Demegen Announces Plan to Initiate Phase I/II Clinical Trial for Oral Candidiasis

Apr 19, 2001, 01:00 ET from Demegen, Inc.

    PITTSBURGH, April 19 /PRNewswire/ -- Demegen, Inc.
 (OTC Bulletin Board:   DBOT), a clinical stage biopharmaceutical company
 specializing in the development of peptides for the treatment of infectious
 diseases and oncology, announced today that it plans to initiate a Phase I/II
 clinical trial for treating oral candidiasis.  The U.S. Food and Drug
 Administration (FDA) has reviewed the clinical study design and has given
 permission to proceed with this clinical trial.
     The trial will assess efficacy in reducing or treating oral candidiasis
 infections in a "proof of principle" clinical study.  The sites for the
 clinical trial will most likely be in San Francisco and Atlanta.  Forty HIV
 patients with oral candidiasis will be enrolled in this two week efficacy
 evaluation.
     Oral candidiasis, also known as thrush, is an AIDS-defining opportunistic
 illness that is highly prevalent in HIV-infected individuals.  Up to 46% of
 AIDS patients experience symptoms of oral candidiasis.  The disease causes
 pain, inability to eat, and increased risk of additional infection.
 Resistance to current therapies is increasing.  Oral candidiasis outbreaks
 often recur and maintenance therapy may be needed.
     The product under development by Demegen is an alcohol-free mouthrinse
 that can be swallowed to help protect the esophagus from infection.  The rinse
 contains the patented P-113 peptide that has demonstrated a high level of in
 vitro activity against Candida albicans, including drug-resistant HIV patient
 isolates.  The results of in vitro studies demonstrating the activity of P-113
 against a number of Candida species is scheduled to be published next month in
 a peer reviewed journal.  The benefits of this product over current treatments
 are its demonstrated safety in humans related to its natural origin and the
 reduced risk of drug resistance due to P-113's unique mechanism of action.
 P-113 is based on naturally occurring antimicrobial proteins found in human
 saliva called "histatins," which play an important role in the body's natural
 defense against disease.  The annual market size in the U.S. for products to
 treat oral candidiasis is estimated to be over $400 million.
     Demegen designs and develops novel peptides, proteins and genes for the
 treatment of infections, cancer, cystic fibrosis, multi-drug resistant
 bacteria and fungi.  In addition to pharmaceutical products, applications also
 include enhanced agricultural products.  Demegen's web site is
 www.demegen.com.
 
     This press release contains forward-looking statements within the meaning
 of The Private Securities Litigation Reform Act of 1995 (the "Act").  In
 particular, when used in the preceding discussion, the words "plan,"
 "confident that," "believe," "expect," or "intend to," and similar conditional
 expressions are intended to identify forward-looking statements within the
 meaning of the Act and are subject to the safe harbor created by the Act.
 Such statements are subject to certain risks and uncertainties and actual
 results could differ materially from those expressed in any of the forward-
 looking statements.  Such risks and uncertainties include, but are not limited
 to, market conditions, general acceptance of the Company's products and
 technologies, competitive factors, the ability to successfully complete
 additional financings and other risks described in the Company's SEC reports
 and filings.
 
     Contacts:
     Demegen, Inc.
     Richard Ekstrom, President or S. Robert Fatora, Ph.D.,
       Chief Operating Officer
     412-241-2150, E-mail: info@demegen.com; www.demegen.com
     The Wall Street Group, Inc., 212-888-4848
 
 

SOURCE Demegen, Inc.
    PITTSBURGH, April 19 /PRNewswire/ -- Demegen, Inc.
 (OTC Bulletin Board:   DBOT), a clinical stage biopharmaceutical company
 specializing in the development of peptides for the treatment of infectious
 diseases and oncology, announced today that it plans to initiate a Phase I/II
 clinical trial for treating oral candidiasis.  The U.S. Food and Drug
 Administration (FDA) has reviewed the clinical study design and has given
 permission to proceed with this clinical trial.
     The trial will assess efficacy in reducing or treating oral candidiasis
 infections in a "proof of principle" clinical study.  The sites for the
 clinical trial will most likely be in San Francisco and Atlanta.  Forty HIV
 patients with oral candidiasis will be enrolled in this two week efficacy
 evaluation.
     Oral candidiasis, also known as thrush, is an AIDS-defining opportunistic
 illness that is highly prevalent in HIV-infected individuals.  Up to 46% of
 AIDS patients experience symptoms of oral candidiasis.  The disease causes
 pain, inability to eat, and increased risk of additional infection.
 Resistance to current therapies is increasing.  Oral candidiasis outbreaks
 often recur and maintenance therapy may be needed.
     The product under development by Demegen is an alcohol-free mouthrinse
 that can be swallowed to help protect the esophagus from infection.  The rinse
 contains the patented P-113 peptide that has demonstrated a high level of in
 vitro activity against Candida albicans, including drug-resistant HIV patient
 isolates.  The results of in vitro studies demonstrating the activity of P-113
 against a number of Candida species is scheduled to be published next month in
 a peer reviewed journal.  The benefits of this product over current treatments
 are its demonstrated safety in humans related to its natural origin and the
 reduced risk of drug resistance due to P-113's unique mechanism of action.
 P-113 is based on naturally occurring antimicrobial proteins found in human
 saliva called "histatins," which play an important role in the body's natural
 defense against disease.  The annual market size in the U.S. for products to
 treat oral candidiasis is estimated to be over $400 million.
     Demegen designs and develops novel peptides, proteins and genes for the
 treatment of infections, cancer, cystic fibrosis, multi-drug resistant
 bacteria and fungi.  In addition to pharmaceutical products, applications also
 include enhanced agricultural products.  Demegen's web site is
 www.demegen.com.
 
     This press release contains forward-looking statements within the meaning
 of The Private Securities Litigation Reform Act of 1995 (the "Act").  In
 particular, when used in the preceding discussion, the words "plan,"
 "confident that," "believe," "expect," or "intend to," and similar conditional
 expressions are intended to identify forward-looking statements within the
 meaning of the Act and are subject to the safe harbor created by the Act.
 Such statements are subject to certain risks and uncertainties and actual
 results could differ materially from those expressed in any of the forward-
 looking statements.  Such risks and uncertainties include, but are not limited
 to, market conditions, general acceptance of the Company's products and
 technologies, competitive factors, the ability to successfully complete
 additional financings and other risks described in the Company's SEC reports
 and filings.
 
     Contacts:
     Demegen, Inc.
     Richard Ekstrom, President or S. Robert Fatora, Ph.D.,
       Chief Operating Officer
     412-241-2150, E-mail: info@demegen.com; www.demegen.com
     The Wall Street Group, Inc., 212-888-4848
 
 SOURCE  Demegen, Inc.