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Phase 2a clinical trial results of CPEX Pharmaceuticals' Nasulin insulin

CPEX Pharmaceuticals Inc. today reported preliminary results related to its Phase 2a proof-of-concept clinical trial of the Company’s nasal insulin product, Nasulin™. The study was designed to evaluate the efficacy and safety of Nasulin versus placebo over a 6-week treatment period in subjects with Type 2 diabetes who were being treated with basal insulin and oral anti-diabetes agents.

18 Mar 2010

CytoDyn commences full humanization of Cytolin immune therapy for treating HIV/AIDS

CytoDyn, Inc. has begun full humanization of Cytolin®, the Company’s unique immune therapy for treating HIV/AIDS. Although a murine (mouse) version of Cytolin® was used for previous human experience that included some 200 patients successfully treated for up to two years, as well as an encouraging Phase I(b)/II(a) study, the Company believes that a fully-humanized version is necessary for the clinical trial that is expected to follow the current one (described at http://clinicaltrials.gov) for the reasons explained below.

17 Mar 2010

ONGLYZA-metformin combination: FDA accepts NDA for review

Bristol-Myers Squibb Company and AstraZeneca today announced that the U.S. Food and Drug Administration (FDA) has accepted for review a New Drug Application (NDA) for an investigational fixed dose combination of ONGLYZA™ (saxagliptin), a dipeptidyl peptidase-4 (DPP4) inhibitor, and metformin HCl extended-release tablets as a once-daily treatment for type 2 diabetes mellitus in adults.

17 Mar 2010

Zogenix announces the initiation of pivotal Phase 3 clinical trial with ZX002

Zogenix, Inc., a privately held pharmaceutical company, announced that it has initiated a pivotal Phase 3 clinical trial with ZX002, a novel, oral, controlled-release formulation of hydrocodone without acetaminophen. ZX002 is being developed for the treatment of moderate to severe pain in individuals who require around-the-clock opioid therapy for the control of pain.

17 Mar 2010

Acucela, Otsuka Pharmaceutical granted FDA Fast Track designation for ACU-4429 in treatment of dry AMD

Acucela Inc., a clinical-stage biotechnology company focused on developing new treatments for blinding eye diseases, and Otsuka Pharmaceutical Co., Ltd., today announced that they have received Fast Track designation from the U.S. Food and Drug Administration (FDA) for ACU-4429, an investigational oral treatment for dry age-related macular degeneration (dry AMD).

17 Mar 2010

CDISC approves Nextrials as one of 15 registered solutions providers

Nextrials, Inc., a leader in clinical research software and services, has been approved by the Clinical Data Interchange Standards Consortium as one of 15 registered solutions providers, and is the only company offering an electronic data capture (EDC) product supporting the CDISC Healthcare Link Initiative.

17 Mar 2010

Abraxis BioScience's Phase 3 trial comparing ABRAXANE with Taxol injection meets primary endpoint

Abraxis BioScience, Inc. today announced that its randomized registrational Phase 3 clinical trial comparing ABRAXANE® (protein-bound paclitaxel) with Taxol® (paclitaxel) injection, both in combination with carboplatin, met the study’s primary endpoint by demonstrating that ABRAXANE showed a significant improvement in overall response rate as compared to Taxol, in the first-line treatment of patients with advanced non-small cell lung cancer (NSCLC), as assessed by independent radiologist review.

17 Mar 2010

SBRT may improve survival rates for lung-cancer patients: Study

A radiation therapy that uses multiple radiation beams to target tumors precisely has been shown to eliminate the primary tumor and ultimately may improve survival rates for lung-cancer patients unable to undergo surgery, according to UT Southwestern Medical Center physicians who led a national clinical trial of the treatment.

17 Mar 2010

Protalix BioTherapeutics commences clinical trial of human acetylcholinesterase for biodefense indications

Protalix BioTherapeutics, Inc. announced today that it has initiated a phase I clinical trial of PRX-105, the Company's plant cell expressed pegylated recombinant human acetylcholinesterase product candidate in development for biodefense indications. The trial is designed to study the safety of PRX-105 by administering a bolus intravenous injection of PRX-105 in healthy volunteers.

17 Mar 2010

TRITON-TIMI 38 study evaluates response rates in patients with common genetic variant in ABCB1 gene

A new analysis of the TRITON-TIMI 38 study evaluated response rates in patients with a common genetic variant in the ABCB1 gene. Patients enrolled in the TRITON-TIMI 38 study were treated with dual antiplatelet therapy with either Plavix® (clopidogrel) plus aspirin or Effient® (prasugrel) plus aspirin and managed with percutaneous coronary intervention (PCI) following an acute coronary syndrome (ACS) event.

17 Mar 2010

AstraZeneca Canada's IRESSA receives approval for treatment of NSCLC

AstraZeneca Canada announces the recently approved indication for IRESSA(R), a once-daily oral targeted therapy for the first-line treatment of patients with locally advanced (not amenable to curative therapy) or metastatic non-small cell lung cancer (NSCLC) who have activating mutations of the epidermal growth factor receptor-tyrosine kinase (EGFR-TK). In conjunction with this approval, AstraZeneca is also announcing the availability of a diagnostic test which can now determine a patient's EGFR mutation status, representing a new era in personalized lung cancer treatment in Canada.

17 Mar 2010

Avid Bioservices highlights data of single-use bioreactors and traditional stainless steel bioreactors

Avid Bioservices, Inc. today presented data highlighting the comparability of production run performance between the company's single-use bioreactors (Thermo Scientific HyClone S.U.B.) and its traditional stainless steel bioreactors at the Thermo Scientific BioProduction Optimization Workshop in San Francisco, California.

From Thermo Fisher Scientific Inc. 17 Mar 2010

Neovasc Reducer three-year follow-up data presented at 2010 ACC annual meeting

Neovasc Inc., a developer of novel technologies used to treat vascular disease, today presented results from the follow-up phase of the initial clinical trial of its Neovasc Reducer(TM) product at the American College of Cardiology 2010 annual meeting. The Neovasc Reducer is a novel implantable product designed to treat heart disease patients who suffer from refractory angina. The new data shows that three years after implantation of the Reducer, the majority of patients continued to show measurable improvement in angina symptoms.

17 Mar 2010

Vertex Pharmaceuticals' telaprevir and VX-222 HCV inhibitor abstracts accepted for presentation at 45th EASL meeting

Vertex Pharmaceuticals Incorporated today announced that multiple abstracts related to the hepatitis C virus (HCV) protease inhibitor telaprevir and the HCV polymerase inhibitor VX-222 were accepted for presentation at the 45th Annual Meeting of the European Association for the Study of the Liver (EASL) in Vienna, Austria, April 14-18, 2010.

17 Mar 2010

Tolerx publishes follow-up data from study of otelixizumab therapy for new onset T1DM patients

Tolerx, Inc., today announced the publication in Diabetologia, the journal of the European Association for the Study of Diabetes, of the four-year follow-up clinical data from new onset type 1 diabetes (T1DM) patients (age 12-39) who received a single short course of therapy with otelixizumab (ChAglyCD3).

16 Mar 2010

Patient enrollment in Spinal Restoration' Phase III study of Biostat System now underway

Spinal Restoration, Inc. announced today that patient enrollment in the company’s Phase III study of the Biostat System for the treatment of discogenic chronic low back pain is now underway. The study, which will be conducted at 15 U.S. clinical sites, is one of only a few multi-center, randomized, blinded, placebo-controlled trials of a nonsurgical treatment for discogenic low back pain ever to be conducted.

16 Mar 2010

Hybrid revascularization procedure is safe and feasible for left main coronary artery stenosis

The left main coronary artery provides most of the blood to the heart, and current guidelines call for patients with blockages in this artery to undergo bypass surgery.

16 Mar 2010

PERSEUS clinical program demonstrates positive results of TAXUS Element Paclitaxel-Eluting Stent System

Boston Scientific Corporation today announced 12-month results from its PERSEUS clinical program that demonstrated positive safety and efficacy outcomes in workhorse lesions for the platinum chromium TAXUS® Element™ Paclitaxel-Eluting Stent System compared to the TAXUS® Express2™ Paclitaxel-Eluting Stent System.

16 Mar 2010

Minimal improvements made in survival rates of AYA population with cancer

Despite cancer survival rates increasing dramatically for children and older adults in the last 20 years, there has been minimal improvement in the survival rates in the Adolescent and Young Adult (AYA) population, an age range defined as 15 – 29 years by the presenters.

16 Mar 2010

Stage IV colorectal cancer: Therapy that improves overall survival over IFL/bevacizumab will earn 60% patient share

Decision Resources, one of the world's leading research and advisory firms for pharmaceutical and healthcare issues, finds that a therapy that would improve median overall survival over IFL (bolus 5-fluorouracil, generics/leucovorin, generics/irinotecan*) plus bevacizumab (Roche/Genentech/Chugai's Avastin), would earn a 60 percent patient share in stage IV colorectal cancer, according to surveyed U.S. oncologists. In Europe, such an agent would earn a 50 percent patient share, according to surveyed European oncologists.

16 Mar 2010

Clinical Trial News and Research

Phase 2a clinical trial results of CPEX Pharmaceuticals' Nasulin insulin

CytoDyn commences full humanization of Cytolin immune therapy for treating HIV/AIDS

ONGLYZA-metformin combination: FDA accepts NDA for review

Zogenix announces the initiation of pivotal Phase 3 clinical trial with ZX002

Acucela, Otsuka Pharmaceutical granted FDA Fast Track designation for ACU-4429 in treatment of dry AMD

CDISC approves Nextrials as one of 15 registered solutions providers

Abraxis BioScience's Phase 3 trial comparing ABRAXANE with Taxol injection meets primary endpoint

SBRT may improve survival rates for lung-cancer patients: Study

Protalix BioTherapeutics commences clinical trial of human acetylcholinesterase for biodefense indications

TRITON-TIMI 38 study evaluates response rates in patients with common genetic variant in ABCB1 gene

AstraZeneca Canada's IRESSA receives approval for treatment of NSCLC

Avid Bioservices highlights data of single-use bioreactors and traditional stainless steel bioreactors

Neovasc Reducer three-year follow-up data presented at 2010 ACC annual meeting

Vertex Pharmaceuticals' telaprevir and VX-222 HCV inhibitor abstracts accepted for presentation at 45th EASL meeting

Tolerx publishes follow-up data from study of otelixizumab therapy for new onset T1DM patients

Patient enrollment in Spinal Restoration' Phase III study of Biostat System now underway

Hybrid revascularization procedure is safe and feasible for left main coronary artery stenosis

PERSEUS clinical program demonstrates positive results of TAXUS Element Paclitaxel-Eluting Stent System

Minimal improvements made in survival rates of AYA population with cancer

Stage IV colorectal cancer: Therapy that improves overall survival over IFL/bevacizumab will earn 60% patient share

Expanding research and clinical options for children with cancer

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

From Puberty to Menopause: Clue’s CEO, Audrey Tsang on the Power of Femtech

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