RestorGenex Announces Data on the Effect of RES-529; Amarantus Enters Into CRO Agreement With Chiltern International to Commence Phase 2b Clinical Development of Eltoprazine Print E-mail
By Marilyn Mullen   
Thursday, 21 May 2015 21:26
Below is a look at some of the headlines for companies that made news in the healthcare sector on May 21, 2015.  
RestorGenex Corporation (OTCQB:RESX), a specialty biopharmaceutical company focused on developing products for oncology, ophthalmology and dermatology, announced that Keith Ferguson, M.D. and Nathan Sandbo, M.D., both of the Division of Allergy, Pulmonary, and Critical Care Medicine, University of Wisconsin School of Medicine and Public Health, presented scientific data utilizing RES-529 in idiopathic pulmonary fibrosis. The poster entitled "The Novel TOR Complex 1/2 Inhibitor RestorGenex 529 (RES-529) Inhibits Human Lung Myofibroblast Differentiation" was presented on Tuesday, May 19, 2015 at the American Thoracic Society International Conference in Denver, Colorado.
 
The presentation discussed results from pre-clinical research evaluating RES-529, a small molecule that interferes with the molecular components which make up TORC1 and TORC2 protein complexes within the PI3K/Akt/mTOR pathway. The focus of the presentation was on in vitro and in vivo models of idiopathic pulmonary fibrosis (IPF). IPF is a disabling progressive and often deadly disorder with very few therapeutic options in which the lungs become progressively scarred over time causing shortness of breath, coughing, and limiting participation in everyday physical activities. Current treatments for IPF include oxygen therapy, pulmonary rehabilitation, and lung transplant. Median survival for IPF patients is only two to four years.
 
The persistent activation of myofibroblasts has been described in IPF and signaling via the PI3K/Akt/mTOR pathway has been shown to mediate myofibroblast differentiation. These studies investigated the potential antifibrotic effect of RES-529 in (1) TGF-β dependent activation of the PI3K/Akt/mTOR pathway, (2) myofibroblast differentiation, and (3) an in vivo pulmonary fibrosis model.
 
RES-529 was shown to inhibit both mTOR-dependent signaling and myofibroblast differentiation in human lung fibroblasts. In a 10-day in vivo mouse model of bleomycin-induced pulmonary fibrosis, RES-529 showed a trend toward improved survival and less histologic fibrosis. "There is a large need for better treatments for patients with idiopathic pulmonary fibrosis. This data support the potential effectiveness of dual inhibition of both TORC1 and TORC2 with RES-529 in halting some of the key cellular events that promote pulmonary fibrosis," said Nathan Sandbo, M.D., senior author of the presentation. 
Stephen M. Simes, chief executive officer of RestorGenex added, "Idiopathic pulmonary fibrosis is a devastating disease. While our current focus is on the use of RES-529 in oncology and ophthalmology, we believe that RES-529 has potentially wide-ranging applications in treating other diseases as demonstrated by this encouraging research of RES-529 as a treatment for pulmonary fibrosis."
 
 
  
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Amarantus BioScience Holdings, Inc. (OTCQB:AMBS), a biotechnology company focused on developing therapeutic and diagnostic products for neurological disorders and orphan indications, announced that it has entered into a clinical trial agreement with Chiltern International (Chiltern), a leading global contract research organization (CRO), to manage the clinical research and monitoring program services for the Phase 2b study of eltoprazine in Parkinson's disease levodopa-induced dyskinesia (PD-LID).
 
The Company also announced that it has completed its clinical investigator meetings in both the United States and European Union and is on track to commence enrollment and dosing for the 60-patient international, multi-center PD-LID study in the second quarter of 2015.
 
"We selected Chiltern as our CRO partner for PD-LID Phase 2b development because of their proven excellence in quality and reliability in drug development along with their exceptional expertise in the managing the comprehensive and extensive international clinical study regulatory requirements," said Gerald E. Commissiong, President & CEO of Amarantus. "Now that our investigator meetings have been completed in both the U.S. and the EU, we are ready to commence the eltoprazine dose response, efficacy and safety trial this quarter. The expansion of our team, via our collaboration with Chiltern, will allow us to advance the PD-LID program as efficiently and quickly as possible. The next step is to initiate our first clinical site and begin screening patients for enrollment in the study."
 
Chiltern will manage all clinical activities related to the Phase 2b eltoprazine study including clinical trial site approval and authorization, investigator and staff training, patient recruitment, timeline and budget monitoring, centralized program tracking systems, regulatory controls and responsibilities, data monitoring committee organization and administration, and trial data quality control and final data lock.
 
Dr. Jim Esinhart, CEO of Chiltern, added, "Our mission is to provide premier CRO services to innovative and forward-thinking biopharmaceutical companies. As such, we are pleased to partner with Amarantus and manage the initiation of their Phase 2b study with eltoprazine. We recognize that PD-LID can be severely disabling and impact quality of life for Parkinson's patients and utilizing our award-winning trial management program and over 30 years of industry expertise, we look forward to advancing eltoprazine to its next level of clinical development and one-step closer to fulfilling its therapeutic potential for patients with PD."
 
The Phase 2b eltoprazine trial is a double-blind, placebo-controlled, four-way crossover, dose range finding, clinical study designed to evaluate dose response effect of repeated eltoprazine dosing on safety, tolerability and dyskinesia severity using state-of-the-art rating scales, diaries and motion sensors. Pharmacokinetics and pharmacodynamics will also be evaluated.
 
 
Also Thursday:
 
 
Adaptimmune Therapeutics plc (Nasdaq:ADAP), a clinical stage biopharmaceutical company focused on the use of T-cell therapy to treat cancer, today announced that it will present data on its lead clinical program, an affinity enhanced T-cell receptor (TCR) therapeutic targeting the NY-ESO-1 cancer antigen at the 2015 Annual American Society of Clinical Oncology (ASCO) Meeting.
 
Anavex Life Sciences Corp. (OTCQX:AVXL), a clinical-stage biopharmaceutical company developing drug candidates to treat Alzheimer's disease, other central nervous system (CNS) diseases, pain, and various types of cancer, is encouraged by recent data published in the Proceedings of the National Academy of Sciences.
  
Capnia, Inc. (Nasdaq:CAPN), focused on the development of novel products based on its proprietary technologies for precision metering of gas flow, today announced that Anish Bhatnagar, M.D., Chief Executive Officer, will present at the 2015 Marcum MicroCap Conference on Thursday, May 28, 2015 at 10:00 AM ET in New York City.
 
Cellectar Biosciences, Inc. (Nasdaq:CLRB), a clinical stage biopharmaceutical company developing innovative agents for the detection and treatment of cancer, is providing an update on its development programs and financial results for the first quarter 2015.
 
Cidara Therapeutics, Inc. (Nasdaq:CDTX), a biotechnology company developing novel anti-infectives and immunotherapies to treat fungal and other infections, today reported financial results for the quarter ended March 31, 2015 and provided an update on its corporate activities and product pipeline.
 
INC Research Holdings, Inc. (Nasdaq:INCR), a leading global Phase I to Phase IV contract research organization, today announced that it is scheduled to participate in three upcoming investor conferences. 
 
MannKind Corporation (Nasdaq:MNKD) today announced that James S. Shannon, MD, MRCP (UK) has been elected to the company's Board of Directors after previously serving as a director from February 2010 until April 2012.
NeoStem, Inc. (Nasdaq:NBS) announced Thursday that it will receive one of the largest research grants of its kind to support its pioneering treatment for patients with stage III recurrent or stage IV metastatic melanoma, a potentially breakthrough approach that teaches the immune system which cells to attack and kill.
 
Otonomy, Inc. (Nasdaq:OTIC), a clinical stage biopharmaceutical company developing innovative therapeutics for diseases and disorders of the inner and middle ear, today announced topline results from its Phase 2b trial evaluating OTO-104 in patients with unilateral Ménière's disease. 
 
REVA Medical, Inc. (ASX:RVA) released initial clinical data on a subset of patients treated with the Fantom sirolimus-eluting bioresorbable scaffold at the Paris Course on Revascularization ("EuroPCR"). 
 
Urologix, Inc.  (OTCQB:ULGX), a market leader for the in-office treatment of benign prostatic hyperplasia (BPH) today announced that data highlighting the costs and outcomes of cooled high energy Transurethral Microwave Therapy (HE-TUMT), Transurethral Needle Ablation (TUNA), and the Prostatic Urethral Lift (PUL) were the topic of a podium presentation this past weekend at the American Urological Association (AUA) 2015 Annual Meeting held in New Orleans, LA.
 
VeriTeQ Corporation (OTC Markets:VTEQ), a provider of implantable medical device identification and radiation dose measurement technologies, announced today that it has been awarded a U.S. Patent for Wireless Molecular Sensor System and Process. 
 
Viatar CTC Solutions Inc. (OTC Pink:VRTT), a medical technology company focused on the treatment of patients with metastatic cancer, today announced that its Chairman and CEO, Ilan Reich, will provide a corporate overview during presentations at the following upcoming investor conferences.



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