HATFIELD, Pa., Nov. 15, 2017 — Genisphere LLC announced positive results from a non-GLP safety study evaluating dose escalation and repeated dose toxicity of the company's 3DNA nanocarrier in Sprague Dawley rats. The study demonstrated no adverse clinical findings after repeated intravenous administration of the maximum achievable dose of 3DNA nanocarrier.
The study was conducted at Calvert Labs, Inc., a premier contract research organization that has been serving the biopharmaceutical community for 45 years. “Calvert is exceptionally pleased to have an opportunity to partner with the Genisphere team to help them advance their 3DNA platform forward,” said Charles Spainhour, V.M.D., Ph.D., DABT, the Company's Chief Scientific Officer. “We look forward to continuing to help Genisphere design and execute IND enabling GLP safety studies that potentially advance one or more of their programs toward human clinical studies.”
Dr. Vincent Meador, a globally recognized toxicologist and pathologist engaged by Genisphere, explained this study made meaningful progress in establishing the safety profile of the 3DNA nanocarrier. Dr. Meador said “Genisphere's licensing to biopharmaceutical partners has great potential to improve the efficacy and safety of life-saving therapeutics. This study makes great strides in demonstrating the inherent safety of 3DNA, and helps answer a crucial question from biopharmaceutical partners. Now the company is planning additional studies to further validate the safety of 3DNA technology.”
Genisphere's Chief Science Officer, Bob Getts, explained this study was key to understanding the biopharmacological implications of 3DNA. He said, “We dosed as high as we were able in this study, orders of magnitude above the dose necessary to achieve efficacy, and have observed no repeat-dose toxicity. We suspect these positive results are driven by the innate biocompatibility of our DNA-based carrier. This finding is fundamental and establishes a solid foundation as we pursue our nanotechnology for targeted drug delivery, in our various programs and collaborations.”
Genisphere LLC is the provider of the 3DNA® platform for targeted drug delivery. 3DNA® is a nanoscale, multivalent scaffold made from proprietary, synthetic DNA formed in a flexible, branched structure. 3DNA® nanocarriers are engineered and cross-linked to form a stable architecture while maintaining the biocompatibility of the nucleic-acid building blocks, and demonstrate efficacy and safety with a variety of drug cargos across multiple indications. Genisphere's technology is IP-protected and fully customizable to deliver small molecules, biologics, and nucleic acids with precise specificity enabled by multivalent targeting via antibodies, peptides and other molecular entities. Genisphere leverages a collaborative model to advance its 3DNA® drug delivery platform, and seeks additional partnerships with biotechnology and pharmaceutical companies to improve efficacy and reduce toxicity. Genisphere is also advancing its own lead compounds based on 3DNA® nanotechnology. For more information, please visit http://genisphere.com.
For more information contact:
Chief Scientific Officer, Genisphere LLC
About Calvert Labs, Inc.
Calvert Labs is a premier Contract Research Organization located in Scranton, PA. Our commitment to providing the highest level of quality and service to both established and emerging biopharma companies worldwide sets the foundation for Calvert conducting hundreds of studies per year to support lead optimization, clinical candidate selection and Investigational New Drug (IND) application filings for our clients. Calvert also annually performs many longer-term toxicology studies to continue supporting our clients' late-stage clinical development programs as well as their NDA (New Drug Application) or BLA (Biologics License Applications) regulatory filings. For more information about Calvert Labs, visit www.calvertlabs.com.
For more information contact:
Michael A. Recny, Ph.D.
Chief Executive Officer, Calvert Labs, Inc.
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