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ReNeuron upbeat on early data from retinitis pigmentosa trials

Fri, 26th Apr 2019 12:09

(Sharecast News) - Cell-based therapeutics developer ReNeuron Group announced updated positive preliminary data in its ongoing phase 1 and 2a clinical trial of its human retinal progenitor cell (hRPC) therapy candidate in the blindness-causing disease, retinitis pigmentosa (RP), on Friday.The AIM-traded company said all three subjects in the first cohort of the phase 2a element of the study had demonstrated a sustained and further improvement in vision, compared with their pretreatment baseline.At the most recent follow-up, subjects in the study showed a mean improvement from baseline in visual acuity of 23 letters in the treated eye, while the untreated control eyes did not show meaningful improvement.An improvement of 23 letters was equivalent to reading an additional four lines of letters on the ETDRS eye chart - the standardised eye chart used to measure visual acuity in clinical trials - the ReNeuron board explained.It said an improvement of at least 15 letters from baseline on the ETDRS chart was considered to be "clinically meaningful" by the US Food and Drug Administration (FDA), as stated in their recent guidance on gene therapy for retinal disorders.As a comparator, the difference between a patient with 20/20 vision and 20/200 vision - the latter being the legal definition for blindness in terms of central visual acuity - would be the equivalent of being able to read an extra ten lines on the ETDRS chart.In addition to those objective measurements, all three subjects reportedly also noted a subjective improvement in vision in their treated eye."I am excited that the rapid and remarkable visual improvement in these RP patients has been sustained and even improved upon at 60 and 120 days," said Pravin Dugel, managing partner at Retinal Consultants of Arizona and study investigator."It is especially gratifying to feel the excitement and joy in my patients where this objective and subjective improvement in their vision has been a source of hope following years of slow but steady progression towards blindness."ReNeuron said RP was a group of hereditary diseases of the eye that led to progressive loss of sight due to cells in the retina becoming damaged and eventually dying.Its RP clinical programme had been granted orphan drug designation in both Europe and the US, as well as 'fast track' designation from the FDA.The Phase 1 and 2a clinical trial was described as an open-label study to evaluate the safety, tolerability and preliminary efficacy of ReNeuron's hRPC stem cell therapy candidate in patients with advanced RP.It said the Phase 2a element of the study, which used a cryopreserved hRPC formulation, enrolled subjects with some remaining retinal function, and was being conducted at two clinical sites in the US -- Massachusetts Eye and Ear in Boston and Retinal Research Institute in Phoenix, Arizona.The company noted that the data remained early, adding it would continue to generate further data including regular ongoing monitoring of the treated subjects, to continue to assess durability of effect and efficacy over a longer period of time and in a larger number of patients."The extent of vision improvement observed in this patient cohort demonstrates the potential for our hRPC cell therapy candidate to make an enormous difference in the lives of patients with RP," said ReNeuron chief executive officer Olav Hellebø."Treatment has already begun in the next cohort of patients, who have a greater baseline level of visual acuity than those treated so far."The results from this cohort will be presented in due course."

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15 Apr 2014 12:23

ReNeuron leases building for relocation of business

AIM-listed ReNeuron has signed a deal with the Welsh government to lease a landmark building at Pencoed Technology Park, near Cardiff in South Wales. The stem cell therapy company explained that it will build a new state-of-the-art facility at Pencoed, to which it will relocate the business next ye

15 Apr 2014 10:01

ReNeuron Leases New Research & Development Facility With Welsh Government

LONDON (Alliance News) - Stem cell therapy company ReNeuron Group PLC said Tuesday that it had signed an agreement with the Welsh Government to lease a new research and development facility at the Pencoed Technology Park near Cardiff, South Wales. ReNeuron expects to begin to relocate its o

15 Apr 2014 07:50

UK MORNING BRIEFING: Aggreko Leads After Mixed Results

LONDON (Alliance News) - Aggreko is leading the FTSE 100 in early trading Tuesday after the temporary power company said it has seen mixed results in its first quarter, with strong underlying revenue growth in two of its three regions being impacted by adverse currency movements as previously exp

27 Mar 2014 13:48

UK MIDDAY BRIEFING: Regulators Confirm UK Energy Market Review

LONDON (Alliance News) - UK regulators have now confirmed they will investigate whether the country's major energy companies are preventing effective competition in the market, a decision that prompted British Gas parent Centrica to warn that the review could delay crucial investments in new i

27 Mar 2014 13:01

UK WINNERS & LOSERS: Babcock, Tullow Oil Lead Blue-Chip Fallers

LONDON (Alliance News) - The following stocks are the leading risers and fallers within the main London indices midday Thursday.

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FTSE 100 - WINNERS

Old Mutual, up 0.5%. The group has agreed to sell Skandia Germany and S

27 Mar 2014 11:13

ReNeuron Gets Approvals To Begin Two New Trials Using Stem Cell Product

LONDON (Alliance News) - ReNeuron Group PLC said Thursday that it has received final regulatory and ethical approvals to begin two new clinical trials using its CTXcyro stem cell product. The company will begin a Phase II clinical trial of its ReN001 investigational therapy in stroke disabi

14 Mar 2014 13:04

ReNeuron Eyes New UK Government Scheme Encouraging Novel Therapies

LONDON (Alliance News) - ReNeuron Group PLC Friday said it will look at whether the UK government's plan to launch a scheme to encourage the take up of novel therapies could be applied to its own therapeutic candidates. The scheme, called the Early Access to Medicines Scheme, is looking to

11 Mar 2014 12:48

US foundation funds ReNeuron stem cell therapy

A US-based charity has agreed to provide funding and access to clinical expertise for ReNeuron's retinal stem cell therapy candidate for a degenerative eye disease. Shares in ReNeuron rose 8.8% to 3.54p on the news. The Foundation for Fighting Blindess has agreed to provide further funding toward

11 Mar 2014 11:27

ReNeuron Retinal Stem Cell System Wins FFB Support

LONDON (Alliance News) - ReNeuron Group PLC said Tuesday its retinal stem cell therapy candidate is to receive support from a retinal research funding foundation. ReNeuron said its ReN003 retinal stem cell therapy candidate for the treatment of retinis pigmentosa is set to receive support

21 Jan 2014 10:04

ReNeuron Sees Positive Data For Stem Cells In Retinal Degeneration Test

LONDON (Alliance News) - ReNeuron Group PLC said Tuesday that a paper detailing the efficiency of its human retinal stem cells in a test model of retinal degeneration had been published in the Journal of Biological Chemistry. The test showed that ReNeuron's cells protected visual function w

21 Jan 2014 08:19

UK MORNING BRIEFING: Shares Higher; Unilever, SABMiller As Expected

LONDON (Alliance News) - UK shares have opened higher Tuesday, as Unilever and SABMiller have released results and trading statements in line with expectations.

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13 Sep 2013 09:02

ReNeuron Moving All Therapeutic Programmes To Phase II Trials In Next 3 Years

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22 Jul 2013 10:50

ReNeuron announces capital increase, funds to enter capital structure

Lifesciences group ReNeuron has announced that it has successfully raised 33m pounds in fresh funding to finance its research into stem-cell development, although it had to offer a small discount for the new equity. Significantly, three new investment funds are to enter its shareholder register with

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28 May 2013 10:39

ReNeuron jumps on stem cell study results

Shares in AIM-listed stem cell business ReNeuron Group rose on Tuesday morning after the group unveiled details of progress with the PISCES clinical trial of its ReN001 stem cell therapy for disabled stroke patients. The group said that the primary aim of the study was to test the safety and toler

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26 Mar 2013 09:45

ReNeuron Group to begin stem cell treatment of critical limb ischaemia

ReNeuron Group has received regulatory approval to begin the first phase of a clinical trial in the UK for the company's ReN009 stem cell therapy treatment for critical limb ischaemia. Critical limb ischaemia, a condition which leads to blood vessel blockage in limbs such as toes and can lead to am

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ReNeuron upbeat on early data from retinitis pigmentosa trials

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