Newly-Published Study Compares SURFAXIN with Animal-Derived Surfactants in Well-Established Model of RDS
WARRINGTON, Pa., Sept. 6, 2012 /PRNewswire/ -- Discovery Laboratories, Inc. (NASDAQ: DSCO), a specialty biotechnology company dedicated to advancing a new standard in respiratory critical care, today announced the publication of SURFAXIN® (lucinactant) preclinical data in Pediatric Research. Using a well-established preterm lamb model of respiratory distress syndrome (RDS), study investigators concluded that early intervention with SURFAXIN may mitigate progression of pulmonary pathophysiological consequences of RDS when compared with the animal-derived surfactants Curosurf® and Survanta®. The newly-published data can be found in the September 2012 issue of Pediatric Research, a peer-reviewed medical journal widely read by academic neonatologists and other neonatal health care professionals.
According to study findings, subjects receiving surfactant replacement therapy (SRT) using SURFAXIN had improved sustained oxygenation and lower ventilatory pressure requirements (p < 0.05) compared with no SRT or SRT using Curosurf or Survanta. In addition, SURFAXIN treatment resulted in an attenuated lung and systemic inflammatory response as well as a more uniform and robust preservation of lung structural integrity.
"Findings such as these improve our understanding of the role of SURFAXIN in modulating lung inflammation and preserving lung structure, and suggest that SURFAXIN may provide protection to the lung on both a mechanical and cellular level for potentially improved clinical outcomes," said Dr. Marla R. Wolfson, lead investigator and Professor of Physiology, Pediatrics, and Medicine at the Temple University School of Medicine. "The use of this RDS model allows us to further our understanding of potential mechanistic differences between surfactants in a way that may explain observations from clinical trials."
Investigators found that the lungs of preterm lambs that were treated with SURFAXIN were more homogenously expanded both within and between lung regions, a finding that is suggestive of more uniform distribution of surfactant throughout the lung. Investigators also found that the lungs of SURFAXIN treated lambs had less cellular debris and fewer inflammatory cells when compared with the lungs of non-treated lambs and the lambs treated with Curosurf and Survanta. The investigators also noted lower levels of inflammatory mediators following treatment with SURFAXIN compared with negative controls as well as both animal-derived surfactants.
RDS is a condition in which premature infants are born with an insufficient amount of pulmonary surfactant, a substance produced naturally in the lungs and essential for breathing. Today, infants with RDS often require surfactant replacement therapy along with mechanical ventilation to survive. Approximately 90,000 premature infants in the United States are treated annually with currently available animal-derived surfactants made from cow or pig lung extract.
This is the first publication of these data, which have been presented previously in part at medical conferences. The study was funded in part by a grant from Discovery Laboratories, Inc. Dr. Marla Wolfson does not have a financial interest in Discovery Laboratories, Inc.
SURFAXIN (lucinactant intratracheal suspension) is the first surfactant approved by the United States Food and Drug Administration in the 21st century and the only approved synthetic, peptide-containing surfactant. SURFAXIN is indicated for the prevention of respiratory distress syndrome (RDS) in premature infants at high risk for RDS. The safety and efficacy of SURFAXIN for the prevention of RDS in premature infants was demonstrated in a large, multinational phase 3 clinical program that included 1294 patients. Discovery Labs anticipates that SURFAXIN will be commercially available in late 2012.
IMPORTANT SAFETY INFORMATION
SURFAXIN (lucinactant intratracheal suspension) is intended for intratracheal use only. The administration of exogenous surfactants, including SURFAXIN, can rapidly affect oxygenation and lung compliance. SURFAXIN should be administered only by clinicians trained and experienced with intubation, ventilator management, and general care of premature infants in a highly supervised clinical setting. Infants receiving SURFAXIN should receive frequent clinical assessments so that oxygen and ventilatory support can be modified to respond to changes in respiratory status.
Most common adverse reactions associated with the use of SURFAXIN are endotracheal tube reflux, pallor, endotracheal tube obstruction, and need for dose interruption. During SURFAXIN administration, if bradycardia, oxygen desaturation, endotracheal tube reflux, or airway obstruction occurs, administration should be interrupted and the infant's clinical condition assessed and stabilized. SURFAXIN is not indicated for use in acute respiratory distress syndrome (ARDS).
ABOUT DISCOVERY LABS
Discovery Laboratories, Inc. is a specialty biotechnology company with one focus – to advance a new standard in respiratory critical care. Discovery Labs' novel proprietary KL4 surfactant technology produces a synthetic, peptide-containing surfactant that is structurally similar to pulmonary surfactant and is being developed in liquid, lyophilized, and aerosolized dosage forms. Discovery Labs is also developing its proprietary drug delivery technologies to enable efficient delivery of aerosolized KL4 surfactant and other inhaled therapies. Discovery Labs believes that its proprietary technologies make it possible, for the first time, to develop a significant pipeline of products to address a variety of respiratory diseases for which there frequently are few or no approved therapies.
ABOUT TEMPLE HEALTH
Temple Health refers to the health, education and research activities carried out by the affiliates of Temple University Health System and by Temple University School of Medicine.
Temple University Health System (TUHS) is a $1.4 billion academic health system dedicated to providing access to quality patient care and supporting excellence in medical education and research. The Health System consists of Temple University Hospital (TUH), ranked among the "Best Hospitals" in the region by U.S. News & World Report; TUH-Episcopal Campus; TUH-Northeastern Campus; Fox Chase Cancer Center, an NCI-designated comprehensive cancer center; Jeanes Hospital, a community-based hospital offering medical, surgical and emergency services; Temple Transport Team, a ground and air-ambulance company; and Temple Physicians, Inc., a network of community-based specialty and primary-care physician practices. TUHS is affiliated with Temple University School of Medicine.
Temple University School of Medicine (TUSM), established in 1901, is one of the nation's leading medical schools. Each year, the School of Medicine educates approximately 720 medical students and 140 graduate students. Based on its level of funding from the National Institutes of Health, Temple University School of Medicine is the second-highest ranked medical school in Philadelphia and the third-highest in the Commonwealth of Pennsylvania. According to U.S. News & World Report, TUSM is among the top 10 most applied-to medical schools in the nation.
To the extent that statements in this press release are not strictly historical, all such statements are forward-looking, and are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. These forward-looking statements are subject to certain risks and uncertainties that could cause actual results to differ materially from the statements made. Examples of such risks and uncertainties, including those related to the Company's research and development programs, are described in Discovery Labs' filings with the Securities and Exchange Commission including the most recent reports on Forms 10-K, 10-Q and 8-K, and any amendments thereto. Any forward-looking statement in this release speaks only as of the date on which it is made. The Company assumes no obligation to update or revise any forward-looking statements.
SOURCE Discovery Laboratories, Inc.
Posted: September 2012