16:20 , May 23, 2018 |  BC Innovations  |  Distillery Techniques

Assays and screens; biomarkers

TECHNOLOGY: Cell-free assays; gene profiling A method for profiling miRNAs in extracellular vesicles could be used to identify diagnostic markers for pancreatic and other cancers. The method involves linking magnetic anti-biotin microbeads to biotinylated antibodies that...
17:36 , Feb 3, 2017 |  BC Week In Review  |  Clinical News

RG-101 regulatory update

Regulus said FDA requested additional safety and efficacy data from ongoing clinical and preclinical studies of RG-101 to treat HCV infection to lift the June clinical hold on the program. The company, which said it...
07:00 , Aug 15, 2016 |  BC Week In Review  |  Clinical News

RG-101 regulatory update

Regulus said FDA issued a request for information related to the clinical hold on RG-101. The agency requested a detailed safety data analysis from preclinical and clinical trials; exploration of potential mechanisms of hepatotoxicity in...
07:00 , Jul 18, 2016 |  BC Week In Review  |  Clinical News

RG-101: Additional Phase II data

Data from 78 evaluable treatment-naive patients with chronic HCV genotype 1 or 4 infection in an open-label, European Phase II trial showed that a single subcutaneous injection of 2 mg/kg RG-101 followed by an approved...
07:00 , Jul 11, 2016 |  BC Week In Review  |  Clinical News

RG-101: FDA hold

FDA placed a full clinical hold on RG-101 after Regulus reported a second severe adverse event of jaundice in an RG-101-treated patient. An HCV-infected patient with end-stage renal disease (ESRD) on dialysis developed jaundice 117...
01:43 , Jun 29, 2016 |  BC Extra  |  Company News

Regulus shares fall after clinical hold news

Regulus Therapeutics Inc. (NASDAQ:RGLS) plummeted $2.47 (49%) to $2.54 on Tuesday after announcing late Monday that FDA placed a full clinical hold on HCV candidate RG-101. Regulus has now reported two cases of jaundice, both...
01:28 , Jun 28, 2016 |  BC Extra  |  Top Story

Regulus sinks on clinical hold

Regulus Therapeutics Inc. (NASDAQ:RGLS) said FDA placed a full clinical hold on RG-101 after the company reported a second case of jaundice, a severe adverse event (SAE), in an ongoing Phase I study to treat...
07:00 , Jun 6, 2016 |  BC Week In Review  |  Company News

GlaxoSmithKline, Regulus deal

The companies will add a second Phase II HCV trial to a 2015 deal. In 4Q16, the companies will start a trial combining a long-acting formulation of GlaxoSmithKline’s GSK2878175 with Regulus’ RG-101. The partners expect...
07:00 , Jun 2, 2016 |  BC Innovations  |  Translation in Brief

Setting boundaries

  The Stanford University laboratory that first showed exogenous shRNA can cause liver damage by overloading the microRNA machinery has found the molecular culprit behind the toxicity, and proposed quantitative guidelines for safer shRNA therapeutics. While...
07:00 , Apr 25, 2016 |  BC Week In Review  |  Clinical News

RG-101: Additional Phase II data

Interim data from 41 evaluable treatment-naive patients with chronic HCV genotype 1 or 4 infection in a Phase II trial showed that a single subcutaneous injection of 2 mg/kg RG-101 followed by an approved once-daily...