Radient Pharmaceuticals and Jaiva Technologies Announce Human Phase II Trials for Cancer Therapy and Vaccine

Strategic Insights -

Radient Pharmaceuticals Corporation and Jaiva Technologies, Inc. have announced plans to submit a clinical trial application to the Central Drugs Standard Control Organization (CDSCO) in India to commence human phase II trials for Radient's Combination Immunogene Therapy (CIT) technology as a vaccine therapy for non-small cell lung carcinoma (NSCLC). The CIT technology, developed by Dr. Lung-Ji Chang, uses allogenic cells to develop a general NSCLC therapy and vaccine, targeting a population segment most likely to develop lung cancer - people over the age of fifty with a history of smoking.

Key Takeaways:

  • The CIT technology, developed by Dr. Lung-Ji Chang, uses a unique approach to develop a general NSCLC therapy and vaccine, utilizing allogenic cells to target cancer cells.
  • The technology has shown promising results in pre-clinical studies, with 100% of control mice surviving at the end of a 3-month trial period.
  • The phase I clinical trial concluded that the treatment is feasible and safe, with patients showing an inflammatory response after injection and an increase in serum C-reactive protein levels.
  • Radient Pharmaceuticals and Jaiva anticipate beginning product commercialization by FY2015, following the successful completion of these trials.
  • The companies expect to secure 5% of the lung cancer treatment market share by 2017, or approximately $200M in CIT sales, and 10% market share by FY2020, or approximately $400M in CIT sales.
  • The therapy has the potential to be more effective in treating cancer patients than chemotherapy or radiation, with fewer side effects.
  • Mr. Douglas MacLellan, Executive Chairman and CEO of Radient Pharmaceuticals, commented, "This submission to the CDSCO for approval to commence human clinical trials for a general non-small cell lung carcinoma vaccine is a major milestone for Radient Pharmaceuticals..."
  • Jaiva expects to initiate phase III trials in India and the United States upon receiving CDSCO approval for the clinical trial application.

Statistics:

  • Worldwide, NSCLC is the most common cancer in terms of both incidence and mortality, with 1.35 million new cases per year and 1.18 million deaths.
  • NSCLC accounts for approximately 87% of all lung cancer cases.
  • The NSCLC drug market is forecasted to reach $4.1B by FY2014, according to Decision Resources, Inc.
  • Radient Pharmaceuticals expects to secure 5% of the lung cancer treatment market share by 2017, or approximately $200M in CIT sales.
  • Jaiva expects to secure 10% market share by FY2020, or approximately $400M in CIT sales.

Sources:

  • Radient Pharmaceuticals Corporation
  • Jaiva Technologies, Inc.
  • Central Drugs Standard Control Organization (CDSCO)
  • University of Alberta
  • University of Florida
  • Decision Resources, Inc.
  • Comtex SmarTrend Alert
  • Marketwire, Inc.