VATIS UPDATE Article

Biotechnology company, APAC Biotech, India, has been granted a commercial license by Indian FDA – Central Drugs Standard Control Organization (CDSCO) to market their product, APCEDEN®, a Dendritic cell-based autologous Immuno-oncology product for four cancer indication namely Prostate, Ovarian, Colo-rectal and Non Small Cell Lung carcinoma.

CDSCO issued the commercial license (Form 46) to conduct a post marketing surveillance on statistically significant number of patients for each indication. APCEDEN, an autologous monocyte-derived mature Dendritic cell when loaded with tumor antigen have the ability to generate an effective immune response against the tumor.

In the year 2011, an ATTEST trial was conducted where refractory solid tumor with multiple chemo failure patients were enrolled and administered with APCEDEN. The trial was designed to understand the potential benefits and risk of the therapy. In the trial 28.9% of cases showed stability of disease with good quality of life.