GammaCan Receives FDA Orphan Drug Designation for Lead Product VitiGam(TM) for Stage IIB to Stage IV Melanoma

  
    
  
  
    
      GammaCan International, Inc. (“GammaCan” 
      or “the Company”) 
      (OTCBB: GCAN), a developer of proprietary immunotherapies for the 
      treatment of melanoma and other cancers, today announced its lead 
      anti-cancer immunotherapy, VitiGam™, has 
      received Orphan Drug designation by the U.S. Food and Drug 
      Administration (FDA) for the treatment of Stage IIB to Stage IV 
      metastatic melanoma. GammaCan anticipates filing an IND with the FDA for 
      a Phase I/II clinical trial by year-end, and initiate clinical testing 
      of VitiGam™ in early 2008.
    
    
      Orphan Drug designation entitles GammaCan to exclusive marketing rights 
      in the United States for VitiGam™ for up to 
      seven years should GammaCan be the first company to receive marketing 
      approval for this therapeutic drug product. Under the Orphan Drug Act 
      (ODA), the FDA will not accept or approve other applications from other 
      sponsors to market an identical medicinal product for the same 
      therapeutic indication for the seven-year period. In addition, the 
      designation allows GammaCan to apply for a waiver from the FDA of 
      certain filing and user fees required by the Prescription Drug User Fee 
      Act (PDUFA).
    
    
      Steven Katz, Chairman of the Board and President of GammaCan said, "We 
      are very encouraged that the FDA has granted VitiGam™ 
      Orphan Drug designation. This will afford GammaCan additional protection 
      in marketing VitiGam™ once we are granted 
      approval. This designation highlights the acute need for new therapies 
      to treat metastatic melanoma.”
    
    
      Jacob Nusbacher, M.D., Director of Medical and Scientific Affairs, 
      commenting on this designation said, “We look 
      forward to working with the FDA as we would like to make VitiGam™ 
      available for all Stage IIB to Stage IV metastatic melanoma patients as 
      quickly as regulators will allow, particularly since these patients have 
      very limited available options for treatment.”
    
    
      About the Orphan Drug Act
    
    
      The Orphan Drug Act (ODA) provides for granting special status to a 
      product to treat a rare disease or condition upon request of a sponsor. 
      The combination of the product and the rare disease or condition must 
      meet certain criteria. This status is referred to as orphan designation. 
      Orphan designation qualifies the sponsor of the product for tax credit 
      and marketing incentives of the ODA. A marketing application for a 
      prescription drug product that has been designated as a drug for a rare 
      disease or condition is not subject to a prescription drug user fee 
      unless the application includes an indication other than the rare 
      disease or condition.
    
    
      About GammaCan
    
    
      GammaCan develops proprietary immunotherapy and related approaches to 
      treat melanoma and other cancers. GammaCan's platform patented 
      technology is based on the use of IgGs (gamma-immunoglobulins), a safe, 
      relatively non-toxic human plasma-derived product used to treat a 
      variety of immune deficiencies and autoimmune diseases. In cancer, 
      IgG-based therapies work by strengthening the patient's immune system. 
      Many experts currently view immunotherapy as a future alternative to 
      chemotherapy. The Company's lead drug candidate, VitiGam™, 
      targets Stage lll and Stage lV melanoma for which no effective treatment 
      currently exists.
    
    
      For more information about GammaCan, visit www.GammaCan.com.
    
    
      About VitiGam™
    
    
      VitiGam™ is a first-in-class IgG-based 
      anti-cancer immunotherapy being developed for the treatment of Stage III 
      and Stage IV melanoma. GammaCan is planning to submit its 
      Investigational New Drug Application (IND) for VitiGam™ 
      to the FDA in the near future. The Company expects to commence human 
      clinical trials shortly thereafter. VitiGam™ 
      is an IgG-based product manufactured from the plasma of donors with 
      Vitiligo, a benign skin condition affecting up to 2% of the general 
      population. Studies have shown that this "enriched" IgG formulation 
      contains potent anti-melanoma activity. Based on these studies, GammaCan 
      expects VitiGam™ to provide both, specific 
      anti-melanoma activity (directed against melanoma cells), and 
      non-specific anti-cancer activity.
    
    
      About Melanoma
    
    
      Melanoma is a deadly form of skin cancer. According to the American 
      Cancer Society, melanoma accounts for approximately 4% of all skin 
      cancers but causes approximately 75% of all skin cancer-related deaths. 
      An estimated 62,000 people will be diagnosed with and nearly 8,000 
      people will die from melanoma in the U.S. alone in 2007. If rapidly 
      diagnosed and surgically removed, early-stage melanoma is usually 
      curable. However, for patients with metastatic melanoma (Stage III and 
      Stage IV), the prognosis is poor since no effective treatment currently 
      exists. These patients have a median survival time of 8.5 months and a 
      5-year survival rate of less than 10%. There has been little change in 
      these results for in excess of 25 years. The incidence of melanoma has 
      increased more rapidly than any other cancer during the past 10 years. 
      The last drug to treat patients with metastatic melanoma was approved by 
      the FDA over 30 years ago.
    
    
      Safe Harbor Statement
    
    
      Statements in this press release that are not purely historical are 
      forward-looking statements. Forward-looking statements in this press 
      release include statements regarding: the commercialization of 
      anti-cancer immunotherapies and the Company's efforts to develop 
      therapies to boost the immune systems of cancer patients by the use of 
      IgG-based therapy. Actual outcomes and the Company's actual results 
      could differ materially from those in such forward-looking statements. 
      Factors that could cause actual results to differ materially include 
      risks and uncertainties such as the inability to finance the planned 
      development of the technology; the inability to hire appropriate staff 
      to develop the technology; unforeseen technical difficulties in 
      developing the technology; the inability to obtain regulatory approval 
      for human use; competitors' therapies proving to be more effective, 
      cheaper or otherwise preferable for consumers; the inability to market a 
      product; all of which could, among other things, delay or prevent 
      product release, as well as other factors expressed from time to time in 
      GammaCan's periodic filings with the Securities and Exchange Commission 
      (the "SEC"). As a result, this press release should be read in 
      conjunction with GammaCan's periodic filings with the SEC, which are 
      incorporated herein by reference. The forward-looking statements 
      contained herein are made only as of the date of this press release and 
      GammaCan undertakes no obligation to publicly update such 
      forward-looking statements to reflect subsequent events or circumstances.