Clinical Trial News and Research

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Phase 3 trial of ataluren commences

PTC Therapeutics, Inc. (PTC) today announced the initiation of a Phase 3 trial of ataluren (formerly PTC124(R)), an investigational protein restoration therapy in patients with nonsense mutation cystic fibrosis (nmCF).

11 Sep 2009

Phase II clinical trial of TAK-700 for treating advanced prostate cancer commences

Takeda Pharmaceutical Company Limited and its wholly-owned subsidiary Millennium: The Takeda Oncology Company today announced the initiation of the Phase II portion of a Phase I/II clinical trial of TAK-700 in patients with advanced prostate cancer.

11 Sep 2009

Children's Hospital to determine optimal duration of antimicrobial treatment for UTIs

In the largest study of its kind, pediatric researchers at The Children's Hospital of Philadelphia have received a federal contract for a project to determine the most beneficial method of using antibiotics to treat urinary tract infections (UTIs) in children.

11 Sep 2009

UBC acquires Cognitive Drug Research

United BioSource Corporation (UBC) today announced the acquisition of Cognitive Drug Research, Ltd. (CDR), the leader in computerized cognitive testing for clinical trials.

11 Sep 2009

Phase II human clinical trial of Exsulin commences

Exsulin Corporation today announced the start of a phase II human clinical trial of Exsulin, a peptide drug product aimed at restoring insulin production in people with diabetes mellitus. The randomized, controlled 12-week trial in patients with established Type 1 diabetes (T1DM) will be co-led by Mayo Clinic in Rochester, Minn., and McGill University Health Centre in Montreal, Canada.

10 Sep 2009

Phase 2b clinical trial results of TC-5214 to be presented at nAChR2009

Targacept, Inc., a clinical-stage biopharmaceutical company developing a new class of drugs known as NNR Therapeutics, today confirmed plans to present data from its completed Phase 2b clinical trial of TC-5214 as an augmentation treatment for major depressive disorder at the Nicotinic Acetylcholine Receptors as Therapeutic Targets Symposium (nAChR2009) in Lincolnshire, Illinois on October 15, 2009.

10 Sep 2009

Teva's COPAXONE holds promise for relapsing remitting multiple sclerosis

Teva Pharmaceutical Industries Ltd. (NASDAQ: TEVA) today presented data that demonstrated patients treated for 10 and 15 years with COPAXONE® (glatiramer acetate injection) had significant reduction in disease severity. These data, generated from the longest continuous prospective study of any disease modifying therapy in relapsing remitting multiple sclerosis (RRMS), were presented today at the 25th Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) in Düsseldorf, Germany.

10 Sep 2009

Acceleron's Phase 1 trial of ACE-031 reveals its potential in treating neuromuscular diseases

Acceleron Pharma, Inc., a biopharmaceutical company developing novel therapeutics that modulate the growth of cells and tissues including red blood cells, bone, and muscle, today announced preliminary results from the ACE-031 Phase 1 single dose clinical trial demonstrating that ACE-031 increased lean body mass and muscle volume. The results from this randomized, placebo-controlled study were presented at the 14th International Congress of the World Muscle Society in Geneva, Switzerland.

10 Sep 2009

Human neural stem cells to treat Pelizaeus-Merzbacher Disease

StemCells, Inc. (NASDAQ:STEM) announced today that it will soon initiate with the University of California, San Francisco (UCSF) Children’s Hospital a Phase I clinical trial to evaluate the therapeutic potential of StemCells’ proprietary HuCNS-SC® product candidate (purified human neural stem cells) to treat Pelizaeus-Merzbacher Disease (PMD), a myelination disorder that primarily affects infants and young children.

10 Sep 2009

FDA approves Ascenta's IND for AT-406 multi-IAP antagonist

Ascenta Therapeutics announced today that following the approval by the U.S. Food and Drug Administration (FDA) of its Investigational New Drug (IND) Application for AT-406, an orally-active, small molecule, multi-IAP antagonist, the company will initiate a Phase I clinical trial in patients with advanced cancer during the fourth quarter of 2009.

10 Sep 2009

Phase III trial demonstrates rapid efficacy of Zelrix in treating acute migraine

NuPathe Inc., a specialty pharmaceutical company developing innovative products for the treatment of neurological and psychiatric diseases, today announced data from the pivotal Phase III trial of Zelrix™, a novel transdermal patch in clinical development for the treatment of acute migraine. Zelrix combines NuPathe’s proprietary SmartRelief™ iontophoretic transdermal technology with sumatriptan, the most prescribed treatment for acute migraine in the United States.

10 Sep 2009

Roche conducts third Phase 1 clinical trial utilizing Halozyme’s Enhanze Technology

Halozyme Therapeutics, Inc. (Nasdaq: HALO), a biopharmaceutical company developing and commercializing products targeting the extracellular matrix, today announced that the first patient was dosed in a Phase 1 pharmacokinetic clinical trial using Enhanze™ Technology (rHuPH20, recombinant human hyaluronidase) in a subcutaneous formulation of a Roche biologic.

10 Sep 2009

Cancer Research UK launches a new Cancer Centre at Cardiff

Cardiff today (Thursday) joins a unique chain of Cancer Research UK Centres that are being launched across the UK.

10 Sep 2009

Affymax to complete Hematide Phase 3 clinical study by the end of 2009

Affymax, Inc. today announced that it has notified clinical trial sites to complete treatment of patients in the Phase 3 clinical program for the investigational drug, Hematide, by the end of 2009.

10 Sep 2009

Cempra commences Phase 2/3 clinical study of CEM-102 for treating acute bacterial skin structure infections

Cempra Pharmaceuticals today announced that enrollment is underway in an adaptive design Phase 2/3 clinical study with CEM-102 for patients suffering from acute bacterial skin structure infections (ABSSI). CEM-102 is an oral antibiotic with an established record of treating staphylococcal infections outside the United States, including those due to methicillin-resistant Staphylococcus aureus (MRSA).

10 Sep 2009

Non-invasive CR-2000 Research System to be used in START clinical trial

Hypertension Diagnostics, Inc., today announced that its non-invasive HDI/PulseWave CR-2000 Research System (CR-2000) has been selected for use in the Strategic Timing of AntiRetroviral Treatment (START) substudy on Arterial Elasticity that will examine blood vessel function and cardiovascular risk during HIV infection.

10 Sep 2009

Galapagos starts new clinical trial for GLPG0259

Galapagos NV (Euronext: GLPG) announced today that it has initiated a second Phase I clinical trial for GLPG0259, a novel candidate drug being developed for rheumatoid arthritis (RA).

10 Sep 2009

Oral GLP-1 Analog approved for human clinical trial

Oramed Pharmaceticals, Inc., a developer of oral drug delivery systems, announced today that it has received approval from the Institutional Review Board (IRB) to commence human clinical trials of an oral GLP-1 Analog.

10 Sep 2009

Clinical trial reveals RENOVA topical treatment cream shows continuous improvement

In 2008, the global anti-aging skincare market approached $15 billion, with 32 percent of U.S. facial skincare product launches boasting anti-aging claims many over-the-counter products are claiming to achieve comparable benefits as prescription anti-aging treatments.

10 Sep 2009

Patient enrollment completed in Phase 2b clinical trial for Pyridorin

NephroGenex, Inc., a privately held drug development company focusing on kidney disease, today announced the completion of patient enrollment in its Phase 2b clinical trial (PYR-210) studying the safety and efficacy of its lead drug candidate Pyridorin (pyridoxamine dihydrochloride) in type 2 diabetic patients with overt diabetic nephropathy. Three hundred and seventeen (317) patients have been randomized.

10 Sep 2009

Clinical Trial News and Research

Phase 3 trial of ataluren commences

Phase II clinical trial of TAK-700 for treating advanced prostate cancer commences

Children's Hospital to determine optimal duration of antimicrobial treatment for UTIs

UBC acquires Cognitive Drug Research

Phase II human clinical trial of Exsulin commences

Phase 2b clinical trial results of TC-5214 to be presented at nAChR2009

Teva's COPAXONE holds promise for relapsing remitting multiple sclerosis

Acceleron's Phase 1 trial of ACE-031 reveals its potential in treating neuromuscular diseases

Human neural stem cells to treat Pelizaeus-Merzbacher Disease

FDA approves Ascenta's IND for AT-406 multi-IAP antagonist

Phase III trial demonstrates rapid efficacy of Zelrix in treating acute migraine

Roche conducts third Phase 1 clinical trial utilizing Halozyme’s Enhanze Technology

Cancer Research UK launches a new Cancer Centre at Cardiff

Affymax to complete Hematide Phase 3 clinical study by the end of 2009

Cempra commences Phase 2/3 clinical study of CEM-102 for treating acute bacterial skin structure infections

Non-invasive CR-2000 Research System to be used in START clinical trial

Galapagos starts new clinical trial for GLPG0259

Oral GLP-1 Analog approved for human clinical trial

Clinical trial reveals RENOVA topical treatment cream shows continuous improvement

Patient enrollment completed in Phase 2b clinical trial for Pyridorin

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