OGF treatment

[Juliana]

Hi guys,

Read something interesting on another site I belong to 'No Surrender'.

A gentleman from America who is being treated for ocular melanoma posted it - here is what he said:

"In addition to my conventional oncology treatment, I also have an integrative MD (specialising in orthomolecular medication) who administers to me three times a week IV drips of Vitamin C, K3 and OGF, all at a very high dose. It is the OGF that I wanted to mention, as my doctor told me that it has been tried on patients with pancreatic cancer and the early findings are very positive. It has no nasty side effects, and can be administered together with the conventional programme by a practitioner".

I looked on the net and found:

http://www.medvision.org/mihpf/medinsight%20-%20ogf%20review.pdf

At the bottom of the page it says:

In order to benefit from OGF, it is possible to enroll in a clinical trial where available. A Phase II trial for pancreatic cancer is underway at Hershey Medical Center, PennState University. A trial for head & neck cancer will be recruiting soon. Another possibility is to obtain OGF as a compounded injectable from non-cGMP or cGMP approved suppliers.

I think we are too late for the clinical trial above, but what I thought very interesting was this:

Availability

One source for OGF is Biofactor GMBH in Germany, where it is sold under the name LUPEX®. LUPEX® is intended for human use in cancer, AIDS and autoimmune diseases, Biofactor Tel +49 5322 96 05 14, Fax +49 5322 30 17.

Their email is info@biofactor.de

I can't seem to find any UK hospitals listed in trials/use of it.....so was wondering if we could we buy it? From what I have read it is used alongside Gemcitabine, which is what most of us are on anyway.

There are a lot of 'inhibitor' style trials (PARP for instance) that show promising results - less toxic etc than chemo - was just wondering how the hell we got on these trials, get the real thing and not a placebo and start kicking some Pancreatic Cancer arse!

Juliana

[Nardobd]

Hi Juliana

Yes, the stage I and II clinical trials for OGF show extremely promising results. However, there is still a stage III trial which will need to be undertaken before the manufacturers can apply for approval for clinical use and the results for early trials are often written in very positive terms so that funding can be attracted for the next stage.

I can't find any trials for OGF in the UK at the moment either. In order for it to become a standard treatment NICE would have to approve OGF for use and I can't find any guidance on the NICE website indicating this is the case.

Most clinical trials operate on a "double blind" system. That means that neither the doctor or patient knows whether the patient is receiving the drug on trial or a placebo. Once the trial is over, if the drug is proven to be beneficial, then the patients who received the placebo are usually offered the treatment. So, the way to guarantee you will receive the treatment from the outset is to receive it outside the confines of a trial. I would normally suggest that you speak with your oncologist but I can understand that you might want to be a bit more proactive than that and want to contact biofactor direct. If you'd like to use it, I've suggested the text for your email to them below.

Kind regards

Nicki x

Dear Sirs

I was most interested to find out about OGF from an online acquaintance. I have stage IVa pancreatic cancer and am currently receiving gemcitabine treatments which will hopefully stabilise the tumour, at least for the time being.

I am desperately searching for any possible treatment which may extend survival time or, dare I say, bring about remission. As you will appreciate, the prescribing of drugs within the UK's National Health Service is dependent on guidance from the National Institute of Clinical Excellence (NICE). I am hoping to bring pressure to bear on NICE by sharing the information received from you and encouraging patients on a web-forum to which I belong to ask their consultants about this treatment.

In the meantime, though, it would be really helpful to know more about the trials, preferably in layman's terms so that I can share it with others. Would you consider carrying out clinical trials in the UK or permitting OGF to be prescribed to patients here? Would there be any conditions attaching to such permission? What would the procedure for prescribing to UK citizens be? What would it cost?

With thanks in anticipation of your help.

Yours faithfully

[Juliana]

Hi Nicki,

Thanks for the letter - I have emailed them, and am awaiting a reply!

Wouldn't it be great if Sue could organise an oncologist who's speciality is Pancreatic Cancer to pop on to the forum once a week and just review some of the trials and new treatments we are finding, and give us some feedback. I've been told that my hospital hasn't got an oncologist who's main interest is in Pancreatic Cancer (even though mine has advised me he has been treating it for 30yrs), I wonder what it would be like if you were being treated by someone who's actively looking for new ways to beat this thing.

Kind regards,

Juliana

[Juliana]

Hi everyone,

Have had a reply from Biofactor in Germany with regards OGF (Lupex) therapy.

Here is what they sent me:

Dear Juliana,

Thank you for your October 25th email. We thank you for your report of your clinical picture and interest in OGF.

OGF is the preparation that we use for over 15 years now and which is known under the name LUPEX – Peptid M. For a longer terms now LUPEX is under clinical trial and not registered in the European Union yet. This preparation is produced in Germany and available for personal use without prescription on your own risk. Even without approval of N.I.C.E.! You just need a physician or a helper who is injecting the preparation as the following therapy plan:

In your case from Monday – Friday (5 days a week), every day 2 vials mixed together with solvent in one shot (that means 10 mg LUPEX/day), injected very, very slowly in typical gluteus area with needle no. 18. Take injection after you have had meal, rest for 10 – 15 minutes after the shot, if you have dry mouth or red skin drink a bit of water, this could be a side effect if you are injecting too fast! After 6 weeks of treatment you could inform us about how you get along with the therapy.

Once again, you do not need an approval or registration if you just use it for your own needs. The costs for 1 O.P. (Original package) of LUPEX – Peptid M with 10 vials plus solvent is EUR 256.00 (plus 19 % VAT).

To learn more about thymus therapy visit our website: http://www.thymustherapy.com

If you have any further questions please contact us again.

Also, I had some attachments, one being the medical instructions and the other an order form (I tried uploading the PDF but the file extension is not allowed, the same information however can be found on the website listed above - under Lupex).

I've worked it out, including the 19% VAT that my course as suggested would cost EUR 1827.84 (£1682.32) which is doable. Considering my 2nd opinion Oncologist suggested I could try Erlotinib, which has been cleared for use - but is not funded by the NHS - and would cost me between £3-£6K a cycle and may add on average 2 weeks to my life (if it worked).

One of my concerns is the injecting, could I get my GP to do it (after a meal though, and you are meant to lie down for 15mins - so a tad awkward), or a community nurse, or would it be something a MacMillan nurse could do? To be honest I would do it myself, if I was shown how. Secondly, does it only work if taken alongside standard chemotherapy? And thirdly, how would I know it was working, would I need to pay for a CT scan myself - who woud interpret the scan for me etc etc (I will email Biofactor with regards it's use with or without chemo).

Anyway - lots to think about. This treatment is being used in the USA already, but not in Europe - even though it is being manufactured here.

Any feedback would be most appreciated!

Juliana

[Nardobd]

Hi Juliana

Whilst the reply is very informative and encouraging, I've looked at the website and there is a warning that Lupex hasn't been fully tested yet and that the manufacturer is required to report all adverse reactions. Additionally, did you see the blurb where they indicate that the course of treatment can last as long as two years?

I'd be reluctant to go ahead without at least speaking to a doctor, preferably your consultant first. Just a thought - would it be worthwhile sharing the information with the Wales Cancer Trials Network I mentioned on your other thread? If nothing comes of it then no harm done, but there's a slim possibility that it could prompt a trial. If you needed additional CT scans to check on whether it was working I suspect that you would have to pay for these (and the subsequent interpretation) yourself. Again, though, your consultant would be able to clarify this.

Hope those thoughts are helpful.

Kind regards

Nicki