NEUMUNE

["Susan McElrath" <smhp@BELLSOUTH.NET>]

Hollis-Eden believes NEUMUNET (HE2100) may be able to provide protection

from the acute effects of radiation on the bone marrow. The Company is

developing NEUMUNE under a new U.S. Food and Drug Administration (FDA)

rule, where it would be unethical to expose humans to life-threatening

pathogens or events such as radiation in an effort to determine clinical

efficacy. Under this new rule, marketing approval as a drug to provide

protection from this exposure may be gained based on the demonstration

of safety in humans and efficacy in relevant animal species. 

In April 2003, the Company announced positive preliminary results from a

pilot study in non-human primates demonstrating that NEUMUNE provides

significant protection from the acute life-threatening effects of whole

body radiation exposure. Preliminary results from the study indicated

when NEUMUNE was given 2 to 4 hours after radiation exposure, a

significant reduction in the occurrence of severe neutropenia a severe

loss of neutrophils (or key infection-fighting white blood cells)  was

observed as compared to control animals not receiving the drug.

Four weeks after radiation, there was a 5-fold decrease in the

percentage of days the animals in the post-radiation treatment group

were at high risk for infection - the leading cause of mortality

following whole body radiation.

Hollis-Eden is co-developing NEUMUNE with the Armed Forces Radiobiology

Research Institute (AFRRI) - an agency within the U.S. Department of

Defense and a leader in studying the short-and long-term effects of

radiation injury. After screening thousands of compounds in an effort to

find a radioprotectant suitable for widespread use, AFRRI selected

NEUMUNE as its leading candidate for radio protection based in part on

its striking efficacy in earlier preclinical models conducted in mice.

These studies showed that up to 100% of animals treated with NEUMUNE

prior to being exposed to radiation survived versus up to 100% mortality

in the animal group receiving no drug. Investigators conducting the

studies attributed the survival advantage to NEUMUNE's ability to

increase a number of cell types associated with immune protection,

including neutrophils and platelets.



http://www.holliseden.com/prod_neumune.cfm



Susan McElrath

smhp@bellsouth.net

(770) 222-0829





************************************************************************

You are currently subscribed to the Radsafe mailing list. To unsubscribe,

send an e-mail to Majordomo@list.vanderbilt.edu  Put the text "unsubscribe

radsafe" (no quote marks) in the body of the e-mail, with no subject line.

You can view the Radsafe archives at http://www.vanderbilt.edu/radsafe/