Member Info for Marmited

It's the teaser at the end of yesterdays RNS..

"so that the next stage of clinical development, in which we will endeavour to show how effective the compound actually is, can be entered into with confidence and support from all those involved."

Who's going to be involved?

Oooo, cheers Uncanny. I meant funding..

How I see it..

Phase 1 trials aim to find out:

how much of the drug is safe to give - Completed
what the side effects are - Completed
how the body gets rid the of drug - Completed
if the treatment helps shrink the cancer - Completed

Status - Phase one VAL 201 complete

Phase II

Phase 2 trials aim to find out:

if the new treatment works well enough to be tested in a larger phase 3 trial - Apparently but awaiting report/data
which types of cancer the treatment works for - Prostate Cancer
more about side effects and how to manage them - Completed/None
more about the best dose to use - Working project

Status - Phase II Not Completed

Phase III

Phase 3 trials aim to find out:

which treatment works better for a particular type of cancer
more about the side effects
how the treatment affects people’s quality of life

They may compare standard treatment with:

a completely new treatment
different doses of the same treatment
having the same treatment more, or less, often
a new way of giving a standard treatment (radiotherapy for example)

21st March 2019

On conclusion of the current Phase l/ll trial, the full data set will be analysed by third-party experts and the compound's profile and behaviour will be published.

The completion of the trial is a mandatory milestone prior to permission being given for further pre-market authorisation efficacy studies (Phase II/III).

After reaching a conclusion based upon analysis of the results from this dose-ranging study, the Company will then decide whether to seek a partner or licencing agreement with a pharma company or proceed to a proprietary pivotal Phase IIb/III study.

20th June 2019

Additionally, the amendment relating to dosing strategies means that, in light of accumulated clinical data, the Company is able to develop further protocols. These will be designed to evaluate a range of defined therapeutic approaches that are to be tested against each other, to determine the most effective approach, in terms of disease management, cost effectiveness and patient welfare, in further clinical trials (**Phase II/III**) These protocols will be the precursor to seeking approval to conduct trials (**Phase II/III**) aimed at gaining sufficient data to secure partnering (**Selling to a pharma**) and then Market Approval Application, new drug application (NDA) with FDA.

Reads as though Val have decided to complete phase II/III. The question is with what?

Dr Linch was an honorary senior lecturer at the University College London (UCL) Cancer Institute, where he was leading the uro-oncology biology group, and was also a consultant medical oncologist specialising in the treatment of prostate and bladder cancer at UCLH.

The approval given to relax the restrictions previously applied to the trial would mean that a more effective use of VAL201 could be achieved with respect to concentration and timing, and regarding increased flexibility in the administration of the drug, the board explained.

ValiRx reported that the trial thus far had met all of its primary and secondary endpoints, with the safety and tolerability results continuing to be acceptable, and further evidence of the compound\'s positive effect in reducing the progress of prostate cancer witnessed.

https://www.hl.co.uk/shares/stock-market-news/aim-and-small-cap-news/aim-bulletin/valirx-secures-substantial-amendment-to-val201-clinical-trials

This includes the appointment of prostate cancer specialist Mark Linch as principal investigator, which is of note as VAL201 is being studied as a treatment for advanced prostate cancer and other hormone-induced unregulated growth.

So far, results from the phase 1/2 trial have shown that VAL201 has a much higher toxicological limit than was previously indicated in pre-clinical studied. Therefore, the dosing restrictions previously applied to the trial have been relaxed.

"Now, as the trial is delivering an extensive and positive output, it is also providing practical information back to the trialling of VAL201, so that the next stage of clinical development, in which we will endeavour to show how effective the compound actually is, can be entered into with confidence and support from all those involved," Morris added.

https://www.morningstar.co.uk/uk/news/AN_1561029535691441200/valirx-val201-trial-protocol-amended-with-dosing-restrictions-relaxed.aspx

There's the teaser..? "so that the next stage of clinical development, in which we will endeavour to show how effective the compound actually is, can be entered into with confidence and support from all those involved."

FDA Approves Merck’s KEYTRUDA® (pembrolizumab) as Monotherapy for Patients with Metastatic Small Cell Lung Cancer (SCLC) with Disease Progression on or After Platinum-Based Chemotherapy and at Least One Other Prior Line of Therapy

“KEYTRUDA is already an established treatment option for non-small cell lung cancer, and today’s approval in small cell lung cancer demonstrates our commitment to bringing forward new treatment options for patients with advanced, difficult-to-treat cancers,” said Dr. Jonathan Cheng, vice president, oncology clinical research, Merck Research Laboratories. “We look forward to continuing to advance important clinical research in small cell lung cancer.”

Immune-mediated adverse reactions, which may be severe or fatal, can occur with KEYTRUDA, including pneumonitis, colitis, hepatitis, endocrinopathies, nephritis and renal dysfunction, severe skin reactions, solid organ transplant rejection and complications of allogeneic hematopoietic stem cell transplantation (HSCT). Based on the severity of the adverse reaction, KEYTRUDA should be withheld or discontinued and corticosteroids administered, if appropriate. KEYTRUDA can also cause severe or life-threatening infusion-related reactions. Based on its mechanism of action, KEYTRUDA can cause fetal harm when administered to a pregnant woman.

https://pipelinereview.com/index.php/2019061971560/Antibodies/FDA-Approves-Mercks-KEYTRUDA-pembrolizumab-as-Monotherapy-for-Patients-with-Metastatic-Small-Cell-Lung-Cancer-SCLC-with-Disease-Progression-on-or-After-Platinum-Based-Chemothe.html

Come on 401..

Plus side of the gamble, something has shifted regarding finances hence why EHGO have been cast aside, managing 'short term' finances carefully, sale of asset for a nominal fee might just see them through to..? Negative.. ugly!

Mmmm? It was true but already out of date. 10th June notification that Val no longer intends to enter any agreement with EGHO and since issued more shares taking the number above 900m. What a mess and shareholders remain in the dark. Not for the faint hearted and currently remains a gamble.

Huge prospects which NONE have been drilled into the lower Cretaceous Aptian/Albian yet have hydrocarbon indicators suggesting they should. It's why I'm here..

I've been looking since the announcement of those what appear to be less attractive 4 blocks for evidence that Exxon will continue to look to swallow up more acreage.. great find J.

Remembering the Sasol drill outboard of the Albatross prospect..

"The well reached its target depth above the Aptian sequence, and it is significant that the hydrocarbon content and wetness as recorded in the well steadily increased towards the bottom of the borehole to target depth."

Need to do some weekend research on this drill but I suspect it was the same as Cormorant. This drill was not located above the prospect yet evidence of migration exists and suspect the same shale channel caused the same problems hence Africa Energy will wait the outcome of Osprey before committing. Its appears to be all the billions of barrels across these licences entering the same channel.

I said it before and i'll say it again, Osprey should not be drilled, those limited funds will be much better spent elsewhere..

From what I can see, GBP of very different different plays going on..?

1. Sand Channel Fairway leading up to Gemsbok
2. Read across thief channel to a trap from fans in PEL 30 & 37 (Maybe South east corner 94 and east Welwit)
3. Direct vertical migration in the deeper Albian/Aptian across large structures in both 94 and 29

What is the likely outcome at Azinam’s investment in the Osprey prospect in PEL 30? What caused Tullow and ONGC to pull out? What would give a great case for Azinam/Seapulse to invest into GBP's licences? May have just found the geological reason?

Read this resource report by Guvtason in Dec 2016 - Page 45

In addition to the 2D seismic leads, the Osprey prospect, which is interpreted to be of Albian age, is interpreted on the new 3D seismic data to be a stratigraphic trap in the Late and Early Cretaceous section. The image from the Cooper 3D seismic data set (Figure 3—20) shows the Osprey amplitude in a 3D sense and how it pinches out at the base of the slope forming a stratigraphic trap. The warmer colors indicate the sand portion of the amplitude event while the cooler colors indicate shales. A post depositional shale filled channel apparently cut the Osprey sand body.

https://www.ecooilandgas.com/wp-content/uploads/2018/09/2016-51-101-Report-Final-14Dec2016.pdf

The last sentence, ‘A post depositional shale filled channel apparently cut the Osprey sand body’

Cormorant - "Wet gas signatures, indicative of oil, were first encountered in the overlying shale section and persisted throughout the target interval, indicating that there has been significant hydrocarbon generation in the area."

I’m no Sherlock Holmes but it seems pretty obvious the same channel cut into the sand body there too. A perfect explanation for a ‘thief channel’ PCL’s perspective or the recent Africa Energy view being migration distance.

Only a few Billion barrels of oil at stake and that channel needs chasing so will they also be reading across?

If it is our acreage that seapulse/Azinam have acquired then it makes geological sense to me.. They would be following the sand channel up from Cormorant all the way to Gemsbok.

Fingers crossed! Feels like waiting forever for the drilling season to begin.

I see Serica have been nosey in Namibia Q&A What countries have you most enjoyed travelling to, for business or leisure, and why? A geological field trip to Namibia gave me the appetite to go back for a holiday. My wife and I hired a 4x4 and spent about three weeks exploring. It’s a magnificent country, the wildlife and scenery are superbly unspoilt; the food is great and the people are so friendly.  https://www.heraldscotland.com/business_hq/17695002.north-sea-oil-and-gas-independent-eyes-bumper-deals/

Basically as soon as they acquired it.

Absolutely! Repsol would have called all the shots as operator.. GBP released prospect locations to deep, the east and south east, trap and play types on top of Cormorant however that energypedia link suggests Repsol gambled a bit on choices and called it wrong going by the indicators.

Enjoy Investor! Slightly jealous! :-)

For the shallow zones...