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Clinical Trials

Arrowhead begins dosing patients in Phase I trial of ARC-AAT to treat AATD By PBR Staff Writer
US-based Arrowhead Research has started dosing patients in Part B of a Phase I clinical trial of its RNAi-based drug candidate ARC-AAT to treat liver disease associated with the rare genetic disorder alpha-1 antitrypsin deficiency (AATD).
Contract Research & Services > Clinical Trials > News
FDA and NIH grant clearance for VistaGen to initiate AV-101 Phase II MDD trial By PBR Staff Writer
The US Food and Drug Administration (FDA) and the US National Institutes of Health (NIH) have granted clearance to VistaGen Therapeutics to initiate a Phase II clinical trial of its orally active AV-101 in patients with treatment-resistant major depressive disorder (MDD).
Contract Research & Services > Clinical Trials > News ProQR begins patient enrollment in Phase Ib trial of QR-010 to treat cystic fibrosis By PBR Staff Writer
ProQR Therapeutics has started enrollment in its Phase Ib clinical trial (PQ-010-001) of QR-010, a new investigational RNA therapeutic designed to repair the genetic mutation in the mRNA of cystic fibrosis (CF) patients due to the DF508 mutation.
Contract Research & Services > Clinical Trials > News
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PRA Named Clinical Company of the Year
PRA Health Sciences (PRA) is pleased to announce that it was once again recognized as the Best Clinical Company of the Year. PRA received the award at the PharmaTimes Clinical Researcher of the Year Americas ceremony in Cary, North Carolina. This award follows PRA’s recognition as the Best International Clinical Company of the Year which was announced earlier this year in London.
Contract Research & Services > Clinical Trials > Press Releases
PRA Continues the Transformation of Clinical Trials with Predictivv
PRA Health Sciences, a leading global contract research organization, today announced its new Predictivv™ platform, the beginning of an entirely new approach on the role technology will play in the future of clinical development. The Predictivv™ platform will be a fully integrated solution for designing, planning and optimizing the management of global clinical studies. Designed around a unified platform that harmonizes data, processes, and people across every aspect of a clinical study, Predictivv™ will enable unprecedented adaptive intelligence and decision support for the ever-increasing complexities of the clinical development process.
Contract Research & Services > Clinical Trials > Press Releases
NIAAA begins clinical study of gabapentin enacarbil to treat patients with AUD
By PBR Staff Writer
The National Institute on Alcohol Abuse and Alcoholism (NIAAA), part of the US National Institutes of Health's (NIH), has started a clinical trial of gabapentin enacarbil (Horizant) in extended-release tablets to treat patients with moderate to severe alcohol use disorder (AUD).
Contract Research & Services > Clinical Trials > News
Immune begins two Phase II trials with bertilimumab to treat ulcerative colitis and bullous pemphigoid
By PBR Staff Writer
US-based Immune Pharmaceuticals has started its Phase II ulcerative colitis clinical trial and is scheduled to begin its Phase II bullous pemphigoid clinical trial on 1 July with bertilimumab.
Contract Research & Services > Clinical Trials > News
Stealth BioTherapeutics reports results from ReVIEW study of Ocuvia in DME patients
Stealth BioTherapeutics (Stealth), a biopharmaceutical company developing drug candidates for treating mitochondrial dysfunction, announced results from its ReVIEW study of Ocuvia in diabetic macular edema (DME) patients.
Contract Research & Services > Clinical Trials > News
Tokai initiates Phase III galeterone trial in patients with AR-V7 positive mCRPC
By PBR Staff Writer
US-based Tokai Pharmaceuticals has initiated a Phase III clinical trial (ARMOR3-SV) of galeterone in patients with AR-V7 positive metastatic castration-resistant prostate cancer (mCRPC).
Contract Research & Services > Clinical Trials > News
Abbvie reports positive Phase IIIb results of Viekirax+ Exviera in HCV patients
By PBR Staff Writer
US-based biopharmaceutical firm AbbVie has reported positive results from its Phase IIIb trial (TURQUOISE-III) of Viekirax (ombitasvir/paritaprevir/ritonavir tablets) plus Exviera (dasabuvir tablets) in genotype 1b (GT1b) chronic hepatitis C virus (HCV) infected adult patients with compensated liver cirrhosis.
Contract Research & Services > Clinical Trials > News
Celator reports positive induction response results from Phase III trial of CPX-351 in AML patients
Celator Pharmaceuticals (CPXX) announced final induction response rate results (complete remission plus complete remission with incomplete hematologic recovery, or CR+CRi) in the Phase III study comparing CPX-351 (cytarabine:daunorubicin) liposome injection to the standard of care regimen, referred to as 7+3 (conventional cytarabine and daunorubicin treatment), in patients with untreated high-risk (secondary) acute myeloid leukemia (AML).
Contract Research & Services > Clinical Trials > News
Agios begins dosing in Phase I trial of AG-881 in patients with advanced solid tumors with IDH
By PBR Staff Writer
US-based Agios Pharmaceuticals has dosed first patient in a Phase I trial of single agent AG-881, a small molecule, in patients with advanced solid tumors with an isocitrate dehydrogenas (IDH) mutation.
Contract Research & Services > Clinical Trials > News
Admune begins patient enrolment in Phase I trial of hetIL-15 to treat metastatic cancers
By PBR Staff Writer
US-based biotechnology firm Admune Therapeutics has started patient enrollment in a Phase I clinical trial evaluating the safety and efficacy of its lead compound Heterodimeric IL-15 (hetIL-15) for the treatment of metastatic cancers.
Contract Research & Services > Clinical Trials > News
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