Log in
E-mail
Password
Remember
Forgot password ?
Become a member for free
Sign up
Sign up
New member
Sign up for FREE
New customer
Discover our services
Settings
Settings
Dynamic quotes 
OFFON

MarketScreener Homepage  >  Equities  >  Australian Stock Exchange  >  Regeneus Ltd    RGS   AU000000RGS6

REGENEUS LTD

(RGS)
  Report
End-of-day quote. End-of-day quote Australian Stock Exchange - 08/13
0.145 AUD   0.00%
08/10REGENEUS LTD (ASX : RGS) and Kyocera Sign Progenza OA Deal
AQ
07/31Regeneus Ltd Quarterly Report
AW
07/27REGENEUS LTD (ASX : RGS) Progenza OA Kyocera Negotiations Update
AQ
SummaryChartsNewsCalendarCompanyFinancials 
News SummaryMost relevantAll newsPress ReleasesOfficial PublicationsSector news

Regeneus : receives approval for Progenza stem cell trial for osteoarthritis (News Release)

share with twitter share with LinkedIn share with facebook
04/21/2015 | 08:42pm EDT

Regeneus (ASX:RGS), a clinical stage regenerative medicine company focused on thedevelopment of cell therapies, announced today that it has received ethics approval for a clinical trial of its new off-the-shelf allogeneic stem cell treatment, known as Progenza, for patients with knee osteoarthritis.

Progenza is produced from adipose (fat) tissue from a healthy donor who has been extensively screened. The mesenchymal stem cells (MSCs) from adipose tissue are expanded through the company's proprietary and scalable manufacturing process that is capable of producing millions of therapeutic doses from one donor.

When Progenza stem cells are injected into a patient's osteoarthritic joint, the MSCs have the potential to reduce pain and inflammation and slow the progression of disease.

The trial is entitled, "A Phase 1 randomised, double-blind, placebo-controlled single ascending dose study to evaluate the safety, tolerability and preliminary efficacy of intra-articular Progenza in adults with symptomatic knee osteoarthritis" (the STEP Trial). The approval clears the way for site initiation and patient recruitment into the STEP Trial.

Leading Sydney-based sports medicine specialist, Dr Donald Kuah, will be the principal investigator on the STEP Trial. Dr Kuah, a principal of Sydney Sportsmed Specialists, has extensive experience in the diagnosis and treatment of patients with osteoarthritis. He is also a pioneer in the testing and use of autologous adipose-derived stem cells and platelet rich plasma for the treatment of musculoskeletal conditions.

The STEP Trial will include 20 participants with knee osteoarthritis. Participants will receive ultrasound-guided injections of Progenza or placebo directly into their arthritic knee joint. The primary objective of the trial is to evaluate the safety and tolerability of Progenza. The secondary objectives are to investigate the effect of Progenza on knee pain and function; quality of life; knee joint structures using magnetic resonance imaging; and osteoarthritis biomarkers. Participants will be monitored for 12 months with an interim safety review at 1 month post treatment.

"I'm excited to be the principal investigator of the STEP Trial evaluating the safety and preliminary efficacy of Progenza for osteoarthritis. The clinical testing of an off-the-shelf allogeneic cell therapy like Progenza which could address the underlying cause of the disease is important for providing a new potential treatment option to patients with osteoarthritis", said Dr Kuah.

The STEP Trial was approved by an independent Human Research Ethics Committee registered with the Australian Government's National Health and Medical Research Council. The Trial will be registered on the Australian New Zealand Clinical Trials Registry (ANZCTR) and notified to the Therapeutic Goods Administration through the Clinical Trials Notification Scheme.

Trial recruitment will commence as scheduled in the first-half of 2015.

distributed by
share with twitter share with LinkedIn share with facebook
All news about REGENEUS LTD
08/10REGENEUS LTD (ASX : RGS) and Kyocera Sign Progenza OA Deal
AQ
07/31Regeneus Ltd Quarterly Report
AW
07/27REGENEUS LTD (ASX : RGS) Progenza OA Kyocera Negotiations Update
AQ
07/10REGENEUS LTD (ASX : RGS) Featured in Morgans' 'Under The Microscope' Podcast ser..
AQ
06/03REGENEUS LTD (ASX : RGS) Director Resignation
AQ
04/28REGENEUS LTD (ASX : RGS) Quarterly Report
AQ
03/22Regeneus Ltd to be granted new key Progenza patent in U.S.
AW
03/19REGENEUS LTD (ASX : RGS) Receives A$1.6M Milestone Payment from Kyocera
AQ
03/01REGENEUS LTD (ASX : RGS) Signs MOU with Kyocera Corporation
AQ
02/28REGENEUS LTD (ASX : RGS) Half-Year Results & Business Update
AQ
More news
Financials
Sales 2019 1,47 M 1,05 M 1,05 M
Net income 2019 -6,02 M -4,30 M -4,30 M
Net Debt 2019 3,52 M 2,52 M 2,52 M
P/E ratio 2019 -2,93x
Yield 2019 -
Capitalization 40,3 M 28,9 M 28,8 M
EV / Sales 2018 9,00x
EV / Sales 2019 14,5x
Nbr of Employees -
Free-Float 68,2%
Chart REGENEUS LTD
Duration : Period :
Regeneus Ltd Technical Analysis Chart | MarketScreener
Full-screen chart
Income Statement Evolution
Managers
NameTitle
Leo Lee Chief Executive Officer & Director
Barry George Sechos Non-Executive Chairman
John Bird Chief Operating & Financial Officer
Graham Vesey Executive Director & Chief Scientific Officer
Charlotte Morgan Head-Research & Development
Sector and Competitors
1st jan.Capitalization (M$)
REGENEUS LTD66.67%29
GILEAD SCIENCES, INC.5.94%86 319
VERTEX PHARMACEUTICALS23.70%70 548
REGENERON PHARMACEUTICALS63.08%64 438
WUXI APPTEC CO., LTD.62.81%37 073
GENMAB A/S53.09%23 475