http://www.proactiveinvestors.co.uk Proactiveinvestors RSS feed en Sun, 22 Jul 2018 21:31:37 +0100 http://blogs.law.harvard.edu/tech/rss Genera CMS action@proactiveinvestors.com (Proactiveinvestors) action@proactiveinvestors.com (Proactiveinvestors) <![CDATA[RNS press release - Notification of Major Holdings ]]> http://www.proactiveinvestors.co.uk/companies/rns/862/LSE20180717070011_13719921/ Tue, 17 Jul 2018 07:00:11 +0100 http://www.proactiveinvestors.co.uk/companies/rns/862/LSE20180717070011_13719921/ <![CDATA[RNS press release - Notification of Major Holdings ]]> http://www.proactiveinvestors.co.uk/companies/rns/862/LSE20180716153927_13719577/ Mon, 16 Jul 2018 15:39:27 +0100 http://www.proactiveinvestors.co.uk/companies/rns/862/LSE20180716153927_13719577/ <![CDATA[RNS press release - Notification of Major Holdings ]]> http://www.proactiveinvestors.co.uk/companies/rns/862/LSE20180716070006_13718237/ Mon, 16 Jul 2018 07:00:06 +0100 http://www.proactiveinvestors.co.uk/companies/rns/862/LSE20180716070006_13718237/ <![CDATA[RNS press release - Notification of Major Holdings ]]> http://www.proactiveinvestors.co.uk/companies/rns/862/LSE20180713115056_13717501/ Fri, 13 Jul 2018 11:50:56 +0100 http://www.proactiveinvestors.co.uk/companies/rns/862/LSE20180713115056_13717501/ <![CDATA[News - ReNeuron Group well funded for the next phase of development ]]> http://www.proactiveinvestors.co.uk/companies/news/200654/reneuron-group-well-funded-for-the-next-phase-of-development-200654.html The plan now is to commence a US phase IIb study with the top-line data expected by the end of next year.

WATCH: Finance director discusses the putative deal ReNeuron's hRPC stem cell candidate was used in a phase I/II clinical assessment of four patients with the eye disease retinitis pigmentosa. The study has now expanded to target people with less impaired vision and the first read-out from this early-stage trial is expected by the middle of next year.   The group's hRPC cells will also be deployed in the phase II study of sufferers of cone-rod dystrophy, which will run in parallel with a planned phase IIb in retinitis pigmentosa. Exosome nanomedicine platform Turning to ReNeuron's exosome nanomedicine platform, the group's research team presented positive pre-clinical data on an ExoPr0 therapy, which has the potential to target multiple diseases. The plan is to lodge an initial clinical trial application next year for its use in cancer.   Echoing Wednesday's update, ReNeuron said there had been "third party interest" in its main therapeutic programmes.   This resulted in the company agreeing a three-month exclusivity period with an unnamed US speciality pharma business, which assessing whether to licence the rights to ReNeuron's hRPC programme. Robust cash position  In return, the AIM-listed stem cell group will receive up to £3.8mln (US$5mln) as the American group carries out its due diligence.   At March 31, the end of the last financial year, the group was sitting on cash of £37.4mln, having deployed £14.9mln on its clinical and pre-clinical activities. In common with most other development groups at this formative stage, ReNeuron was loss-making as it posted a deficit of £17.6mln for the 12 months.   "Our cash position remains robust and we are positioned to deliver significant clinical milestones across our therapeutic programmes during each of the next three years," said chief executive Olav Hellebø.   ]]>
Thu, 12 Jul 2018 07:59:00 +0100 http://www.proactiveinvestors.co.uk/companies/news/200654/reneuron-group-well-funded-for-the-next-phase-of-development-200654.html
<![CDATA[RNS press release - Preliminary Results ]]> http://www.proactiveinvestors.co.uk/companies/rns/862/LSE20180712070005_13714750/ Thu, 12 Jul 2018 07:00:05 +0100 http://www.proactiveinvestors.co.uk/companies/rns/862/LSE20180712070005_13714750/ <![CDATA[Media files - ReNeuron signs retinal stem cell exclusivity agreement ]]> http://www.proactiveinvestors.co.uk/companies/stocktube/9821/reneuron-signs-retinal-stem-cell-exclusivity-agreement-9821.html Wed, 11 Jul 2018 11:30:00 +0100 http://www.proactiveinvestors.co.uk/companies/stocktube/9821/reneuron-signs-retinal-stem-cell-exclusivity-agreement-9821.html <![CDATA[News - ReNeuron stands to net an initial US$5mln as US company runs rule over its retinal stem cell technology ]]> http://www.proactiveinvestors.co.uk/companies/news/200555/reneuron-stands-to-net-an-initial-us5mln-as-us-company-runs-rule-over-its-retinal-stem-cell-technology-200555.html The company has two distinct platforms. Its CTX cell lines are being developed for serious conditions such as stroke, while its human retinal progenitor cells (hRPC) have been deployed in Phase I/IIa trials for people with a blindness-causing condition called retinitis pigmentosa. 

The shares jumped 22% on the back of Wednesday’s announcement, pushing the stock to just shy of £1. 

 

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Wed, 11 Jul 2018 08:10:00 +0100 http://www.proactiveinvestors.co.uk/companies/news/200555/reneuron-stands-to-net-an-initial-us5mln-as-us-company-runs-rule-over-its-retinal-stem-cell-technology-200555.html
<![CDATA[RNS press release - Signs retinal stem cell exclusivity agreement ]]> http://www.proactiveinvestors.co.uk/companies/rns/862/LSE20180711070004_13713021/ Wed, 11 Jul 2018 07:00:04 +0100 http://www.proactiveinvestors.co.uk/companies/rns/862/LSE20180711070004_13713021/ <![CDATA[RNS press release - Notification of Preliminary Results ]]> http://www.proactiveinvestors.co.uk/companies/rns/862/LSE20180704141502_13705804/ Wed, 04 Jul 2018 14:15:02 +0100 http://www.proactiveinvestors.co.uk/companies/rns/862/LSE20180704141502_13705804/ <![CDATA[RNS press release - Capital Markets Event ]]> http://www.proactiveinvestors.co.uk/companies/rns/862/LSE20180517070002_13644329/ Thu, 17 May 2018 07:00:02 +0100 http://www.proactiveinvestors.co.uk/companies/rns/862/LSE20180517070002_13644329/ <![CDATA[News - ReNeuron Group head of research to present encouraging early data on potential cancer treatment ]]> http://www.proactiveinvestors.co.uk/companies/news/196410/reneuron-group-head-of-research-to-present-encouraging-early-data-on-potential-cancer-treatment-196410.html ReNeuron Group Plc's (LON:RENE) shares rose on Friday after the group revealed its head of research will present exciting early-stage data on the potential use of cell-derived exomes in the treatment of cancer.  

Exosomes are nanoparticles secreted from many different types of cells and play a key role in cell-to-cell signalling.

READ: ReNeuron wins £1.5mln to fund further development of its hRPC cell therapy candidate

Early research with ExoPr0 exomes has demonstrated their potential as both a possible therapy and as a drug delivery vehicle.

Dr Randolph Corteling and his team have discovered the ExoPr0 candidate they have identified induces a process called apoptosis in cancer, which simply means cell death. It also appears to arrest cell growth.

Used in tumour models 

Using the xenograft tumour models ExoPr0 significantly reduced the mass in a number of different cancers.

When combined with the standard of care for the various growths, the ReNeuron discovery brought about an "additive reduction of tumour volume".

It should be cautioned that this is very early stage work, though nevertheless encouraging.

Corteling will deliver his findings during a podium presentation later Friday at the 2018 International Society of Cell Therapy conference in Montreal, Canada.

"We draw considerable encouragement from these new pre-clinical results and look forward to presenting further progress with the development of ExoPr0 as a potential new and highly novel cancer therapy in the months ahead," he said ahead of the gathering.

In lunchtime trading, ReNeuron shares were 3.2% higher at 62p.

 -- Adds share price --

 

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Fri, 04 May 2018 08:15:00 +0100 http://www.proactiveinvestors.co.uk/companies/news/196410/reneuron-group-head-of-research-to-present-encouraging-early-data-on-potential-cancer-treatment-196410.html
<![CDATA[RNS press release - Exosome data presented at ISCT conference ]]> http://www.proactiveinvestors.co.uk/companies/rns/862/LSE20180504070007_13629826/ Fri, 04 May 2018 07:00:07 +0100 http://www.proactiveinvestors.co.uk/companies/rns/862/LSE20180504070007_13629826/ <![CDATA[RNS press release - Capital Markets Event and Webcast ]]> http://www.proactiveinvestors.co.uk/companies/rns/862/LSE20180430070014_13622786/ Mon, 30 Apr 2018 07:00:14 +0100 http://www.proactiveinvestors.co.uk/companies/rns/862/LSE20180430070014_13622786/ <![CDATA[News - ReNeuron wins £1.5mln to fund further development of its hRPC cell therapy candidate ]]> http://www.proactiveinvestors.co.uk/companies/news/195332/reneuron-wins-15mln-to-fund-further-development-of-its-hrpc-cell-therapy-candidate-195332.html Cell-based therapeutics specialist ReNeuron Group Plc (LON:RENE) has won a £1.5mln grant to further develop its human retinal progenitor cell (hRPC) therapy which is used to treat blindness-causing, degenerative eye diseases.

The grant has been awarded by Innovate UK, the UK’s innovation agency, which has backed ReNeuron and its partners before.

READ: ReNeuron making good progress with all key therapeutics programmes

This time the money will co-fund a collaborative programme of work by ReNeuron, the Cell & Gene Therapy Catapult, Roslin Cell Therapies and University College London.

They will work together to advance the development of the hRPC cell therapy candidate, which is currently in a phase I/II clinical trial in the US, in patients suffering from retinitis pigmentosa.

“We and our collaborators are delighted to have won this latest grant from Innovate UK to develop a suite of robust and reliable release and characterisation assays reflecting the mechanism of action of our hRPC cell therapy candidate,” said ReNeuron’s Sharon Grimster.

“This is a challenging but vital part of the broader commercial manufacturing strategy for the therapy and we are pleased to be working with leading academic and commercial manufacturing partners on this important programme of work.”

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Thu, 19 Apr 2018 07:42:00 +0100 http://www.proactiveinvestors.co.uk/companies/news/195332/reneuron-wins-15mln-to-fund-further-development-of-its-hrpc-cell-therapy-candidate-195332.html
<![CDATA[RNS press release - Wins grant for retinal cell therapy development ]]> http://www.proactiveinvestors.co.uk/companies/rns/862/LSE20180419070029_13610131/ Thu, 19 Apr 2018 07:00:29 +0100 http://www.proactiveinvestors.co.uk/companies/rns/862/LSE20180419070029_13610131/ <![CDATA[News - ReNeuron appoints new chief medical officer based in recently established US office ]]> http://www.proactiveinvestors.co.uk/companies/news/194632/reneuron-appoints-new-chief-medical-officer-based-in-recently-established-us-office-194632.html ReNeuron Group PLC (LON:RENE) has announced the appointment of Dr Richard Beckman as chief medical officer, to lead the company’s clinical and medical affairs team based in its recently established US office in Boston.

The AIM-listed firm said Beckham will replace Dr Julian Howell, who has left the company to pursue another opportunity.

WATCH: Reneuron’s Michael Hunt updates on product development

The cell-based therapeutics specialist said Beckman brings to ReNeuron more than 25 years of executive and consultancy experience in drug and device development.

Prior to joining ReNeuron, he was the chief medical officer of several innovative biotech and device firms, including Clearside, Ophthotech and Neurotech.

He also had leadership roles at Alcon, Lux Bio, Becton Dickinson and Co (NYSE:BDX) and Allergan PLC (NYSE:AGN).

Olav Hellebø, chief executive officer at ReNeuron, said: "His many years’ experience in medical practice and industry in the US will be invaluable to us as we build out our Boston team and increase our clinical activities in the US.”  

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Tue, 10 Apr 2018 13:33:00 +0100 http://www.proactiveinvestors.co.uk/companies/news/194632/reneuron-appoints-new-chief-medical-officer-based-in-recently-established-us-office-194632.html
<![CDATA[RNS press release - Appointment of US-based Chief Medical Officer ]]> http://www.proactiveinvestors.co.uk/companies/rns/862/LSE20180410130001_13598973/ Tue, 10 Apr 2018 13:00:01 +0100 http://www.proactiveinvestors.co.uk/companies/rns/862/LSE20180410130001_13598973/ <![CDATA[Media files - ReNeuron's Michael Hunt updates on product development ]]> http://www.proactiveinvestors.co.uk/companies/stocktube/8948/reneuron-s-michael-hunt-updates-on-product-development-8948.html Mon, 26 Mar 2018 14:55:00 +0100 http://www.proactiveinvestors.co.uk/companies/stocktube/8948/reneuron-s-michael-hunt-updates-on-product-development-8948.html <![CDATA[News - ReNeuron increases number of clinical sites in its PISCES III study ]]> http://www.proactiveinvestors.co.uk/companies/news/193777/reneuron-increases-number-of-clinical-sites-in-its-pisces-iii-study-193777.html Cell-based therapeutics specialist ReNeuron Group Plc (LON:RENE) is to increase the number of clinical sites in its PISCES III study from 25 to 40.

PISCES III is a phase IIb clinical study in the US of ReNeuron’s CTX cell therapy candidate for stroke disability.

READ: ReNeuron's CTX cells play a part in positive artificial nerve tissue study

ReNeuron said it had taken the decision to increase the number of sites to ensure that patient recruitment targets in the study are met.

First patient dosing in the study is expected in mid-2018 and top-line data from the study, as previously indicated, is expected in late 2019.

The group also updated the market on its hRPC stem cell therapy candidate for retinal diseases and its exosome nanomedicine platform.

hRPC stem cell therapy candidate for retinal diseases

Four cohorts of three patients each have been dosed in the ongoing US phase I/II clinical trial for the blindness-causing inherited retinal disease, retinitis pigmentosa (RP).

ReNeuron said it now expects its hRPC therapy to be most effective in RP patients with sufficiently intact retina to enable good grating of the hRPC cells and subsequent regeneration of functional photoreceptors.

As a result, it is now extending the study to expand the safety database in patients with less impaired vision than those treated thus far.

WATCH: ReNeuron's Michael Hunt updates on product development

This patient group will be targeted in a subsequent clinical trial, which, as previously flagged, will be a controlled phase IIb study.

The expanded phase I/II study will allow ReNeuron to optimise the formulation and dosing of the hRPC therapy ahead of the start of the subsequent study.

Based on the above, ReNeuron expects short-term read-outs from the ongoing phase I/II clinical trial in the first half of 2019, which is later than originally planned, with the phase IIb study commencing shortly thereafter.

Exosome nanomedicine platform

Pre-clinical development work continues with ExoPr0, ReNeuron’s first CTX-derived exosome therapeutic candidate.

Subject to continued success with ongoing pre-clinical development work, ReNeuron hopes to be able to commence clinical development with ExoPr0 during 2019, as previously indicated, targeting a solid tumour cancer indication.

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Mon, 26 Mar 2018 08:49:00 +0100 http://www.proactiveinvestors.co.uk/companies/news/193777/reneuron-increases-number-of-clinical-sites-in-its-pisces-iii-study-193777.html
<![CDATA[RNS press release - Product Development Update ]]> http://www.proactiveinvestors.co.uk/companies/rns/862/LSE20180326070005_13580262/ Mon, 26 Mar 2018 07:00:05 +0100 http://www.proactiveinvestors.co.uk/companies/rns/862/LSE20180326070005_13580262/ <![CDATA[RNS press release - Block Listing Review and TVR ]]> http://www.proactiveinvestors.co.uk/companies/rns/862/LSE20180301070004_13550102/ Thu, 01 Mar 2018 07:00:04 +0000 http://www.proactiveinvestors.co.uk/companies/rns/862/LSE20180301070004_13550102/ <![CDATA[RNS press release - Block Listing Application ]]> http://www.proactiveinvestors.co.uk/companies/rns/862/LSE20180216070004_13535508/ Fri, 16 Feb 2018 07:00:04 +0000 http://www.proactiveinvestors.co.uk/companies/rns/862/LSE20180216070004_13535508/ <![CDATA[News - ReNeuron's CTX cells play a part in positive artificial nerve tissue study ]]> http://www.proactiveinvestors.co.uk/companies/news/191575/reneuron-s-ctx-cells-play-a-part-in-positive-artificial-nerve-tissue-study-191575.html ReNeuron Group PLC (LON:RENE) received a boost today from the publication of new positive data from an artificial nerve tissue study.

In afternoon trading, ReNeuron shares were 1.5% higher at 103.5p.

The pre-clinical model of nerve injury demonstrated comparable nerve regeneration compared to standard of care treatment and a stronger muscle function response.

The model, using ReNeuron's CTX cells as a component of artificial nerve tissue, was developed as part of a grant-funded collaboration with University College London (UCL) and Sartorius Stedim Biotech. 

ReNeuron said this is one of a number of early-stage projects that it is exploring through partnerships and grant funding.

ReNeuron's CTX cells are already being tested in clinical trials for the treatment of disability resulting from an ischaemic stroke but this is the first time they have been combined with an engineered support to guide nerve repair, both in vitro and in vivo (i.e. both in and outside of the body).

"Peripheral nerve damage can be severe and extremely debilitating, causing a loss of sensation or movement and the possibility of chronic pain. It is often as a result of trauma from road traffic accidents and frequently affects young people at huge personal cost. Currently, there are no engineered cellular therapies to treat nerve damage and where large gaps exist in damaged nerves, grafts are taken from a healthy part of the body to repair a more important function,” explained Dr James Phillips, the lead study author.

READ: ReNeuron Group presents positive stroke data to US conference

“We're impressed with how well the living artificial nerve tissue performed against the autologous nerve grafts. Although it is only in an animal model, it demonstrates that nerves can be repaired using engineered living constructs and opens up possibilities for future treatment options for repairing severe nerve damage," he noted.

Professor Martin Birchall, the chair of laryngology at the UCL Ear Institute and the consultant head and neck surgeon said many patients undergoing nerve repair for trauma or after cancer surgery are not fully served by conventional repairs which may lead to slow and inaccurate regrowth.

“The development of a targeted, stem-cell based repair product, available to all surgeons, especially in the emergency setting, would represent a massive breakthrough in care," he said.

ReNeuron’s chief scientific officer, Dr John Sinden, was understandably delighted that the study had shown the potential of ReNeuron’s CTX cells in the area of nerve repair.

“The combination of ReNeuron's clinically-validated CTX neural stem cells along with self-aligning collagen technology represents a step forward in developing a readily available cell-based treatment for nerve repair at reasonable cost," he said.

Shares in ReNeuron were up 1.9% at 103.9p in a flat market late in the morning.

-- Adds share price --

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Tue, 13 Feb 2018 11:51:00 +0000 http://www.proactiveinvestors.co.uk/companies/news/191575/reneuron-s-ctx-cells-play-a-part-in-positive-artificial-nerve-tissue-study-191575.html
<![CDATA[RNS press release - Positive pre-clinical data in nerve injury ]]> http://www.proactiveinvestors.co.uk/companies/rns/862/LSE20180213100001_13531161/ Tue, 13 Feb 2018 10:00:01 +0000 http://www.proactiveinvestors.co.uk/companies/rns/862/LSE20180213100001_13531161/ <![CDATA[Media files - ReNeuron pleased to secure podium presentation for stroke data at US conference ]]> http://www.proactiveinvestors.co.uk/companies/stocktube/8669/reneuron-pleased-to-secure-podium-presentation-for-stroke-data-at-us-conference-8669.html Fri, 26 Jan 2018 12:48:00 +0000 http://www.proactiveinvestors.co.uk/companies/stocktube/8669/reneuron-pleased-to-secure-podium-presentation-for-stroke-data-at-us-conference-8669.html <![CDATA[News - ReNeuron Group presents positive stroke data to US conference ]]> http://www.proactiveinvestors.co.uk/companies/news/190670/reneuron-group-presents-positive-stroke-data-to-us-conference-190670.html ReNeuron Group PLC (LON:RENE) said positive long-term data on its CTX cell therapy for stroke was presented at the American Heart Association International Stroke Conference in Los Angeles on Thursday.

Professor Keith Muir, of the Queen Elizabeth University Hospital, Glasgow, and Principal Investigator for ReNeuron’s PISCES II study, told the audience that upper limb functional recovery was “durable and maintained” out to 12 months post-treatment.

WATCH: ReNeuron pleased to secure podium presentation for stroke data at US conference

A total of 30% of patients responded when assessed using the ARAT scale, a measure of upper limb mobility.

Data was also presented showing a response rate in 30% of people at 12 months post-treatment of at least a one point improvement on the modified Rankin Scale. This is a seven-point global measure of disability or dependence upon others in carrying out activities of daily living.

A one-point improvement is proven to be clinically meaningful for patients, both in terms of quality of life and healthcare resources needed to care for them.

READ: ReNeuron opens US office ahead of clinical trials

Analysis of a subgroup of patients who had residual upper limb movement showed an “appreciably higher response rate” of 43% when measured using the modified Rankin scale.

ReNeuron shares were down 0.5% to 136.8p in late afternoon trading on Friday.

--Updates for share price and video link--

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Fri, 26 Jan 2018 07:34:00 +0000 http://www.proactiveinvestors.co.uk/companies/news/190670/reneuron-group-presents-positive-stroke-data-to-us-conference-190670.html
<![CDATA[RNS press release - Phase II stroke data presented at AHA conference ]]> http://www.proactiveinvestors.co.uk/companies/rns/862/LSE20180126070004_13510369/ Fri, 26 Jan 2018 07:00:04 +0000 http://www.proactiveinvestors.co.uk/companies/rns/862/LSE20180126070004_13510369/ <![CDATA[RNS press release - Approval of Share Capital Reorganisation ]]> http://www.proactiveinvestors.co.uk/companies/rns/862/LSE20180123110638_13506201/ Tue, 23 Jan 2018 11:06:38 +0000 http://www.proactiveinvestors.co.uk/companies/rns/862/LSE20180123110638_13506201/ <![CDATA[RNS press release - Further re Share Capital Reorganisation ]]> http://www.proactiveinvestors.co.uk/companies/rns/862/LSE20180111070003_13492391/ Thu, 11 Jan 2018 07:00:03 +0000 http://www.proactiveinvestors.co.uk/companies/rns/862/LSE20180111070003_13492391/ <![CDATA[News - ReNeuron hopes share consolidation will improve the marketability and liquidity of the stock ]]> http://www.proactiveinvestors.co.uk/companies/news/189570/reneuron-hopes-share-consolidation-will-improve-the-marketability-and-liquidity-of-the-stock-189570.html ReNeuron Group Plc (LON:RENE) plans a share consolidation, which it hopes will improve the marketability and liquidity of the stock along with trading activity.

The stem cell specialist said it wants to reduce its equity base by a factor of 100, which, based on Thursday’s close of 1.825p, would push the price to 182.5p.

WATCH: 'Lots to look forward to' as ReNeuron gets go-ahead for phase IIb stroke trial

“The board of the company believes that the share capital reorganisation will result in a capital structure more conducive to attracting new institutional investors based both in the UK and in other overseas jurisdictions,” investors were told.

The proposal will be put to a shareholder vote on January 23.

For more information on the ReNeuron share re-organisation, particularly how fractional shareholdings will be treated, click here.

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Fri, 05 Jan 2018 07:39:00 +0000 http://www.proactiveinvestors.co.uk/companies/news/189570/reneuron-hopes-share-consolidation-will-improve-the-marketability-and-liquidity-of-the-stock-189570.html
<![CDATA[RNS press release - Proposed Share Capital Reorganisation ]]> http://www.proactiveinvestors.co.uk/companies/rns/862/LSE20180105070003_13486177/ Fri, 05 Jan 2018 07:00:03 +0000 http://www.proactiveinvestors.co.uk/companies/rns/862/LSE20180105070003_13486177/ <![CDATA[Media files - 'Lots to look forward to' as ReNeuron gets go-ahead for phase IIb stroke trial ]]> http://www.proactiveinvestors.co.uk/companies/stocktube/8553/-lots-to-look-forward-to-as-reneuron-gets-go-ahead-for-phase-iib-stroke-trial-8553.html Mon, 18 Dec 2017 12:06:00 +0000 http://www.proactiveinvestors.co.uk/companies/stocktube/8553/-lots-to-look-forward-to-as-reneuron-gets-go-ahead-for-phase-iib-stroke-trial-8553.html <![CDATA[News - ReNeuron receives approval from US authorities to kick off phase IIb stroke trial ]]> http://www.proactiveinvestors.co.uk/companies/news/188779/reneuron-receives-approval-from-us-authorities-to-kick-off-phase-iib-stroke-trial-188779.html ReNeuron Group Plc (LON:RENE) has been given the green light from US authorities to kick off a phase IIb study of its CTX cell therapy candidate for stroke disability.

Long-term data from the PISCES II trial earlier this year showed the treatment has the potential to improve the disability of stroke patients.

READ: ReNeuron boss 'delighted' with long-term stroke data

PISCES III – as this next study will be called – will be much bigger, recruiting 110 patients across 25 sites in the US.

It will compare how many patients treated with either the CTX therapy or a placebo demonstrate a “clinically important improvement” on the Modified Rankin Scale – a measure of disability and dependence.

Data from the study is expected towards the end of 2019.

"We are delighted to have received regulatory approval to commence our first clinical trial in the US with our CTX cell therapy candidate for stroke disability,” said chief executive Olav Hellebø.

“No therapeutic interventions are currently available to improve motor function and quality of life for disabled stroke patients.

“This important clinical trial represents a further step towards potentially meeting that very significant unmet need and we look forward to initiating the study during the first half of next year.”

Progress made in first half

Thursday’s approval caps off a productive six months for the cell-based therapeutics specialist, during which it also started dosing patients in the phase II element of the ongoing phase I/II clinical trial of its hRPC stem cell therapy candidate for retinitis pigmentosa.

A phase II trial of hRPC in the degenerative eye disease is due to get underway in the middle of 2018, alongside a phase II study in cone rod dystrophy.

Elsewhere, pre-clinical data of ReNeuron’s ExoPr0 exosome therapy candidate also showed it may have a “significant effect” in regulating cell growth and reducing cancer cell proliferation.

The company also thinks it could be used to target “multiple” other diseases but for the time being it will focus on cancer, and an initial clinical trial application is planned for 2019.

Well funded

ReNeuron recorded a loss of £9.6mln (2016: loss of £7.7mln) for the six months through to September 30

At the end of the period the AIM-quoted group had £45.3mln of cash and cash equivalents (31 March: £53.1mln).

“During the period, our therapeutic development programmes have continued to progress to plan,” added Hellebø.

“This progress positions us for the delivery of further significant clinical milestones across our therapeutic programmes during each of the next three years.”

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Thu, 14 Dec 2017 07:51:00 +0000 http://www.proactiveinvestors.co.uk/companies/news/188779/reneuron-receives-approval-from-us-authorities-to-kick-off-phase-iib-stroke-trial-188779.html
<![CDATA[RNS press release - Interim results ]]> http://www.proactiveinvestors.co.uk/companies/rns/862/LSE20171214070007_13464973/ Thu, 14 Dec 2017 07:00:07 +0000 http://www.proactiveinvestors.co.uk/companies/rns/862/LSE20171214070007_13464973/ <![CDATA[RNS press release - Stroke clinical trial regulatory approval in US ]]> http://www.proactiveinvestors.co.uk/companies/rns/862/LSE20171214070006_13464897/ Thu, 14 Dec 2017 07:00:06 +0000 http://www.proactiveinvestors.co.uk/companies/rns/862/LSE20171214070006_13464897/ <![CDATA[News - ReNeuron establishes Boston office ahead of US clinical trials ]]> http://www.proactiveinvestors.co.uk/companies/news/188492/reneuron-establishes-boston-office-ahead-of-us-clinical-trials-188492.html Stem cell therapy specialist ReNeuron Group Plc (LON:RENE) said it is opening an office in Boston, Massachusetts, in order to support planned clinical programmes.

It will be a base for medical and scientific communications staff ahead of three phase IIb trials in the US of its CTX and hRPC cell therapy candidates in people recovering from strokes and patients with retinal diseases.

READ: ReNeuron making good progress with all of its key therapeutic programmes

Having a presence Stateside will allow ReNeuron to more closely manage its relationship with the clinical research organisations carrying out the studies, the company said.

It will also allow the UK research group to establish stronger ties with key opinion leaders in America, it added.

"We are delighted to have established operations in Boston, one of the US's most vibrant academic and commercial biotechnology hubs,” said Olav Hellebø, chief executive. 

WATCH: ReNeuron's Michael Hunt discusses very encouraging long-term stroke data

“The US is a major future market for our cell-based therapies and a presence on the ground represents a key element of ReNeuron's clinical and commercial development strategy as our therapeutic candidates move closer to market." 

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Fri, 08 Dec 2017 07:23:00 +0000 http://www.proactiveinvestors.co.uk/companies/news/188492/reneuron-establishes-boston-office-ahead-of-us-clinical-trials-188492.html
<![CDATA[RNS press release - ReNeuron opens US office ]]> http://www.proactiveinvestors.co.uk/companies/rns/862/LSE20171208070004_13458428/ Fri, 08 Dec 2017 07:00:04 +0000 http://www.proactiveinvestors.co.uk/companies/rns/862/LSE20171208070004_13458428/ <![CDATA[RNS press release - Notification of Interim Results ]]> http://www.proactiveinvestors.co.uk/companies/rns/862/LSE20171113113001_13429403/ Mon, 13 Nov 2017 11:30:01 +0000 http://www.proactiveinvestors.co.uk/companies/rns/862/LSE20171113113001_13429403/ <![CDATA[News - ReNeuron jumps at opening bell as it gets green light to begin second part of phase I/II eye disease trial ]]> http://www.proactiveinvestors.co.uk/companies/news/186931/reneuron-jumps-at-opening-bell-as-it-gets-green-light-to-begin-second-part-of-phase-iii-eye-disease-trial-186931.html The ongoing phase I/II trial of ReNeuron Group Plc’s (LON:RENE) human retinal progenitor cell (hRPC) therapy has been given the green light by regulators to move into the phase II part of the study.

The hRPC therapy candidate is being trialled in patients with retinitis pigmentosa – a rare degenerative eye disease which can lead to blindness.

READ: ReNeuron making good progress with all of its key therapeutic programmes

The Data Safety Monitoring board gave its approval following short-term data from the nine patients taking part in the study, which indicated the therapy was safe and well-tolerated at the three doses tested.

ReNeuron has been hard at work developing a new formulation of hRPC recently which can be cryopreserved (frozen), extending its shelf life and allowing it to be shipped anywhere around the globe.

Cryopreserved formulation to be used in phase II trial

The final high-dose cohort patients in the phase I part of the study was treated with this new formulation, and the company expects to this version in the phase II element of the study.

This part of the trial will recruit six patients whose diseases haven’t progressed as much as those in the phase I element.

Readouts from the phase II trial are expected in the second half of next year, with efficacy data from a subsequent, larger phase IIb study due in 2020.

ReNeuron confirmed once again that an application will also be filed later this year to test the same hRPC therapy in a phase II trial in cone-rod dystrophy patients, and it hopes to have both phase II trials (RP and CRD) running concurrently.

‘High commercial potential’

"We are delighted that the Data Safety Monitoring Board has given its approval to progress our ongoing clinical trial in retinitis pigmentosa into its Phase II element,” said chief executive Olav Hellebø.

“Our hRPC cell therapy candidate offers the potential for an entirely new therapeutic option for patients suffering from diseases of the retina such as retinitis pigmentosa and cone-rod dystrophy, and represents a therapeutic platform technology with high commercial potential for ReNeuron.”

Shares rose 7.3% to 2.05p at the opening bell on Wednesday.

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Wed, 08 Nov 2017 08:06:00 +0000 http://www.proactiveinvestors.co.uk/companies/news/186931/reneuron-jumps-at-opening-bell-as-it-gets-green-light-to-begin-second-part-of-phase-iii-eye-disease-trial-186931.html
<![CDATA[RNS press release - Retinal disease clinical trial moves into Phase II ]]> http://www.proactiveinvestors.co.uk/companies/rns/862/LSE20171108070007_13423922/ Wed, 08 Nov 2017 07:00:07 +0000 http://www.proactiveinvestors.co.uk/companies/rns/862/LSE20171108070007_13423922/ <![CDATA[News - ReNeuron making good progress with all of its key therapeutic programmes ]]> http://www.proactiveinvestors.co.uk/companies/news/186516/reneuron-making-good-progress-with-all-of-its-key-therapeutic-programmes-186516.html Cell-based therapeutics specialist ReNeuron Group Plc (LON:RENE) has delivered another encouraging update from its phase II clinical study treating stroke patients with its CTX stem cells.

Last December, ReNeuron reported that seven-out-20 patients taking part in the PISCES II trial saw a discernible improvement in their disability.

READ: Encouraging short-term data from PISCES II stroke study WATCH: CFO Michael Hunt discusses encouraging long-term stroke data

The AIM-quoted group said the positive response rates reported at three months after treatment were sustained at 12 months after treatment, with seven people still showing a “clinically relevant improvement”.

"We are delighted that the long term follow-up data from the PISCES II clinical trial has shown the potential of our CTX cell therapy candidate to permanently improve function in patients living with chronic consequences following stroke,” said ReNeuron chief executive Olav Hellebø.

“Further, the study we plan to commence early in 2018 will allow critical placebo-controlled data with CTX in stroke disability to be available earlier than originally planned.”

IND application to be lodged “shortly”

ReNeuron confirmed it will “shortly” submit an investigational new drug application to the US Food and Drug Administration to kick off a clinical trial in the US in stroke patients.

Data from that study is expected at some point in the second half of 2019. After that, the company reckons it will need one more trial in order to get global marketing approval of the therapy.

Rare eye disease drug “progressing well”

ReNeuron is more than one-trick pony though. It also has its human retinal progenitor cell (hRPC) therapy which is used to treat the degenerative eye disease retinitis pigmentosa.

At September’s AGM Hellebø told investors that the phase I/II clinical trial was “progressing well” with all nine patients in the Phase I part of the study having now been treated.

Short term safety and tolerability data from that part of the study is expected in the final quarter of this year.

ReNeuron is also working on finalising the “relevant protocols” to enlarge the Phase II clinical development plan.

It expects additional read-outs from the RP phase I/II clinical trial in the second half of 2018, with further Phase II efficacy data from a larger group of patients expected in mid-2019. 

ReNeuron has developed a new formulation of hRPC which can be cryptopreserved (frozen), extending its shelf life and allowing it to be shipped anywhere around the globe.

An application will also be filed later this year to test the same hRPC therapy in a phase II trial in cone-rod dystrophy patients. ReNeuron said it hopes to have both phase II trials (RP and CRD) running concurrently.

Cancer-fighting cell technology

 Early research into the company’s Exo Pr0 therapeutic candidate has shown that it may have a “significant effect” in regulating cell growth and reducing cancer cell proliferation.

ReNeuron hopes to take ExoPr0 into the clinic within the next year to 18 months, targeting solid tumours.  

READ: ReNeuron presents more data on potential of its exosometherapy as potential cancer treatment

Exosomes are nano-sized particles in the bloodstream and other body fluids that can be absorbed by other cells.

Interestingly they can be used as a novel treatment candidate themselves or as a drug delivery vehicle.

New research, including by ReNeuron, points to them having a major impact on the way cells behave with a number of advantages in therapeutic treatments, especially in the way they can be engineered to be strong and precise delivery mechanism

Financially well-supported

At the end of March 2017 when it published its full-year results, ReNeuron had £53mln in the bank having burnt through £12.6mln in the period.

The company still only has a market cap of around £56mln, which means just a £3mln value is placed on its pipeline.

City broker N+1 Singer thinks the current share price of around 1.7p is far too cheap and believes they are worth closer to 9p each.

On top of the cash already in the bank, ReNeuron also benefits from various grants and R&D tax credits.

READ: ReNeuron awarded new grant by Welsh government

In fact, it was only recently awarded another grant by the Welsh government to advance its emerging exosome therapy platform.

The grant, awarded under the SMARTExpertise scheme, will help fund a £1.2mln collaborative programme of work to be undertaken by ReNeuron, Ig Innovations and Swansea University Medical School.

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Tue, 31 Oct 2017 15:40:00 +0000 http://www.proactiveinvestors.co.uk/companies/news/186516/reneuron-making-good-progress-with-all-of-its-key-therapeutic-programmes-186516.html
<![CDATA[Media files - ReNeuron's Michael Hunt discusses very encouraging long-term stroke data ]]> http://www.proactiveinvestors.co.uk/companies/stocktube/8308/reneuron-s-michael-hunt-discusses-very-encouraging-long-term-stroke-data-8308.html Tue, 31 Oct 2017 12:00:00 +0000 http://www.proactiveinvestors.co.uk/companies/stocktube/8308/reneuron-s-michael-hunt-discusses-very-encouraging-long-term-stroke-data-8308.html <![CDATA[News - ReNeuron boss “delighted” with long-term stroke data ]]> http://www.proactiveinvestors.co.uk/companies/news/186477/reneuron-boss-delighted-with-long-term-stroke-data-186477.html ReNeuron Group Plc (LON:RENE) was in demand early on Tuesday after the cell-based therapeutics specialist delivered another encouraging update from its phase II clinical study treating stroke patients with its CTX stem cells.

Last December, ReNeuron reported that seven-out-20 patients taking part in the PISCES II trial saw a discernible improvement in their disability.

READ: Encouraging short-term data from PISCES II stroke study

The AIM-quoted group said on Tuesday that the positive response rates reported at three months after treatment were sustained at 12 months after treatment, with seven people still showing a “clinically relevant improvement”.

The PISCES II trial also showed that the CTX treatment was well-tolerated both in the short and longer-term.

"We are delighted that the long term follow-up data from the PISCES II clinical trial has shown the potential of our CTX cell therapy candidate to permanently improve function in patients living with chronic consequences following stroke,” said ReNeuron chief executive Olav Hellebø.

“Further, the study we plan to commence early in 2018 will allow critical placebo-controlled data with CTX in stroke disability to be available earlier than originally planned.”

IND application to be lodged “shortly”

ReNeuron confirmed it will “shortly” submit an investigational new drug application to the US Food and Drug Administration to kick off a clinical trial in the US in stroke patients.

Data from that study is expected at some point in the second half of 2019. After that, the company reckons it will need one more study in order to get global marketing approval of the therapy.

Shares were up 2.1% to 1.71p in early deals on Monday.

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Tue, 31 Oct 2017 08:22:00 +0000 http://www.proactiveinvestors.co.uk/companies/news/186477/reneuron-boss-delighted-with-long-term-stroke-data-186477.html
<![CDATA[RNS press release - Positive stroke clinical data & regulatory update ]]> http://www.proactiveinvestors.co.uk/companies/rns/862/LSE20171031070004_13413978/ Tue, 31 Oct 2017 07:00:04 +0000 http://www.proactiveinvestors.co.uk/companies/rns/862/LSE20171031070004_13413978/ <![CDATA[News - ReNeuron awarded new grant by Wales for exosome research ]]> http://www.proactiveinvestors.co.uk/companies/news/186329/reneuron-awarded-new-grant-by-wales-for-exosome-research-186329.html ReNeuron Group Plc (LON:RENE) has been awarded a further grant by the Welsh Government to advance its emerging exosome therapy platform.

The grant, awarded under the SMARTExpertise scheme, will help fund a £1.2m collaborative programme of work to be undertaken by ReNeuron, Ig Innovations and Swansea University Medical School. 

READ: ReNeuron presents more data on potential for its Exosome therapy as cancer treatment

Exosomes are nano-sized particles in the bloodstream and other body fluids that can be absorbed by other cells.

New research, including by ReNeuron, points to them having a major impact on the way cells behave with a number of advantages in therapeutic treatments, especially in the way they can be engineered to be strong and precise delivery mechanisms.

ReNeuron will use the new grant to optimise the manufacture of CTX cell-derived exosomes, enhance them against solid tumours to identify new cancer targets and methods to characterise exosomes with potential therapeutic benefit.  

WATCH: It's 'all systems go' as ReNeuron gears up for Phase III stroke disability study

The exosome therapy platform is being developed as a potential new nano-medicine targeting cancer and as a potential delivery system for drugs that would otherwise be unable to reach their site of action.  

Dr Randolph Corteling, Reneuron’s head of research, said:  “As a Wales-based business, we are very pleased to be able to work with leading Welsh academic and industry collaborators."

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Fri, 27 Oct 2017 08:03:00 +0100 http://www.proactiveinvestors.co.uk/companies/news/186329/reneuron-awarded-new-grant-by-wales-for-exosome-research-186329.html
<![CDATA[RNS press release - Wins further UK grant ]]> http://www.proactiveinvestors.co.uk/companies/rns/862/LSE20171027070003_13410831/ Fri, 27 Oct 2017 07:00:03 +0100 http://www.proactiveinvestors.co.uk/companies/rns/862/LSE20171027070003_13410831/ <![CDATA[RNS press release - PDMR Interest in Shares and Share Options ]]> http://www.proactiveinvestors.co.uk/companies/rns/862/LSE20171011133111_13393526/ Wed, 11 Oct 2017 13:31:11 +0100 http://www.proactiveinvestors.co.uk/companies/rns/862/LSE20171011133111_13393526/ <![CDATA[News - ReNeuron presents more data on potential for its Exosome therapy as cancer treatment ]]> http://www.proactiveinvestors.co.uk/companies/news/185236/reneuron-presents-more-data-on-potential-for-its-exosome-therapy-as-cancer-treatment-185236.html ReNeuron Group PLC (LON:RENE) is to present more pre-clinical data highlighting the potential of its exosome therapy as a cancer treatment.

Data will show a significant reduction in cancer cell proliferation when treated with ExoPr0 and provides important proof-of-concept for applications across a range of cancers, ReNeuron said in a statement.

READ: ReNeuron Group's therapeutic programme progressing to plan

Dr Randolph Corteling, head of research at ReNeuron, added the data built upon data presented earlier this year relating to the characterisation and scale-up potential of ExoPr0 and the ability to deliver ExoPr0 by local or systemic administration to target specific organs. 

“Taken together, this already substantial body of pre-clinical evidence clearly demonstrates the potential of this novel therapeutic platform to target multiple diseases, including cancer."

Professor Karol Sikora, a leading UK-based oncologist and an adviser to ReNeuron, added: "This is a novel and completely unexplored strategy for selectively targeting the growth of cancer cells.

“This work has the potential to uncover a whole new area in cancer therapeutics."

WATCH: It's 'all systems go' as ReNeuron gears up for Phase III stroke disability study

ReNeuron will present the data to the American Society for Exosomes and Microvesicles (ASEMV) 2017 meeting currently underway in San Francisco.

Exosomes are nano-sized particles in the bloodstream and other body fluids that can be absorbed by other cells.

New research, including by ReNeuron, points to them having a major impact on the way cells behave with a number of advantages in therapeutic treatments, in particular that they can be engineered to be strong and targeted delivery mechanisms.

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Mon, 09 Oct 2017 07:36:00 +0100 http://www.proactiveinvestors.co.uk/companies/news/185236/reneuron-presents-more-data-on-potential-for-its-exosome-therapy-as-cancer-treatment-185236.html
<![CDATA[RNS press release - Presentation of positive pre-clinical data ]]> http://www.proactiveinvestors.co.uk/companies/rns/862/LSE20171009070004_13389599/ Mon, 09 Oct 2017 07:00:04 +0100 http://www.proactiveinvestors.co.uk/companies/rns/862/LSE20171009070004_13389599/