NEW YORK, March 24, 2003 – An immune-enhancing carbohydrate polymer significantly protected mice injected with a lethal dose of anthrax spores, according to a study published today by Medscape General Medicine, a peer-reviewed, on-line general medical journal at www.medgenmed.com.

This early-stage research demonstrates that WGP Beta Glucan^TM, a highly purified particulate form of yeast beta 1,3 glucan provides protection when administered orally after anthrax exposure, expanding upon earlier published results showing protection when administered orally prior to infection.  This new study also found that 90% of mice given a single injection of WGP Beta Glucan two days before anthrax exposure were cured, based upon examination of their bacteria-free lungs. The article, entitled “Anthrax-Protective Effects of Yeast Beta 1,3 Glucans,” is available at www.medscape.com/viewarticle/450700.

The experiment is part of more than a decade of ongoing research on immune modulators by Defence R&D Canada, an agency within the Canadian Department of National Defence. The study was conducted by Defence R&D Canada – Suffield in conjunction with Biopolymer Engineering, Inc. and Biophage Pharma Inc.

"These highly promising results are important first steps that could lead to a new orally effective immunomodulatory anthrax treatment.  Work is now in progress to determine if WGP Beta Glucan will work synergistically with traditional antibiotics and vaccines,” said Bill Kournikakis, Ph.D., a Defence Scientist in the Chemical and Biological Defence Section at Defence R&D Canada - Suffield. “More research is needed to determine whether these protective effects of WGP Beta Glucan extend to humans.”

WGP Beta Glucan is a particulate form of yeast beta 1,3 glucan whose unique structural properties stimulate macrophages and other cells of the immune system to produce a heightened immune state. Macrophages are among the body’s first-line immune defenders, engulfing and destroying foreign intruders. However, anthrax spores often evade this killing mechanism and the deadly anthrax toxins kill the macrophages, allowing further anthrax replication and toxin production that eventually causes death. It is believed that the prophylactic immune-enhancing effects of WGP Beta Glucan leads to the killing of anthrax spores before they germinate, clearing the infection from the body.

“It’s a race against time and WGP Beta Glucan helps give the immune system a critical advantage,” said Gary Ostroff, Ph.D., chief technology officer for Biopolymer Engineering, which owns the patents for WGP Beta Glucan. “It primes the macrophages and other innate immune cells so that their microbial killing capability is enhanced before they encounter an anthrax spore. This mechanism suggests that WGP Beta Glucan enables the macrophage to kill the spore before the anthrax infection kills the macrophage.”

Study Design
Beta 1,3-glucan immune modulators were administered by either subcutaneous injection to mice 2 days prior to challenge, or WGP Beta Glucan (Imucell WGP^TM) was administered orally for 7 days prior to challenge, or in drinking water for 10 days post-challenge with a lethal dose of Bacillus anthracis Vollum 1B.  Survival, survival time and microbial bioburden relative to an infected, untreated control group were assessed.

Results
A single dose of PGG-Glucan or WGP Beta Glucan immune modulators given two days before challenge significantly:

• Increased the survival rate of infected mice (2.5-fold);

• Diminished the bacterial load in the lungs of infected mice
  (9-37 fold); and

• Increased the proportion of bacteria-free animals amongst the surviving animals 10 days after challenge (2-fold).

In mice prophylactically administered oral WGP Beta Glucan for one week prior to infection, survival increased significantly from 50% to 100%. Therapeutic administration of oral WGP Beta Glucan for ten days post-infection increased survival significantly from 30% up to 90% in treatment groups.

Next Steps
Conduct further studies to optimize protection, evaluate activity in combination with other treatment options, demonstrate activity in a validated primate model of infection, and determine if protection is effective against other potential biowarfare agents.

About the Authors
Bill Kournikakis, Ph.D. is a scientist in the Chemical and Biological Defence Section at Defence R&D Canada - Suffield, Ralston, Alberta, Canada.

Gary Ostroff, Ph.D. is Chief Technology Officer at Biopolymer Engineering, Inc., Eagan, Minnesota.

Rosemonde Mandeville, M.B. ChB. Ph.D. is President and Chief Scientific Officer of Biophage Pharma Inc., Montreal, Quebec, Canada.

Pauline Brousseau, Ph.D. is Director of CRO and Special Programs at Biophage Pharma Inc.

The study was commissioned by Defence R&D Canada – Suffield and conducted by Biophage Pharma Inc. using WGP Beta Glucan supplied and owned by Biopolymer Engineering, Inc. Dr. Kournikakis and Defence R&D Canada have no affiliation with either company. Biophage Pharma and Biopolymer Engineering have a research and commercialization agreement for pharmaceutical applications that protect against biowarfare agents.

Contact Information:

David Walsh
Biopolymer Engineering, Inc.
651-256-4606
dwalsh@biopolymer.com

Jennifer Faust
Defence R&D Canada
403-544-4622
jennifer.faust@drdc-rddc.gc.ca

Rosemonde Mandeville, M.B. ChB. Ph.D.
Biophage Pharma, Inc.
514-496-1488
email@biophage.com