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XenoPort commences Phase 2b arbaclofen placarbil clinical trial for treating gastroesophageal reflux disease

XenoPort, Inc. announced today that it has initiated a Phase 2b clinical trial of arbaclofen placarbil (AP), also known as XP19986, in patients with gastroesophageal reflux disease (GERD) who remain symptomatic despite treatment with a proton pump inhibitor (PPI). The trial is a multi-center, randomized, double-blind, placebo-controlled study designed to assess the efficacy and safety of AP as adjunctive therapy to PPIs.

19 Oct 2009

Antisense Pharma's SAPPHIRE Phase III trial evaluating trabedersen approved by Health Canada

The biopharmaceutical company Antisense Pharma GmbH has announced today that it has received the approval by Health Canada for its pivotal Phase III clinical trial SAPPHIRE in patients with recurrent or refractory anaplastic astrocytoma.

19 Oct 2009

Genentech reports results of ACTEMRA Phase III study for rheumatoid arthritis

Genentech, Inc., a wholly-owned member of the Roche Group, today announced two-year results from a Phase III study, which showed that people with rheumatoid arthritis (RA) who received either a 4 mg/kg or 8 mg/kg dose of ACTEMRA® (tocilizumab), in combination with methotrexate, had no progression of joint damage, (75 and 83 percent, respectively, as assessed by radiograph) compared with people who received methotrexate alone (66 percent).

19 Oct 2009

Angiochem reports Phase 1/2 efficacy study results of ANG1005 for treating brain cancer

Angiochem, Inc. a clinical-stage biotechnology company developing drugs that are uniquely capable of crossing the blood-brain barrier to treat brain diseases, announced today that its lead drug candidate, ANG1005, has demonstrated a favorable safety and efficacy profile in more than 100 patients with brain cancer from two separate Phase 1 /2 clinical studies in patients with progressive gliomas, including recurrent glioblastoma, and in patients with progressive brain metastases.

19 Oct 2009

NanoBio's NB-401 preclinical data to be presented at the 2009 North American Cystic Fibrosis Conference

NanoBio Corporation today announced compelling preclinical data for NB-401, a nebulized nanoemulsion-based agent that kills highly drug-resistant strains of bacteria commonly found in cystic fibrosis patients. Currently there are limited treatment options available that effectively address these resistant bacteria. The study results are being presented today at the 2009 Annual North American Cystic Fibrosis Conference (NACFC) in Minneapolis, Minn.

19 Oct 2009

Angiochem announces results of Phase 1 /2 clinical trials of ANG1005

19 Oct 2009

Cardium Therapeutics reports positive findings from Excellarate Phase 1/2 clinical study

Cardium Therapeutics today announced the publication of positive findings from the open label multi-center Phase 1/2 clinical study of Excellarate(TM) (GAM501, Ad5PDGF-B / 2.6% collagen), its product candidate for the potential treatment of non-healing diabetic foot ulcers.

19 Oct 2009

Phase I clinical study of PENNVAX-B preventive DNA vaccine using electroporation technology

Inovio Biomedical Corporation, a leader in DNA vaccine design, development and delivery, and the HIV Vaccine Trials Network (HVTN) announced today the initiation of a phase I clinical study of Inovio’s PENNVAX-B preventive DNA vaccine delivered using its proprietary electroporation technology.

19 Oct 2009

FDA grants marketing approval for Elitek

Sanofi-aventis U.S. announced that the U.S. Food and Drug Administration (FDA) has granted marketing approval for Elitek (rasburicase) to be used for the initial management of plasma uric acid (PUA) levels in adult patients with leukemia, lymphoma, and solid tumor malignancies who are receiving anti-cancer therapy expected to result in tumor lysis syndrome (TLS) and subsequent elevations of plasma uric acid.

19 Oct 2009

China's SFDA approves Celsion’s global Phase III ThermoDox HEAT trial for treating liver cancer

Celsion Corporation announced today that it has received official approval from China’s State Food and Drug Administration (“SFDA”) for its Clinical Trial Application for ThermoDox that permits Celsion to include Chinese clinical trial sites in its Phase III ThermoDox HEAT trial for the treatment of primary liver cancer, also known as hepatocellular carcinoma (HCC).

15 Oct 2009

Soligenix commences enrollment in its Phase 3 Orbec clinical trial for acute GI GVHD

Soligenix, Inc., formerly known as DOR BioPharma, Inc., a late-stage biotechnology company, announced today that it has initiated enrollment in its confirmatory Phase 3 randomized, double-blind, placebo-controlled, multicenter clinical trial evaluating orBec(®) for the treatment of acute gastrointestinal Graft-versus-Host disease (GI GVHD).

15 Oct 2009

Inspire to present its denufosol tetrasodium cystic fibrosis program data at the 23rd NACFC

Inspire Pharmaceuticals, Inc. announced today Inspire scientists and collaborators will present data from the denufosol tetrasodium cystic fibrosis (CF) program in a poster presentation at the 23rd Annual North American Cystic Fibrosis Conference (NACFC) October 15 - 17, 2009 in Minneapolis, MN.

15 Oct 2009

Positive results from Protalix BioTherapeutics Phase III UPLYSO clinical trial

Protalix BioTherapeutics, Inc., announced today positive top-line results from the Company's pivotal Phase III clinical trial of UPLYSO (taliglucerase alfa, previously referred to as prGCD) in treatment naive patients diagnosed with Gaucher disease.

15 Oct 2009

pSivida achieves milestone in Phase III Iluvien trial, last patient completes two-year follow up visit

pSivida Corp., a leading drug delivery company that has developed two of the only three products approved by the FDA for the long-term, sustained release delivery of drug to treat chronic back of the eye disease, today announced that the last patient in the Phase III clinical trial being conducted by its collaborative partner, Alimera Sciences, for a new treatment for diabetic macular edema (DME) has completed the two-year follow up visit.

15 Oct 2009

Cytheris initiates Phase I/IIa dose escalation study of patients suffering from ICL

Cytheris SA, a clinical stage biopharmaceutical company focused on research and development of new therapies for immune modulation, today announced the initiation of a Phase I/IIa dose escalation study of patients suffering from idiopathic CD4 lymphocytopenia (ICL).

15 Oct 2009

Jazz Pharmaceuticals to present Phase III sodium oxybate trial data at ACR 2009 meetings

Jazz Pharmaceuticals, Inc. announced that data from the company's first Phase III clinical trial of sodium oxybate (JZP-6) for the treatment of fibromyalgia will be presented during the American College of Rheumatology 2009 Annual Meeting (ACR) in Philadelphia, Pennsylvania and also in November during the US Psychiatric and Mental Health Congress (US Psych Congress) in Las Vegas, Nevada.

15 Oct 2009

Positive data from Cardium Therapeutics' Matrix Phase 2b Excellarate trial

Cardium Therapeutics today reported positive data from its Matrix Phase 2b clinical trial of Excellarate(TM) for the potential treatment of patients with chronic non-healing diabetic foot ulcers based on the Company's Gene Activated Matrix (GAM) technology platform.

15 Oct 2009

FDA approves ZyStor Therapeutics' ZC-701 for Phase I human safety trial

ZyStor Therapeutics, Inc., a biotechnology company developing a new class of targeted protein therapeutics for the treatment of Lysosomal Storage Diseases using the Company's proprietary Glycosylation Independent Lysosomal Targeting technology, today announced that it has received clearance from the U. S. Food and Drug Administration to proceed into a clinical trial for its first drug candidate, ZC-701, an enzyme replacement therapy for the treatment of Pompe disease.

14 Oct 2009

Positive data from ZIOPHARM's palifosfamide sarcoma Phase II trial

ZIOPHARM Oncology, Inc. announced today positive top line interim data from the multicenter randomized Phase II trial of palifosfamide (ZymafosTM, ZIO-201) treating patients with unresectable or metastatic soft tissue sarcoma. The analysis evaluated 62 patients treated as of the end of September, with 58 being analyzed.

14 Oct 2009

EMEA grants ArQule's ARQ 197 orphan drug designation

ArQule, Inc. today announced that the European Medicines Evaluation Agency (EMEA) has designated ARQ 197 as an orphan medical product for the treatment of soft tissue sarcoma.

14 Oct 2009

Drug Trial News

XenoPort commences Phase 2b arbaclofen placarbil clinical trial for treating gastroesophageal reflux disease

Antisense Pharma's SAPPHIRE Phase III trial evaluating trabedersen approved by Health Canada

Genentech reports results of ACTEMRA Phase III study for rheumatoid arthritis

Angiochem reports Phase 1/2 efficacy study results of ANG1005 for treating brain cancer

NanoBio's NB-401 preclinical data to be presented at the 2009 North American Cystic Fibrosis Conference

Angiochem announces results of Phase 1 /2 clinical trials of ANG1005

Cardium Therapeutics reports positive findings from Excellarate Phase 1/2 clinical study

Phase I clinical study of PENNVAX-B preventive DNA vaccine using electroporation technology

FDA grants marketing approval for Elitek

China's SFDA approves Celsion’s global Phase III ThermoDox HEAT trial for treating liver cancer

Soligenix commences enrollment in its Phase 3 Orbec clinical trial for acute GI GVHD

Inspire to present its denufosol tetrasodium cystic fibrosis program data at the 23rd NACFC

Positive results from Protalix BioTherapeutics Phase III UPLYSO clinical trial

pSivida achieves milestone in Phase III Iluvien trial, last patient completes two-year follow up visit

Cytheris initiates Phase I/IIa dose escalation study of patients suffering from ICL

Jazz Pharmaceuticals to present Phase III sodium oxybate trial data at ACR 2009 meetings

Positive data from Cardium Therapeutics' Matrix Phase 2b Excellarate trial

FDA approves ZyStor Therapeutics' ZC-701 for Phase I human safety trial

Positive data from ZIOPHARM's palifosfamide sarcoma Phase II trial

EMEA grants ArQule's ARQ 197 orphan drug designation

Advancing brain microphysiological systems (bMPS)

PhD researcher at LifeArc

Unveiling Hidden Potential: Organoids for Disease Modeling in Neuroscience Research

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