Bolder BioTechnology Receives $1.2 Million NIH Grant To Continue Development Of Long-Acting EPO Analog For Chronic Kidney Disease

Main Category: Urology / Nephrology
Also Included In: Clinical Trials / Drug Trials;  Pharma Industry / Biotech Industry
Article Date: 18 Sep 2009 - 1:00 PDT

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Bolder BioTechnology, Inc. announced that it has been awarded a $1.2 million Phase II Small Business Innovation Research (SBIR) grant, entitled "Long-Acting EPO Analog for Treating Anemia Associated with Chronic Kidney Disease," from the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) of The National Institutes of Health (NIH). Receipt of the entire grant award is contingent upon the achievement of certain research milestones.

George (Joe) Cox, Ph.D., Company President and Principal Investigator for the grant, stated, "We are delighted to receive continued support from NIDDK for our long-acting EPO analog program. Each additional grant awarded is further validation for our unique protein engineering technology."

The new grant award will be used to perform preclinical toxicology studies, required by the Food and Drug Administration for filing an Investigational New Drug application, to begin testing Bolder BioTechnology, Inc.'s long-acting EPO analog in people.

Recombinant EPO products have annual worldwide sales of approximately $12 billion, with anemia associated with CKD accounting for more than half. A limitation of EPO therapy is the requirement for 2-3 injections weekly. Bolder BioTechnology, Inc.'s long-acting EPO analog has the potential to be administered once every 2-8 weeks, significantly reducing healthcare costs by allowing patients to make fewer visits to clinics for their treatments and by reducing costs associated with patient treatments. In addition, the increased potency and long duration of action of Bolder BioTechnology, Inc.'s EPO analog may provide patients with superior therapeutic benefits over current EPO products.

The NIH SBIR program is a peer-reviewed grant program that provides research support to small businesses to discover and develop innovative biomedical products for the treatment of serious unmet medical needs.

Bolder BioTechnology, Inc. uses advanced protein engineering technologies to create proprietary human protein pharmaceuticals with enhanced therapeutic properties for the treatment of hematopoietic and endocrine disorders, cancer and infectious diseases.

Statements contained herein that are not historical facts are forward-looking statements that are subject to a variety of risks and uncertainties. There are a number of important factors that could cause actual results to differ materially from those expressed in any forward-looking statements made by the Company. These factors include, but are not limited to: (1) the Company's ability to successfully complete product research and development, including pre-clinical and clinical studies, and commercialization; (2) the Company's ability to obtain required government approvals; (3) the Company's ability to attract and/or maintain manufacturing, sales, distribution and marketing partners; and (4) the Company's ability to develop and commercialize its products before its competitors.

Source: Bolder BioTechnology, Inc