TKRTM is our adjuvant treatment using radiation and AdV-tk gene therapy along with corresponding cycles of a Prodrug.  Additionally, the Prodrug is self administered on an outpatient basis.  Previous attempts for similar types of treatments were much more arduous and costly -- requiring intravenous Prodrug administration and hospital stays.  Advantagene has advanced this technology to minimize patient discomfort and allow its application as an outpatient procedure. TKRTM has been well accepted by patients, clinicians and institutions participating in the study and offers the potential for a new weapon on the war against cancer.  Break the paradigm -- Simplify the science:

• Use vectors that are simple to manufacture and use.
• Simplify clinical trials for patient comfort and lower costs.
• Promote patient, physician and institutional participation.
• Use product as adjuvant to facilitate early intervention and reduce morbidity and costs.
  

Additional preclinical studies were conducted to evaluate the use of AdV-tk in conjunction with surgery, chemotherapy and radiation therapy, with emphasis on areas where freedom of operation was expected to exist. These studies led to identification of novel properties of AdV-tk and synergistic effects with standard anti-cancer therapies.  Principal among the discoveries was the increased local and systemic anti-tumor effect when HSV-tk gene therapy is combined with radiation therapy.  In addition, our studies demonstrated the potential to use an orally administered prodrug instead of the intravenous infusion.  This was a key advancement since it greatly decreased the morbidity of the study to the patients (a few pills a day, versus two or three one hour intra-venous infusions a day for fourteen days per course of treatment) and greatly reduced the cost per patient in the trial. With the advent of the oral prodrug, we were able to design clinical gene therapy studies that involved only simple outpatient procedures.