3/3/2014 10:21:52 AM
3 March 2014: Cobra Biologics, a leading contract manufacturer of clinical and commercial scale biologics and pharmaceuticals, and targeted cancer therapy company BioCancell have announced an agreement to manufacture BioCancell’s BC-821 cancer drug for clinical trials.
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”.
For more information about Cobra Biologics, please contact Peter Coleman, CEO, on +44 (0)1782 714181 or email firstname.lastname@example.org
For media enquiries, please contact Tristan Jervis or Alex Heeley on +44 (0)207 861 3019 or email: email@example.com.
About Cobra Biologics
Cobra Biologics is a leading international contract manufacturing organisation (CMO) of biologics and pharmaceuticals for clinical and commercial supply.
Cobra has three GMP approved facilities, each with expertise tailored to serving our customers around the world. We offer a broad range of integrated and stand-alone contract services, stretching from cell line and process development through to fill and finish for the supply of products for clinical trials and the commercial market.
We take pride in manufacturing excellence and being a trusted provider, delivering what we promise and helping our customers to develop medicines for the benefit of patients. Cobra supplies manufacturing solutions to the pharmaceutical industry covering antibodies, recombinant proteins, viruses, phage, DNA, whole cell vaccines and therapeutics as well as biologics and small molecule API lyophilisation and fill finish.
For more information please visit: www.cobrabio.com
BioCancell is a biopharmaceuticals company that specializes in the development of Targeted Cancer Therapies for the treatment of numerous types of cancer. The Company's technology offers a safe and long-term treatment of cancer, with no adverse effects.
BioCancell was co-founded in 2004 by Professor Avraham Hochberg, Professor of Molecular Biology at the Hebrew University of Jerusalem, based on technology developed by him over the past 25 years.
The drug candidates developed by the Company are targeted and their goal is to selectively destroy the cancer cells without affecting healthy cells (‘Targeted Cancer Therapy'). The approach is based on the identification of target genes, such as H19, that are expressed only in cancerous tumours, and not in healthy cells, and on the use of those genes' regulatory sequences for the activation of a toxin inside the cancerous cells only, thus destroying them without harming healthy cells. BioCancell's leading drug candidate, BC-819, has completed a Phase IIb clinical trial for the treatment of bladder cancer, as well as additional clinical trials for other medical indications.
For more information please visit: www.biocancell.com
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