Reneuron Share Discussion Threads

[52ron] 05/5/2015 07:59

Approves Start of Phase I/II Trial


RNS Number : 1472M

ReNeuron Group plc

05 May 2015











5 May 2015

AIM: RENE




ReNeuron Group plc

("ReNeuron" or "the Company")



FDA gives ReNeuron approval to start a Phase I/II clinical trial in the US

in retinitis pigmentosa



Guildford, UK, 5 May 2015:ReNeuron Group plc (AIM: RENE), a leading UK-based stem cell therapy company, today announces that it has received regulatory approval from the US Food and Drug Administration (FDA) to commence a Phase I/II clinical trial in the US with its human Retinal Progenitor Cell (hRPC) therapy candidate for retinitis pigmentosa (RP). RP is a group of hereditary diseases of the eye that lead to progressive loss of sight due to cells in the retina becoming damaged and eventually dying.



The Company announced on 13 April 2015 that it had filed an Investigational New Drug (IND) application with the FDA to commence the Phase I/II clinical trial. The Company has since received notification from the FDA that the review of the application is complete and that ReNeuron is free to begin clinical studies. ReNeuron's cell therapy candidate for RP has already been granted Orphan Drug Designation in both Europe and the US by the European Commission and the FDA, respectively.



The Phase I/II clinical trial will be conducted at Massachusetts Eye and Ear, Boston, a world-renowned clinical centre for the treatment of retinal diseases. The trial design is an open-label, dose escalation study to evaluate the safety, tolerability and preliminary efficacy of the hRPC stem cell therapy candidate in up to 15 patients with advanced RP. Preparations for the study have commenced and ReNeuron expects the study to begin in the second half of this year.



Olav Hellebø, Chief Executive Officer of ReNeuron, commented:

"We are delighted to have received regulatory approval to commence our first clinical trial in the US with our hRPC stem cell therapy candidate for RP. It is a testament both to our staff and to the quality of our hRPC technology that this first-in-man clinical trial application was approved so promptly. We are delighted to be working with Massachusetts Eye and Ear on this important clinical trial and we look forward to initiating the study later this year."

[algernon2] 04/5/2015 01:28

worth repeating:
Reneuron at RegenMed Investor Day:

[madengland] 01/5/2015 13:28

Looks primed for another decent leg up

[madengland] 30/4/2015 09:43

Been a few hefty ones over the last couple weeks.

[rayrac] 29/4/2015 21:21

Norbus, here's another early stager...TRX. Could mend a few scars. Or heal an old wound!!

[bigspuds] 29/4/2015 14:01

Next leg up?

[stewart_25] 24/4/2015 17:41

Yes Bigspuds - was tempted to let some go knowing that we often fall back .... Held firm though - onwards and upwards - lots going on and with further good news on the phase 2 trials it should keep moving north! Expect a big clinical co to take these out on good news....

[bigspuds] 24/4/2015 17:25

Only us lol

[bigspuds] 24/4/2015 17:25

You have to expect profit taking. It's inly U.S. Weary long termers that watch the daily push and pull. If all goes to plan these prices may soon be a distant memory

[stewart_25] 24/4/2015 16:25

maybe not - but a nice pull back late today...

[madengland] 24/4/2015 12:36

Maybe not :-)

[madengland] 22/4/2015 17:27

Nice gains over the past couple days..... Think we could break 5p by weekend

[stewart_25] 22/4/2015 16:35

Up up and away ... About time ....

[bigspuds] 22/4/2015 16:12

interesting, increasing volume too, seems to have gained some following at last

[madengland] 22/4/2015 08:54

Thanks for the history, can imagine it's painful for those who have been through it. Hopefully the coming months we'll see losses recouped

[norbus] 22/4/2015 08:18

jpuff

ER was the Patron of Stroke Society; Rene, Chris Evans, took her for a ride when shares bought back for pennies and came on the market again later;

[jpuff] 21/4/2015 17:22

Bought in for the first time today. I notice Woodford has a decent stake too from his website and the muttering here sound quite encouraging apart from the news! If the Queen bought in at 200p then I wonder if she will be averaging down? A great cause too so happy to have them in in my SIPP now. GLA Jeff

[jeffcranbounre] 21/4/2015 15:01

I chat about ReNeuron on today's ADVFN podcast with technical analyst Nicola Duke.

To listen click here>

[bonzo] 21/4/2015 12:56

I have been holding more than 10 years, fortunately no record of what I paid. Long predates ADVFN though... I remember when...(but enough of that!).

[norbus] 21/4/2015 11:43

Oh for the ignorance of youth; The shares were originally issues at £2 and the Queen bless her bought some at £2

[madengland] 21/4/2015 07:08

Makes you wonder how a 25p issue price was justified? Any chance of a history lesson?

[alimo] 20/4/2015 23:33

I wonder how many PIs have been faithfully holding since the approx 25p issue price in 2005? Perhaps 2015 will be the year their long term vision will start to pay real returns. Hope so.

[bonzo] 20/4/2015 16:04

They are not talking about small improvements here; the improvements must be significant or they could not measure them... I have been involved in a number of stroke product developments which have some to nothing. To still see changes after 2 years is amazing.