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RNS today states that they have now received regulatory approval to continue in all locations. This means , even if there are.no further hitches, that the trial data will not be available until Q1 next year.
A few months back this was 150p+ after encouraging news on exosomes collabs.
SP should not be at current price IMO.
Hi, I am expecting the 3 month results in the expanded trial to be announced on 12th November. This is the AOO conference, American Academy of Opthalmology, they previously said they would release the results at one of these events and the date would tie in nicely. It would be great to see a further improvement with the higher cell dose although as previously stated they could seek approval based on the results of the lower dose.
Hi hopefulmast
Agree that RENE have not been the best at keeping us PI's up to date on the RP trial but hopefully something will be RNS'ed by the time we reach Christmas..... in the meantime an Exosomes deal would be very welcome news....
Chester.
Hi Chester. Thanks for the info.Just to clarify I took my info from the Reneuron site Clinical Trials section and whilst the company issued statements on 8th July 2021 the last available update on data for the original patients was Nov 2020 -"In June 2020 (and updated in November 2020), subsequent long-term efficacy data from the study continued to show a meaningful clinical effect from the therapy at all time points out to twelve months post-treatment". Thus no updates on those patients for nearly a year and it would be interesting to know how the treatment is faring all these months later (better/worse/as expected).
Re the expanded trials, OH stated n the Annual Report and Accounts referring to the regulatory approval for UK/Spain "It is anticipated that this process will conclude in August and if so this would allow dosing to resume in all three territories". AGM was September but there has been no update as to whether they met the target of August for the UK/Spain trial sites so at present all we know is the USA is recruiting/carrying out trials after receipt of relevant authorisations.I get the impression reporting of 3 month data for that trial is an aspiration not a definite.
With Reneuron's track record on reporting I think December would be more likely for the next update,although an update with good news in October would be most welcome.
Hi hopefulmast
You are missing the 'Update for hRPC therapy candidate study' in June this year explaining that one patient had experienced an eye infection in the treated eye 5 days after the injection. At that time the enrolment was put on hold.
On the 8th July we were told,
'hRPC stem cell therapy candidate for retinal disease:
· Efficacy signal seen in phase 2a subjects reaching 12 months follow up with some variability of response seen between subjects
· Regulatory approval has been received for the expanded Phase 2a study in US, UK and Spain. This Phase 2a extension study incorporates a doubling of the previous dose, which with other study elements was designed to build on the efficacy signal seen in the earlier cohorts of the study whilst trying to remove some of the variability
· Four out of the nine additional subjects have been treated to date but a presumed case of bacterial endophthalmitis led to precautionary temporary study enrolment suspension; however, following a completed investigation, and with Data & Safety Monitoring Board approval, the study has reopened to enrolment in the US with amendments being filed to reopen in the UK and Spain
· Three-month data from extension segment of Phase 2a study to be available in Q4 2021'
We reach Q4 on Friday so an update is possible during October.
Chester.
Agree completely.What I find extremely disappointing is the lack of update regarding original RP trials.How are those patients faring?Has the treatment held up over time or would they be looking at additional dosage/treatments?Or maybe there has been further improvement? All we know is there is nothing "negative" to report.Last update was Nov 2020 so surely there must be more data by now? Also,we are promised data from the USA trials of the increased dosage by y/e 2021 but have not been updated re those trial restarts for Europe-expected restart by end of Aug. Have they recommenced those trials or not?
When you read the glossy brochure it mentions "proof of concept".RP is a potential "proof of concept" treatment that would really launch this company if approved. Loads of positive vibes relating to the science and from the board regarding hopes for the next 15 months or so but definitely lacking in hard data and updates! We can only hope the board know how good their product will be and are not prepared to "sell at any price" but will wait for true value once they release more data. Question is WHEN?? I am holding on as I feel very positive yet despair at the drop in share price...even though we know "smart money" has been invested in this share! With any luck a very happy Xmas???
Very frustrating watching it sink back following the breakout earlier in the year. I've added again at these levels, but that's me now done. . . Although never say never.
I'm very much of the opinion that the odds are stacked in our favour here due to the portfolio of treatments being developed. It would only take one programme to be successful for us to enjoy some significant gains from these levels. If more than one is successful, then the returns could be life changing. The calibre of the recent appointments suggest there is significant expectation from within the organisation, even if the recent share price action doesn't reflect this.
Iain Ross quote when announced as Chairman in July:
“I am delighted to be joining ReNeuron at such a pivotal time and look forward to working with the board and management, and to ensuring a significant uplift in shareholder value over the next few years.”
Catherine Isted quote when announced as CFO in August:
"I am delighted to be joining ReNeuron at what I think is an exciting time in the company’s evolution, not only for the Groups lead stem cell programme in Retinitis Pigmentosa but also for their proprietary Exosomes and induced pluripotent stem cell (iPSC) platform technologies where there is growing excitement in the healthcare industry around their significant potential in a multiple of therapeutic areas. I look forward to working with the whole team and Board at ReNeuron to help realise the opportunity for the company in these leading fields of science.”
I think a lot of people will regret the day they sold. Do your research, make your own decisions based on your belief and be prepared to see it through. I am as confident today as I was in 2015, not sold a share but added to average out. It was reading Warren Buffet’s book “The Making of an American Capitalist” that gave men the confidence to back my own research. Something dramatic is coming, be prepared to hold even with reasonable gains the best is yet to come.