Biotechs and Chronic Fatigue Syndrome:Is Zadaxin a New Effective Treatment?

[Guest guest]

Check this one out. I am so excited about the possibilities of this experimental

drug. If any are interested you can read more about it at

http://www.sciclone.com

Here is my article posted at ImmuneSupport

a Carnes

http://www.immunesupport.com/library/showarticle.cfm/id/4633

Biotechs and Chronic Fatigue Syndrome:

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Is Zadaxin a New Effective Treatment?

ImmuneSupport.com

05-28-2003

By a M. Carnes

I have a confounding disease called chronic fatigue syndrome

(CFS). Eight years ago I began a Don Quixote-like quest for

effective treatment.

In the first year I found myself tilting at windmills, put on an

antidepressant, told to take zinc, strapped to a tilt table, stuck

with needles, told to quit eating tomatoes. Then a PCR blood

test indicated a mycoplasma infection. I started seven years of

antibiotics and improved a great deal, but was not cured.

That positive test for infection revealed that not all my battles

were " jousting at windmills. " Some were an actual enemy. But

progress was slow. I began to suspect that many cases of CFS

had infectious causes. Was the infection still there? Were there

several infections? Was the underlying cause an immune system

gone haywire?

I jousted with the government for awhile, making my

impassioned speeches at the CDC and NIH. Although I held my

lance proudly, the windmill just kept turning. If government funded

research was not the place to win the battle, where would I fight?

Where could patients turn for help?

Biotechs are the wave of the future for medical research. Smart

scientists, rather than working for a university, set out to build a

company that will solve a medical problem and, along the way,

make the scientist a millionaire. It's the American way. One

stock-trader wrote on a biotech message board, " I love the idea I

might be a part of something good and that I get paid for it, for

wishing the best. "

I began to search for companies with immune modulator

products in research, working on the assumption that CFS is an

immune system disorder, never mind the cause.

Klimas, M.D., has done research on CFS and the

immune system which indicates a shift from Th1 immunity to Th2

in CFS patients. Klimas wrote the following:

" Based on the postulates of viral and autoimmune etiologies of

CFS, several interventions have been designed and tested by

different research groups around the world, including the United

States, Sweden, United Kingdom, Italy, and Japan. This review

addresses those interventions aimed at altering the balance of

certain cytokines, the mediators of immune responses. Patients

with CFS who show evidence of activation of the immune system

have poor immune cell function and a predominance of what is

called a T -helper (Th)2-type cytokine response when their

lymphocytes are activated. A Th2-type response, which is

characterized by production of cytokines such as interleukin

(IL)-4, -5, and -10, favors the function of B lymphocytes, the

cellular factories of immunoglobulins.

A predominance of a Th2-type response is therefore consistent

with pathologies, such as autoimmunity and atopy, which are

based on inappropriate production of immunoglobulins. Many of

the CFS therapies discussed decrease the Th2-type

predominance seen at baseline in CFS patients, thereby

allowing a greater predominance of a Th1-type response, which

favors the function of macrophages and natural killer cells.

The function of the latter cells, which have the natural ability of

directly destroying invading microbes and cancer cells, is

defective in untreated CFS patients. Typical Th1-type cytokines

include IL-2 and interferon-gamma, and some of the therapies

induce their production. "

http://www.immunesupport.com/library/showarticle.cfm/ID/4181/

Among the hundreds of small biotech firms I have investigated

thus far, I found only a handful studying immune system

modulators. It is not the " in " thing as most scientists are

impressed with drugs carefully designed to target specific

infections, cancers or genetic defects. This is not possible with

CFS as the specific causes are unknown. In my search I

discovered one company with a product already available in

several countries and relatively close to approval in the United

States.

SciClone Pharmaceuticals in San Mateo, California is

researching an immune modulator, thymalfasin or thymosin

alpha 1, commercially known as Zadaxin.

" ZADAXIN is a subcutaneously administered, synthetic

preparation of a natural peptide, thymosin alpha 1, which among

other positive actions enhances the body's Th1 immune

response to viral infections (current clinical studies target

hepatitis C and hepatitis and to certain cancers (current

clinical studies target malignant melanoma and hepatocellular

carcinoma). ZADAXIN promotes stem cell differentiation into

helper T-cells and differentiation of those cells into the Th1

subset by increasing the production of cytokines such as IL-2

and gamma interferon and decreasing production of IL-4. In

addition, studies suggest that ZADAXIN also increases the

number and function of cytotoxic T-cells and natural killer cells.

http://www.sciclone.com

What really caught my attention as I was reading about Zadaxin

was the connection between what Klimas was saying

about CFS patients' immune system and the use of Zadaxin in

just this sort of immune system dysfunction. SciClone's website

states:

" Disease-causing agents which circulate in the blood are usually

quickly recognized as " foreign " by the body's humoral, or

antibody-based, immune component. By contrast, diseases

such as hepatitis C, hepatitis B, certain cancers and HIV, require

a predominantly cellular immune response. These chronic

diseases remain the most resistant to therapeutic intervention

and are at the frontier of current medical investigation.

The cellular immune response encompasses T-lymphocytes

differentiated into T-helper cells of two types, referred to as

" Th1 " and " Th2 " subsets. Studies have shown that Th1 cells are

fundamental to the eradication of hepatitis C. Conversely, when

T-cells are predominantly of the Th2 type, the hepatitis C virus is

able to evade the body's immune response and the disease

becomes chronic. Thus, compounds which drive the immune

response toward a Th1 profile could be highly effective in fighting

chronic viral infection. "

http://www.sciclone.com/products/zadaxin/howZadaxin_works.html

When I heard that SciClone scientist, Tuthill, Ph.D., Vice

President of Scientific Affairs, would be presenting research at

the TIDES 2003 conference on oligonucleotides and peptides I

made a point to attend her lecture.

As the name " thymalfasin " suggests this drug is the peptide

originally isolated from the thymus gland and tested on animals

after the thymus gland was removed to reconstitute the immune

system. A healthy functioning thymus is essential to a healthy

immune system. Alternative medicine and anti-aging physicians

have been prescribing thymus extract for some time. But this

peptide is not readily absorbed through the gut, and there are

some safely risks to the use of animal glandulars. Zadaxin, or

thymalfasin, is a synthetic peptide which exactly matches the

human thymosin alpha 1 peptide. It is taken by injection and has

none of the risks of an animal product.

Zadaxin's safety profile is outstanding. The SciClone website

states, " ZADAXIN has been administered to more than 10,000

patients in both clinical and commercial use, alone and in

combination with anti-viral and anti-cancer drugs, without

producing any ZADAXIN related significant side effects or

toxicities. "

This product is also under study for vaccine enhancement and in

treatment of cancer, namely melanoma. Indeed, one major

problem in research is that Zadaxin would be useful in so many

diseases it was difficult to figure out where to start. The company

made some wise choices. One was to get market approval for

Zadaxin in 28 foreign countries. At the same time focus in the

United States was on hepatitis C, the predominant form of

hepatitis in the U.S. SciClone tells us, " The trials are accruing

1,000 patients in over 40 sites throughout the U.S. and are

multicenter, randomized, and double-blinded. "

A fascinating outgrowth of this decision to market first in foreign

countries has been that Zadaxin is already marketed in China

and Hong Kong. During the SARS epidemic SciClone has

made $15,000,000 in sales, enough to fund research through

2006. This is a huge accomplishment for a biotech firm, most

small biotechs are millions of dollars in debt at any given time.

Does Zadaxin cure SARS? There is no research to tell, but

these sales will be used to push forward the research needed to

give us the answers.

What does all this have to do with the CFS patient? Zadaxin is

indicated in infections that shift the immune system to Th 2 when

a Th 1 response is needed. Patients with CFS, fibromyalgia,

and Gulf War Illness seem to have an immune system shifted

toward Th 2 immunity. I spoke to Dr. Tuthill about this following

her lecture. Her comment was that Zadaxin should be useful in

any disease where the immune system needs to be shifted

toward Th 1 immunity.

Klimas lists several possible reasons the immune system is out

of kilter. Some of these reasons include infections such as

viruses and certain bacteria which are intracellular such as

Chlamydia, rickettsia , mycoplasma, and post Q fever syndrome.

A combination protocol similar to the one being used in phase 3

trials for hepatitis C would include either antivirals or antibiotics

in combination with two injections of Zadaxin per week for six

months to a year. This is not currently being tested, therefore a

patient would need to assume responsibility for this treatment

including the cost of purchasing Zadaxin in another country.

I currently own stock in this company. This is because I am

convinced this company's product will prove to be useful to many

needy patients. I have put my money where my mouth is. May

you succeed in health and wealth!