Latest updates to the FAQ (June 15th 2013)

Now you have the full £2 million what happens next?

Even when we have the money at hand it will take plenty of hard work to get the trial going. The virus will have to be produced at a GMP Laboratory and tested at a GLP laboratory.

We then need to discuss with the MPA and Ethics committees and involve an external monitor (a CRO company with documented GCP procedures) to unbiased monitor and evaluate the study. I would be very pleased if the study can start at the end of 2014 or at the latest the beginning of 2015.

The trial itself will probably last for one year.

Can I apply to be on the trial?

Just like every clinical trial there will be inclusion and exclusion criteria also in this study. They have not been fully described yet.

First of all, the criteria are based on the medical conditions of the patients and it is Kjell Öberg as the clinical PI who has the last word. For example, the patient must have at least 6 months expected survival to be included.

If the disease is stable, i.e. not progressive, a patient may be excluded, at least for the time being. Chronic liver dysfunction will be an exclusion criteria since such patients will not be able to cope with injection of virus into the liver. Generally speaking we will not be allowed to treat patients who are responding well to their ongoing treatment.

The patient group has to be somewhat homogenous when it comes to the NET medical history to make it easier to interpret the results.

We plan to treat patients with virus 4 times on days 1, 8, 22 and 50. If we see responses or stabilizing disease, up to four more injections can be given once a month. Therefore, it will primarily be patients from the area, who can easily come to the hospital that will be included although patients from far away will absolutely not be excluded. We just need to make sure that such patients are willing to go through with the whole trial providing that their medical conditions let them. If we include patients from far away who does not want to come back for their third and forth injection, we will be unable to follow their responses and evaluate them for the study. The study then risks to become non-conclusive and it can become difficult to continue with a follow up trial.

What happens after the trials?

If the trial is successful the donor has expressed a wish to help develop the treatment for wider use. He is clearly interested in continuing supporting research and possibly also businesses for new treatment of NETs.

An unsuccessful trial does by no way mean an end for our efforts to develop a treatment for NET patients that that works. Kjell Öberg’s history in the field of NET research and treatment clearly speaks in our favor.

Thanks to his and others effort, patients with NETs live three times as long today as they did when Kjell started his career in the early 80′s. We have plenty of interesting finding which are at earlier steps of development. With your help and contacts I am sure that we will be able to make a difference in the end.

Original FAQ:

 

Who are we?

We are a group of five individuals who have been touched by NETs, a rare cancer of the neuroendocrine system.  We are:
Dominic Nutt – a NET patient diagnosed with a neuroendocrine tumour in January this year (2012), author and campaigner Alexander Masters, whose friend and editor Dido Davies has an advanced Net cancer, Liz Scarff a social media campaigner and consultant and friend of Dominic Nutt, Maia Sommers, a NET specialist who works for the Net Patient Foundation and Colin Midstone, a publicist who has worked with Alexander promoting his biographical novel, Stuart: A Life Backwards.

What are we doing?

We are raising £2m needed to pay for the testing of a NET-eating virus that could end deaths from this cancer. We are doing it direct – through Twitter and Facebook and Youtube, using Kickstarter (?). We are cutting out the middleman, the drugs companies and appealing straight to you. We are not a charity, we have no budget and the money goes direct to the research team – not us.
There are no wristbands, no fancy launches and no rock concerts. It’s just us and you.

Why are we doing it?

We are frustrated that there is a potential therapy for NET cancers and it will only cost £2m to find out if it works.
We are frustrated that the barriers in the way of testing this are piffling, petty and bureaucratic.
We are inspired by our friends who have been touched by this cancer and for whom a remedy may be within touching distance.
We are motivated by the fact that this cancer is on the increase, that it is often undiagnosed, that it will kill many more – and kill more unnecessarily.
We are also fired up by the responses we have had already on Twitter. You want to help. We want you to help. This is people power. We don’t need to pay deference to the rules – we can fund this in a heartbeat.

 

What is this virus – how does it work?

The NET-targetting virus is based on adenovirus serotype 5, a virus that normally gives you a bad cold. Thanks to designed genetic alterations it only replicates in and kill NET cancer cells. Healthy cells in humans are programmed to die when they become infected by a virus, because this prevents the infection spreading to other parts of the body.  But through its mutations, a cancer cell has somehow managed to turn off the bits of its genetic programme that enforce cell suicide – that is how an ordinary, healthy cell becomes cancerous.   This means that, if a suitable virus infects a cancer cell, it can continue to replicate inside cancer cell uncontrollably, causing the cell to tear apart.  The progeny viruses then spread to other cancer cells nearby and repeat the process.  A virus becomes, in effect, a cancer of cancer.

 

Will it work in humans?

The Swedish team is hopeful that it will – and that what the tests we want to fund are designed to discover.

 

Is it a cure?

No. It is a treatment that will, if successful, manage the cancer and keep it at bay for a significant period of time. It will probably be used in combination with other treatments. It could turn NETs – and possibly other cancers – into a ‘chronic disease’, rather like diabetes or heart disease. Just as a diabetic injects insulin and therefore doesn’t die for a lack of insulin, a NETs patient could be kept alive – and have an excellent quality of life – by being treated with this virus.

 

Why this research – there’s loads of other research out there?

This research is acknowledged by many top experts to be at the cutting edge in its field. For example, NETs cancer expert Prof Alan Melcher, Professor of Clinical Oncology and Biotherapy at the University of Leeds, said: “This virus has the potential to prolong the quality and length of life of sufferers. If we get this right, virus treatments may have huge potential – not just for NETs but for other cancers too.”

But if we raise the money for this virus, we plan to use the same approach to fund other streams of research that have not been picked up by other funders or pharmaceutical companies.

 

Will it work for other cancers?

We need to see if it will work for NETs. But experts are hopeful that it could be adjusted to have applications for other cancers.
Are you diverting money from other diseases and cancers?
No. This is a new way of funding cancer research. We are asking people to donate directly to the research project, in small amounts – as a one off. We do not want people to stop giving to medical charities.

If it’s so good, why is no one funding it?

Pharmaceutical companies are interested in research only when it looks likely it will produce a profit. This research is some years away from that at this stage. Not only that, the Swedish research team placed much of their research in to the public domain, in order to help others with their research.

This act of altruism has meant that the Swedish team is unable to patent their research. This, in turn, means that pharmaceutical companies cannot guarantee that they alone will own the research at this stage and therefore profit from it. Only when it has been trialled and developed further, can a new set of patents be applied – giving a drugs company sole ownership of the product, and a guaranteed profit.
The Swedish team has received grants from Swedish government funding and the Swedish Cancer Society (equivalent to Cancer Research UK). The grants cover the research to develop viruses for therapy but they are not big enough to run clinical trials with an advanced medicinal product where special rules apply (viruses falls under this category in Europe).

 

Is the Swedish research credible?

Yes. Hugely. It has been supported by many UK and European experts, including  Professor Kevin Harrington (a Reader in Biological Cancer Therapies at The Institute of Cancer Research and an Honorary Consultant Clinical Oncologist at The Royal Marsden NHS Foundation Trust) See:

http://www.icr.ac.uk/research/team_leaders/Harrington_Kevin/index.shtml

It is also supported by Professor Kjell Oberg, President of the European Neuroendocrine Tumour Society (ENETS) who are supporters of this research.

The research leading to this virus has been published in several internationally recognised and credible biomedical journals, including in Clinical Cancer Research 2007 (Impact factor 7.742 position 14 out of 196 oncology journal), PLoS ONE 2010 (IF 4.411, a general scientific journal), Gene Therapy 2011 (IF 4.538, 2nd best gene therapy journal), and the Journal of Virology 2011 (IF 5.402, Best virology journal).

Are you a charity?

No. We are a group of people who have come together who want to see the research happen.

Where is my money going?

If you donate via our indiegogo page your money is going directly from indiegog into the bank account of Uppsala University or directly into the Paypal account of Uppsala University – depending on which method of payment you chose.

 

Have you asked Apple for the money?

Yes. However, at this time they feel unable to help.