BioCancell’s Phase I clinical trial for BC-821, scheduled to commence in 2015, is a continuity of the success of pre-clinical studies that examined the use of BC-821 as a treatment for several cancer indications such as Non-small-cell lung carcinoma, Ovarian cancer, Glioblastoma (brain tumour) and Liver metastasis.
Cobra will provide GMP manufacture of BC-821 plasmid DNA, and fill and finish the product in accordance with aseptic manufacturing procedures before releasing it for clinical trials. Cobra’s experienced and expert team have a strong track record for producing non-GMP, high quality, and GMP plasmid DNA for preclinical, clinical and commercial supply, operating efficiently and consistently through a platform DNA process. Cobra’s DNA programs have full regulatory support from a dedicated Quality Assurance (QA) team.
BC-821 is a potential therapeutic product that penetrates cancerous cells and activates the synthesis of DTA under the control of H19 and /or P4 promoter of the target gene IGF2. Both H19 and P4-IGF2 transcription factors are expressed only in cancerous cells. This double-promoter method has the potential to reach a large patient population, as patients expressing either of the target genes will be treatable. An international patent application (PCT) for this product was filed by BioCancell in 2008.
Peter Coleman, CEO Cobra Biologics commented: “Cobra has been manufacturing plasmid therapeutics and DNA vaccines for more than 16 years and I am delighted that we are able to announce this partnership with BioCancell. Our DNA platform process is based on Cobra’s pioneering heritage in gene therapy manufacturing and technology development”.