Bolder BioTechnology awarded NIH grant to continue development of growth hormone product

Dec 16 2008

Bolder BioTechnology, Inc. today announced that it has been awarded a $1.9 million Phase II Small Business Innovation Research (SBIR) grant from the National Institute of Allergy and Infectious Diseases (NIAID) of The National Institutes of Health (NIH).

The grant will be used to perform additional preclinical toxicology and pharmacology studies of the company's proprietary long-acting growth hormone product, which is being developed as a potential treatment for growth hormone deficiency, short stature in children and HIV-associated adipose redistribution syndrome (HARS). 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 NIAID for our long-acting growth hormone program. Funding from a Phase I SBIR grant from NIAID allowed us to complete many of the studies required by the Food and Drug Administration for filing an Investigational New Drug application to begin testing our long-acting growth hormone analog in people. We obtained important proof-of-concept data demonstrating that our long-acting growth hormone analog can be administered less frequently, but with comparable efficacy, as a leading daily growth hormone therapy in a validated animal model of growth hormone deficiency. Recombinant human growth hormone products have annual worldwide sales of over $2 billion. However, these products are inconvenient to use because they must be injected daily, typically for many years. We expect our product will be a once weekly growth hormone therapy, providing patients with an easier to use and potentially more effective treatment for their disease."

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.