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Optimum Dose of rhCC10 for Lung Protection in IRDS

Award Information
Agency: Department of Health and Human Services
Branch: National Institutes of Health
Contract: PHS2001-2
Agency Tracking Number: 1R41HL067612-01
Amount: $99,965.00
Phase: Phase I
Program: STTR
Solicitation Topic Code: N/A
Solicitation Number: N/A
Timeline
Solicitation Year: N/A
Award Year: 2001
Award Start Date (Proposal Award Date): N/A
Award End Date (Contract End Date): N/A
Small Business Information
335 PAINT BRANCH DR COLLEGE PARK, MD 20742
COLLEGE PARK, MD 20742
United States
DUNS: N/A
HUBZone Owned: No
Woman Owned: No
Socially and Economically Disadvantaged: No
Principal Investigator
 APRILE PILON
 (301) 405-8593
 AP96@UMAIL.UMD.EDU
Business Contact
 PILON, APRILE L
Phone: (301) 405-8593
Email: MZ45@UMAIL.UMD.EDU
Research Institution
 TEMPLE UNIVERSITY
 
TEMPLE UNIVERSITY
PHILADELPHIA, PA 19152
United States

 Nonprofit college or university
Abstract

DESCRIPTION (Scanned from the applicant's description): The proposed study
involves an evaluation of the dose response to recombinant human CC10 in the
preterm lamb, a surfactant-dependent model of neonatal/infant respiratory
distress syndrome (IRDS). The preterm lamb model was used in the clinical
development of artificial surfactants for the treatment of IRDS. CC10 is
normally secreted by the Clara cells of the tracheal and bronchial epithelia of
the mature lung. It is abundant in the extracellular fluids of the lungs and is
a natural component of endogenous surfactant. Analogous to surfactant, CC10 is
not present in the lungs of preterm babies. Preliminary results indicate that
CC10 is, in fact, essential to normal lung function, and that a replacement
strategy with rhCC10 may be effective in reducing pulmonary inflammation and
incidence of chronic lung disease (CLD) in premature babies treated for
respiratory distress. The safety of administration of high doses of rhCC10 has
already been established in pre-clinical studies in newborn piglets. A
controlled study to optimize the dose response for maximal lung protection and
define the clinical parameters to measure efficacy of rhCC10, administered in
conjunction with artificial surfactant, in a preterm surfactant dependent model
of IRDS, is now proposed.
PROPOSED COMMERCIAL APPLICATION:
CC10 is currently in Phase I of clinical development of rhCC10 for the prevention of neonatal broncho-pulmonary dysplasia. This study is important in designing effective dosing strategies
for further clinical development. According to recent estimates, approximately 90,000
premature babies are born in the U.S. each year. Of those, about 50,000 will have infant
respiratory distress syndrome (IRDS) AND 20,000 of those babies with IRDs will develop
BPD or some form of chronic lung disease. The annual cost of treating these babies in the
first three months of life is about $200,000 each for an annual expense of a minimum of
$4 billion. Many of these babies continue to have respiratory problems throughout childhood
and the cost of this continued care have not been included in the $4 billion/year estimate.
Recombinant human CC10 has the potential to prevent this disease and reduce the annual
economic burden of caring for these children. RhCC10 may also be important in treating
many pediatric and adult respiratory diseases as well.

* Information listed above is at the time of submission. *

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