Zadaxin

[Guest guest]

Hi steve,I sent a copy of the website on zadaxin to Dr.Goldstein,here

in Calif.the problem is if the drug is still in phase 2 and 3,it is

still unavailable to the public.Dr.Klimas,is one of the few Doctors

who can get funded by the government,to get funds to do a study,keep

us updated on what Dr.Klimas thinks,about zadaxinyou can also call

the company in Calif. for updates on its approval.

> I found your post very interesting, Bill. I sent a copy of in to

Klimas and

> her assistant Dr. Mohamed. Dr. K never returns her email but Dr. M

does.

> This seems to be just what they are researching. I can never

remember what

> th1 v th2 does but, hopefully, my dr will. I would be very

interested in

> hearing from others who try this drug. Thanks again for posting it

Bill.

>

> cheers

>

> Steve

>

>

>

[Guest guest]

Hi All,

News on Zadaxin...wish they would do a trial on CFS!!!

http://biz./bw/040301/15175_1.html

SciClone's ZADAXIN Demonstrates Significant Anti-Fungal Efficacy in Invasive

Aspergillosis Animal Study

Monday March 1, 6:30 am ET

SAN MATEO, Calif.--(BUSINESS WIRE)--March 1, 2004--SciClone Pharmaceuticals

(Nasdaq:SCLN - News) today announced the publication of results from a new

animal model study demonstrating, for the first time, that its lead drug

candidate ZADAXIN® is an effective anti-fungal treatment for invasive

aspergillosis. The study showed that ZADAXIN significantly contributed to the

activation of the appropriate Th1 helper cells to combat the Aspergillus fungus

through the use of toll-like receptors (TLRs), the first line of defense against

invading infections.

This study was conducted in Italy by a team led by Francesco Bistoni, M.D. and

Luigina Romani, M.D. of the University of Perugia and Enrico Garaci, M.D. of the

University of Tor Vergata in Rome. Dr. Garaci commented, " Thymosin alpha 1

(ZADAXIN) opens up a new frontier for the successful management of organ or

bone-marrow transplantation and the treatment of immunodeficiency diseases.

Since the Aspergillus fungus is the leading cause of infection in patients with

suppressed immune systems, largely a result of receiving organ or bone marrow

transplants or suffering from leukemia, there is now a real opportunity for an

effective immune enhancing treatment for these patients. "

An immune suppressed mouse model was used to examine the effects of treating

mice infected with the Aspergillus fungus with either ZADAXIN or the standard

treatment of amphotericin B. Seven separate groups received the following

treatments: untreated or placebo control; low, medium, and high dose ZADAXIN;

amphotericin B; amphotericin B plus low dose ZADAXIN.

Importantly, at the 60 day endpoint of the study, all of the mice that had

received medium or high dose ZADAXIN alone were fully cured of invasive

aspergillosis. Additionally, it was observed that low dose ZADAXIN, when used in

combination with amphotericin B, was statistically significant in improving the

efficacy of amphotericin B and increased the median survival rate from 11 days

to 18 days. Untreated or placebo treated animals had a median survival of only 4

days. The investigators also evaluated the subcellular pathways involved in

ZADAXIN's therapeutic effectiveness against Aspergillus.

Dr. Tuthill, Ph.D., SciClone's Vice President of Scientific Affairs,

explained, " This study demonstrates that the mechanism of action of ZADAXIN

includes in its pathway effects on toll-like receptors (TLRs) of the innate

immune system, which highlights ZADAXIN's ability to affect both the innate arm

of the immune system as well as its previously well documented effects on the

adaptive immune system. "

The results of this study were recently published in Blood Online

(www.bloodjournal.org) and showed increased survival and decreased lung

pathology after treatment with ZADAXIN in a mouse model of invasive

aspergillosis.

About Aspergillus fumigatus

The incidence of invasive aspergillosis has been steadily increasing over the

past two decades and now represents the most common life-threatening fungal

infection in the world. Mortality rates do vary, but can be as high as 95% in

patients who have received allogeneic bone-marrow transplants and those with

aplastic anemia. Left untreated, invasive aspergillosis most often proves to be

fatal; however, if treatment is started early one third to one half of patients

will survive. Aspergillus is a fungus that affects individuals with compromised

immune systems, most often from disease or organ transplants. Aspergillus causes

illness in three ways, the most serious being invasive aspergillosis that

infects the lungs and can later spread through the bloodstream to other organs

in the body.

About SciClone

SciClone Pharmaceuticals is a biopharmaceutical company engaged in the

development of therapeutics to treat life-threatening diseases. SciClone is

currently evaluating its lead product ZADAXIN in several late stage clinical

trials, including two phase 3 hepatitis C clinical trials in the U.S., a

completed phase 3 hepatitis B clinical trial in Japan, a phase 2 malignant

melanoma clinical trial in Europe, two phase 2 liver cancer pilot studies in the

U.S., and a hepatitis C triple therapy pilot clinical trial in Mexico. The

Company's other principal drug development candidate is SCV-07, a potentially

orally available therapeutic to treat viral and infectious diseases. For more

information about SciClone, visit www.sciclone.com.

This press release may contain forward-looking statements because the

experimental or clinical data described may imply certain actual results in

larger patient populations. Experimental data and clinical results derived from

studies with animals or a limited group of patients may not be predictive of the

results of larger studies and, therefore, such experimental or clinical data is

not necessarily predictive of efficacy or safety or the results of larger

studies and clinical trials.

---------------------------------

Contact:

SciClone Pharmaceuticals A. Waldron, 650-358-3437

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

ImmuneSupport.com

06-02-2003

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!

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