Proactiveinvestors United Kingdom ReNeuron Group PLC https://www.proactiveinvestors.co.uk Proactiveinvestors United Kingdom ReNeuron Group PLC RSS feed en Thu, 20 Jun 2019 15:58:44 +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 ]]> https://www.proactiveinvestors.co.uk/companies/rns/862/LSE20190618160129_14115556/ Tue, 18 Jun 2019 16:01:29 +0100 https://www.proactiveinvestors.co.uk/companies/rns/862/LSE20190618160129_14115556/ <![CDATA[RNS press release - Webcast of Preliminary Results ]]> https://www.proactiveinvestors.co.uk/companies/rns/862/LSE20190618070005_14114067/ Tue, 18 Jun 2019 07:00:05 +0100 https://www.proactiveinvestors.co.uk/companies/rns/862/LSE20190618070005_14114067/ <![CDATA[News - ReNeuron wins Breakthrough of the Year at 2019 Mediscience Awards ]]> https://www.proactiveinvestors.co.uk/companies/news/222146/reneuron-wins-breakthrough-of-the-year-at-2019-mediscience-awards-222146.html ReNeuron Group PLC (LON:RENE) has won the Breakthrough of the Year award at the 2019 Mediscience Awards in London for the clinical development and commercial progress it has made over the past year.

The developer of stem cell technologies said the award acknowledges positive data from its ongoing phase I/II clinical trial of its hRPC treatment for a rare blindness-causing disease called retinitis pigmentosa.

READ: ReNeuron well funded for pivotal period clinically and commercially

Another recent highlight for the group was the signing of an exclusive licence agreement with Shanghai Fosun Pharmaceutical Industrial Development Co., Ltd. for the development, manufacture and commercialisation of ReNeuron's cell therapy programmes in China.

"We are delighted to have been awarded the Breakthrough of the Year award at the 2019 European Mediscience Awards,” said ReNeuron chief executive Olav Hellebø.

“We are greatly encouraged by the progress we have made with our cell therapy clinical development programmes for retinitis pigmentosa and stroke disability over the past year and look forward to continuing to advance our clinical and business development activities in the months ahead."

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Fri, 14 Jun 2019 11:29:00 +0100 https://www.proactiveinvestors.co.uk/companies/news/222146/reneuron-wins-breakthrough-of-the-year-at-2019-mediscience-awards-222146.html
<![CDATA[RNS press release - ReNeuron wins Breakthrough of the Year Award ]]> https://www.proactiveinvestors.co.uk/companies/rns/862/LSE20190614110927_14111665/ Fri, 14 Jun 2019 11:09:27 +0100 https://www.proactiveinvestors.co.uk/companies/rns/862/LSE20190614110927_14111665/ <![CDATA[RNS press release - Total Voting Rights ]]> https://www.proactiveinvestors.co.uk/companies/rns/862/LSE20190603070008_14095158/ Mon, 03 Jun 2019 07:00:08 +0100 https://www.proactiveinvestors.co.uk/companies/rns/862/LSE20190603070008_14095158/ <![CDATA[RNS press release - Jefferies 2019 Global Healthcare Conference ]]> https://www.proactiveinvestors.co.uk/companies/rns/862/LSE20190531070005_14093308/ Fri, 31 May 2019 07:00:05 +0100 https://www.proactiveinvestors.co.uk/companies/rns/862/LSE20190531070005_14093308/ <![CDATA[RNS press release - Exercise of options, PDMR dealing and TVR ]]> https://www.proactiveinvestors.co.uk/companies/rns/862/LSE20190509170559_14068817/ Thu, 09 May 2019 17:05:59 +0100 https://www.proactiveinvestors.co.uk/companies/rns/862/LSE20190509170559_14068817/ <![CDATA[Media files - ReNeuron Group encouraged by level of interest in its key programmes ]]> https://www.proactiveinvestors.co.uk/companies/stocktube/13261/reneuron-group-encouraged-by-level-of-interest-in-its-key-programmes-13261.html Wed, 08 May 2019 16:02:00 +0100 https://www.proactiveinvestors.co.uk/companies/stocktube/13261/reneuron-group-encouraged-by-level-of-interest-in-its-key-programmes-13261.html <![CDATA[News - ReNeuron Group primed for a pivotal 18 months ]]> https://www.proactiveinvestors.co.uk/companies/news/219881/reneuron-group-primed-for-a-pivotal-18-months-219881.html ReNeuron Group PLC (LON:RENE) has unique stem cell technologies that can be administered “off-the-shelf”. Its lead candidate has been developed to treat people disabled by a stroke.

Its human retinal progenitor cells (hRPC), meanwhile, have scored some early success. A Phase I/II assessment of a very small group of sufferers of a blindness-causing disease called retinitis pigmentosa saw a significant improvement in vision after treatment.

As at the end of March, the business had just over £29mln in the bank. Including the £6mln upfront payment from its collaboration with Fosun Pharma of China, ReNeuron reckons it has funds enough for at least the next 12 months.

Inflexion Points

In a May 8 update, the company confirmed a second group of three people suffering retinal disease have been dosed with its hRPC cell line. The vision of this latest trio is more impaired than the first. In all, ReNeuron expects to dose 12 people suffering from the degenerative condition retinitis pigmentosa with results from the phase IIa study expected by the end of the year.

The company has announced positive Phase II data from patients treated with its neural stem cells, with a Phase IIb trial, called PISCES III, underway. The results from this trial are expected in the second-half of next year rather than the first-half as planned.

ReNeuron is also “pursuing opportunities to capitalise on the significant scientific and industry interest in its exosomes technology by forming value-generating, business partnerships”.

Exosomes are nanoparticles released by cells and contain a number of active proteins and micro RNAs that are believed to play a key role in cell-to-cell communication. A growing body of evidence demonstrates that exosomes can modulate cellular immunity and promote the activation of regenerative or repair programmes in diseased or injured cells. The company’s CTX cells release large amounts of exosomes when grown in the laboratory enabling its scientists to purify and characterise them.

ExoPr0 is ReNeuron’s first CTX-derived exosome therapeutic. It has demonstrated pre-clinical potential as both a treatment and a drug delivery vehicle. In January the firm told investors it had signed an exomes collaboration agreement with an unnamed US-based group. On May 8 it revealed it is in “active early discussions” with other commercial third parties.

A big long-term value kicker was announced in April when the company struck a licensing deal with Chinese pharma Fosun worth up to £80mln over the next few years. Deals for its two clinical-stage treatments would provide third-party validation for the technology, but could conceivably be worth much more than the Fosun tie-up.

Blue Sky

The share price has rocketed from 50p to 300p on the back of the recent news flow. But even so, analysts believe there is more ‘upside’. Edison Research believes the company is worth 630p. The broker Stifel has a price target of 690p. “The business remains significantly undervalued,” Stifel said in April.

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Wed, 08 May 2019 11:54:00 +0100 https://www.proactiveinvestors.co.uk/companies/news/219881/reneuron-group-primed-for-a-pivotal-18-months-219881.html
<![CDATA[News - ReNeuron well funded for pivotal period clinically and commercially ]]> https://www.proactiveinvestors.co.uk/companies/news/219860/reneuron-well-funded-for-pivotal-period-clinically-and-commercially-219860.html ReNeuron Group PLC (LON:RENE) revealed it is in a strong financial position as it heads into a pivotal 18 months both clinically and commercially.

Having secured a partnership for its cell technology in China with local company Fosun Pharma, the company confirmed the group is pursuing other collaborations "and/or" out-licensing deals across all its programmes.

ReNeuron in an update reprised the significant clinical headway it has made with successful early studies on patients suffering stroke and those with a blindness causing disease.

Second group dosed

It also confirmed a second group of three people suffering retinal disease have been dosed with its hRPC cell line. Earlier results revealed the treatment improved eyesight in the first three patients. The vision of this latest trio is more impaired than the first.

In all, ReNeuron expects to dose 12 people suffering from the degenerative condition retinitis pigmentosa with results from the phase IIa study expected by the end of the year.

Dosing for the PISCES III phase IIb clinical trial in 110 stroke patients at up to 40 clinical trial sites in the US began in January with the results expected in the second-half of next year rather than the first-half as planned.

The drug developer said the latest clinical assessment of its CTX therapy, if positive, will be one of two trials required to support marketing authorisations.

Exomes potential 

ReNeuron also said it is “pursuing opportunities to capitalise on the significant scientific and industry interest in its exosomes technology by forming value-generating, business partnerships”.

Exosomes are nanoparticles released by cells and contain a number of active proteins and micro RNAs that are believed to play a key role in cell-to-cell communication.

A growing body of evidence demonstrates that exosomes can modulate cellular immunity and promote the activation of regenerative or repair programmes in diseased or injured cells.

The company’s CTX cells release large amounts of exosomes when grown in the laboratory enabling its scientists to purify and characterise them.

First candidate 

ExoPr0 is ReNeuron’s first CTX-derived exosome therapeutic. It has demonstrated pre-clinical potential as both a treatment and a drug delivery vehicle.

In January the firm told investors it had signed an exomes collaboration agreement with an unnamed US-based group. On Wednesday it revealed it is in “active early discussions” with other commercial third parties.

As at the end of March, the business had just over £29mln in the bank. Including the £6mln upfront payment from its collaboration with Fosun, ReNeuron reckons it has funds enough for at least the next 12 months.

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Wed, 08 May 2019 08:08:00 +0100 https://www.proactiveinvestors.co.uk/companies/news/219860/reneuron-well-funded-for-pivotal-period-clinically-and-commercially-219860.html
<![CDATA[RNS press release - Year-end update and results notification ]]> https://www.proactiveinvestors.co.uk/companies/rns/862/LSE20190508070005_14065695/ Wed, 08 May 2019 07:00:05 +0100 https://www.proactiveinvestors.co.uk/companies/rns/862/LSE20190508070005_14065695/ <![CDATA[RNS press release - Total Voting Rights ]]> https://www.proactiveinvestors.co.uk/companies/rns/862/LSE20190502154355_14061441/ Thu, 02 May 2019 15:43:55 +0100 https://www.proactiveinvestors.co.uk/companies/rns/862/LSE20190502154355_14061441/ <![CDATA[RNS press release - Second Price Monitoring Extn ]]> https://www.proactiveinvestors.co.uk/companies/rns/862/LSE20190426164038_14054264/ Fri, 26 Apr 2019 16:40:38 +0100 https://www.proactiveinvestors.co.uk/companies/rns/862/LSE20190426164038_14054264/ <![CDATA[RNS press release - Price Monitoring Extension ]]> https://www.proactiveinvestors.co.uk/companies/rns/862/LSE20190426163545_14054257/ Fri, 26 Apr 2019 16:35:45 +0100 https://www.proactiveinvestors.co.uk/companies/rns/862/LSE20190426163545_14054257/ <![CDATA[Media files - ReNeuron 'very encouraged' by positive retinitis pigmentosa study results ]]> https://www.proactiveinvestors.co.uk/companies/stocktube/13119/reneuron--very-encouraged--by-positive-retinitis-pigmentosa-study-results-13119.html Fri, 26 Apr 2019 14:29:00 +0100 https://www.proactiveinvestors.co.uk/companies/stocktube/13119/reneuron--very-encouraged--by-positive-retinitis-pigmentosa-study-results-13119.html <![CDATA[News - ReNeuron says eye disease patients see “sustained and further improvement” after cell treatment ]]> https://www.proactiveinvestors.co.uk/companies/news/219157/reneuron-says-eye-disease-patients-see-sustained-and-further-improvement-after-cell-treatment-219157.html Shares in ReNeuron Group PLC (LON:RENE) were up 18% after it said the first group of patients receiving cell therapy for a blindness-causing disease have seen “sustained and further improvement” to their sight.

This was the top-line from the latest data assimilated from a Phase IIa study of its human retinal progenitor cell (hRPC) treatment for retinitis pigmentosa.

It assessed the first three people to be administered the new medication and looked at their progress at the 60- and 120-days stage.

The update follows encouraging eye sight results earlier in the process. Followers of the company will be heartened by the news that improvements were sustained and enhanced over the longer period, even if this first study group is an incredibly small one.

Michael Hunt, the company's chief financial officer, echoed those sentiments, before adding: "We need to treat more patients and look to the longer-term duration of this effect we are seeing now."

Rapid and remarkable

Dr Pravin Dugel, of Retinal Consultants of Arizona and one of the study investigators, called the sight enhancement both rapid and remarkable.

“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," he added.

These latest results are being presented later today at a conference in Vancouver, Canada, by Dr Jason Comander, who is the Associate Director of the Inherited Retinal Disorders Service at Massachusetts Eye and Ear. He is also an assistant professor at the Harvard Medical School.

Treatment has already begun in the next group of patients, who have a greater baseline level of sight loss than those assessed so far. 

Up to 12 patients to be treated

The current protocol allows the company to dose up to 12 patients and CFO Hunt said it likely a dozen people will be treated in the phase II part of the trial.

Results from the second cohort of three patients are likely to be released later this year, most probably at a scientific conference, he added.

ReNeuron, following the last batch of data, is certainly starting to register on the radar screens of potential industry partners and investors, Hunt confirmed.

“That’s very gratifying,” he told Proactive's Andrew Scott. “It is worth noting that ophthalmology generally, or back of the eye retinal degeneration, is a hot area for advanced therapies at the moment, including both cell and gene therapies.”

The shares were changing hands for 310.12p, up 48.12p, valuing the business at just shy of £100mln.

-- Adds comments from the CFO--

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Fri, 26 Apr 2019 07:53:00 +0100 https://www.proactiveinvestors.co.uk/companies/news/219157/reneuron-says-eye-disease-patients-see-sustained-and-further-improvement-after-cell-treatment-219157.html
<![CDATA[RNS press release - Clinical update and conference presentation ]]> https://www.proactiveinvestors.co.uk/companies/rns/862/LSE20190426070010_14052770/ Fri, 26 Apr 2019 07:00:10 +0100 https://www.proactiveinvestors.co.uk/companies/rns/862/LSE20190426070010_14052770/ <![CDATA[RNS press release - Share Purchases by Directors ]]> https://www.proactiveinvestors.co.uk/companies/rns/862/LSE20190418154059_14046953/ Thu, 18 Apr 2019 15:40:59 +0100 https://www.proactiveinvestors.co.uk/companies/rns/862/LSE20190418154059_14046953/ <![CDATA[News - ReNeuron primed for further progress ]]> https://www.proactiveinvestors.co.uk/companies/news/218786/ReNeuron-primed-for-further-progress--218786.html It has unique stem cell technologies that can be administered “off-the-shelf”. Its lead candidate has been developed to treat people disabled by a stroke.

The company has announced positive Phase II data from patients treated with its neural stem cells, with a Phase IIb trial imminent.

Its human retinal progenitor cells (hRPC), meanwhile, have scored some early success. A Phase I/II assessment of a very small group of sufferers of a blindness-causing disease called retinitis pigmentosa saw a significant improvement in vision after treatment.

"We remain extremely encouraged by the positive efficacy data we have seen thus far,” said chief executive Olav Hellebø recently. “These results have already attracted considerable interest, particularly from those in the ophthalmology field.”

Inflexion Points

PISCES III trial: This is the Phase IIb study in the US for people suffering from a stroke. This particular trial is placebo-controlled, which means half the patients will receive a substance with no therapeutic value to provide a control group. A total of 110 people are being recruited at 40 site across the States.

Additional data from the ongoing Phase I/II trial of the retinal stem cell treatment are being presented at gene and cell therapy conference on April 26.

A big long-term value kicker was announced earlier this month (April) when the company struck a licensing deal with Chinese pharma Fosun worth up to £80mln over the next few years.

Deals for its two clinical-stage treatments would provide third-party validation for the technology, but could conceivably be worth much more than the Fosun tie-up.

Blue Sky

The share price has rocketed from 50p to 250p on the back of the recent news flow. But even so, analysts believe there is more ‘upside’. However, Edison Research believes the company is worth 630p. The broker Stifel has a price target of 690p. “The business remains significantly undervalued, and we look forward to further clinical data on the retinal programme at the end of April, and potential further licensing activity, as near-term catalysts to build on recent momentum,” it said in a note earlier this month.

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Wed, 17 Apr 2019 14:42:00 +0100 https://www.proactiveinvestors.co.uk/companies/news/218786/ReNeuron-primed-for-further-progress--218786.html
<![CDATA[RNS press release - Exercise of Share Options and TVR ]]> https://www.proactiveinvestors.co.uk/companies/rns/862/LSE20190412143634_14039870/ Fri, 12 Apr 2019 14:36:34 +0100 https://www.proactiveinvestors.co.uk/companies/rns/862/LSE20190412143634_14039870/ <![CDATA[RNS press release - Share Purchases by Directors ]]> https://www.proactiveinvestors.co.uk/companies/rns/862/LSE20190411163112_14038278/ Thu, 11 Apr 2019 16:31:12 +0100 https://www.proactiveinvestors.co.uk/companies/rns/862/LSE20190411163112_14038278/ <![CDATA[RNS press release - Director/PDMR Shares and Share Options ]]> https://www.proactiveinvestors.co.uk/companies/rns/862/LSE20190410143748_14036479/ Wed, 10 Apr 2019 14:37:48 +0100 https://www.proactiveinvestors.co.uk/companies/rns/862/LSE20190410143748_14036479/ <![CDATA[Media files - ReNeuron Group agrees £80mln cell therapy licensing deal for China ]]> https://www.proactiveinvestors.co.uk/companies/stocktube/12938/reneuron-group-agrees-80mln-cell-therapy-licensing-deal-for-china-12938.html Wed, 10 Apr 2019 09:40:00 +0100 https://www.proactiveinvestors.co.uk/companies/stocktube/12938/reneuron-group-agrees-80mln-cell-therapy-licensing-deal-for-china-12938.html <![CDATA[News - ReNeuron shares up 30% after it strikes deal worth up to £80mln with Chinese pharma ]]> https://www.proactiveinvestors.co.uk/companies/news/218229/reneuron-shares-up-30-after-it-strikes-deal-worth-up-to-80mln-with-chinese-pharma-218229.html Shares in ReNeuron Group PLC (LON:RENE) rose 30% after it inked a deal potentially worth up to £80mln in success-based payments with an arm of one of China's leading drug companies.

Fosun Pharma is licensing the rights to the company’s CTX and hRPC cell therapy programmes in the People’s Republic for an initial £6mln.

WATCH: ReNeuron Group agrees £80mln cell therapy licensing deal for China

The UK innovator, which is developing treatments for stroke and disease that causes blindness, will receive the same sum again in what is described as “near-term operational milestones”.

Also on offer is £8mln linked to future regulatory landmarks, while post-launch it will receive 5% of net profits from products using ReNeuron technology, taking it to the £80mln total.

Investors will also have noted the tiered royalties on sales of between 12% and 14%.

“This agreement furthers our core strategy to build shareholder value through the clinical development and commercialisation of our cell therapy programmes,” said ReNeuron chief executive Olav Hellebø.

“China represents a significant market opportunity for our products and we look forward to working with Fosun Pharma to ultimately bring these treatments to the many patients in China who may benefit from them."

The news was well received by the market with the shares marked up 50.6p at 221.3p, valuing the business at £70mln.

Broker upbeat

N+1 Singer called the deal a “commercial breakthrough”, adding that the estimated size of the Chinese stem cell market was around £5bn (US$6.4bn) “and developing rapidly”.

It pointed out that “several hundred clinical trials currently underway, propelled by government initiatives and private funding”.

“In our view, Fosun Pharma (a large, reputable company dual-listed in Shanghai and Hong Kong) is an ideal development and commercialisation partner for ReNeuron’s CTX (stroke) and hRPC (ophthalmic disorders) programmes in China,” N+1 said in a note to clients.

--- Adds analyst comment ---  

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Tue, 09 Apr 2019 10:16:00 +0100 https://www.proactiveinvestors.co.uk/companies/news/218229/reneuron-shares-up-30-after-it-strikes-deal-worth-up-to-80mln-with-chinese-pharma-218229.html
<![CDATA[RNS press release - ReNeuron partners with Fosun Pharma in China ]]> https://www.proactiveinvestors.co.uk/companies/rns/862/LSE20190409095043_14034155/ Tue, 09 Apr 2019 09:50:43 +0100 https://www.proactiveinvestors.co.uk/companies/rns/862/LSE20190409095043_14034155/ <![CDATA[RNS press release - ReNeuron to present at UK investor conference ]]> https://www.proactiveinvestors.co.uk/companies/rns/862/LSE20190405070003_14029942/ Fri, 05 Apr 2019 07:00:03 +0100 https://www.proactiveinvestors.co.uk/companies/rns/862/LSE20190405070003_14029942/ <![CDATA[Media files - ReNeuron eyes profits after sustained efficacy in blindness treatment ]]> https://www.proactiveinvestors.co.uk/companies/stocktube/12873/reneuron-eyes-profits-after-sustained-efficacy-in-blindness-treatment-12873.html Thu, 04 Apr 2019 15:38:00 +0100 https://www.proactiveinvestors.co.uk/companies/stocktube/12873/reneuron-eyes-profits-after-sustained-efficacy-in-blindness-treatment-12873.html <![CDATA[News - ReNeuron provides further encouraging update for potential sight-saving treatment ]]> https://www.proactiveinvestors.co.uk/companies/news/217933/reneuron-provides-further-encouraging-update-for-potential-sight-saving-treatment-217933.html ReNeuron Group PLC (LON:RENE) shares leapt higher on Thursday after the group said its cell therapy for blindness-causing disease retinitis pigmentosa is proving efficacious in the first group of phase II patients receiving the treatment.

This follows from February’s update from which it emerged that the first three people taking part in the phase I/II study were able to read an additional three lines of a standard eye chart.

READ: ReNeuron starts dosing second cohort in eye disease trial

The latest group to be treated with human retinal progenitor cells (hRPCs) comprises patients who have a greater baseline level of visual acuity (clarity of vision) than those taking part in the clinical assessment thus far.

Further data from the trial will be shared at the Sixth Annual Retinal Cell and Gene Therapy Innovation Summit, in Vancouver, Canada, later this month.

"We remain greatly encouraged by the continued positive efficacy we are seeing in the ongoing phase I/II study with our hRPC cell therapy candidate for retinitis pigmentosa,” said ReNeuron chief executive Olav Hellebø.

“We look forward to providing a further update on progress with the study at the time of the Innovation Summit in Vancouver later this month."

In mid-morning trading, ReNeuron shares soared 17% higher to 142p.

 -- Adds share price --

 

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Thu, 04 Apr 2019 07:27:00 +0100 https://www.proactiveinvestors.co.uk/companies/news/217933/reneuron-provides-further-encouraging-update-for-potential-sight-saving-treatment-217933.html
<![CDATA[RNS press release - Clinical update and conference presentation ]]> https://www.proactiveinvestors.co.uk/companies/rns/862/LSE20190404070011_14028213/ Thu, 04 Apr 2019 07:00:11 +0100 https://www.proactiveinvestors.co.uk/companies/rns/862/LSE20190404070011_14028213/ <![CDATA[RNS press release - Second Price Monitoring Extn ]]> https://www.proactiveinvestors.co.uk/companies/rns/862/LSE20190328140545_14019880/ Thu, 28 Mar 2019 14:05:45 +0000 https://www.proactiveinvestors.co.uk/companies/rns/862/LSE20190328140545_14019880/ <![CDATA[RNS press release - Price Monitoring Extension ]]> https://www.proactiveinvestors.co.uk/companies/rns/862/LSE20190328140026_14019872/ Thu, 28 Mar 2019 14:00:26 +0000 https://www.proactiveinvestors.co.uk/companies/rns/862/LSE20190328140026_14019872/ <![CDATA[RNS press release - Alliance for Regenerative Medicine presentation ]]> https://www.proactiveinvestors.co.uk/companies/rns/862/LSE20190318120003_14005979/ Mon, 18 Mar 2019 12:00:03 +0000 https://www.proactiveinvestors.co.uk/companies/rns/862/LSE20190318120003_14005979/ <![CDATA[News - ReNeuron starts dosing second cohort in eye disease trial ]]> https://www.proactiveinvestors.co.uk/companies/news/216616/reneuron-starts-dosing-second-cohort-in-eye-disease-trial-216616.html ReNeuron Group PLC’s (LON:RENE) Phase I/II clinical trial in the US of its blindness-causing disease, retinitis pigmentosa, has progressed to the next stage.

Following a positive data safety monitoring board review of the clinical data from the first Phase II patient cohort in the study, dosing of the second cohort of three Phase II subjects has now commenced, with the first subject in the cohort treated last week at Massachusetts Eye and Ear, in Boston.

READ: ReNeuron shares spike 20% after it provides encouraging update to Phase II eye disease trial

ReNeuron said this next dose cohort comprises patients who have a greater baseline level of visual acuity than those treated in the study thus far, thus providing a framework to better evaluate the safety of the treatment and to gain further clarity on the strong efficacy signal that was seen in the first Phase II cohort.

"We remain extremely encouraged by the positive efficacy data we have seen thus far in the Phase I/II study with our hRPC cell therapy candidate in RP patients. These results have already attracted considerable interest, particularly from those in the ophthalmology field, and we look forward to reporting further results from the study as it progresses over the coming months," said Olav Hellebø, the chief executive officer of ReNeuron.

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Mon, 18 Mar 2019 07:55:00 +0000 https://www.proactiveinvestors.co.uk/companies/news/216616/reneuron-starts-dosing-second-cohort-in-eye-disease-trial-216616.html
<![CDATA[RNS press release - Retinal clinical trial progresses to next stage ]]> https://www.proactiveinvestors.co.uk/companies/rns/862/LSE20190318070007_14005019/ Mon, 18 Mar 2019 07:00:07 +0000 https://www.proactiveinvestors.co.uk/companies/rns/862/LSE20190318070007_14005019/ <![CDATA[RNS press release - Notification of Major Holdings ]]> https://www.proactiveinvestors.co.uk/companies/rns/862/LSE20190312143018_13999436/ Tue, 12 Mar 2019 14:30:18 +0000 https://www.proactiveinvestors.co.uk/companies/rns/862/LSE20190312143018_13999436/ <![CDATA[RNS press release - Notification of Major Holdings ]]> https://www.proactiveinvestors.co.uk/companies/rns/862/LSE20190305125633_13990964/ Tue, 05 Mar 2019 12:56:33 +0000 https://www.proactiveinvestors.co.uk/companies/rns/862/LSE20190305125633_13990964/ <![CDATA[RNS press release - Notification of Major Holdings ]]> https://www.proactiveinvestors.co.uk/companies/rns/862/LSE20190305070029_13989879/ Tue, 05 Mar 2019 07:00:29 +0000 https://www.proactiveinvestors.co.uk/companies/rns/862/LSE20190305070029_13989879/ <![CDATA[RNS press release - Block Listing Review and Total Voting Rights ]]> https://www.proactiveinvestors.co.uk/companies/rns/862/LSE20190228070013_13984428/ Thu, 28 Feb 2019 07:00:13 +0000 https://www.proactiveinvestors.co.uk/companies/rns/862/LSE20190228070013_13984428/ <![CDATA[Media files - ReNeuron provides encouraging update to phase II eye disease trial ]]> https://www.proactiveinvestors.co.uk/companies/stocktube/12303/reneuron-provides-encouraging-update-to-phase-ii-eye-disease-trial-12303.html Wed, 20 Feb 2019 12:14:00 +0000 https://www.proactiveinvestors.co.uk/companies/stocktube/12303/reneuron-provides-encouraging-update-to-phase-ii-eye-disease-trial-12303.html <![CDATA[News - ReNeuron shares spike 20% after it provides encouraging update to Phase II eye disease trial ]]> https://www.proactiveinvestors.co.uk/companies/news/214931/reneuron-shares-spike-20-after-it-provides-encouraging-update-to-phase-ii-eye-disease-trial-214931.html Shares in ReNeuron Group PLC (LON:RENE) surged by a fifth after reporting “early efficacy signals from its cell-based treatment for sufferers of a disease that can cause blindness.

Researchers in the US are currently carrying out a Phase I/II clinical trial on people with retinitis pigmentosa.

The first three patients in a group taking part in the Phase II portion of the study were able on average to read an additional three lines on the standard ETDRS eye chart after receiving treatment, ReNeuron reported.

Doctors used human retinal progenitor cells (hRPC) developed by the AIM-listed life sciences company.

Pre-clinical studies have shown they have the potential to preserve existing photoreceptors found in the retina, which could reduce or halt further deterioration of vision.

In addition, these progenitor cells have been shown to mature into functional photoreceptors that could then help restore sight.

“We are very, very encouraged by what we are seeing so far in this study,” said ReNeuron chief financial officer Michael Hunt in an interview with Proactive.

“To see a very strong reaction or signal in every patient treated so far was very surprising to us. We weren’t expecting to see that level of response in every patient at this point in the study.”

The shares rose 9.9p to 57.4p as the market welcomed the news.

Short term, the company will continue with the efficacy study to replicate the findings in more patients, Hunt said, which will lead to a Phase IIb study later this year.

Looking ahead

It will speak to the US regulator – the Food & Drug Administration – before embarking on a more formal controlled trial.

It is worth noting that retinitis pigmentosa is a rare, or orphan disease, which means any new therapy may receive certain incentives and preferential treatment. ReNeuron’s breakthrough has been given fast-track designation by the FDA.

The company, which is also using its stem cell lines to treat stroke victims, is currently in talks with potential commercial partners for its hRPC line.

Hunt admitted the latest results “give us a leg up”.

“In terms of our ongoing discussions with potential partners if we can demonstrate some level of efficacy signal, albeit early stage, that is only going to help our discussions,” he added.

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Wed, 20 Feb 2019 07:37:00 +0000 https://www.proactiveinvestors.co.uk/companies/news/214931/reneuron-shares-spike-20-after-it-provides-encouraging-update-to-phase-ii-eye-disease-trial-214931.html
<![CDATA[RNS press release - Positive preliminary data in US retinal trial ]]> https://www.proactiveinvestors.co.uk/companies/rns/862/LSE20190220070004_13974906/ Wed, 20 Feb 2019 07:00:04 +0000 https://www.proactiveinvestors.co.uk/companies/rns/862/LSE20190220070004_13974906/ <![CDATA[News - ReNeuron partner to unveil production scale-up data ]]> https://www.proactiveinvestors.co.uk/companies/news/213692/reneuron-partner-to-unveil-production-scale-up-data-213692.html Cell therapy specialist ReNeuron Group PLC (LON:RENE) said new data will be presented that demonstrate the feasibility of scaling up production of ReNeuron's CTX-derived exosomes.

Exosomes are nanoparticles released by cells that are believed to play a key role in cell-to-cell communication.

READ: First person treated in ReNeuron’s mid-stage US stroke trial

A growing body of evidence suggests they can modulate cellular immunity and/or promote the activation of regenerative or repair programmes in diseased or injured cells.

Dr Nicola Goddard, of University College London, will tell a California conference the exomes scale-up was achieved using state-of-the-art bioreactor systems.

The ability to generate exomes in this way, ReNeuron said, represented a “significant advance towards an industrial-scale production process without affecting the quality and consistency of the final product”.

The company is working with Goddard and the team as part of a cell and gene therapy collaboration part-funded by a government grant.

Goddard will take to the podium at the ECI conference in Coronado later today (Jan 31). For more information click here.

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Thu, 31 Jan 2019 08:00:00 +0000 https://www.proactiveinvestors.co.uk/companies/news/213692/reneuron-partner-to-unveil-production-scale-up-data-213692.html
<![CDATA[RNS press release - New exosome production scale-up data presented ]]> https://www.proactiveinvestors.co.uk/companies/rns/862/LSE20190131070003_13952655/ Thu, 31 Jan 2019 07:00:03 +0000 https://www.proactiveinvestors.co.uk/companies/rns/862/LSE20190131070003_13952655/ <![CDATA[Media files - ReNeuron Group's phase IIb stroke trial kicks off with first patient treated ]]> https://www.proactiveinvestors.co.uk/companies/stocktube/11973/reneuron-group-s-phase-iib-stroke-trial-kicks-off-with-first-patient-treated-11973.html Thu, 24 Jan 2019 11:23:00 +0000 https://www.proactiveinvestors.co.uk/companies/stocktube/11973/reneuron-group-s-phase-iib-stroke-trial-kicks-off-with-first-patient-treated-11973.html <![CDATA[News - First person treated in ReNeuron’s mid-stage US stroke trial ]]> https://www.proactiveinvestors.co.uk/companies/news/213226/first-person-treated-in-reneurons-mid-stage-us-stroke-trial-213226.html The first person has been treated in the US Phase IIb clinical study of ReNeuron Group PLC’s (LON:RENE) CTX stem cell therapy candidate for stroke disability.

The mid-stage trial, called PISCES III, will see 110 patients with stable post-stroke disability given either the CTX therapy or a placebo.

WATCH: ReNeuron Group's phase IIb stroke trial kicks off with first patient treated

ReNeuron wants to show that the patients on its treatment see a “clinically significant” improvement on the Modified Rankin Scale – a measure of disability and dependence – after six months.

Top-line results are due early next year.

“We are delighted that the first subject has been treated in the PISCES III stroke clinical trial in the US with our CTX stem cell therapy candidate,” 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 moves us forward to potentially meeting this very significant unmet need.”

In midday trading, ReNeuron shares were 2% higher at 51,50p.

 -- Adds share price --

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Thu, 24 Jan 2019 07:27:00 +0000 https://www.proactiveinvestors.co.uk/companies/news/213226/first-person-treated-in-reneurons-mid-stage-us-stroke-trial-213226.html
<![CDATA[RNS press release - First patient treated in US stroke trial ]]> https://www.proactiveinvestors.co.uk/companies/rns/862/LSE20190124070006_13944861/ Thu, 24 Jan 2019 07:00:06 +0000 https://www.proactiveinvestors.co.uk/companies/rns/862/LSE20190124070006_13944861/ <![CDATA[Media files - ReNeuron seeing increased interest across its assets from potential licensee partners ]]> https://www.proactiveinvestors.co.uk/companies/stocktube/11809/reneuron-seeing-increased-interest-across-its-assets-from-potential-licensee-partners-11809.html Fri, 11 Jan 2019 11:42:00 +0000 https://www.proactiveinvestors.co.uk/companies/stocktube/11809/reneuron-seeing-increased-interest-across-its-assets-from-potential-licensee-partners-11809.html <![CDATA[Media files - ReNeuron signs exosome collaboration deal with US biopharma ]]> https://www.proactiveinvestors.co.uk/companies/stocktube/11703/reneuron-signs-exosome-collaboration-deal-with-us-biopharma-11703.html Fri, 04 Jan 2019 12:07:00 +0000 https://www.proactiveinvestors.co.uk/companies/stocktube/11703/reneuron-signs-exosome-collaboration-deal-with-us-biopharma-11703.html <![CDATA[News - ReNeuron signs exosome collaboration deal with US biopharma ]]> https://www.proactiveinvestors.co.uk/companies/news/211941/reneuron-signs-exosome-collaboration-deal-with-us-biopharma-211941.html An unnamed US biopharmaceutical company is to run the rule over ReNeuron Group Plc’s (LON:RENE) exosome drug delivery platform.

Under the terms of the collaboration agreement, the biopharma will explore the use of exosomes as a potential delivery vehicle for synthetic oligonucleotides used in gene therapy.

ReNeuron will provide the exosomes as well as sequence-based know-how while its new partner will provide its expertise in the field of synthetic oligonucleotides to optimise their loading into exosomes. 

READ: ReNeuron primed for significant commercial progress

“Exosomes are biological nanoparticles ideally suited to the delivery of nucleic acid-based therapeutics due to their natural occurrence and abundance, their ability to protect their cargo from degradation and their potential for favourable bio-distribution,” said ReNeuron chief executive Olav Hellebø.

“We are delighted to be collaborating with a biopharmaceutical company that has considerable experience in the development of novel oligonucleotide-based therapeutics.”

During the initial feasibility stage there are no cash payments between the parties, but should it prove successful, it is anticipated that a product cross-licensing agreement will be signed by the parties ahead of the pre-clinical and clinical development of the therapeutic candidates.

In early morning trading, ReNeuron shares were 6.2% higher at 51.50p.

 -- Adds share price --

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Fri, 04 Jan 2019 07:25:00 +0000 https://www.proactiveinvestors.co.uk/companies/news/211941/reneuron-signs-exosome-collaboration-deal-with-us-biopharma-211941.html
<![CDATA[RNS press release - ReNeuron signs exosome collaboration ]]> https://www.proactiveinvestors.co.uk/companies/rns/862/LSE20190104070003_13923561/ Fri, 04 Jan 2019 07:00:03 +0000 https://www.proactiveinvestors.co.uk/companies/rns/862/LSE20190104070003_13923561/