively advance XL184, XL147 and XL765, each of which is the subject of a large clinical development program.

9 Mar 2010

Phase III study demonstrates superiority of imiquimod cream 2.5% and 3.75% in treatment of AK

The Journal of the American Academy of Dermatology (JAAD) has published Phase III data evaluating the safety and efficacy of imiquimod cream at two doses - 2.5% and 3.75% - administered daily on a 2-week treatment cycle. The study demonstrates that both formulations were superior to placebo, and that imiquimod 3.75% on a daily 2-week treatment cycle is superior to imiquimod 2.5% in treating actinic keratosis (AK) on a large surface area - the face or balding scalp.

9 Mar 2010

Nanoparticles: Targeted cancer therapy

Another weapon in the arsenal against cancer: Nanoparticles that identify, target and kill specific cancer cells while leaving healthy cells alone.

9 Mar 2010

Viatronix V3D-Colon software used for the President's colon cancer screening exam

Viatronix Incorporated, a Stony Brook, New York, based company announced that its V3D-Colon software is used at the National Naval Medical Center where the President's annual physical was done. "Our software is being utilized at several DOD facilities since the landmark Virtual Colonoscopy clinical trial published in the New England Journal of Medicine back in December 2003," said Zaffar Hayat, President of Viatronix Incorporated.

9 Mar 2010

JAAD publishes Phase III data evaluating safety and efficacy of imiquimod in patients with AK

The Journal of the American Academy of Dermatology has published Phase III data evaluating the safety and efficacy of imiquimod cream at two doses – 2.5% and 3.75% – administered daily on either 2-week or 3-week treatment cycles.

9 Mar 2010

IEEE, AMA to host conference: Overcoming challenges in individualized healthcare, technological innovations

IEEE, the world's largest technical professional association, and the American Medical Association, are joining together to host the First Conference on Medical Technology and Individualized Healthcare.

9 Mar 2010

Medica Research Institute launched for applying innovation to healthcare delivery

Medica today announced the launch of the Medica Research Institute as a non-profit company that will serve as the research arm within the broader organization. Built on the principals of systematic investigation, some potential areas of study include health services research, comparative effectiveness research and clinical trial studies.

9 Mar 2010

invendo medical seeks premarket clearance for new C20 colonoscopy system

invendo medical announced today that the company has filed its 510(k) notice submission with the Food and Drug Administration for premarket clearance of the company's new C20™ colonoscopy system including the SC20™ single-use colonoscope. This is the first FDA submission for invendo medical in the United States.

8 Mar 2010

Poniard Pharmaceuticals reports net loss of $13.2M for fourth-quarter 2009

Poniard Pharmaceuticals, Inc., a biopharmaceutical company focused on innovative oncology therapies, today reported financial results for the fourth quarter and year ended December 31, 2009.

8 Mar 2010

Rexahn Pharmaceuticals granted Japanese patent for Archexin

Rexahn Pharmaceuticals, Inc, a clinical stage pharmaceutical company commercializing potential best in class oncology and CNS therapeutics, today announced that the Japanese Patent Office has issued a patent for its novel anti-cancer compound, Archexin®.

8 Mar 2010

NOVAVAX' Stage B 2009 H1N1 VLP pandemic influenza vaccine study in Mexico: Enrollment complete

Novavax, Inc. announced today that the enrollment of over 3,500 subjects in Mexico has been completed in Stage B of its pivotal 2009 H1N1 virus-like-particle (VLP) pandemic influenza vaccine study. With the 1,000 subjects already enrolled in Stage A of the trial, the enrollment in this pivotal trial is now complete with over 4,500 subjects.

8 Mar 2010

Acceptance of initial regulatory filings for BMS-PCSK9Rx triggers $6M milestone payment to Isis Pharmaceuticals

Isis Pharmaceuticals, Inc. announced today that it has earned a $6 million milestone payment from Bristol-Myers Squibb Company related to the acceptance of initial regulatory filings to begin Phase 1 clinical studies for BMS-PCSK9Rx. BMS-PCSK9Rx is an antisense drug that arose out of the ongoing collaboration between Bristol-Myers Squibb and Isis to identify antisense drugs targeting PCSK9 to lower low-density lipoprotein (LDL) cholesterol.

8 Mar 2010

KCI receives reimbursement approval for use of V.A.C. ATS Therapy System in Japan

Kinetic Concepts, Inc. today announced it has received reimbursement approval from Japan’s Health Insurance Bureau for use of the innovative V.A.C. ATS® Therapy System in the country. The approval signifies an important advancement in the company’s plans for market launch in April and follows Japan’s Ministry of Health, Labor and Welfare’s decision in November 2009 to grant final regulatory approval for the product.

8 Mar 2010

Research Roundup: Childhood obesity, insurance coverage in cancer trials, hospitals stays and need for nursing homes

Health Affairs this month is devoted to the topic of childhood obesity, with the first study of the group - National, State, And Local Disparities In Childhood Obesity - pointing out that "new data from the 2007 National Survey of Children's Health show that the percentage of children ages 10-17 who are overweight ... remained stable, while the national prevalence of obesity (BMI in the ninety-fifth percentile and higher) grew significantly, from 14.8 percent in 2003 to 16.4 percent in 2007.

6 Mar 2010

Poniard Pharmaceuticals' picoplatin Phase 2 study in metastatic CRPC: Positive results

Poniard Pharmaceuticals, Inc., a biopharmaceutical company focused on innovative oncology therapies, today announced the presentation of positive final data, including survival data, from the Company's Phase 2 clinical trial of picoplatin as a first-line therapy in men with metastatic castration-resistant (hormone-refractory) prostate cancer (CRPC). The results were presented in a General Poster Session today at the 2010 American Society of Clinical Oncology's Genitourinary Cancers Symposium in San Francisco, CA.

6 Mar 2010

New anti-tumour vaccine for mesothelioma shows promising results

A vaccine against mesothelioma, a cancer associated with exposure to asbestos, has shown early promise in its first clinical trial.

5 Mar 2010

Opexa Therapeutics reports net loss of $1,433,922 for year ended December 31, 2009

Opexa Therapeutics, Inc., a company developing Tovaxin®, a novel T-cell therapy for multiple sclerosis (MS), today reported financial results for the year ended December 31, 2009 and provided an update on its progress.

5 Mar 2010

Insurance and risk management challenges in overseas clinical trials for U.S.-based life sciences companies

The ACE Group of insurance and reinsurance companies today announced the availability of an informational white paper focusing on insurance and risk management issues faced by life sciences companies as they conduct business in the U.S. and globally. The paper, “Managing the Complex Challenges of a Global Insurance Program: Foreign Clinical Trials Case Study,” appeared in the November issue of John Liner Review, and is part of ACE Progress ReportsSM, a collection of white papers, articles and executive reports on current and emerging risk management issues.

5 Mar 2010

Successful periodontal treatment reduces preterm birth risk

Previous studies have explored the effect of periodontal treatment, irrespective of efficacy of treatment, in reducing infant prematurity. In a study titled "Risk of Preterm Birth Is Reduced with Successful Periodontal Treatment," lead researcher M. Jeffcott, and colleagues S. Parry and M. Sammel (all from the University of Pennsylvania, Philadelphia) and G. Macones (Washington University, St. Louis, Missouri) determined whether a reduction in infant prematurity was associated with successful periodontal treatment.

5 Mar 2010

Clinical Trial News and Research

Bypass surgery: New method of growing arteries could lead to non-invasive option for treatment

Restructuring results in reduction of Exelixis’ workforce by 40% and increases financial strength

Phase III study demonstrates superiority of imiquimod cream 2.5% and 3.75% in treatment of AK

Nanoparticles: Targeted cancer therapy

Viatronix V3D-Colon software used for the President's colon cancer screening exam

JAAD publishes Phase III data evaluating safety and efficacy of imiquimod in patients with AK

IEEE, AMA to host conference: Overcoming challenges in individualized healthcare, technological innovations

Medica Research Institute launched for applying innovation to healthcare delivery

invendo medical seeks premarket clearance for new C20 colonoscopy system

Poniard Pharmaceuticals reports net loss of $13.2M for fourth-quarter 2009

Rexahn Pharmaceuticals granted Japanese patent for Archexin

NOVAVAX' Stage B 2009 H1N1 VLP pandemic influenza vaccine study in Mexico: Enrollment complete

Acceptance of initial regulatory filings for BMS-PCSK9Rx triggers $6M milestone payment to Isis Pharmaceuticals

KCI receives reimbursement approval for use of V.A.C. ATS Therapy System in Japan

Research Roundup: Childhood obesity, insurance coverage in cancer trials, hospitals stays and need for nursing homes

Poniard Pharmaceuticals' picoplatin Phase 2 study in metastatic CRPC: Positive results

New anti-tumour vaccine for mesothelioma shows promising results

Opexa Therapeutics reports net loss of $1,433,922 for year ended December 31, 2009

Insurance and risk management challenges in overseas clinical trials for U.S.-based life sciences companies

Successful periodontal treatment reduces preterm birth risk

Sensing a Healthier Future

Achieving and maintaining ISO/IEC 27001 and BS 10012 certifications

Expanding research and clinical options for children with cancer

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