(OXB) Oxford BioMedica

I was not talking about the cost/benefit of the test, that would be excellent, but TROVAX! NICE would want to see the cost benefit of that (TROVAX), and that requires long term survival data etc. Which currently has not been proven, and will not be provided by the kid's test, but by a proper phase 3 trial and monitoring disease regression, and yes death rates.

As for banning imports etc, yes they can, if they want to.

Saw this in the Mail today. Not trialled yet but still, cheap eye drops may prove to be stiff competition for an expensive alternative genetic cure. OXB cannot afford these delays.

http://www.dailymail.co.uk/health/article-2343533/Shark-pills-save-sight-grow-older.html

HawkOne

You couldn't make it up.

http://en.wikipedia.org/wiki/Jack_Andraka#cite_note-Intel-1

'The Andraka test will probably be a game changer, for cancer diagnostics, will it be a home test kit? No, the medics will not want that, and who wants to test for something like that at home, they will want it to be carried out in your GP's surgery as part of a health screening.'

Nobody has told the kid.

'He has patented his method of sensing pancreatic cancer and is communicating with companies about developing an over-the-counter test.[7] '

Are they going to ban imports? Will doctors strike patients of their list / refuse to see them / do nothing if they present with a home test result? I am not too worried about that. I have a good clin. neg. solicitor in the family.

I also have the fortune not to be a lady of childbearing age, but I am of an age where I face an ever increasing risk of dying from cancer. I would be upset to discover from a home test kit that I had cancer. I would be even more upset to discover from my GP that I had an advanced cancer that was going to kill me. I would be reassured to know from a home test kit that I was in the majority that don't have to worry about some of the more common cancers. My GP would be happy not to have so much of his time taken up by the 'worried well'. You wait for the NHS to organise a screening programme, I will be on the internet ordering my US test kit.

'As for using the test now as part of a phase 3, yes that could be done, but they will still need to carry out all the long term tests to determine the overall survival etc.'

OK that's what I said.

'The FDA would not approve a cancer drug without that information,'

Cannot argue with that.

' particularly using a new test.'

Irrelevant, it's not the new test that will be delivering data on 'overall survival etc.'

'Also NICE would want to see that data to approve it [the test 'costing around three cents' ] for the NHS, so that they can judge its cost/benefit.'

Really?

'A dose-response curve was constructed with an R2 value of .9992. Tests on human blood serum obtained from both healthy people and patients with chronic pancreatitis, pancreatic intraepithelial neoplasia (a precursor to pancreatic carcinoma), or pancreatic cancer showed a similar response. The sensor’s limit of detection sensitivity was found to be 0.156 ng/mL; 10 ng/mL is considered the level of overexpression of mesothelin consistent with pancreatic cancer. Andraka's sensor costs $0.03 (to compare to a $800 cost of a standard test[10]) and 10 tests can be performed per strip, taking 5 minutes each. The method is 168 times faster, 26,667 times less expensive, and 400 times more sensitive than ELISA, and 25% to 50% more accurate than the CA19-9 test.[6] '

They know the test works and it only costs three cents, what more information do NICE need for a cost benefit analysis? They must know it costs more than three cents to treat an advanced cancer.

'So the Andraka test will add information for the clinician and patient especially in the long term, but I do not see it speeding trovax through the clinic.'

Agreed, but it would de-risk the trial process in the short term. The test will tell them something about efficacy (which they would not have known before the test was available ) and right from the early beginnings of the trial processes. That should make it more likely to get a drug into the clinic in the first place, or as is the problem with Trovax, back into the clinic.

d gaser.

Just suppose there was a deal for Trovax between OXB, a Venture Capitalist and a Contract research organization, (CRO).

https://en.wikipedia.org/wiki/Contract_research_organization

OXB take a modest /nominal up front payment from the VC pus rights to the 20% they could have expected from a big pharma. The VC and the CRO split the cost of funding a Phase 3 and the rights to the remaining 80% between them. OXB could be retained as consultants on the project.

I have shares in Immupharma who are currently contemplating a deal which could be with a CRO. They don't need the VC because they have the funds to do a deal directly with a CRO.

Hi Festering,

The Andraka test will probably be a game changer, for cancer diagnostics, will it be a home test kit? No, the medics will not want that, and who wants to test for something like that at home, they will want it to be carried out in your GP's surgery as part of a health screening. I do not see this like a ClearBlue pregnancy test, where a negative result, whilst being upsetting is not the news you have cancer, which for a lot of people still equates with death.

As for using the test now as part of a phase 3, yes that could be done, but they will still need to carry out all the long term tests to determine the overall survival etc. The FDA would not approve a cancer drug without that information, particularly using a new test. Also NICE would want to see that data to approve it for the NHS, so that they can judge its cost/benefit.

So the Andraka test will add information for the clinician and patient especially in the long term, but I do not see it speeding trovax through the clinic.

That is what is required, Trovax passing a phase 3 trial in one cancer, just one carried out well, getting licensed then it can be used by clinicians either off-label in other cancers, or being trialed in phase 4 (post approval) trials for other cancers, or for earlier use as you suggest, and maybe even earlier as a true cancer vaccine for people around 50 years old, men could have it earlier, but not ladies of child bearing age.

Dave's suggestion of a venture capitalist could be one way of getting the cash to carry this out, and I believe Aegian hinted at this from the AGM. Trovax could be spun out, OXB providing the IP and product for a percentage of the company, and so retaining interest, and the venture capitalist providing the cash for the other remaining percentage.

The OXB board are not so completely daft or desperate that unlike you they cannot see potential in retaining at least some stake in Trovax. Maybe the venture capitalists that you speak of could already be known to OXB. A venture capitalist would presumably go on do some sort of deal with a contract developer.

Although I don't think Vulpes are buying at present, Dave raises an interesting point.

If OXB is indeed doing well, and likely to do even better, Vulpes are in a good position to know. At what price would the holders of most of the existing shares be prepared to sell? I suspect the majority would settle for a figure a lot lower than many of us longer standing shareholders paid!

I do hope that scenario is not correct, but it would be better than the oblivion some may have thought, and may still think, likely.

It appears many have written Trovax off here ,but it is not unusual for drugs to be dropped by their developers only to regret it sometime down the line .When others with vision see what can be done with just a little further thought or buy other drugs to go with it, and reintroduce it to the market as a billion dollar drug .A typical example of that ,is a drug called Zytiga see link below ,so far at least 6 companies’ have tried to make it work ,but Sanofi have now done it and are awaiting FDA and European approval .Zytiga is a prostate cancer drug, and has been around since the mid-19 ,but nobody saw it potential until now ,another example is lamtrada also known as alemtuzumab,it was originally a treatment for B-cell chronic lymphocytic leukaemia, before they realised surgeons were using it on MS patients, and was potentially worth billions ,and this drug has been around since the 1990 ,even Viagra started out as a hart cure ,but the side effects made Pfizer look at an alternative drug ,and made billions out of it .
To me Trovax is another one of those products ,and it will take someone with vision, and the ability to understand it ,and adapt it ,and when that happens, it will make someone billions of pounds in sale’s ,and safe thousands of life’s ,but that can only happen if someone finds the guts to do what the FDA wanted ,when the trial was pulled ,and that is to get it back into stage 3 development.
Hopefully the present trials at Cardiff university hospital, will be the catalyst for that to happen, and prove Trovax is worth developing, I just hope, OXB will still own it, when that big day come’s , rather than see us sell it on for pea nuts .I really believe Trovax will come write in the end ,and no matter how negative some posters get regarding Trovax and its ability to become a billion dollar drug, somewhere out there is a company or a venture capitalist who can see the future ,and as with lemtrader ,and Zytiga,and like them Trovax will eventually find a home, and make the owners billions
BE HAPPY
REGARDS
DAVE.
http://www.fiercebiotech.com/story/sanofi-finally-nears-goal-line-ms-drug-lemtrada/2013-06-10

http://www.iii.co.uk/investment/detail?code=cotn%3ABTG.L&display=discussion&threshold=0&action=detail&id=10664018

REGARDS
DAVE

HawkOne

This much we know about the kid's test. :-

A dose-response curve was constructed with an R2 value of .9992. Tests on human blood serum obtained from both healthy people and patients with chronic pancreatitis, pancreatic intraepithelial neoplasia (a precursor to pancreatic carcinoma), or pancreatic cancer showed a similar response. The sensor’s limit of detection sensitivity was found to be 0.156 ng/mL; 10 ng/mL is considered the level of overexpression of mesothelin consistent with pancreatic cancer. Andraka's sensor costs $0.03 (to compare to a $800 cost of a standard test[10]) and 10 tests can be performed per strip, taking 5 minutes each. The method is 168 times faster, 26,667 times less expensive, and 400 times more sensitive than ELISA, and 25% to 50% more accurate than the CA19-9 test.[6]
Officials at Intel have said that Andraka's method is more than 90 percent accurate in detecting the presence of mesothelin.[1] He has patented his method of sensing pancreatic cancer and is communicating with companies about developing an over-the-counter test.[7]

None of that is a dream. It works. We don't need to spend years doing Phase123 trials to know the kid's test works. We can do the kid's test today, in the lab.

How does that change things? You will still have to do Phase123 trials on the drugs. The difference is that you no longer have to wait years and spent hundreds of millions of dollars, counting the dead in a Phase 3 trial, before you can gauge the efficacious properties of the drug. You can do that with the kid's test. You can do a Phase1/2 and run the kid's test as frequently as you like, every day if necessary, plotting the level of biomarker in the patients. You could do that with any drug. Trovax has the advantage that it has already gone through a Phase 3 with no safety issues.

Will this encourage someone to take up Trovax and have a go with the kid's test ? I think that's very likely based on what is now know. Others in the 'I remember MetXia' school of thinking will continue in a mindset where generalities, however irrelevant to the known particulars, trump all else.

Quite right as Tovax has never been tested in a way like this, as an early stage treatment.

The TRIST trial was with patients who had had their cancers partially removed.
The Mesothelioma trial is in combination with chemotherapy to see if it improves survival.
The bowel cancer trial is with inoperable tumors. (which to quote CR-UK "This pilot study is not large enough to show whether the vaccine works as a treatment, ") http://www.cancerresearchuk.org/cancer-help/trials/a-study-looking-at-vaccine-trovax-after-treatment-for-bowel-cancer-that-has-spread-tacticc

None of these are with early stage, it could be a potential vaccine, and if it worked like that it could even be given at say 50 as a prophylactic. But this is all dreams!

Three years ago, there were meant to be expressions of interest on the table....result ZERO, if it was so great a product someone would have taken on by now.

Even Pfizer might be second to market with a anti-5T4 antibody, as Active Biotech have one which has completed a phase II/III, not totally successfully but with a doubling of survival times, called naptumomab.

http://www.activebiotech.com/press-releases?pressurl=http://cws.huginonline.com/A/1002/PR/201306/1706561.xml

It all sounds great but you talk as though Trovax is ready to market. My faith in this company's ability to market anything is almost zero at the moment. They have currently halted our only lifeline left, rightly or wrongly, at a time when we simply cannot afford it. It begs great questions of management, if it does prove to be the right decision, as to why it was allowed to get this far. If this method of testing is so crucial then why was it not introduced earlier?

I'm sorry to be negative about this thread but the clock is ticking and things are not looking positive. At worst we are months or even weeks away from losing our investment altogether. At best, we are nicely positioned for a cheap takeover. Either way, its not looking good.

I don't see the point in dreaming about Trovax until we know we have a future. In fact, I read Naylors departure is a signal that the company is intending to move away from cancer treatments altogether.

When the over-the-counter test kits becomes available for a few pence, anyone in their right mind will be testing their urine at regular intervals. NICE will not be able to rationing it. The NHS would save a fortune if all those cancers were detected early, before they become expensive to treat. The NHS may even have the sense to promote self testing. This could vastly increase the market for Trovax, something that is relatively inexpensive to produce, simple to administer, covers a whole range of cancers, has no side effects, and can be stated straight away, as soon as you report to the doctor with the result of your regular self test.

The only downside might be the cost of pensions for all those extra survivors.

HawkOne.

Andraka was awarded the $75,000 Award, named in honor of the co-founder of Intel Corporation, for his work in developing a new, rapid, and inexpensive method to detect an increase of a protein that indicates the presence of pancreatic, ovarian, and lung cancer during early stages when there is a higher likelihood of a cure.

http://en.wikipedia.org/wiki/Jack_Andraka#cite_note-Intel-1

I have not seen prostate mentioned for that particular protein, only pancreatic, ovarian, and lung, but I think there was at least one article that suggested the test could be developed to be used in detecting other biomarkers specific to other cancers.

I know you did not say the test the kid developed was a test for 5T4. But the kid does not have to test for 5T4 to detect the cancer. Once the kid has detected the cancer, if he can distinguish the type he will know if it is a type that has 5T4.

Even it he cannot distinguish between types, 5T4 is present on the majority of solid tumours, as high as 90% has been suggested. Having detected the early stages of a cancer, they can hardly refuse you Trovax because there is only a 50% - 90% chance it has 5T4 on it. What's more they can repeat the kids test and they will know if the Trovax is working or if it is not working (no 5T4 present).

If it's detected very early, which would you like to start with, surgery, chemo, a drug with some nasty side effects, Trovax, Trovax in combination with other drugs, preferably ones that like Trovax have no side effects? You choose.

It appears Vulpes have to put in a compulsory bid for OXB, if there holding reaches 30% of issued stock under section 9 of the takeover panel rules, at present vulpes hold 28% of the company, and today some body has been buying again, yet the price has hardly moved, if Voles increases its holding above 30% then the following rules apply.
BE HAPPY
REGARDS
DAVE
---------------------------------------------------------------------------------------
9.1 WHEN A MANDATORY OFFER IS REQUIRED AND WHO IS
PRIMARILY RESPONSIBLE FOR MAKING IT
Except with the consent of the Panel, when:
(a) any person acquires, whether by a series of transactions over a
period of time or not, an interest in shares which (taken together with
shares in which persons acting in concert with him are interested) carry
30% or more of the voting rights of a company; or
(b) any person, together with persons acting in concert with him, is
interested in shares which in the aggregate carry not less than 30% of
the voting rights of a company but does not hold shares carrying more
than 50% of such voting rights and such person, or any person acting
in concert with him, acquires an interest in any other shares which
increases the percentage of shares carrying voting rights in which he is
interested,
such person shall extend offers, on the basis set out in Rules 9.3, 9.4
and 9.5, to the holders of any class of equity share capital whether
voting or non-voting and also to the holders of any other class of
transferable securities carrying voting rights. Offers for different
classes of equity share capital must be comparable; the Panel should
be consulted in advance in such cases.
An offer will not be required under this Rule where control of the offeree
company is acquired as a result of a voluntary offer made in
accordance with the Code to all the holders of voting equity share
capital and other transferable securities carrying voting rights.
(See Notes on Dispensations from Rule 9.)

The one point we must not lose sight of, or delude ourselves about, is that Trovax failed its phase III testing. It failed in a very public way and even when all the facts and figures were available. We may want to give reasons other than ineffectiveness for its failure but Sanofi dropped it entirely although they would have been well aware of all the factors. No one has been willing to finance another phase III trial since. With each year that passes it becomes less likely that another company will finance trovax. Reading between the lines from OXB's newsrelases and the changing of the oncological CSO it looks to me as if OXB do not expect much progress with Trovax or MetXia. The long term survival data from the phase III test would have been interesting particularly with the fairly short average survival time from renal cancer but OXB have decided to keep this secret. I wonder why.

Our main hopes - our only hopes- for this company rest on the success of prosavin, ocular drugs or commercial success for their new plant.

Festering your probably right regarding Sanofi and them interfering, but even so, OXB and the people who designed the Trist and selected the hospitals and end points, and subsequently carried out the trial were ultimately to blame, for the failure of the Trovax program in 2009, and not Trovax itself .And according to the FDA report released after the Trial/Trist was prematurely brought to a close , they clearly blamed one hospital, and the way the Trist was run there , for the premature failure of the Trovax trial ,and not the product itself.
What I don’t understand is why OXB allowed that to happen? Had that been one of my products, I would have insisted on being involved throughout the consultation, and I would have checked everything was OK, before giving my blessing for any trial to proceed, so why didn’t OXB do the same? After all, it was there product that was being tested, and their future as a company financially was on the line, so if they had concerns about the Trist then, why didn’t they say something? Before Sanofi submitted Trovax to the FDA?
I hope things at OXB have changed since 2009, and that this type of thing can’t happen again. As the old saying goes’ the Buck stops with the man at the top or with the person who it owns it, in this case the owner of the product was OXB and the man at the top has now gone .
BE HAPPY
REGARDS
DAVE

I did not say the test the kid developed was a test for 5T4, it was specific test for prostate cancer, as such not applicable to other solid tumors. A simple test to detect cancer is a holy grail in oncology research, and would be worth billions, even if it was sold for pennies. But for Trovax to work the tumor has to be 5T4 positive, and it is not found on all carcinomas, so the either the tumor has to be biopsied or labelled in situ (using the ImaginAb antibody). Once the 5T4 status is known then you can give Trovax, or the Pfizer antibody. This is the same for herceptin, if the breast tumor is HER2 negative, there is no point in giving Herceptin, it would not work.

HawkOne.

'A simple test for a 5T4 positive cancer would be great....but unlike the test the kid developed, 5T4 is fixed in the membranes of cancerous (and placental) cells, so a nice dip stick will not be feasible.'

I think you may be missing the point Hawk. The test that the kid developed was a way of detecting accurately extremely low levels of a cancer biomarker. That biomarker was not 5T4. You would not have to be able to detect 5T4. Any biomarker that tells you there is a cancer to be treated and can be used to measure disease progress, would provide for a means of determining the use of Trovax in a vaccine capacity.

d gaser

I don't think you can lay all the blame for the problems with TRIST at OXB's door. I don't know how much input OXB had once it was licensed but I think Sanofi were in the driving seat. I remember some comment to the effect that Sanofi insisted on doing the trial in renal cancer which was not OXB's preference. Renal cancer has a short survival time and was allegedly selected to produce an early result. Hence it may have been Sanofi that were rushing things.

City,

We would not need supercomputer time to repeat the work reported in the link you posted as it does not involve any massive computer work, it is just using the same principle farmers have carried out for thousands of years, selecting the best strain for what they want (milk yield, meat, wool, drought resistance) and using it to produce daughters (plants, cows, sheep etc), then selecting the best from them and breeding them until you get the product you want, that is what in-vivo directed evolution is.

The problem with the reported technique is they have developed a virus which is fantastic at infecting mouse eyes but not so good with other species. To get an improved one for humans we would need to randomly mutate lentivector, infect a live human eye, or retina, harvest the viruses which prefer to infect the retina, randomly mutate them and repeat with a fresh retina, until you get a virus which is totally specific for human retina tissue. Hence the technique being years away from being able to be used in humans.

A simple test for a 5T4 positive cancer would be great....but unlike the test the kid developed, 5T4 is fixed in the membranes of cancerous (and placental) cells, so a nice dip stick will not be feasible.

However there is a test for 5T4, that detects approximately 40% of tumors:

http://www.google.co.uk/patents/US7968317
http://www.ncbi.nlm.nih.gov/pubmed/11708475

But once cancer is suspected then the ImaginAb antibody test would be the test to see if it is 5T4 positive:

http://www.iii.co.uk/investment/detail?code=cotn%3AOXB.L&display=news&it=le&period=2012

Which would mean injecting you with their product waiting 10- 30 minutes then into an imager depending on the label they have put on the antibody, if it shows up then down the corridor for your shot of Trovax, or Pfizers antibody.....or both. If the test is negative, then it is the standard route of surgery, radio or chemotherapy.

It is just disappointing that the supposed expressions of interest have not resulted in anything over the last three years, from the link Dave posted:

"OXFORD BIOMEDICA IS IMPLEMENTING A BROAD PARTNERING INITIATIVE AND EXPRESSIONS OF INTEREST HAVE ALREADY BEEN RECEIVED"

I saw this guy on news night last Thursday ,and he was hysterical ,but he is very clever, and It just shows how far science can take us ,with regards to finding tests for cancers ,hopefully Phyzer will be able do the same with our 5T4 protein, and that Trovex can then be used to cure cancer .
We have to remember Trovax did work, The problem laid for the failure of the trial laid with those in charge , as it was they, who set the end point far too high for a new vaccine, especially for an experimental vaccine such as Trovax , the board also elected to use un trustworthy hospital, as one of the test site’s, and exploratory analyses suggested that a number of factors may have compromised the outcome of the study, including an imbalance with respect to patients' baseline prognostic factors ,and atypical results from a single clinical site. hence that hospital failed us, by not sticking to the trial agreement, and using blood they shouldn’t have used , in order to keep up the numbers of patients required for the trial .If nothing else, that trial proved Trovax and other such vaccines do work, in early diagnosis, and when used in personal medicine, the problem with Trovax was our board were over ambitious, and wanted to prove to the world, OXB had the cure, and not just a vaccine that worked on some people, had we walked first instead of trying to run and used good science to get our end point right then things would have turned out differently .
Trovax failed thanks to human incompetence, however the trials did show science had moved on, and that the human immune system could be made to induce healing, had OXB, lowered their requirements of the end point in the first place , then Trovax would have been OK, and in use now, as a fist first stage medicine for hard cancers, or, as an individual cancer care medicine, rather than a one fits all cure, and no money left to get the trials restarted .Personally I still have high hopes for Trovax and that the new trials will produce the evidence the FDA needed for someone else to come in and restart the trials, as the FDA asked ,only this time it would be done properly , and personally I hope that company is Pfizer.
BE HAPPY
REGARDS
Dave
Go to for full info http://www.iii.co.uk/investment/detail?display=news&code=cotn:OXB.L&pageno=3&period=2009
Extract from the conclusion of the FDA panel dated 6th July 2009
Importantly, analysis of the data confirms prior clinical results, demonstrating that TroVax is both immunologically active and that there is a correlation between the strength of the 5T4-specific antibody response and improved survival. Exploratory analyses also suggest that a number of factors may have compromised the outcome of the study, including an imbalance with respect to patients' baseline prognostic factors and atypical results from a single clinical site.
In its comments, the FDA acknowledged that confounding factors may have contributed to the increased number of deaths in the TroVax arm at the August cut-off date. Furthermore, the FDA accepted that there was no evidence of specific adverse events that could attribute the imbalance of deaths to TroVax. The most frequent TroVax-related side effect was low-grade transient irritation at the injection site.
A prospectively agreed sub-set analysis of Intent to Treat (ITT) patients showed a significant advantage to TroVax in good prognosis patients receiving interleukin-2 (n= 50 in TroVax arm; and n= 50 in placebo arm) as at 13 March 2009. In addition, analyses suggest that abnormal baseline haematological parameters may have impacted on the ability of patients to mount effective immune responses to TroVax. Over 50% of patients in the TRIST study had 'normal' baseline platelet, monocyte and haemoglobin levels (n= 372) and, in these patients, there was evidence of a survival benefit in favour of TroVax. These observations are potentially valuable for future studies of TroVax, enabling the selection of patients at

Presumably this new gene delivery system involves an injection into some part of the eye, if not directly into the retina. Repeated injections directly into the retina no doubt carry a significant risk of damage. However if they are going to compete with the likes of Retinostat they would have to get it down to a one off injection.

As a non expert, the article suggests, it will take many years of research before they know if it is an effective way of transfering genes into the human body.

http://www.technologyreview.com/news/515876/virus-that-evolved-in-the-lab-delivers-gene-therapy-into-the-retina/

the future of OXB will be decided by the amounts of computing power they can access.



The new Medical officer would be well advised to have a big data computing expert on board who is well-networked.

We dont need our own supercomputer but shared time on existing networks like The GRID, which Oxford University can facilitate.

Great story.

Handover

You remember MetXia? I don't much care if you can remember Noah's flood. Don't you have something useful that you could be doing?

No I agree with your points about the test; my doubts are just about how effective Trovax is.
I remember that MetXia was tested at stage II on pancreatic cancer ( in 2006?) Promising results but dropped in favour of concentrating on Trovax. Certainly vaccines could work better on the asymptomatic tumours revealed by this test but woiuld trovax?

Anyway I like your positive posting.

That was no jest handover. I do not have a negative default setting.

If you want to use a vaccine before the cancer becomes symptomatic you need a simple cheap screening test.

If you can also use the screening test to show that the vaccine has worked, all the better.

You may also be able to use the test to predict the outcome and/or monitor the progress of further vaccine (Trovax ) trials.

FH
Stated in those terms OXB are a wonderful investment and I can understand your enthusiasm for it. It's just after so many OXB disappointments and Trovax failure at phase III I don't think it is too likely.
The link you posted is a wonderful story although one wonders what all of these pharmaceutical research companies have been up to when a fifteen year old runs rings around them.

Thanks for your posting which I think was meant in a light hearted way but with a kernel of truth it makes you remember why we invested in OXB in the first place. Not only would the process you describe be a boon it wouldmake a tremendous amount of money for us. It's just I don't think Trovax will do what you suggest. Anyway great posting it almost makes me want to buy more.
well almost . . .

Don't forget to to do another test in say 6 months time to check that the Trovax has worked.

Nip out to the chemists, get your cheap as chips over the counter cancer screening test. Five minutes in the bathroom (simple urine test). In the unlikely event that it is positive, no worries, you have caught it early. Pop down the Doc's and get your Trovax jab. How nice would that be? Why wouldn't you?

http://www.voanews.com/content/teenager-prize-cancer-test-jack-andraka/1603357.html

Going forward this should be a good result, it will mean royalty free access to the use of human genes in gene therapy products. But OXB will still be able to protect their products as these are an artificial combination of the genes and other features such as promoters, ribosome binding sites etc and as such are an invention and are patentable.

I always have thought that patenting human DNA/genes was wrong or impossible as every human would have to pay royalties to the patent owner each time our DNA was expressed in normal life or passed on to our children.

USA govt have banned gene patents. Will this affect OXB?

http://www.bbc.co.uk/news/world-us-canada-22895161

Yes it was OXB who stopped the trial, but once you stop a trial like that, it is up to the FDA to give permission for the trial to restart in the USA, it would be the MHRA or EMA in the UK or Europe.

But the best outcome is for the FDA to allow OXB to use the current batch, if they manufacture a new batch for this trial, it has to be identical to the old one, made in the same way as the CMO made it for OXB. It has to be fully tested, to prove it is safe sterile and has no adventitious agents. This all takes time, a full safety testing for a viral product takes up to 12 weeks. That would mean even if they started manufacturing when they discovered the contaminant, which is impossible if it is made to GMP, the product would not be ready for use until late September, probably mid October at the earliest.

From a risk based approach, making a new batch is the safest, but from a business perspective using the current batch in this trial would be the best.

It was OXB that stopped the trials not the FDA. If the FDA says its OK to use old stuff. OK. Well maybe not. OXB may not want to use contaminated stuff even if the FDA says it OK. But I don't think OXB will be waiting for the FDA before they start the manufacture of the next batch of contaminant free Retinostat. They will find a use for it either way, and when that's ready, what's the FDA got to object to?

Fair do's, I've done the company an injustice. There are a few larger holders left as well as Vulpes, particularly M & G, see; http://markets.ft.com/research/Markets/Tearsheets/Business-profile?s=OXB:LSE

We probably will not know until the FDA give permission to restart the clinical trial.

OXB will need to confirm the amount of the contaminant in the clinical batch, and how much the patient will be exposed to. Then they will need to assess how much potential risk there is to the patient. They will need to then put this together in a justification to the FDA to restart the clinical trial. Depending upon the risk and amount of evidence that is available from literature, this should not take too long, and they might have completed this already.

Then it is up to the FDA to examine the justification, have their scientists look at the evidence, come to a conclusion, then report this back to OXB. This is in the FDA's hands and this could take days/weeks again it depends on the risk and evidence and how busy they are. If it is a green light the trial recruitment could be restarted immediately, if it is a red light then it will depend on what the FDA say, which could be more testing, some increased pre-clinical/animal work, or production of a new batch. And of course OXB will have an opportunity to challenge/submit additional evidence if they want to.

I would not expect any news for a couple of more weeks at the minimum, and it probably could be longer.

Nearly 2 weeks in and no update.

Anyone got any idea how these kinds of investigations take and how long before we get to know more?

something to look forward to if I live that long.