Fw: Collaboration Formed to Develop Drug for Protection Against Radiation Damage

["John Jacobus" <jenday1@EMAIL.MSN.COM>]

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John Jacobus, MS

Certified Health Physicist

3050 Traymore Lane

Bowie, MD 20715-2024

jenday1@email.msn.com (H)



----- Original Message -----

From: <CBS970@AOL.COM>

To: <RADIOBIOLOGY@JISCMAIL.AC.UK>

Sent: Thursday, February 14, 2002 4:03 PM

Subject: Collaboration Formed to Develop Drug for Protection Against

Radiation Damage





Department of Defense Medical School and Hollis-Eden Form Collaboration to

Develop Drug for Protection Against Radiation Damage



SAN DIEGO--(BW HealthWire)--Feb. 14, 2002--Hollis-Eden Pharmaceuticals, Inc.

(NASDAQ:HEPH - news), a pharmaceutical company located in San Diego,

California, today announced the signing of a Cooperative Research and

Development Agreement (CRADA) with the Uniformed Services University of the

Health Sciences (USUHS) and The Henry M. Jackson Foundation for the

Advancement of Military Medicine, Inc. (HMJF). USUHS is a fully accredited

federal school of medicine administered by the U.S. Department of Defense

and is located in Bethesda, Maryland. HMJF, located in Rockville, Maryland,

is a private, not-for-profit organization chartered by Congress to support

medical education and research at USUHS and throughout the military medical

community. The CRADA provides for joint development of Hollis-Eden's

investigational drug, HE2100, for use in the area of radiation protection.

Hollis-Eden will retain all commercial rights to HE2100, including rights to

supply the compound to the U.S. !

Government.



In discussing the CRADA, Vice Admiral James A. Zimble, M.D. (U.S. Navy

retired), President of USUHS, stated, ``We view this as an important

investment in our national security. With the events of September 11th and

subsequent reports of terrorist threats to use nuclear radiation as a weapon

in some manner, including through the use of 'dirty bombs,' the need for a

practical radioprotectant has never been more acute. While more testing

needs to be performed with HE2100, it represents a potential breakthrough in

this important area of medical research.''



Representatives from the Armed Forces Radiobiology Research Institute

(AFRRI), a research institution/department within USUHS, were informed by

the U.S. Food and Drug Administration (FDA) in November 2001, that HE2100

will qualify for review for radiation protection under a proposed new rule

published in the Federal Register of October 5, 1999 vol. 64, no. 192, if

this rule is finalized. Traditional drug development programs require

large-scale clinical studies to establish efficacy in humans. However,

pursuant to the proposed rule, in cases where traditional efficacy studies

would be deemed unethical in evaluating a drug intended for use against

lethal or permanently disabling toxic substances (such as in this situation

which would otherwise require healthy human volunteers to be exposed to

potentially lethal effects of radiation), approval may be granted solely on

the basis of proof of efficacy in several animal species and proof of safety

in humans.



AFRRI is a leader in studying the short and long-term effects of radiation

injury. A principal AFRRI mission is the development of pharmaceutical

agents that can be used prophylactically to prevent injury from radiation

caused by a nuclear accident or event. Over the past several years, AFRRI,

in concert with another Department of Defense project, has screened

thousands of compounds in an effort to find a radioprotectant suitable for

widespread use. Out of this screening and profiling effort, HE2100 has

emerged as a leading candidate based on its striking efficacy in preclinical

models to date, its safety profile, and the comparatively low-cost nature of

its manufacturing process. AFRRI has conducted numerous preclinical studies

with HE2100. Results of several of these studies have been published in the

International Journal of Immunopharmacology and in Radiation Research. These

studies showed that HE2100, when given to animals shortly before or shortly

after exposure to let!

hal doses of radiation, provided significant survival advantages in HE2100

treated animals versus placebo treated animals.



AFRRI investigators conducting the study attributed the survival advantage

to HE2100's ability to increase a number of cell types (including

neutrophils and platelets) associated with immune protection.



``We are very encouraged by the protective results we have seen with HE2100

in our models of radiation injury,'' stated Dr. Thomas Seed, Team Leader,

Radiation Casualty Management at AFRRI. This sentiment was echoed by Dr.

Mark Whitnall, the principal staff investigator on the project at AFRRI, in

highlighting the preclinical findings. ``In the experiments we have

conducted, a single injection of the compound has produced survival rates in

treated animals as high as 100% after exposure to a level of radiation that

is rapidly fatal in 80% or more of placebo treated animals.''



U.S. Army Colonel Robert Eng, Ph.D., Director of AFRRI added, ``We have been

searching for an effective and practical radioprotectant for a number of

years and this compound appears to date to meet all of our criteria. We are

excited by the opportunity to work closely with Hollis-Eden, which has

substantial expertise in the development of immune regulating hormones, in

an effort to quickly develop this compound for an important and as yet

unserved indication. We are also pleased that the FDA has indicated to us

that, in the setting of radioprotection, HE2100 will qualify for evaluation

under the proposed new rule for experimental drugs that will be used against

lethal or permanently disabling toxic substances. While the demand for a

novel radioprotectant is difficult to estimate at this time, the need for

rapid treatment after radiation exposure, and the diverse nature of the

threat, may make HE2100 a candidate for stockpiling on a local as well as a

federal and internationa!

l level.''



``This agreement paves the way for us to cooperate closely with the U.S.

Armed Forces on developing a novel radioprotectant for use by both military

personnel as well as civilians at risk of exposure to high doses of

radiation,'' stated Richard Hollis, Chairman and CEO of Hollis-Eden. ``In

light of recent world events, it is an honor and a privilege to be

collaborating with scientists at AFRRI on a project that is potentially so

important to our homeland defense, and we share their sense of urgency on

the need to quickly develop this compound.''



``We believe this collaboration with the U.S. military provides further

validation of the valuable role immune regulating hormones can potentially

play in treating a variety of diseases and conditions, including some of the

major health threats confronting the world today,'' Hollis added. ``In

addition to our work with HE2100 in the area of radioprotection, we have

also recently shown exciting results in an initial clinical trial with our

lead immune regulating hormone, HE2000, in the setting of malaria, a disease

which strikes more than 300 million people each year. Hollis-Eden has been

collaborating for a number of years with the U.S. Navy in the area of

malaria. HE2000 has also shown encouraging results when given as a single

agent to HIV patients in South Africa, which implies that the compound may

be useful in increasing the percentage of patients who are long-term

non-progressors towards AIDS. Given the attractive safety profile to date

and the cost-effective nature of!

 the manufacturing process, HE2000 may represent a practical alternative

that could potentially provide relief in epidemics that are affecting

millions of patients around the world. Further, based on its mechanism of

action, which involves boosting the immune system rather than directly

attacking the pathogen itself, we believe HE2000 will not lead to the

development of resistance, which is an issue with current approaches to both

malaria and HIV. This mechanism of action also implies the compound may be

useful against a variety of other pathogens including those that may be used

in biowarfare, and we are currently exploring these opportunities with other

branches of the U.S. military.''



Hollis-Eden Pharmaceuticals, Inc. is a development-stage pharmaceutical

company based in San Diego, California, engaged in the development of

products for the treatment of infectious diseases and immune systems

disorders. The Company's vision is to become the world leader in immune

regulating hormones and their application to numerous diseases. Hollis-Eden

is conducting a series of Phase I/II and Phase II clinical trials in HIV

patients with the Company's lead immune regulating hormone, HE2000, in South

Africa and the United States. Phase II studies in Thailand are also being

conducted with HE2000 in the treatment of malaria, and in Singapore for the

treatment of hepatitis B. The Company is also conducting a Phase I clinical

trial in the United States with another of its immune regulating hormones,

HE2200, which along with HE2100 is licensed from Dr. Roger Loria, a

Professor at Virginia Commonwealth University. In addition, through its

relationship with Aeson Therapeutics, t!

he Company also has access to HE2500, which is in Phase II clinical trials

in cardiovascular disease and actinic keratosis. For more information on

Hollis-Eden, contact the Company's website at www.holliseden.com.



Statements made in this press release may constitute forward-looking

statements and are subject to numerous risks and uncertainties, including

the potential inability of the U.S. government and the Company to provide

the resources necessary to conduct the program described above, the failure

to successfully complete clinical trials, the Company's future capital

needs, the Company's ability to obtain sufficient funding and required

regulatory approvals, the development of competitive products by other

companies, and other risks detailed from time to time in the Company's

filings with the Securities and Exchange Commission. The actual results may

differ materially from those contained in this press release.







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