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Press Release

Phase II stroke data presented at AHA conference

ReNeuron Group
Posted on: 31 Jan 18

Positive long-term data from Phase II stroke disability clinical trial accepted for a late-breaking podium presentation at the American Heart Association International Stroke Conference 2018

 

ReNeuron Group plc (AIM: RENE), a UK-based global leader in the development of cell-based therapeutics, is pleased to announce that positive long-term data from the Phase II clinical trial (PISCES II) of its CTX cell therapy candidate for stroke disability was accepted for a podium presentation given yesterday at the American Heart Association International Stroke Conference 2018 (“ISC 2018”), taking place this week in Los Angeles.

 

PISCES II is a single arm, open-label study in which a total of 23 patients living with significant disability resulting from ischaemic stroke were treated with ReNeuron’s CTX cell therapy candidate. The Company recently announced positive top-line long-term data from the PISCES II clinical trial in which response rates in key measures reported at 3 months after CTX cell treatment were sustained at 12 months post-treatment. 

 

Professor Keith Muir, SINAPSE Chair of Clinical Imaging, Clinical Director for Stroke, Queen Elizabeth University Hospital, Glasgow, and Principal Investigator for the PISCES II study, presented data at the conference showing upper limb functional recovery was durable and maintained out to 12 months post-treatment, with 30% of patients responding on the ARAT scale, a measure of upper limb mobility.  

 

Data was also presented showing a response rate in 30% of subjects at 12 months post-treatment of at least a one point improvement on the modified Rankin Scale (mRS), a 7-point, clinician-reported global measure of disability or dependence upon others in carrying out activities of daily living.  A one-point improvement in mRS is proven to be clinically meaningful for patients, both in terms of quality of life and healthcare resources needed to care for them.  For example, improving from mRS 3 to 2 means that a person with a stroke regains their ability to live independently; perhaps returning home from a care facility, or enabling a spouse or carer to return to work.

 

Further, data analysis from a pre-specified subgroup of patients in the PISCES II study who had residual upper limb movement was presented, showing the appreciably higher response rate of 43% in these patients on the mRS.  Patients similar to those in this subgroup, with moderate or moderate-to-severe disability (mRS of 3 or 4) and some remaining arm movement, will be the target population for the Company’s upcoming PISCES III clinical trial with its CTX cell therapy candidate.

 

The data presented at the ISC 2018 conference indicate that the CTX therapy has the potential to produce meaningful and sustained improvements in the level of disability or dependence as well as motor function in disabled stroke patients.  The PISCES II study also demonstrated that the CTX treatment was well-tolerated in both short and longer term follow-up.

 

ReNeuron recently announced that the FDA had given regulatory approval for the Company to commence a Phase IIb clinical study in the US with its CTX cell therapy candidate for stroke disability.  The study, designated PISCES III, is a randomised, placebo-controlled clinical trial involving 110 patients across 25 clinical trial sites in the US.  The primary end-point of the study will be a comparison of the proportion of patients in the treated and placebo arms showing a clinically important improvement on the mRS at 6 months post-treatment compared with baseline.  Data from the study are expected in late 2019.

 

A copy of the ISC 2018 presentation will shortly be available on ReNeuron’s website.

 

Further information about the conference may be found at:

https://buchanan.enablecloud.co.uk/index.php?entryPoint=campaign_trackerv2&track=9a52b024-0261-11e8-99f0-78e7d1587cae&identifier=ddbd171e-0266-11e8-8d5f-001a4bbe9414

 

ENQUIRIES:

 

ReNeuron

+44 (0)20 3819 8400

Olav Hellebø , Chief Executive Officer

 

Michael Hunt, Chief Financial Officer

 

Buchanan

+44 (0) 20 7466 5000

Mark Court, Sophie Wills, Stephanie Watson

 

 

 

Stifel Nicolaus Europe Limited

+44 (0) 20 7710 7600

Jonathan Senior, Stewart Wallace, Ben Maddison (NOMAD and Joint Broker)

 

Nplus1 Singer Advisory LLP

+44 (0) 20 7496 3000

Mark Taylor (Joint Broker)

Editor's Details

Mike Wood
PharmiWeb.com
www.pharmiweb.com
editor@pharmiweb.com

Last updated on: 31/01/2018

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