Hollis-Eden Presents Data Showing Immune Regulating Hormones Improve Immune Response to Vaccination in Preclinical Model in Aged Animals

Apr 24, 2001, 01:00 ET from Hollis-Eden Pharmaceuticals, Inc.

    SAN DIEGO, April 24 /PRNewswire Interactive News Release/ --
 Hollis-Eden Pharmaceuticals, Inc. (Nasdaq:   HEPH) today announced a
 presentation of preclinical results with investigational drug candidate
 HE2200, an immune regulating hormone.  Highlights from the study demonstrated
 that HE2200 and other immune regulating hormones given to aged mice
 concurrently with a hepatitis B vaccine significantly improved immune
 responses to the vaccine, as measured by the amount of vaccine-specific
 antibody.  Response to hepatitis B vaccine in aged animals is being used as a
 model system for analyzing the ability of immune regulating hormones to
 correct immune dysregulation in the elderly.  In addition to enhanced antibody
 responses, the drug candidates demonstrated a correction from the depressed
 cell-mediated immunity (Th2 bias) of aged mice to the balanced Th1/Th2
 response seen in young animals.  The results of the study were presented in an
 abstract and poster session at the 4th Annual Conference on Vaccine Research
 being held April 23rd to 25th in Arlington, Virginia.
     Results from the experiment demonstrated that administration of hepatitis
 B vaccine to young animals resulted in vaccine-specific antibody titers that
 were approximately 5-fold higher (2500 ng/ml on day 21) compared to untreated
 aged animals (approximately 500 ng/ml on day 21).  Aged animals given HE2200
 in conjunction with the hepatitis B vaccine produced vaccine-specific antibody
 titers that were more than 4-fold higher (approximately 2200 ng/ml on day 21)
 than those seen in untreated, aged mice and approached the levels achieved in
 young mice.  In addition, administration of HE2200 to aged mice showed a
 correction of the Th2-bias seen in untreated aged mice (IgG1 to IgG2a ratio of
 28 to 1), to the more balanced Th1/Th2 ratio seen in young animals (IgG1 to
 IgG2a of 8 to 1).
     In healthy young adults, there are two types of adaptive immunity that
 exist in balance: Th1, or cell-mediated immunity, and Th2, or humoral
 immunity.  The Th1 branch of the immune system is responsible for controlling
 intracellular invaders such as viruses and certain parasites, while Th2
 immunity includes the humoral response necessary for controlling extracellular
 pathogens such as certain bacteria.  Both types of immunity are critical to a
 well functioning immune system; however, the ability to mount a strong
 cell-mediated response is frequently lost in the elderly and in patients
 suffering from chronic infectious diseases such as HIV.  Immune regulating
 hormones have been shown to be part of the body's natural regulatory mechanism
 for the cytokines and dendritic cells that drive Th1/Th2 balance.  These same
 immune regulating hormones have also been shown to be depleted in the elderly
 and in a variety of other conditions of immune dysregulation, suggesting that
 a hormone replacement therapy with these compounds may be of significant
 benefit.
     The study was performed in conjunction with Dr. Raymond Daynes, Professor
 and Associate Chairman of Pathology at the University of Utah, who is a
 consultant to Hollis-Eden and a leader in the area of adrenal hormones.  The
 study used young and aged mice as an animal model system to evaluate the
 improvement of immune activity from the Company's proprietary immune
 regulating hormone, HE2200.  The animals were injected with either HE2200 or
 vehicle (placebo) within approximately 20 minutes of receiving a Hepatitis B
 vaccine.  The animals were evaluated for immune response as measured by the
 vaccine-specific antibody titer found in the plasma after the vaccination.
 Prior to and after the injection of HE2200, the animals were also evaluated
 for the ratio of antibody subtypes IgG1 to IgG2a found in the plasma.  IgG1
 and IgG2a are well accepted immune markers indicating the immune status of
 animals.  In aged animals, low antibody titers and Th2-bias (indicated by a
 higher IgG1 to IgG2a ratio) is characteristic of the reduced protective
 immunity believed to be responsible for inadequate immune responses to
 vaccination and vulnerability to infectious diseases and cancer.
     The Company recently announced it has filed an investigational new drug
 (IND) application with the United States Food and Drug Administration to test
 HE2200 in a Phase I clinical trial in healthy adults and healthy elderly
 volunteers.  In addition to assessing safety and tolerance of two dosage
 levels of HE2200, changes in a number of key immune markers in both groups of
 volunteers will be evaluated in this trial.  If these results are successful,
 the Company expects to conduct future studies with HE2200 in a variety of
 indications, potentially including the ability of HE2200 to improve immunity
 in the elderly.
     "These results add to an already impressive array of preclinical
 publications and presentations demonstrating that immune regulating hormones,
 including HE2200, can have impressive effects in restoring immunity in models
 of immune dysregulation," stated Richard B. Hollis, Chairman and CEO of
 Hollis-Eden Pharmaceuticals, Inc.  "These findings imply that HE2200 may be
 useful in restoring appropriate immune responses in the elderly and represents
 an important new potential development path and commercial opportunity for the
 Company, including the opportunity to potentiate a variety of prophylactic and
 therapeutic vaccines in immunocompromised patients.  Compromised immunity in
 the elderly is a major healthcare problem and represents an enormous use of
 healthcare dollars."
     "This data is exciting because of the potential utility of using a
 non-androgenic immune regulating hormone to treat immune senescence," said Dr.
 Raymond Daynes.  "This class of adrenal hormones has been found to affect
 dendritic cell maturation and survival of those cells.  I believe that
 abnormal dendritic cell function is one of the major causes of loss of
 cell-mediated immunity and lack of effective immune response to vaccine
 administration in the elderly.  In addition to immune senescence in the
 elderly, similar immune defects are evident in cancer and a number of chronic
 infectious diseases.  The ability to correct immune dysfunction with this
 class of drug candidates thus holds promise across a variety of indications."
 
     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 currently testing
 its lead drug candidate HE2000 in Phase I/II and Phase II clinical trials in
 treatment naive HIV infected South African patients.  The Company is also
 conducting a Phase I/II clinical trial with HE2000 in the United States in HIV
 infected patients failing at least their second antiviral drug regimen.
 Additionally the Company is pursuing clinical trials with HE2000 in HIV,
 malaria and hepatitis.  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
 failure to successfully complete pivotal clinical trials, the Company's future
 capital needs, the Company's ability to obtain additional 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.
 
                     MAKE YOUR OPINION COUNT -  Click Here
                http://tbutton.prnewswire.com/prn/11690X44840462
 
 

SOURCE Hollis-Eden Pharmaceuticals, Inc.
    SAN DIEGO, April 24 /PRNewswire Interactive News Release/ --
 Hollis-Eden Pharmaceuticals, Inc. (Nasdaq:   HEPH) today announced a
 presentation of preclinical results with investigational drug candidate
 HE2200, an immune regulating hormone.  Highlights from the study demonstrated
 that HE2200 and other immune regulating hormones given to aged mice
 concurrently with a hepatitis B vaccine significantly improved immune
 responses to the vaccine, as measured by the amount of vaccine-specific
 antibody.  Response to hepatitis B vaccine in aged animals is being used as a
 model system for analyzing the ability of immune regulating hormones to
 correct immune dysregulation in the elderly.  In addition to enhanced antibody
 responses, the drug candidates demonstrated a correction from the depressed
 cell-mediated immunity (Th2 bias) of aged mice to the balanced Th1/Th2
 response seen in young animals.  The results of the study were presented in an
 abstract and poster session at the 4th Annual Conference on Vaccine Research
 being held April 23rd to 25th in Arlington, Virginia.
     Results from the experiment demonstrated that administration of hepatitis
 B vaccine to young animals resulted in vaccine-specific antibody titers that
 were approximately 5-fold higher (2500 ng/ml on day 21) compared to untreated
 aged animals (approximately 500 ng/ml on day 21).  Aged animals given HE2200
 in conjunction with the hepatitis B vaccine produced vaccine-specific antibody
 titers that were more than 4-fold higher (approximately 2200 ng/ml on day 21)
 than those seen in untreated, aged mice and approached the levels achieved in
 young mice.  In addition, administration of HE2200 to aged mice showed a
 correction of the Th2-bias seen in untreated aged mice (IgG1 to IgG2a ratio of
 28 to 1), to the more balanced Th1/Th2 ratio seen in young animals (IgG1 to
 IgG2a of 8 to 1).
     In healthy young adults, there are two types of adaptive immunity that
 exist in balance: Th1, or cell-mediated immunity, and Th2, or humoral
 immunity.  The Th1 branch of the immune system is responsible for controlling
 intracellular invaders such as viruses and certain parasites, while Th2
 immunity includes the humoral response necessary for controlling extracellular
 pathogens such as certain bacteria.  Both types of immunity are critical to a
 well functioning immune system; however, the ability to mount a strong
 cell-mediated response is frequently lost in the elderly and in patients
 suffering from chronic infectious diseases such as HIV.  Immune regulating
 hormones have been shown to be part of the body's natural regulatory mechanism
 for the cytokines and dendritic cells that drive Th1/Th2 balance.  These same
 immune regulating hormones have also been shown to be depleted in the elderly
 and in a variety of other conditions of immune dysregulation, suggesting that
 a hormone replacement therapy with these compounds may be of significant
 benefit.
     The study was performed in conjunction with Dr. Raymond Daynes, Professor
 and Associate Chairman of Pathology at the University of Utah, who is a
 consultant to Hollis-Eden and a leader in the area of adrenal hormones.  The
 study used young and aged mice as an animal model system to evaluate the
 improvement of immune activity from the Company's proprietary immune
 regulating hormone, HE2200.  The animals were injected with either HE2200 or
 vehicle (placebo) within approximately 20 minutes of receiving a Hepatitis B
 vaccine.  The animals were evaluated for immune response as measured by the
 vaccine-specific antibody titer found in the plasma after the vaccination.
 Prior to and after the injection of HE2200, the animals were also evaluated
 for the ratio of antibody subtypes IgG1 to IgG2a found in the plasma.  IgG1
 and IgG2a are well accepted immune markers indicating the immune status of
 animals.  In aged animals, low antibody titers and Th2-bias (indicated by a
 higher IgG1 to IgG2a ratio) is characteristic of the reduced protective
 immunity believed to be responsible for inadequate immune responses to
 vaccination and vulnerability to infectious diseases and cancer.
     The Company recently announced it has filed an investigational new drug
 (IND) application with the United States Food and Drug Administration to test
 HE2200 in a Phase I clinical trial in healthy adults and healthy elderly
 volunteers.  In addition to assessing safety and tolerance of two dosage
 levels of HE2200, changes in a number of key immune markers in both groups of
 volunteers will be evaluated in this trial.  If these results are successful,
 the Company expects to conduct future studies with HE2200 in a variety of
 indications, potentially including the ability of HE2200 to improve immunity
 in the elderly.
     "These results add to an already impressive array of preclinical
 publications and presentations demonstrating that immune regulating hormones,
 including HE2200, can have impressive effects in restoring immunity in models
 of immune dysregulation," stated Richard B. Hollis, Chairman and CEO of
 Hollis-Eden Pharmaceuticals, Inc.  "These findings imply that HE2200 may be
 useful in restoring appropriate immune responses in the elderly and represents
 an important new potential development path and commercial opportunity for the
 Company, including the opportunity to potentiate a variety of prophylactic and
 therapeutic vaccines in immunocompromised patients.  Compromised immunity in
 the elderly is a major healthcare problem and represents an enormous use of
 healthcare dollars."
     "This data is exciting because of the potential utility of using a
 non-androgenic immune regulating hormone to treat immune senescence," said Dr.
 Raymond Daynes.  "This class of adrenal hormones has been found to affect
 dendritic cell maturation and survival of those cells.  I believe that
 abnormal dendritic cell function is one of the major causes of loss of
 cell-mediated immunity and lack of effective immune response to vaccine
 administration in the elderly.  In addition to immune senescence in the
 elderly, similar immune defects are evident in cancer and a number of chronic
 infectious diseases.  The ability to correct immune dysfunction with this
 class of drug candidates thus holds promise across a variety of indications."
 
     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 currently testing
 its lead drug candidate HE2000 in Phase I/II and Phase II clinical trials in
 treatment naive HIV infected South African patients.  The Company is also
 conducting a Phase I/II clinical trial with HE2000 in the United States in HIV
 infected patients failing at least their second antiviral drug regimen.
 Additionally the Company is pursuing clinical trials with HE2000 in HIV,
 malaria and hepatitis.  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
 failure to successfully complete pivotal clinical trials, the Company's future
 capital needs, the Company's ability to obtain additional 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.
 
                     MAKE YOUR OPINION COUNT -  Click Here
                http://tbutton.prnewswire.com/prn/11690X44840462
 
 SOURCE  Hollis-Eden Pharmaceuticals, Inc.