Wasting Disease

[angelofcharlie20]

Hi All,

Anyone know of a way to combat this?

Any input would be greatly appreciated,

Shirley

[RandyW]

This is something I had sent to someone else and had found an article discussing Fish Oil but that did not pan out so here is the back up and best info I can find for you;

Ark Therapeutics Grp - Research Update

RNS Number:9512W

Ark Therapeutics Group PLC

16 January 2006

Ark Therapeutics Group plc

Full Analysis of Vitor Study Confirms Therapeutic Effect in Cancer Cachexia

Vitor significantly slows progression of cachexia in two cancer types and

statistical significance achieved in two secondary endpoints across all cancers

Confirmatory Phase III trial to be planned with the Regulators

16 January 2006, London UK: Ark Therapeutics Group plc today announces the full

analysis from the first safety and efficacy study of Vitor in cancer

cachexia. The results are consistent with the preliminary results previously

announced on 28 October 2005 and provide additional statistical confirmation.

The study examined whether Vitor changes the pattern of cancer cachexia

(unintentional weight loss) in three types of cancer: colorectal, non-small cell

lung (NSCL) and pancreatic cancer. 200 patients with cancer cachexia were

included in the study.

Full results from patients completing the study showed the reduction in the rate

of cachexia in patients with NSCL and colorectal cancer following treatment with

Vitor was statistically significant (p<0>0.05). The statistical results in the primary

endpoints were principally confounded by pancreatic cancer patients showing a

different response from the other two cancer types and a large proportion (42%)

of study non-completers causing high variability in the data. For the co-

primary endpoint of hand grip strength across all cancers, Vitor treatment

attenuated the reduction in mean hand grip strength by 42% compared with placebo

but the results did not reach statistical difference. Statistical significance

was reached in two secondary endpoints, extent of fatigue since last visit (p<

0.039) and level of fatigue at the reporting time (p<0.0072).

Patients had lost an average of 15% body weight (av. 24 lbs) in the six months

prior to entering the study. The rate of weight loss on entering the study

slowed markedly in both treated and untreated groups. It is possible that

because patients had lost so much weight prior to entry, they could lose little

more; however, a 'study entry' effect may have existed. Nevertheless, the trial

population lost an average of 2.3lbs during the 12 week period with treated

patients losing an average of 1.91lbs and controls 2.68lbs. After four weeks in

the study, the beneficial effect of Vitor on rate of weight change became

evident in all cancer types. Pancreatic cancer patients on Vitor on average

lost 0.020lbs/day from week 4 to week 12 with controls losing 0.061lbs/day and

NSCL and colon cancer patients showed average net weight gains of +0.0025lbs/day

on Vitor whilst controls lost 0.022lbs/day. The patients who had lost the

most weight on study entry appeared to show the greatest response to Vitor.

The safety profile showed Vitor to be well tolerated and the study did not

reveal any unexpected events.

Professor John Martin, Chief Scientific Officer at Ark, commented: 'These

results are both scientifically and clinically encouraging. Although there is

variation in the data across the cancer and patient types, there is a consistent

difference in favour of the Vitor treatment group on virtually all clinical

endpoints measured. We have therefore seen a definite therapeutic effect from

Vitor and we now have to work with the understanding gained to refine how we

assess this disease and take the product forward so that cachexia patients can

benefit from the clinical effects Vitor produces. The potential for

efficacy combined with an established safety profile makes Vitor a very

promising agent.'

Dr David Eckland, R&D Director at Ark, added: 'Ark will now be working to apply

the information gained from this study into the design of a confirmatory Phase

III trial of Vitor in cancer cachexia and we expect to be discussing this with

the regulators in the near future.'

For further information please contact:

Ark Therapeutics +44 (0)20 7388 7722

Dr Nigel Parker, Chief Executive Officer

Martyn Williams, Chief Financial Officer

Financial Dynamics +44 (0)20 7831 3113

David Yates / Davina Langdale

Notes to Editors

Vitor and cachexia in cancer

Vitor is an oral small molecule therapy for the treatment of muscle wasting

(cachexia), a secondary, often fatal, condition commonly seen in patients with

cancer. The active ingredient was originally developed as a treatment for high

blood pressure and is currently marketed in Japan and certain countries in

Europe. Vitor has been shown to up-rate the ability of mitchondria to

produce energy. In addition by working on the ubiquitin proteasome pathway, it

prevents the breakdown of muscle proteins (actin and myosin) and reverses the

impaired muscle protein production, which both occur as a result of the action

of chemicals secreted by the cancer tumour and lead to the weight loss.

Ark Therapeutics Group plc

Ark is an emerging healthcare group (the 'Group') now entering the

commercialisation phase, with one product introduced into hospitals and three

further lead products in late stage clinical development. Capitalising on over

ten years of research in vascular biology and gene-based medicine, Ark has a

balanced portfolio of proprietary healthcare products targeted at specific unmet

clinical needs within vascular disease and cancer. These are large and growing

markets, where opportunities exist for effective new products to generate

significant revenues.

Ark's products are sourced from related but largely non-dependent technologies

within the Group and have been selected to enable Ark to take each product

through development and to benefit from Orphan Drug Status and/or Fast Track

Designation, as appropriate. The Group generally retains ownership of its

product candidates throughout clinical development. Ark has secured patents or

has patent applications pending for all its lead products in principal

pharmaceutical markets and retains the right to market its lead products in the

key North American and European markets.

Ark has its origins in businesses established in the mid-1990s by Professor John

Martin and Mr Stephen Barker of University College London and Professor Seppo

Yla-Herttuala of the AI Virtanen Institute at the University of Kuopio,

Finland, all of whom play leading roles in the Company's research and

development programmes.

Ark's shares were successfully listed through an initial public offering on the

London Stock Exchange in March 2004 (AKT.L).

This announcement includes 'forward-looking statements' which include all

statements other than statements of historical facts, including, without

limitation, those regarding the Group's financial position, business strategy,

plans and objectives of management for future operations (including development

plans and objectives relating to the Group's products and services), and any

statements preceded by, followed by or that include forward-looking terminology

such as the words 'targets', 'believes', 'estimates', 'expects', 'aims',

'intends', 'will', 'can', 'may', 'anticipates', 'would', 'should', 'could' or

similar expressions or the negative thereof. Such forward-looking statements

involve known and unknown risks, uncertainties and other important factors

beyond the Group's control that could cause the actual results, performance or

achievements of the Group to be materially different from future results,

performance or achievements expressed or implied by such forward-looking

statements. Such forward-looking statements are based on numerous assumptions

regarding the Group's present and future business strategies and the environment

in which the Group will operate in the future. Among the important factors that

could cause the Group's actual results, performance or achievements to differ

materially from those in forward-looking statements include those relating to

Ark's funding requirements, regulatory approvals, clinical trials, reliance on

third parties, intellectual property, key personnel and other factors. These

forward-looking statements speak only as at the date of this announcement. The

Group expressly disclaims any obligation or undertaking to disseminate any

updates or revisions to any forward-looking statements contained in this

announcement to reflect any change in the Group's expectations with regard

thereto or any change in events, conditions or circumstances on which any such

statements are based. As a result of these factors, readers are cautioned not to

rely on any forward-looking statement.

This information is provided by RNS

The company news service from the London Stock Exchange

END

RESLELLFQFBBBBL_SN_RNS9512W_SU_RNSTEST_XX_070118.4048_RZ__RT_R.xRoute.001

~

Data provided by Hemscott Group Limited.Disclaimer

[ma's kid]

Randy W,

You are so helpful and I just wanted to say thank you for always being here for all of us.

You bring a sense of *comfort* to this board

Libby

[Linda661]

Randy, it was me you sent the info. to and we really can't say that the Fish Oil didn't pan out. Research had shown that EPA (Eicosapentaenoic Acid), a component found readily in oily fish, was effective in combatting/interrupting the effects of Wasting Syndrome. The only problem was that the research article made no recommendation on amount of EPA necessary to administer. Also consider that my mom got pretty wasted darn fast by the time I asked the question --- The best I could do with that was buy fish oil pills locally that had the most EPA in them I could find: that was 300mg per daily recommended intake of the capsules -- with no other information, we are following label directions and that probably isn't enough to be as effective as it could be, but I have no guidelines on how much to really administer....and the medical community doesn't know what to do with it either (if it ain't a drug, they're stumped...lol) and my chiropractor didn't know what else to do there either.

So far, mom's physical deterioration from wasting isn't getting any worse that I can tell and might be slightly improving -- she's a little more mobile now (not bedridden now with zero energy) even though she is a significant fall risk. Her last labs weren't showing any improvement in protein utilization that I would expect to see, but she'd only been on fish oil for a short time when they were drawn -- natural substances generally take a bit longer to show signs of working in things like labs. Mom never did lose significant amounts of weight (about 15-20 pounds over the last year): she's within her normal weight range, but looks wasted and starved nonetheless from the loss of muscle all over her body.

Bottom line: Fish oil is worth a try in my opinion if Vitor isn't a viable short-term option. There is no down-side risk to it either.

Linda

[RandyW]

Thank you for that info I searched hi and low for that info in posts or letters Saw another post and thought you had said it was not working and thank you for clarifying my tired eyes that night.

[EastCoastLadi]

Shirley,

I don't know if you have heard about "ATP" - Adenosine 5-triphosphate... my husbands' radiologist recommended it to him today, it is a supplement, ( some athletes use ), it is suppose to increase energy levels, and help with weight gain... I'm still trying to find out about it myself for my husband, you can buy it over the counter, but it is not that easy to find, he told my husband only 1 drug store in our city has it...

If I find out more I will let you know

Grace

[angelofcharlie20]

Thank you so much Randy for that information. I bought my father some fish oil capsules a few weeks ago. I don't know how many mg it is though.

Grace - Please let me know if you find out more about that.

Praying and Hoping,

Shirley

[Linda661]

Thanks for the info. on ATP. Appears to have real merit -- check this out:

http://www.ncbi.nlm.nih.gov/entrez/quer ... t=Abstract

Randomized clinical trial of adenosine 5'-triphosphate in patients with advanced non-small-cell lung cancer.

Agteresch HJ, Dagnelie PC, van der Gaast A, Stijnen T, Wilson JH.

Department of Internal Medicine, Erasmus University Medical Center Rotterdam, The Netherlands.

BACKGROUND: Extracellular adenosine 5'-triphosphate (ATP) is involved in the regulation of a variety of biologic processes, including neurotransmission, muscle contraction, and liver glucose metabolism, via purinergic receptors. In nonrandomized studies involving patients with different tumor types including non-small-cell lung cancer (NSCLC), ATP infusion appeared to inhibit loss of weight and deterioration of quality of life (QOL) and performance status. We conducted a randomized clinical trial to evaluate the effects of ATP in patients with advanced NSCLC (stage IIIB or IV). METHODS: Fifty-eight patients were randomly assigned to receive either 10 intravenous 30-hour ATP infusions, with the infusions given at 2- to 4-week intervals, or no ATP. Outcome parameters were assessed every 4 weeks until 28 weeks. Between-group differences were tested for statistical significance by use of repeated-measures analysis, and reported P values are two-sided. RESULTS: Twenty-eight patients were allocated to receive ATP treatment and 30 received no ATP. Mean weight changes per 4-week period were -1.0 kg (95% confidence interval [CI] = -1.5 to -0.5) in the control group and 0.2 kg (95% CI = -0.2 to +0.6) in the ATP group (P =.002). Serum albumin concentration declined by -1.2 g/L (95% CI= -2.0 to -0.4) per 4 weeks in the control group but remained stable (0.0 g/L; 95% CI = -0.3 to +0.3) in the ATP group (P =.006). Elbow flexor muscle strength declined by -5.5% (95% CI = -9.6% to -1. 4%) per 4 weeks in the control group but remained stable (0.0%; 95% CI= -1.4% to +1.4%) in the ATP group (P =.01). A similar pattern was observed for knee extensor muscles (P =.02). The effects of ATP on body weight, muscle strength, and albumin concentration were especially marked in cachectic patients (P =.0002, P =.0001, and P =. 0001, respectively, for ATP versus no ATP). QOL score changes per 4-week period in the ATP group showed overall less deterioration than in the control group-physical scores (-0.2% versus -2.4%; P =. 0002); functional scores (+0.4% versus -5.5%; P =.02); psychologic scores (-0.7% versus -2.4%; P =.11); overall QOL score (+0.1% versus -3.5%; P =.0001). CONCLUSIONS: This randomized trial demonstrates that ATP has beneficial effects on weight, muscle strength, and QOL in patients with advanced NSCLC.

This particular link will take you to related articles on the topic as well -- fascinating stuff. Couldn't easily find where to purhase it either (but I didn't spend much time at that search) -- the studies reported using IV infusion of it and the cancer community seems to know about it (it shows up in cancer site searches) -- wonder if any oncs. are using it as a supplement in chemo?????

Linda

[teresag]

My "cancer scam" sensors went on alert when I read this thread. Please keep in mind that the study was done with intravenous ATP, not the oral OTC supplement. Drugs that are effective by one route may be utterly useless when administered by another route. Many drugs cannot be orally administered without losing their effectiveness (insulin is one example). Ask yourself, "Why would the study use the IV form, which requires a needle stick and sterile equipment, when the oral form is available OTC?" The usual reason for this is that the oral form does not work. Please be cautious about supplements; there are so many that are useless and even harmful.

[Welthy]

I echo teresag's comments. Check with the Doctor before taking ANY supplements.

Welthy

[EastCoastLadi]

I know it is the best thing to approach anything new w/ some skepticism, but my husbands' radiologist has had some patients who have felt better after taking ATP, so like w/ many other otc, med, treatments it is an individual thing. With my husbands' current condition he said it wouldn't hurt him, but of course he couldn't say if it would help him at all. The only thing he could do is to try... so we're still looking into this..

Grace

[Linda661]

You're absolutely correct Teresa about caution when investigating and considering the use of these sorts of things (and always clear it with your doctor) -- I guess I thought I had made the point of the study using IV method rather than OTC...just not clearly enough; just saying that the compound appears to have merit for further investigation (didn't mean folks should run out and get it). There is another study out there that found some limited merit to OTC, but not enough to hang their hat on, and they conclude that more testing needs to be done. There may be others........

On another caution note: highlighting a research article or two on anything needs to be taken with caution as well. While we all want to help, topic interests based on research presented should be reviewed and followed up individually -- I'd never presume that there isn't more to be found to round out my understanding of something new to me and possibly of interest to my journey with this. Add things like not all studies published out there are valid or something else may be out there to counter the conclusions of a highlighted study in post that might affect my decision on what to pursue....very important never to assume that any of us have posted "the bottom line" on research -- we try to help with information leads, but it can take alot of time to follow-through thoroughly on research information, depending on the subject.

I had found a study on a cancer site on my own followup that countered Randy's lead on EPA, for example -- it concluded that fish oil pills were a waste of time and didn't work. However, in my review, I found that the researchers had megadosed study participants (oral) for two weeks -- that's it and it created problems for study participants. That study has questionable merit in my mind from my own personal experience so I decided to take my findings to our doctor, who said it was worth a try in our case, but we couldn't conclude anything on dosage end.....I took a lead posted here and further investigated on my own before doing anything. Which information is correct, if any? Will it actually help my mom? We don't really know: all we have is a possibility on this topic of wasting.

Linda

[teresag]

Anther twist on this is that there are accepted drugs that work for increasing appetite, which is not the sole answer to wasting disease, but maintaining nutritional intake is important. These drugs' brand names are Megace and Marinol. In some states, medical marijuana (ingested or smoked) is legal and is useful for this purpose for some people.

Wasting (cachexia) is a difficult problem, to be sure. Although it seems counter-intuitive, moderate frequent exercise (e.g., a little a day) helps, too.

Best of luck to you in solving this challenging problem, Shirley.

[Bill]

I heard my father and the plumonologist talking about this. my mothers body became a human furnace with the cancer consuming huge amount of energy. robbing the healthy part of her body of nutrition. up til about the last week of her life she had a good appetite. ate alot and recieved supppements and still lost about 25 pounds in a few weeks. every body was pushing food hi carb drinks and appetite boosters like megace and none of it could stop the weight decline and weakness

rob

[Linda661]

I found your original link you sent me on this topic, Randy. It's http://www.supportiveoncology.net/journ ... 103159.pdf.

I investigated many, many, many others along the way, including ones published as late as early this year -- never found any that were any better at understanding cachexia and why it is so difficult to manage. Though it's technical, it also did the best job of explaining things that the layperson has some chance of grasping.

Edit: I see that there may be some trouble getting the link to work now. If it doesn't work, simply go to www.supportiveoncology.net. On their homepage, you'll want their 2003 journal articles. The title of the article is "Pathogenesis of Cancer Cachexia," by Michael J. Tisdale, DSc, PhD, Volume 1, Number 3, in the September/October 2003 issue of their journal.

You rock RandyW, in case you don't know that yet!

Linda

P.S. When you look at study content, you want to look for statistical significance of p<.01 as being the cadillac-era of a marker of something that's working; p<.05 is good, but it should be better if you're going to solidly rely on it long-term (note Randy's Vitor study -- they've got enough going there for Phase III investigation at p<.05 -- Vitor is promising so far); p<.1 or worse isn't good study result.....then there's the issue of the study design, sample size (less than 50 studied [if it's even a random sample of study participants] leaves more room for result errors), and methodology that the statistical results are based on......easy to get garbage in, garbage out. Just a friendly warning on what everyone is looking at in studies -- I'm not a medical professional, but I am really well schooled in probability and statistics, including study design (Masters level with teaching assistant experience on these issues). There is a bit of an art to knowing what you are looking at here.