ONCONASE(R) Granted Orphan Drug Status for Malignant Mesothelioma in Australia

28 Mar, 2005, 00:00 ET from Alfacell Corporation

    BLOOMFIELD, N.J., March 28 /PRNewswire-FirstCall/ -- Alfacell Corporation
 (Nasdaq:   ACEL) announced today that the Therapeutic Goods Administration (TGA)
 in Australia has granted ONCONASE(R) (ranpirnase) Orphan Drug status for the
 indication of malignant mesothelioma (MM).  ONCONASE is also designated as an
 Orphan Drug for MM in Europe.
     The TGA defines orphan drug products as "drugs, vaccines or in vivo
 diagnostic agents which physicians use to treat, prevent or diagnose rare
 diseases."  The TGA's Orphan Drug Program encourages sponsors to market orphan
 drugs in Australia by reducing costs through waiving fees.  In addition,
 orphan drug status in Australia confers priority evaluation for ONCONASE ahead
 of other therapies.
     The Australian Mesothelioma Register, produced by the Epidemiology Unit of
 the National Occupational Health and Safety Commission (NOHSC), indicates
 that:
      * Australia has the world's highest incidence rate of MM
      * incidence rates of MM have been increasing there since 1965
      * there is no indication of when MM incidence rates will start to decline
 
     About the ONCONASE Phase IIIb Study
     ONCONASE, Alfacell's lead investigational drug candidate, is currently
 being evaluated in a confirmatory Phase IIIb study as a treatment for MM, an
 asbestos-related cancer.  Over 50 sites in the U.S., Canada, Europe, New
 Zealand and Australia are participating in the trial.  The global MM market is
 estimated at $300M annually.  For more information about the trial, please
 visit http://www.centerwatch.com/alfacellmeso .
 
     About Alfacell Corporation
     Alfacell Corporation is a biopharmaceutical company focused on the
 discovery, development and commercialization of ribonucleases (RNases).  The
 Company's mission is to develop new therapeutics based on its proprietary
 RNase technology for the treatment of cancer, infectious diseases and other
 life-threatening conditions.  For more information, please visit
 http://www.alfacell.com .
 
     This press release includes statements that may constitute
 "forward-looking" statements, usually containing the words "believe,"
 "estimate," "project," "expect" or similar expressions.  Forward-looking
 statements involve risks and uncertainties that could cause actual results to
 differ materially from the forward-looking statements.  Factors that would
 cause or contribute to such differences include, but are not limited to,
 difficulties encountered in enrolling patients into its current Phase IIIb
 clinical trial, uncertainties involved in transitioning from concept to
 product, uncertainties involving the ability of the Company to finance
 research and development activities, potential challenges to or violations of
 patents, uncertainties regarding the outcome of clinical trials, the Company's
 ability to secure necessary approvals from regulatory agencies, dependence
 upon third-party vendors, and other risks discussed in the Company's periodic
 filings with the Securities and Exchange Commission. By making these forward-
 looking statements, the Company undertakes no obligation to update these
 statements for revisions or changes after the date of this release.
 
      Contact:
 
      Alfacell Corporation:               Financial Inquiries:
      Kuslima Shogen                      RJ Falkner & Company, Inc.
      Andrew Savadelis                    Investor Relations Counsel
      (973) 748-8082                      (800) 377-9893
      info@alfacell.com                   info@rjfalkner.com
 
 
 

SOURCE Alfacell Corporation
    BLOOMFIELD, N.J., March 28 /PRNewswire-FirstCall/ -- Alfacell Corporation
 (Nasdaq:   ACEL) announced today that the Therapeutic Goods Administration (TGA)
 in Australia has granted ONCONASE(R) (ranpirnase) Orphan Drug status for the
 indication of malignant mesothelioma (MM).  ONCONASE is also designated as an
 Orphan Drug for MM in Europe.
     The TGA defines orphan drug products as "drugs, vaccines or in vivo
 diagnostic agents which physicians use to treat, prevent or diagnose rare
 diseases."  The TGA's Orphan Drug Program encourages sponsors to market orphan
 drugs in Australia by reducing costs through waiving fees.  In addition,
 orphan drug status in Australia confers priority evaluation for ONCONASE ahead
 of other therapies.
     The Australian Mesothelioma Register, produced by the Epidemiology Unit of
 the National Occupational Health and Safety Commission (NOHSC), indicates
 that:
      * Australia has the world's highest incidence rate of MM
      * incidence rates of MM have been increasing there since 1965
      * there is no indication of when MM incidence rates will start to decline
 
     About the ONCONASE Phase IIIb Study
     ONCONASE, Alfacell's lead investigational drug candidate, is currently
 being evaluated in a confirmatory Phase IIIb study as a treatment for MM, an
 asbestos-related cancer.  Over 50 sites in the U.S., Canada, Europe, New
 Zealand and Australia are participating in the trial.  The global MM market is
 estimated at $300M annually.  For more information about the trial, please
 visit http://www.centerwatch.com/alfacellmeso .
 
     About Alfacell Corporation
     Alfacell Corporation is a biopharmaceutical company focused on the
 discovery, development and commercialization of ribonucleases (RNases).  The
 Company's mission is to develop new therapeutics based on its proprietary
 RNase technology for the treatment of cancer, infectious diseases and other
 life-threatening conditions.  For more information, please visit
 http://www.alfacell.com .
 
     This press release includes statements that may constitute
 "forward-looking" statements, usually containing the words "believe,"
 "estimate," "project," "expect" or similar expressions.  Forward-looking
 statements involve risks and uncertainties that could cause actual results to
 differ materially from the forward-looking statements.  Factors that would
 cause or contribute to such differences include, but are not limited to,
 difficulties encountered in enrolling patients into its current Phase IIIb
 clinical trial, uncertainties involved in transitioning from concept to
 product, uncertainties involving the ability of the Company to finance
 research and development activities, potential challenges to or violations of
 patents, uncertainties regarding the outcome of clinical trials, the Company's
 ability to secure necessary approvals from regulatory agencies, dependence
 upon third-party vendors, and other risks discussed in the Company's periodic
 filings with the Securities and Exchange Commission. By making these forward-
 looking statements, the Company undertakes no obligation to update these
 statements for revisions or changes after the date of this release.
 
      Contact:
 
      Alfacell Corporation:               Financial Inquiries:
      Kuslima Shogen                      RJ Falkner & Company, Inc.
      Andrew Savadelis                    Investor Relations Counsel
      (973) 748-8082                      (800) 377-9893
      info@alfacell.com                   info@rjfalkner.com
 
 
 SOURCE  Alfacell Corporation