Clinical Trial News and Research

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Phase III clinical trial results demonstrate effectiveness of spinosad suspension

ParaPRO, LLC announced today the results of two Phase III clinical studies published online this month in the journal Pediatrics (Pediatrics 2009; 124:e389-e395) which concluded that a spinosad suspension was significantly more effective in eliminating head lice (pediculosis capitis) than permethrin.

30 Sep 2009

Orphan drug designation for pixantrone applied by Cell Therapeutics

Cell Therapeutics, Inc. ("CTI") announced today that it has applied to the European Medicines Agency (EMEA) for orphan drug designation for pixantrone. CTI initiated the process of obtaining marketing approval in Europe in July, 2009, for the treatment of relapsed or refractory aggressive NHL.

30 Sep 2009

Medgenics announces unaudited half-yearly results for the six months ended 30 June 2009

Medgenics (AIM:MEDG) (AIM:MEDU) is pleased to announce its unaudited half-yearly results for the six months ended 30 June 2009.

30 Sep 2009

Polymedix commences Phase 1B study of novel anticoagulant reversing agent

PolyMedix, Inc., an emerging biotechnology company developing new therapeutic drug products to treat infectious diseases and acute cardiovascular disorders based on biomimetics, has initiated dosing and commenced a second clinical trial, a Phase 1B pilot proof of concept study, in the U.S. with its anticoagulant reversing agent PMX-60056 under an Investigational New Drug application (IND) filed with the U.S. Food and Drug Administration (FDA).

30 Sep 2009

Sanofi-aventis announces study results comparing efficacy of Lantus to detemir

Sanofi-aventis announced today results of a head-to-head study providing further evidence on the efficacy of once-daily, 24-hour basal insulin Lantus(R) (insulin glargine (rDNA) injection) compared to twice-daily insulin detemir. The study was presented during the 45th Annual Meeting of the European Association for the Study of Diabetes (EASD) in Vienna.

30 Sep 2009

Savvion and Patni partner to deliver BPM-enabled solutions

Savvion® and Patni Life Sciences announced today a strategic partnership to jointly deliver Business Process Management (BPM)-enabled solutions for clinical operations on top of Savvion’s Life Sciences Foundation.

30 Sep 2009

Reuters examines how HIV vaccine trial results will guide future studies

Reuters reports on how the results of an experimental AIDS vaccine, which showed modest potential for preventing infection, are leading researchers back "to the drawing board" as they try to better understand how the AIDS vaccine works.

30 Sep 2009

Synta commences Phase 1/2 clinical study of novel Hsp90 inhibitor in hematologic malignancies

Synta Pharmaceuticals Corp., a biopharmaceutical company focused on discovering, developing, and commercializing small molecule drugs to treat severe medical conditions, today announced that it has initiated a Phase 1/2 clinical study of its novel heat shock protein 90 (Hsp90) inhibitor, STA-9090 in hematologic malignancies with a once-a-week dosing schedule.

29 Sep 2009

Acrux reports Phase III trial results evaluating AXIRON for testosterone deficiency

Australian company, Acrux, today announced positive results from a Phase III trial evaluating the safety and efficacy of AXIRON™ in 155 men with testosterone deficiency (hypogonadism), across 26 sites in six countries.

29 Sep 2009

BioClinica to demonstrate integrated eClinical technology at the SCDM conference

BioClinica, Inc., a leading global provider of clinical trial services, is helping to advance the discipline of clinical data management and will demonstrate integrated eClinical and imaging data management technology and expertise at the 2009 Society of Clinical Data Management (SCDM) Annual Conference, October 4-6, 2009 in Seattle, WA (Booth # 401).

From Clario 29 Sep 2009

Also in Global Health news: News outlets explore AIDS vaccine research; chloroquine resistance unraveled; authorities contest maternal mortality report

The Associated Press examines the role of the Thai participants in the recent clinical trial of an experimental HIV vaccine which showed modest potential for preventing infection. "Nearly 16,000 Thais ignored the false rumors that they were being infected by the AIDS virus, and overcame their fears of becoming social outcasts to participate in trials of the first vaccine found to prevent infection with the deadly virus," the news service writes (Ahuja/Casey, 9/27).

29 Sep 2009

AAPS Annual Meeting to discuss new research and technologies in pharmaceutical sciences

More than 8,500 individuals from the field of pharmaceutical research are expected to attend this year's AAPS Annual Meeting and Exposition November 8 - 12, 2009 at the Los Angeles Convention Center in California.

29 Sep 2009

NovoCure initiates newly-diagnosed GBM clinical trial

NovoCure, Ltd., a privately held medical device company focused on developing the Novo-TTF device, a non-invasive portable medical device for the treatment of cancer, announced the completion of a new funding round today. Key investors in this round included Pfizer Inc, Johnson & Johnson Development Corporation and Index Ventures.

29 Sep 2009

Conditional IDE approval for Flexstent Femoropopliteal Self Expanding Stent System

Flexible Stenting Solutions Inc. (“FSS”), a leading developer of next generation peripheral arterial and biliary stents, announced today that it has received Conditional Investigational Device Exemption (IDE) approval for its FlexStent® Femoropopliteal Self Expanding Stent System.

29 Sep 2009

Hookworms can prevent asthma

A study conducted in Vietnam has added further weight to the view that parasitic gut worms, such as hookworm, could help in the prevention and treatment of asthma and other allergies.

29 Sep 2009

International Medica Foundation sponsors rotavirus vaccine trial in Ghana

More than half a million children – or 1,400 to 1,600 each day – die from rotavirus, the most common cause of severe childhood diarrhea. Almost all of these deaths occur in developing countries, where lifesaving medical care may not be affordable or available to the families with the most critical needs. In addition, income loss due to the need for parents to take care of sick children can have a very significant economic burden on families that can least afford it.

29 Sep 2009

Halozyme Therapeutics announces Phase 1 clinical study to assess three insulin analogs

Halozyme Therapeutics, Inc. today announced the commencement of a Phase 1 clinical study that will assess the effects of three approved prandial (mealtime) insulin analogs administered with its proprietary rHuPH20 (PH20) hyaluronidase enzyme compared to each of the analogs alone. This randomized, three-way cross-over design, euglycemic clamp study will compare the postprandial pharmacokinetics (PK) and glucodynamics (GD) of the insulin analogs.

28 Sep 2009

Increasing insulin levels can aid muscle building in the elderly

Recently, scientists have recognized that loss of responsiveness to insulin plays a major role in the loss of physical strength that occurs as people grow older. Now, University of Texas Medical Branch at Galveston researchers have demonstrated that by increasing insulin levels above the normal range in elderly test subjects, they can restore the impaired muscle-building process responsible for age-related physical weakness.

28 Sep 2009

Preliminary results from procedural review of Menaflex released by the FDA

The U.S. Food and Drug Administration (FDA) yesterday released preliminary results of a review of its internal procedures surrounding the review of ReGen Biologics’Menaflex collagen meniscus implant for use in the U.S.

28 Sep 2009

Phase 2 clinical trial results of IMO-2055 announced

Idera Pharmaceuticals, Inc., today announced the presentation of final data from a clinical trial evaluating IMO-2055, an agonist of Toll-like Receptor (TLR) 9, as monotherapy in patients with Renal Cell Carcinoma (RCC). The data are being presented during the Eighth International Kidney Cancer Symposium being held in Chicago, September 25-26, 2009.

28 Sep 2009

Clinical Trial News and Research

Phase III clinical trial results demonstrate effectiveness of spinosad suspension

Orphan drug designation for pixantrone applied by Cell Therapeutics

Medgenics announces unaudited half-yearly results for the six months ended 30 June 2009

Polymedix commences Phase 1B study of novel anticoagulant reversing agent

Sanofi-aventis announces study results comparing efficacy of Lantus to detemir

Savvion and Patni partner to deliver BPM-enabled solutions

Reuters examines how HIV vaccine trial results will guide future studies

Synta commences Phase 1/2 clinical study of novel Hsp90 inhibitor in hematologic malignancies

Acrux reports Phase III trial results evaluating AXIRON for testosterone deficiency

BioClinica to demonstrate integrated eClinical technology at the SCDM conference

Also in Global Health news: News outlets explore AIDS vaccine research; chloroquine resistance unraveled; authorities contest maternal mortality report

AAPS Annual Meeting to discuss new research and technologies in pharmaceutical sciences

NovoCure initiates newly-diagnosed GBM clinical trial

Conditional IDE approval for Flexstent Femoropopliteal Self Expanding Stent System

Hookworms can prevent asthma

International Medica Foundation sponsors rotavirus vaccine trial in Ghana

Halozyme Therapeutics announces Phase 1 clinical study to assess three insulin analogs

Increasing insulin levels can aid muscle building in the elderly

Preliminary results from procedural review of Menaflex released by the FDA

Phase 2 clinical trial results of IMO-2055 announced

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