Reneuron Share Discussion Threads

[elsa7878] 14/10/2019 10:57

How big is the potential market for RP treatments? Thanks in advance

[small crow] 14/10/2019 10:32

Correct, you really need time series of individual patients to analyse this properly and we don't have that - why not is the interesting question - confidentiality??

[masingi] 14/10/2019 09:48

Scubadiverr- The results are presented in a way that needs careful interpretation.
The 'drop' between 180 days and 270 days doesn't compare the same patient population. The data point at 270 days is one patient, the data point at 180 days is three patients- the patient that is shown at 270 days plus two others that had an even greater improvement! It does not mean that any patient lost any efficacy. Once the two additional patients at 180 days reach 270 days, the 270 day data point will increase and so on. It is a very odd way of presenting data and does not demonstrate the true efficacy achieved. Superficially, it looks as though the improvement is lost, when in fact it isn't.

[rrb] 14/10/2019 07:31

Very clear the two patients who lost vision due to surgery have skewed the overall numbers. This is phase I/II study. If there were concerns around SAFETY then trial would have been stopped. It is not the stem cells, rather the surgical procedure holds risk.

As I said after the summary was released, the share price battering was a massive overreaction. There is clear potential with this therapy. Shares should react positively.

[bonzo] 14/10/2019 07:24

Market response to the "poor" CT result a massive over reaction as usual. Looking forward to a steady share price recovery.

[14dragon] 13/10/2019 18:47

Back to conference coverage
Cell-Based Therapy Shows Early Promise for Retinitis Pigmentosa
OCTOBER 12, 2019
Silas Inman
Pravin U. Dugel, MD
Pravin U. Dugel, MD

Treatment with subretinal transplantation of allogeneic human retinal progenitor cells (hRPC) showed promising early signs of efficacy as a treatment for individuals with retinitis pigmentosa, according to findings from a phase 1/2a study presented at the 2019 American Academy of Ophthalmology (AAO) Annual Meeting.

In the open-label study, the hRPC treatment led to a gain of 18.5 ETDRS letters from baseline to 180 days post treatment. In untreated eyes, there was a 7.8 gain in letters read, demonstrating a 10.7 letter difference between the two eyes.

"There appears to be an acceptable safety profile. There were biological efficacy signals that were very rapid and profound in some patients and slower in others," said lead investigator Pravin U. Dugel, MD, from Retinal Consultants of Arizona. "This is potentially a promising new therapy for patients with retinitis pigmentosa."

Early studies looking at allogeneic transplantation with RPCs in pigs showed promising signs of integration and paracrine effects, leading to further studies in humans, noted Dugel. For the study presented at the AAO meeting, cells for the RPC therapy, which is manufactured by ReNeuron, were extracted from fetal retina and have the potential to differentiate into retinal cells. The cells are cryopreserved, with a 9-month shelf life, and no immunosuppression is required prior to administration.

"The potential benefits of subretinal hRPC include direct delivery into subretinal space, on demand shipment to site of care, and, perhaps most importantly, treatment agnostic to genetic subtype of disease," said Dugel.

In the phase 1 portion of the study, 12 patients were enrolled to determine the safety of the therapy. At baseline, 11 patients read 0 ETDRS letters and only 1 read 1 letter. The visual acuity was 20/800. Doses in this portion ranged from 250,000 fresh cells to 1 million cryopreserved cells, the latter dose was continued in the phase 2a portion of the study that enrolled an additional 10 patients. Patients in the phase 2a group saw 9 to 56 ETDRS letters and had a visual acuity of 20/640 to 20/80.

The safety analysis looked at all 22 participants across both stages of the study. In general, the dose escalation in phase I was generally well-tolerated, Dugel said. "There was no evidence of inflammation or proliferative vitreoretinopathy," he added.

There were 2 ocular serious adverse events reported in the study, both were deemed unrelated to study drug. One patient had progression of a pre-existing epiretinal membrane, and another had persistent sub retinal fluid/patent retinotomy, which led to vision loss. One additional patient experienced a retinal pigment epithelium tear leading to vision loss.

When factoring out the 2 patients with vision loss, the gain in ETDRS letters at 180 days was much more dramatic between eyes. In the treated eyes, there was a 28.7 letter increase compared with a 9.0 letter increase in the untreated eyes, for a 19.7 letters difference between groups.

At 90 days follow study entry, there was a 6.1-letter gain in the treatment eye compared with a gain of 6.8 letters in the untreated eye. However, when factoring out the 2 patients with vision loss, there was a 17.8-letter gain at the 90-day analysis in the treated eye compared with 6.8 in the untreated eye (11-letter difference).

Commenting on the findings, Dugel noted that the patient numbers were small for the analysis and advised that more data were needed. "These study results will provide a better understanding of optimal patient selection and surgical procedure standardization for future study design," he said.

Additional analyses from the phase 1/2a study are planned, with longer follow up. Additionally, ReNeuron has announced that it plans to consult with regulatory agencies in the United States and Europe to design a larger pivotal study to assess the human RPCs for retinitis pigmentosa.
Pravin U. Dugel, MD. Subretinal Human Retinal Progenitor Cells in Retinitis Pigmentosa: A Phase I/IIa Study. Presented at: 2019 AAO Annual Meeting, San Francisco, CA, October 12-15, 2019.

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[luffness] 11/10/2019 18:47

"After 180 days any clinical is shows to reside and return to baseline"

Well that is just not true is it - the clue is that the baseline is the 0 line on the charts so after 180 days there is a 18 letter improvement (average) and 28 if you exclude the 2 impacted by the procedure

[scubadiverr] 11/10/2019 18:08

The link shows pretty disappointing efficacy data. After 180 days any clinical is shows to reside and return to baseline. It shows a short term improvement in some patients, while the procedure has shown to cause damage to others. Admittedly, data is on a very small sample, they would need 20-30 times this many patients before they could proceed to the next stage of testing, IF data showed a positive risk/benefit ratio. Is anyone with any understanding of treatments and clinical trials still in holding? I can only see this heading back to 50p

[lauders] 11/10/2019 06:59

Thanks to "JustFundamentals" for a good post on the LSE BB pointing out Olav's presentation yesterday:

[lauders] 11/10/2019 02:50

Will we see any reaction (positive hopefully!) to the highlighted below or have to wait for tomorrow?

The results will be presented in further detail at the American Academy of Ophthalmology Annual Meeting in San Francisco on 12 October and at the Ophthalmology Innovation Summit on 10 October.

[hashertu] 04/10/2019 16:14

MF. 7313.

This is what I believe Olav thinks:

"We are greatly encouraged by the latest efficacy data from the ongoing Phase 1/2a clinical study of our hRPC cell therapy candidate in patients with RP. It is especially gratifying to see positive data given the inherent challenge in addressing a disease as complex as RP and we look forward to further progressing the clinical development of this promising cell therapy candidate."

[napoleon 14th] 04/10/2019 15:58

Remember XTL. Post 7259.

I still hold - just!
Expect it to get back to c. 250p, more if they get another deal.

[napoleon 14th] 04/10/2019 15:58

Remember XTL. Post 7259.

I still hold - just!
Expect it to get back to c. 250p, more if they get another deal.

[rrb] 04/10/2019 15:36

If it was truly bad news, shares would have collapsed to 50p. The news was, for me, pretty much as expected. I didn't expect some miracle cure headline where patients' vision was restored. The best we can hope for is that this therapy shows positive efficacy, which it did. The extent of the efficacy is dependent on individual patients.

[rrb] 04/10/2019 15:36

If it was truly bad news, shares would have collapsed to 50p. The news was, for me, pretty much as expected. I didn't expect some miracle cure headline where patients' vision was restored. The best we can hope for is that this therapy shows positive efficacy, which it did. The extent of the efficacy is dependent on individual patients.

[martinfrench] 04/10/2019 15:12

i asked this question on lse but no takers, so will try on here


q: does this rns before the presentation qualify as olav "letting us know if results are bad" ?

that bit i cant quite decide and that was always a ridiculous statement to make

[king1pin2] 04/10/2019 15:06

Yes It might well recover as you say . Its sad that quite a few LTHolders have left tho because of a badly worded rns but in saying that I suspect that they will be fingers on the buy button as I write this. ITs a tug of war with your head trying to decide what you should do with this type of RNS . Read and reread it perhaps 20 times but still cant quite decide if its good news or bad news.

[rrb] 04/10/2019 13:28

I fully expect this to recover to 250-300p range into the conference.

[king1pin2] 04/10/2019 11:02

Ok so its now safe to add now in the run up to the conferance i think .
No fall to 140 any time soon without more news.

[eggy6198] 04/10/2019 10:50

my issue is the lack of trying in the RNS. Its a finger up to people who are invested. Now with a cornerstone investor that would take less than 3 quid I guess for the lot he might find himself out on his ear if this dropped too low. Why do a commerical deal with a company you can buy for the same amount?

[rrb] 04/10/2019 10:38

EGGY - sadly this is the same for most UK biotechs. The science is cutting edge but they are clueless when it comes to commercialising it.

[eggy6198] 04/10/2019 10:29

agreed SC but thanks guys the level of posts about the science and company and process have been very good today.

Really learnt something today and shows what a great investment chance this is.

I do believe the company is not being marketed well and clearly they dont care about investors. The CEO could be out of a job if the science goes well and he drops the value of the company with poor RNS.

[small crow] 04/10/2019 10:14

There has clearly been a concerted shorter attack here so I'm not sure there's any point conversing with the shorters. Whether they know the facts or not, they are going to ignore them until they are ready to go long.

[marwalker] 04/10/2019 10:05

Statistics ..... the chances of Ph 2 drug proceeding to Ph3 is 30.7 %

Chances of a Ph3 drug proceeding to regulatory approval is 50.1 %

Chances of regulatory approval is 85.3 %.

Of course these stats. are over the whole range of clinical endeavour ..... oncology drugs fare much much worse for example.

Some will think that taking on these odds will be more than reflected in the rise in share price if successful.

[rrb] 04/10/2019 09:48

regarding the patients with vision loss, the Kite and Juno CAR-T therapy trials had patient deaths due to CRS (cytokine release syndrome). Both companies still got taken out for massive premiums and the therapies got approved.

The procedure-related vision loss is a risk that most patients will take.