BioSante Pharmaceuticals, Inc. Announces Positive Pre-Clinical and Phase I Human Clinical Trial Results

Bulletin Board: BTPH

Canadian Venture Exchange: BAI



Apr 24, 2001, 01:00 ET from BioSante Pharmaceuticals, Inc.

    LINCOLNSHIRE, IL, April 24 /PRNewswire/ - BioSante Pharmaceuticals, Inc.
 (OTCBB- BTPH; CDNX-BAI) today announced positive results of pre-clinical and
 human clinical testing of its proprietary vaccine adjuvant and delivery
 system. The pre-clinical results were presented today at The Fourth Annual
 Conference on Vaccine Research in Arlington, Virginia, sponsored by the
 National Foundation for Infectious Diseases.
     Results of this pre-clinical trial indicate that using BioSante's CAP
 (calcium phosphate nanoparticles) as a vaccine adjuvant and delivery system
 enhanced immune response better than alum, the only vaccine adjuvant approved
 for human use in the United States. This study confirms previously published
 CAP results in which a vaccine formulated with Herpes Simplex Virus-2 and CAP
 (HSV-2+CAP) induced high levels of immune response (IgG2a/Th1 response) along
 with high and sustained mucosal IgA levels in mice. IgE antibody was not
 detected, nor was any overt local irritation detected.
     "The efficacy and safety results in both studies met our expectations --
 especially gratifying is the comparison with alum," said Stephen M. Simes,
 president and chief executive officer of BioSante Pharmaceuticals, Inc. "These
 results represent important progress for BioSante and will help advance our
 ongoing efforts to establish partnerships with vaccine developers."
     The pre-clinical trial examined the use of BioSante's CAP as a vaccine
 adjuvant and delivery system versus "alum". In the study, mice were inoculated
 with HSV-2+CAP or HSV-2+alum. HSV-2+CAP induced a statistically significant
 greater immune response (IgG) than HSV-2+alum. BioSante scientists formulated
 both vaccines.
     Also presented today were findings that CAP is a stable adjuvant and easy
 to formulate with antigens, that the antigens used did not lose their
 antigenicity, degrade or denature during manufacture and storage, and that CAP
 is nontoxic, non-antigenic, biocompatible and biodegradable.
 
     Phase I human clinical trial results
     The pre-clinical safety data presented today are supported by the results
 of a BioSante-sponsored 18 patient Phase I double-blind, placebo-controlled
 human clinical trial conducted to determine the safety of CAP as a vaccine
 adjuvant. Analysis of the study data showed no difference in side-effect
 profile between CAP and placebo, including no skin irritation at the injection
 site.
     Previous CAP results
     As previously reported and published, in pre-clinical testing CAP-
 formulated vaccines elicited protection against a challenge with lethal doses
 of live Herpes Simplex Virus-2 and influenza, respectively. In an HSV-2 trial,
 all mice immunized with the HSV-2+CAP vaccine survived with no ill effects. In
 contrast, all mice immunized with HSV-2 without CAP died within eight days of
 live virus challenge. In an influenza trial, all mice immunized with
 influenza/M1+CAP remained healthy with no weight loss after challenge with
 live influenza virus, whereas the mice immunized with influenza/M1 without CAP
 became ill and lost significant amounts of weight before recovering to normal
 baseline weight.
 
     About CAP
     BioSante's novel CAP may represent a safe and effective mucosal adjuvant.
 Mucosal surfaces are both the primary interface between the host and the
 environment and the first line of defense against pathogens like herpes and
 flu. Until now, the development of mucosal vaccines has been limited due to
 the lack of a safe and effective mucosal adjuvant.
     Therefore, the availability of a vaccine that elicits effective mucosal
 immunity will offer improved protection from and treatment of certain
 diseases. Although several potential mucosal adjuvants are in development,
 none have been approved for human use. The results produced in BioSante's pre-
 clinical trials will have to be reproduced in human clinical trials.
 
     About BioSante Pharmaceuticals, Inc.
     BioSante is an emerging pharmaceutical company developing a robust
 pipeline of hormone replacement products to treat hormone deficiencies in men
 and women. BioSante also is developing its nanoparticulate-based platform
 technology (CAP) for novel vaccines, vaccine adjuvants and drug delivery
 systems.
 
     This press release contains forward-looking statements within the meaning
     of Private Securities Litigation Reform Act of 1995. The statements
     regarding BioSante contained in this press release that are not
     historical in nature, particularly those that utilize terminology such as
     "may," "will," "should," "likely," "expects," "anticipates," "estimates,"
     "believes" or "plans," or comparable terminology, are forward-looking
     statements based on current expectations and assumptions, and entail
     various risks and uncertainties that could cause actual results to differ
     materially from those expressed in such forward-looking statements.
     Important factors known to BioSante that could cause such material
     differences are identified and discussed from time to time in BioSante's
     filings with the Securities and Exchange Commission, including those
     factors discussed on pages 14 to 19 of BioSante's Form 10-KSB, which
     discussion also is incorporated herein by reference.
 
     The Canadian Venture Exchange has neither approved nor disapproved the
     information herein contained.
 
 
 

SOURCE BioSante Pharmaceuticals, Inc.
    LINCOLNSHIRE, IL, April 24 /PRNewswire/ - BioSante Pharmaceuticals, Inc.
 (OTCBB- BTPH; CDNX-BAI) today announced positive results of pre-clinical and
 human clinical testing of its proprietary vaccine adjuvant and delivery
 system. The pre-clinical results were presented today at The Fourth Annual
 Conference on Vaccine Research in Arlington, Virginia, sponsored by the
 National Foundation for Infectious Diseases.
     Results of this pre-clinical trial indicate that using BioSante's CAP
 (calcium phosphate nanoparticles) as a vaccine adjuvant and delivery system
 enhanced immune response better than alum, the only vaccine adjuvant approved
 for human use in the United States. This study confirms previously published
 CAP results in which a vaccine formulated with Herpes Simplex Virus-2 and CAP
 (HSV-2+CAP) induced high levels of immune response (IgG2a/Th1 response) along
 with high and sustained mucosal IgA levels in mice. IgE antibody was not
 detected, nor was any overt local irritation detected.
     "The efficacy and safety results in both studies met our expectations --
 especially gratifying is the comparison with alum," said Stephen M. Simes,
 president and chief executive officer of BioSante Pharmaceuticals, Inc. "These
 results represent important progress for BioSante and will help advance our
 ongoing efforts to establish partnerships with vaccine developers."
     The pre-clinical trial examined the use of BioSante's CAP as a vaccine
 adjuvant and delivery system versus "alum". In the study, mice were inoculated
 with HSV-2+CAP or HSV-2+alum. HSV-2+CAP induced a statistically significant
 greater immune response (IgG) than HSV-2+alum. BioSante scientists formulated
 both vaccines.
     Also presented today were findings that CAP is a stable adjuvant and easy
 to formulate with antigens, that the antigens used did not lose their
 antigenicity, degrade or denature during manufacture and storage, and that CAP
 is nontoxic, non-antigenic, biocompatible and biodegradable.
 
     Phase I human clinical trial results
     The pre-clinical safety data presented today are supported by the results
 of a BioSante-sponsored 18 patient Phase I double-blind, placebo-controlled
 human clinical trial conducted to determine the safety of CAP as a vaccine
 adjuvant. Analysis of the study data showed no difference in side-effect
 profile between CAP and placebo, including no skin irritation at the injection
 site.
     Previous CAP results
     As previously reported and published, in pre-clinical testing CAP-
 formulated vaccines elicited protection against a challenge with lethal doses
 of live Herpes Simplex Virus-2 and influenza, respectively. In an HSV-2 trial,
 all mice immunized with the HSV-2+CAP vaccine survived with no ill effects. In
 contrast, all mice immunized with HSV-2 without CAP died within eight days of
 live virus challenge. In an influenza trial, all mice immunized with
 influenza/M1+CAP remained healthy with no weight loss after challenge with
 live influenza virus, whereas the mice immunized with influenza/M1 without CAP
 became ill and lost significant amounts of weight before recovering to normal
 baseline weight.
 
     About CAP
     BioSante's novel CAP may represent a safe and effective mucosal adjuvant.
 Mucosal surfaces are both the primary interface between the host and the
 environment and the first line of defense against pathogens like herpes and
 flu. Until now, the development of mucosal vaccines has been limited due to
 the lack of a safe and effective mucosal adjuvant.
     Therefore, the availability of a vaccine that elicits effective mucosal
 immunity will offer improved protection from and treatment of certain
 diseases. Although several potential mucosal adjuvants are in development,
 none have been approved for human use. The results produced in BioSante's pre-
 clinical trials will have to be reproduced in human clinical trials.
 
     About BioSante Pharmaceuticals, Inc.
     BioSante is an emerging pharmaceutical company developing a robust
 pipeline of hormone replacement products to treat hormone deficiencies in men
 and women. BioSante also is developing its nanoparticulate-based platform
 technology (CAP) for novel vaccines, vaccine adjuvants and drug delivery
 systems.
 
     This press release contains forward-looking statements within the meaning
     of Private Securities Litigation Reform Act of 1995. The statements
     regarding BioSante contained in this press release that are not
     historical in nature, particularly those that utilize terminology such as
     "may," "will," "should," "likely," "expects," "anticipates," "estimates,"
     "believes" or "plans," or comparable terminology, are forward-looking
     statements based on current expectations and assumptions, and entail
     various risks and uncertainties that could cause actual results to differ
     materially from those expressed in such forward-looking statements.
     Important factors known to BioSante that could cause such material
     differences are identified and discussed from time to time in BioSante's
     filings with the Securities and Exchange Commission, including those
     factors discussed on pages 14 to 19 of BioSante's Form 10-KSB, which
     discussion also is incorporated herein by reference.
 
     The Canadian Venture Exchange has neither approved nor disapproved the
     information herein contained.
 
 
 SOURCE BioSante Pharmaceuticals, Inc.