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Very good news this morning for Redx's porcupine inhibitor in view of the history of this trial. Not only has the first cohort of patients been recruited and dosed but the Safety Review Committee has approved an escalation of the dose for the next cohort.

Good stuff.

Inanaco., can you please provide a link

Sorry Chelsea, re. your 16.25, not sure that I remember exactly but most likely I was trying to say that the issue wasn't necessarily a problem with the device per se - just that both Ichor and Scancell need to submit sufficient data to convince the FDA that the device is safe when used to administer SCIB1, that it delivers the correct dose in the correct way and does so every single time.

Dracula, I'm not sure that I agree it's unfair to a small bio and I'm sure there's no politics involved. It's down to Ichor and Scancell to provide sufficient information/data to the FDA and they clearly hadn't. US vaccine developer Inovio had a very similar situation when the FDA refused to clear their IND for a phase III trial using a new electroporation device. In Inovio's case, the FDA wanted more data to support the shelf life of the disposable parts of the device. It took about 9 months for the FDA to finally give them the go ahead.

The business update issued by Scancell on 1st July seemed to suggest that they had sent in all requirements and the ball was now in the FDA's court. Let's hope they were satisfied and didn't come back with any further questions. If so, we should be hearing very shortly that the IND has been cleared.

Good to hear from you.

It is incredibly frustrating. At the last AGM we were told that the trial was ready to start as soon as approval was received - it's there in black and white on Scancell's website. On 25th April we were told that UK Regulatory and ethical approval had been received and the RNS clearly stated 'Dosing in UK arm due to commence during this quarter, as planned '. Note they actually say dosing - not recruiting, not screening but dosing.

It's hard to understand how they can have made such an unequivocal statement and yet here we are nearly 4 months later and we're still waiting. The business update issued on 1st July was a chance to offer some explanation but said very little and actually raised more questions than it answered.

We talk of a delay of 5, 6, 7 weeks and I think if it was just that we'd all be a little more patient but let's not forget that the first start date given for this trial was H2 2016 and it has constantly slipped back ever since.

Courtesy of sushifishman, Cel-Sci published an updated fact sheet on 9th August which shows that they are still waiting for 298 events (deaths) in their ongoing Multikine phase III trial.

The head & neck cancer trial completed recruitment with its 928th patient in September 2016 and is continuing to monitor survival. The trial will end when 298 events have occurred and that was expected to happen in 2018 so the fact that they haven't yet reached that threshold may be promising.

https://cel-sci.com/wp-content/uploads/2019/08/CVM_FactSheet_website_080919.pdf

DEBRA of America is a high profile Epidermolysis Bullosa medical research charity and they will be hosting their annual benefit evening in New York in October. Amryt is one of three companies (& the only non US one) being recognised with a Partners in Progress award to be presented on the night. Good stuff and well done Amryt.

https://debra.salsalabs.org/2019benefit/index.html

Link below is to a new article giving much more detail around the new HyCEAD Ziplex technology and future strategy around ovarian cancer. A bit technical in parts but well worth a read.
https://www.genomeweb.com/liquid-biopsy/angle-testing-integrated-cell-sorting-molecular-analysis-tech-ovarian-cancer-detection#.XU2Zg2fsZjp

Please read my post again. In no way did I play down the significance of the resected data or state it wasn't relevant. I simply said that it wasn't relevant in the context of the one paragraph quoted from a Trinity Delta. It wasn't a full research note but a quick update regarding the combination trial and quite rightly they quoted SCIB1 results from the relevant patient population.

Knowlesi,

Thanks but the shame of it is that we all know there are good posters on both boards. Opinions seem to have become polarised but we're all looking for the same end result.

Chelsea,

Why the negative slant? There is nothing negative about a cancer vaccine achieving a 20% response rate in patients with late stage, inoperable melanoma. The reason Trinity have quoted the results is because they highlight precisely why there is hope for this combination trial.

Balerno,

Trinity Delta have fully published all results and they're very clear. If you actually read original report it covers them in great detail, including;-

'Out of the 20 patients with fully resected disease, 15 were disease free after a median observation time of 37 months, and all were still alive (Exhibit 9).'

The reason they are talking about these 15 patients is because they're discussing the combination trial and this is setting of that trial - the results of the resected patients are therefore not relevant in this context.

Morning all,

C7/Balerno, there are no errors, the figures quoted in the Trinity Delta link are correct.
The phase I/II trial treated a mixture of 15 patients with inoperable melanoma ie. tumour present and 20 resected patients (where tumour had been surgically removed). The results of 1 partial response and 2 patients with stable disease refer to those 15 patients with tumour present. The survival figures in your 8.53 post Chelsea are from the resected patients, so a different set of patients.

SFM

Simply a regulatory requirement in the UK that companies must disclose via RNS if there have been any changes in voting rights during the month. In this case, the number of shares in issue (with attached voting rights) has increased very slightly. Think this was due to Dr Reljanovic exercising share options.

Interesting interactive tool in link below highlights just how few new ABs are in development - you can track the trend over the last 5 years and the progress of individual drugs, including Ridinilazole. Just hit the play button above 2014.

https://www.pewtrusts.org/en/research-and-analysis/data-visualizations/2019/five-year-analysis-shows-continued-deficiencies-in-antibiotic-development

If/when the deal with Aegerion is completed, Amryt will acquire the FDA approved drug Myalept for generalised lipodystrophy. It gets a mention in the article below, bearing in mind that it must be administered daily, it's not cheap!

https://www.pharmacist.com/article/new-yorkers-charged-most-prescription-drugs

ennombrede -

Yes, some interesting comments from AN regarding Abbott. I'm sure the webcast will be added to Angle's website and it's well worth a listen.

The ovarian cancer clinical trial is due to start soon (early in Q3). This is a 200 patient trial for women with a pelvic mass who are scheduled for surgery. Angle's Parsortix and HyCEAD-Ziplex platforms will capture and perform downstream RNA analysis on CTCs to distinguish between patients with malignant and benign masses. Angle have said that a successful trial will allow them to launch a clinical assay for the detection of ovarian cancer in women with an abnormal pelvic mass. Knowing in advance whether a mass is cancerous or not means that women can be referred to specialist oncology surgeons with better outcomes than when surgery is performed by general gynae surgeons and cancer is discovered on the table.

Worth noting that this analysis (RNA) can't be carried out by any of the ctDNA platforms and that Angle have estimated the size of the market for this assay alone at $1 billion per annum. It will be interesting to hear what AN has to say about future commercial strategy here and whether or not they intend to file for FDA clearance on completion of the trial.

stanman,

Angle are applying to the FDA for De Novo clearance. The De Novo classification pathway is for medical devices that are novel and for which there are no existing, approved equivalent devices. I believe the FDA aim for a 150 day review period but of course it could be much quicker or much longer.

An article featuring Angle was published yesterday in NS Medical Devices - some interesting quotes from AN

https://www.nsmedicaldevices.com/news/liquid-biopsy-angle-cancer-diagnosis/

Impressive interview with new CFO Richard Barfield

https://www.proactiveinvestors.co.uk/mediaFiles/stocktubeDetails/14185/ergomed-in-robust-shape-as-it-continues-to-perform--above-expectations--14185.html