From: Billi Goldberg <bigoldberg@igc.apc.org>
Subject: Immunomodulator: Acemannan
Note: Copyright 1992, Dan R. Greening. Non-commercial reproduction allowed.
Archive-Number: 5962
Organization: unspecified
Date: Fri, 21 Aug 92 23:10:10 PDT

The article, copyrighted 1992 Charles R. Caulfield, was printed in the 
Thursday, July 23 1992, edition of the San Francisco Sentinel. It is 
posted with the permission of the author. 
************************************************************************ 

                               ACEMANNAN
                                  by
                         Charles R. Caulfield

  Dallas based Carrington Laboratories recently cleared several hurdles 
in their 7 year long attempt to obtain regulatory approval for their 
anti-HIV drug, Acemannan, also known as Carrisyn.

  The USDA has granted Carrington a conditional license to market the 
drug for the treatment Fibrosarcoma, a soft-tissue cancer in mammals, 
not unlike Kaposi's Sarcoma in humans, for which there has been no 
available treatment.

  The substance marketed for this indication under the name Acemannan 
Immunostimulant, is currently being distributed through Carrington 
Veterinary Medical Division in injectable form for the treatment of dogs 
and cats with this condition. The product license is conditional while 
efficacy studies are in progress. the company plans to begin clinical 
trials using Acemannan in the treatment of human cancers during the next 
twelve months.

  Carrington has also obtained a license to market the drug as a vaccine 
adjuvant for the prevention of Marek's disease, a viral disease in 
chickens which renders them unfit for human consumption. Acemannan is 
now being marketed by Solvay Corporation under the name ACM-1, to be 
used in combination with Solvay's MD-VAC vaccine. Solvay has indicated 
that the addition of Acemannan to their poultry vaccine provides earlier 
and more effective protection against the disease than the vaccine 
alone.

  Carrington scientists recently presented the results of a study 
testing Acemannan against Feline Immunodeficiency Virus (FIV) which 
causes a disease like AIDS in cats. This material was presented at the 
International Symposium on FIV at the University of California Davis. 
The date presented showed that Acemannan produced significant increases 
in t-cells of the affected cats, as well as a decrease in the incidence 
of systemic bacterial infections. The clinical status of the FIV-
infected cats improved with their prognosis for survival appearing to be 
substantially higher than those in the control group.

  Acemannan is a complex carbohydrate extracted from the aloe vera 
plant. It has been shown to have a broad spectrum of action against 
viruses which infect warm blooded animals. In addition to this, the drug 
has been shown to stimulate host-immunity. Due to this property, the 
drug belongs to a new class of substances known as biological response 
modifiers. Acemannan is unlike other complex carbohydrates in that 
rather than being digested and burned for energy, the molecule is 
absorbed intact into the blood stream, and accumulates in macrophages.

  The macrophage is a multi-purpose white blood cell vital to the 
function of the immune system. Upon absorption of Acemannan, the 
macrophage has been shown to respond by increasing its production of 
vital immunologic protein substances, call cytokines. Among these 
substances are interleukin-1 (T cell stimulator factor), tumor necrosis 
factor and gamma interferon. These substances elicit the immune cascade 
of host defenses including an escalation of the production of natural 
killer cells vital to the body's ability to fight off so-called 
opportunistic infections.

  This drug has a long and convoluted history of research into it 
application against HIV. this process has been confounded by regulatory 
agency red tape as well as Carrington's lack of experience in the drug 
approval process. The Texas-based company, a small biotechnology firm, 
has been no match for the pharmaceutical industry giants competing in 
the market place for approval of HIV treatments. this is unfortunate 
since pre-clinical animal studies as well as FDA-supervised Phase I dose 
tolerance studies in humans have demonstrated that the drug has 
virtually no overt toxicity.

  Between 1985 and 1988, the company conducted three uncontrolled FDA-
sanctioned clinical pilot studies in human volunteers with AIDS and ARC. 
results of theses studies, which are a matter of public record, have 
been extremely encouraging. Initial investigation of Acemannan in AIDS 
treatment was conducted by H. Reg McDaniel, Director of Clinical 
Laboratories at Dallas/Ft. Worth Medical Center in conjunction with the 
private practices of five Dallas physicians. Using Acemannan as the 
primary treatment for ARC and AIDS patients they observed significant 
results. Using a modified v version of the Walter Reed Scale, designed 
by the CDC to define symptomatology, as well as by using T-cell subsets 
and the patients' subjective reports, there was an overall 69% reduction 
in symptoms during the initial ninety days of therapy. T-cell counts 
increased significantly for the group and circulating viral core protein 
(P-24 antigen) levels were reduced or eliminated in the majority of 
subjects. This was accompanied by an average of two full Walter Reed 
Scale levels of improvement for the groups.

  Despite these encouraging results, Carrington has had little success 
in gaining attention for this drug in the U.S. this has not been the 
case, however, internationally. Other countries having socialized 
medicine, where profit is not the determining factor in which drugs 
reached the market place, Acemannan has received wider attention. In 
particular, the government of Canada has undertaken formal 
investigations of the drug for several indications. In 1990 the Canadian 
HIV Trials Network, a branch of Health and Welfare of Canada, underwrote 
a Phase II placebo-controlled efficacy study of Acemannan in human 
volunteers with symptomatic HIV infection. Earlier research by Alabama-
based Southern Research Institute, a contract drug screening lab used by 
the National Cancer Institute, had found that in addition to stimulating 
the immune system, Acemannan acted synergistically with AZT to the 
extent that the dose of AZT required to inhibit HIV replication can be 
reduced by 90 percent. Based on theses findings, the Canadian government 
is currently testing Acemannan in combination with AZT in HIV infected 
humans with low T-cell counts. It is theorized that this combination 
therapy will help maintain lymphocyte counts, and reduce the toxicity 
associated with higher doses of anti-retroviral drugs. In March of 1992, 
the Health Protection Branch of the Canadian government performed an 
interim analysis of the data conducted to date. Encouraged by the 
results, they recommended that the trial continue as outlined in the 
original study protocol. Similar studies are in the developmental stage 
in Los Angeles by the Search Alliance Group as well as in Houston, 
Texas.

  In light of this information, one might ask oneself why so little has 
been heard about this drug. It is likely that this is affected by the 
relatively small size of Carrington Labs compared to its competitors. 
There has certainly been no lack of published material in the medical 
literature. Acemannan's properties and mode of action have been 
documented in such journals in the "International Journal of 
Immunopharmacology," "The Journal of Molecular Biotherapy," and 
"Glycobiology." But the AIDS activist press has for some reason been 
less attentive despite the fact that this material has been repeatedly 
brought to the attention of both Project Inform and the publisher of 
"AIDS Treatment News" by this author as well as other sources since 
1987. Awareness of Acemannan in the HIV treatment community has been 
minimal.

  Carrington has been able to make Acemannan available to the public in 
its raw form through a stabilization process which preserves it from 
breakdown in an aloe beverage marketed under a private label by DeVeras, 
Inc. There is a known therapeutic equivalent between 1000 mg. of 
Acemmanan and twenty ounces of the DeVeras beverage. This dose is 
proposed as the daily therapeutic minimum to induce the desired changes 
in human physiology. For information on obtaining this product, one 
should contact DeVeras Inc., 3404 Greenville Ave., Suite 104, Dallas, 
Texas, 75206; (214) 823-4659. Since Carrington is pursuing FDA approval 
for this substance, no medical claims are being made about the beverage. 
Thus, DeVeras is able to provide only scant information. More extensive 
material may be obtained by contacting Carrington Laboratories directly 
at (214) 518-1300, or by writing them at 2001 Walnut Hill Lane, Irving, 
Texas, 75038. Information of future studies can be obtained by 
contacting Search Alliance, 7461 Beverly Blvd., Suite 304, Los Angeles, 
CA 90036; (213) 930-8820, or by corresponding with this author in care 
of the Sentinel.

  Acemannan is only one member of a new class of drugs emerging on the 
medical horizon called glycobiologics. These drugs, extracts from plant 
gums and showing a variety of systemic responses appear to have little 
or no toxicity. It is becoming apparent that we are entering an age in 
which expensive toxic therapeutic agents are being made obsolete by more 
natural and affordable substances. Carrington appears to have produced 
the most effective of these to date. It is unfortunate that the U.S. 
healthcare system and the pharmaceutical industry is so slow to explore 
this promising new area of study.
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