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2004 World Technology Awards Winners & Finalists

Hydra Biosciences, Inc.

Please describe the work that you are doing that you consider to be the most innovative and of the greatest likely long-term significance.

Focused on Cardiac Regeneration: Hydra Biosciences is developing novel medicines designed to regenerate heart muscle and improve cardiac function in millions of people. Several million myocardial infarctions (MIs) occur each year world wide and result in compromised heart function ultimately contributing to the two million annual diagnoses of congestive heart failure (CHF). Current therapies for MIs attempt to minimize the damage incurred by loss of blood flow to the contracting heart muscles. Additionally, drug regimes for treating chronic CHF attempt to reduce the work required for pumping, either by increasing contractility of the undamaged myocardium or reducing systemic resistance against which the heart pumps. Both approaches to address long-term cardiac function have limited impact because they do not treat the underlying problem: the loss of function that occurs when damaged heart muscle heals by scarring. When medical therapies reach their limit, heart transplantation is the only remaining option and available for a few thousand people per year. As a result, over 300,000 people die of heart failure each year worldwide. Hydra Biosciences is developing its proprietary first-in-class protein therapeutics to regenerate cardiac muscle, eliminate scar formation and restore heart function in heart attack and heart failure patients. The Company’s research has made major advancements based on the work of its co-founder, Dr. Mark Keating, a Harvard Medical School professor recently nominated to the National Academy of Science for his cardiology research. Hydra is now advancing the candidate protein therapeutics into animal studies under the direction of its Chief Scientific Officer, Dr. Glenn Larsen, an industry veteran who has over 20 years of experience in developing protein therapeutics such as Enbrel for arthritis and BMP-2 for bone fracture.

Product Development Pathway and Market - A Unique Alternative to Stem Cells and Gene Therapy: Ongoing efforts to regenerate human tissues in vivo include stem cell approaches and gene therapy. In addition to the medical challenges with these therapies such as stem cell harvesting and immunologic rejection, stem cell and gene therapy approaches have additional hurdles including the undefined drug approval process at the US Food and Drug Administration (FDA) and the societal and ethical issues associated with stem cell use. Hydra’s protein-based therapeutics offer a compelling and unique alternative to cell-based therapies for cardiac tissue restoration by modulating cardiomyocyte proliferation with human growth factors. Hydra’s approach will accelerate the arrival of regenerative medicines to the marketplace by capitalizing on the established pathway for drug approval for protein-based therapeutics. Upon the completion of an investigational new drug application to appropriate national or pan-national regulatory agency, Hydra’s selected protein therapeutics will complete clinical trials for indications involving acute myocardial infarction and congestive heart failure. The Company expects to conduct detailed clinical trials to establish optimal administration of the drug to improve patient outcome. The total world-wide market for drugs used to treat the millions of people with congestive heart failure exceeds $10 billion dollars annually. The costs associated with hospitalization, lowered productivity and diminished quality of life adds tens of billions more. Successful development and marketing of a cardiac regeneration drug could yield billions of dollars in revenues and could result in millions of patients living healthier and more productive lives. Hydra is uniquely positioned to attract the investments and pharmaceutical partners required to develop and launch its cardiac regeneration therapies. The Company’s innovations will change the way physicians treat their heart attack and heart failure patients from diminishing the symptoms to curing the disease.