|Singers update, on RENE
I suspect the placebo will be done in the way it has for the trial of another neuro surgical procedure i.e. the placebo patients will be prepared for the surgical procedure and then have a small incision so that they are unaware that they haven't had the full procedure.
It is amazing how often there is a real placebo affect.
Having said that I have first hand experience of a close relative who has suffered a major stroke six months ago and would say that a 75% chance of some clinical improvement seems to be well worth trying given the only treatment option is physiotherapy with diminishing returns as time goes on.|
|Having this kind of brain op is really no big deal these days. It's not as if they, as in some procedures, saw the top of your skull off and expose the entire cerebral hemispheres, lift them up and play with the bits underneath. No, a small hole is drilled through the skull and a very fine needle delivers the stem cells. If you have lost the use of your hands and arms, I suspect that taking part in a randomised trial where you have a 50% chance of receiving the treatment (which so far has seen excellent results, so you have 50% x 75% = 37.5% overall chance of seeing significant benefits after 12 months) is the least of your worries. And it's actually better than this because, if the trial goes well, it is possible that it could be stopped early and, if you were one of the placebo groups, you would probably be transferred immediately over to the therapeutic. And, remember, just taking a pill in a trial can be very dangerous:
|Norbus, true. it's not like taking a pill, however there is also very little alternative for stroke patients. On placebo, I've no idea how this might be done in this treatment and one wonders if they can't use either a control group of similar size or natural history?
However they will need some sort of placebo as they will need to prove that the improvements seen are above the normal recovery curve.
I guess I'm starting to understand the market reaction as I also hoped to see clearer transformative progression, although the 75% seeing clinical benefit is - on the surface - rather good.|
Messing inside brains is dangerous and expensive; The pull to go for treatment needs to be really convincing for there to be a serious market against alternate choice|
|Some interviews with one of the 4 might also help bring it into focus.|
|Waterloo01 - good points I agree. You've literally laid out all the points I had in mind. I do find it strange when companies fail to promote their good news in the most effective positive fashion. What do they employ brokers and PR companies for for heavens sake!! What a waste of money PR is in my investing experience. Clueless.
And yes there is a seller out there and they have largely caused the brakes to be slammed on the share price IMO. The great unknown is how much more stock they want to shift. If it's not too big then we might find the share price starting to elevate in the next few days or weeks. Perfectly possible as the news IS positive and the company has stacks of cash. A new II coming on board would help of course.|
I guess it's the missed endpoint (because endpoint was after 3 months and they met it after the deadline) that has caused the initial reaction, but 4 of 21 patients (20%) made significant improvement in the main score.
If the end point had been longer, the headline would have been different, in patients who normally don't show much recovery.
I'd definitely have led with ...."In all, 15 out of 21 patients had a clinically significant response on at least one efficacy measure, with these improvements kept up throughout the follow-up period".
That's 75% did show a 'clinically significant response" and that's impressive.|
|Thank you for your post, waterloo01, & I think you summarise the situation as well as can be. There's quite a limit to how insightful we can hope to get !|
|Odd reaction to today's news. What would have happened if the trial had been negative!
My reading of the trial results was essentially very positive (especially for the 3/4 patients who had the best response), although I would have put the headline in the RNS that 15 of 21 had a meaningful clinical response. I guess some were expecting an instant fuller recovery from more patients? The company have always slated the need to do a placebo phase 3, so don't think that's it?
We do however seem to have a seller, which is odd as you would have thought they might have allowed a rise before cashing in.
Having said all that, I've known stocks to react days later to news, especially if a seller clears.
Any other insight from anyone?|
|IP would be worth a huge amount if it was effective; You need to know what is out there against Rene. These companies are not asset strip jobs, they burn cash. and no company takes into account a shut down w/down Going Concern , if heavens forbid, nothing material is delivered|
|Norbus - transparently uninformed and casual comment. Cash on the BS alone is worth at least 2p on the share price
So you are effectively valuing IP at ZERO or less. Not that you knew it clearly ...|
|More likely to drift to nearer 2 with not a great deal on the immediate horizon. They might do well to buy into another string to their bow whist they have cash|
|British biotech ReNeuron has posted generally encouraging midstage data which showed their stem cell therapy could help certain stroke patients move their arms better, after being left disable by their condition. Despite not hitting its primary endpoint, it is still plotting a pivotal test starting next year.
Its CTX cell therapy candidate was being tested in a small, phase 2 trial, known as Pisces II, that worked as a single arm, open-label study in patients living with disability resulting from ischaemic stroke.
The study’s primary endpoint was relatively modest: It needed two patients, out of 21, to reach a minimum two-point improvement in what is known as the grasping and lifting test, a part of the Action Research Arm Test (ARAT), at three months after treatments.
In the end, three of the 21 patients achieved this at three, six or 12 months respectively after treatment, and were within a group of four responders who also showed “clinically relevant improvements” on the total ARAT score of arm motor performance.
But it missed its target as some responses came later than the three-month target. The biotech however still said that the result was “nonetheless highly encouraging,” and the market tended to agree, with its shares jumping over 22% on the news today.
This was also because “strongly positive results” were also reported in the other endpoints of the study, with seven patients (33%) showing a “clinically relevant improvement” on the Modified Rankin Scale (a measure of disability and dependence) and eight patients (38%) showing a clinically relevant improvement on the Barthel Index (a measure of performance in activities of daily living).
In all, 15 out of 21 patients had a clinically significant response on at least one efficacy measure, with these improvements kept up throughout the follow up period.
The company says that it will now seek a chat with the FDA and EMA about starting a randomised, placebo-controlled, pivotal trial in patients who are living with disability post-stroke.
Olav Hellebø, CEO of ReNeuron, said: “We are delighted that the Pisces II clinical trial has shown our CTX cell therapy candidate has the potential to become a treatment option for patients living with chronic consequences following stroke. We are particularly excited by the response rate seen on the measures relating to disability and activities of daily living, given that these are the most important for patients and their carers.”
Hellebø noted that these measures are also the ones viewed by regulatory authorities as most relevant for late-stage clinical development.
He added that the co has a “strong balance sheet” to fund its planned pivotal study.
Stem cell therapies, once seen as a great hope in the research filed for a variety of diseases, has in recent years been beset with testing setbacks, with progress in getting new therapies to market much slower than originally hoped for.
Back in the summer, Teva returned the full rights of a phase 3 experimental heart drug that back to Mesoblast as it walked away from development. And in the spring, CA-based BioCardia delayed its plans to raise $50 million for its stem cell research.|
|Obviously not good news...well, not good enough. I wonder what Woodford thinks.
|A nod is as good as a wink to a blind Arab. There is no drama here to applaud ; The leak got some insiders excited to do some buying last week, but there is no real drive or conviction. I had hoped for far better having seen the demo with a rat gripping a grid before and after ; Rene, is now in a hugely competitive field with clearer results demonstrated . The £60m cash will of course help but I would not get back, having sold at 6.5 a few years back , .. re009 would be where I would look for relief|
|Perhaps even a better result than some might think. This kind of trial compares improvement within individuals, and we see an improvement. The next trial, randomised, will compare between individuals given therapeutic or placebo. Under normal circumstances most recovery from stroke has happened in the first 3 months but the RENE trial hints that stem cell therapy may encourage recovery beyond that period. So, if they measure end-points up to, say, one year, they may find the placebo and therapy more similar in the first 3 months, then the therapeutic pulling away in an increasing advantage over the next 9 months as the patients continue to improve. That would be great for the patients and great for RENE's profitability.|
|In total, 15 out of 21 patients had a clinically significant response on at least one efficacy measure. Improvements in the ARAT scores, Modified Rankin Scale and Barthel Index were all sustained throughout the follow up period.
Might not be the instant cure, but the above is a very good result.|
|Yes, decision to progress to next stage of clinical trials should be seen positively by the market, even in these risk-averse times.|
|Un-clenched buttocks. Results look good!|
|Sunday share tips: ReNeuron, Clipper Logistics, RM Secured Direct Lending
Sun, 4th Dec 2016 14:45
(ShareCast News) - Shares of ReNeuron are for brave investors only, said the Sunday Times' Inside the City column. The stem cell pioneer is scheduled to publish the results of second-phase clinical trials of its potential stroke paralysis treatment alongside its interim results on Monday. ReNeuron's therapy for stroke disability involves injecting CTX neural stem cells generated using the company's proprietary technologies into the patient's brain.
If the 21-patient pilot study, the world's first fully regulated clinical trial of a neural stem cell therapy for disabled stroke patients, is a success then the company would progress to a final-stage trial in more patients and then look to turn it into a commercial product. After a fundraising in 2015, the company has £65.7m in the bank, which should provide for around two years' worth of future drug development. Fingers crossed, said the column, for ReNeuron as the rest of the pipeline is a lot less advanced than the CTX stroke disability candidate.
Clipper Logistics shares are worth holding, according to Questor in the Sunday Telegraph. Retail logistics is Clipper's bread and butter, with the rise and rise of internet shopping being a big boon, especially the need to remotely return items. Clipper says its Boomerang returns service is the best as it ensures goods are returned in a state where they are ready for resale, which saves retailers time. Marks & Spencer is a customer, while Clipper's 10-year contract with John Lewis includes operating its national returns centre.
This contract with John Lewis also includes click-and-collect services, where items are bought online and picked up in store. This service is also being opened up to other clients and is expected to be a growth driver, along with expansion in Europe sometimes on the back of contracts with existing UK clients. Sales have grown on average by a compound rate of around 31% in the last decade and a half, while profit margins have remained little altered - and are expected to be slightly boosted by the move into click and collect. First-half results last week indicated trading continues to be positive, with significant increases in activity in all sectors.
Income hunters looking for a long-term investment might buy RM Secured Direct Lending, said Midas in the Mail on Sunday, which is being floated by parent RM Capital in London with a planned 4% dividend next year rising to 6.5% from 2018, paid quarterly. The business gives £2-£10m loans to SMEs and mid-sized outfits that have visible cash flows and are typically from non-cyclical industries, offering asset-backed lending secured against assets such as real estate or plant and machinery and/or income streams such as account receivables.
The fund is tapping into a market that has seen smaller firms struggled to borrow from high street banks if their financial needs are relatively complex. As a result, RM generally lends at rates of 8-12% due to their more complex nature and higher risk of small companies, which is how the fund can pay such a chunky dividend. Risk is spread across sectors and via the secured nurture of the loans.
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