Trial Expands the Potential Application of Surfaxin
to Pediatric Critical Care
Conference Call Today at 10:00 A.M. EDT
WARRINGTON, Pa., June 7, 2007 (PRIME NEWSWIRE) -- Discovery Laboratories, Inc. (Nasdaq:DSCO) today announced the initiation of a Phase 2 clinical trial evaluating the use of Surfaxin(r) (lucinactant) in children up to two years of age suffering from Acute Respiratory Failure (ARF). Surfactant dysfunction is a key component of ARF. This new trial will explore the expanded application of surfactant therapy to pediatric critical care medicine. Surfaxin, the first peptide-containing (KL-4) synthetic surfactant, has received an Approvable Letter from the FDA for the prevention of Respiratory Distress Syndrome (RDS) in premature infants. In addition, a reduction in morbidity was observed with Surfaxin in a Phase 2 clinical trial for premature infants at risk for Bronchopulmonary Dysplasia (BPD).
Discovery Labs will hold a conference call today at 10:00 AM EDT to further discuss the foregoing. The call in number is 866-332-5218. Further details are provided below.
Acute Respiratory Failure occurs when lung tissue is significantly damaged, leading to an impairment in lung function and the requirement for endotracheal intubation and mechanical ventilation (the current standard of care). The most common cause of respiratory failure in these children is viral infection of the lung, particularly influenza and respiratory syncytial virus (RSV). Acute Respiratory Failure affects approximately 15,000 children under two years of age in the United States with an estimated 30,000-40,000 children afflicted in developed countries each year, depending on severity of the viral season. Presently there are no approved drugs for the management of ARF.
Adrienne G. Randolph, M.D., M.Sc., Associate Professor of Anaesthesia, Harvard Medical School and Senior Associate in Critical Care at Boston Children's Hospital, commented, "Acute Respiratory Failure is a major cause for the admission of children into the intensive care unit. There is a clear unmet medical need for better therapeutic options to help these children. A new medical therapy that reduces the duration of mechanical ventilation for patients with Acute Respiratory Failure would be considered clinically important."
Children with Acute Respiratory Failure have reduced levels of functional surfactant. Damage to the lung that causes ARF usually leads to surfactant dysfunction and decreased surfactant production. When there is insufficient functional surfactant in the lung, the air sacs collapse and are unable to support sufficient oxygenation. Discovery Labs is conducting a clinical program to determine if restoration of surfactant with Surfaxin will improve lung function and result in a shorter duration of mechanical ventilation and Pediatric Intensive Care Unit (PICU) stay for children with Acute Respiratory Failure.
Discovery Labs' Phase 2 clinical trial is a multicenter, randomized, masked, placebo-controlled trial that will compare Surfaxin to standard of care with sham air control. Approximately 180 children under the age of two with ARF will receive standard of care and be randomized to receive either Surfaxin at 5.8 mL/kg of body weight (expected weight range up to 15 kg) or sham air control. The trial will be conducted at approximately 20 sites throughout the United States, Chile, and Europe. The objective of the study is to evaluate the safety and tolerability of Surfaxin administration and to assess whether such treatment can decrease the duration of mechanical ventilation in young children with ARF. The trial is expected to be completed by mid-year 2008.
Robert Segal, M.D., Senior Vice President & Chief Medical Officer of Discovery Labs, commented, "This Phase 2 clinical trial begins the expansion of our Surfactant Replacement Therapy pipeline into pediatric critical care medicine. Our Scientific Advisory Board, consisting of leading pediatric critical care experts, has strongly supported a clinical program using Surfaxin to help treat these young children. Published data with animal-derived surfactants suggest that surfactant therapy holds promise in treating children with Acute Respiratory Failure. We believe that Surfaxin, our peptide-containing synthetic surfactant with anti-inflammatory properties, is ideally suited to address ARF. To date, Surfaxin has demonstrated a robust clinical profile in our Phase 3 neonatal RDS program and encouraging results in a recently completed BPD Phase 2 clinical trial. We look forward to advancing Surfactant Replacement Therapy into the PICU."
Discovery Lab's Proprietary KL-4 Surfactant Technology: Product Candidate Surfaxin(r)
KL-4 is a 21 amino acid peptide that is designed to closely mimic the essential attributes of human surfactant protein B (SP-B). SP-B is the most important surfactant protein for the proper functioning of the respiratory system, and is essential for survival. KL-4 surfactant has the potential to be precisely formulated, either as a liquid instillate, aerosolized liquid or dry powder, to address various respiratory diseases affecting premature infants, children and adults.
Surfaxin, is a precision-engineered version of natural human lung surfactant and contains Discovery Lab's novel KL-4 peptide. Surfaxin, administered as a liquid-instillate, represents a potential alternative to the commercially available animal-derived surfactants. Data from Discovery Lab's pivotal, multinational SELECT study demonstrate that Surfaxin is significantly more effective in the prevention of RDS and results in improved survival (continuing through at least one year of life) and other outcomes versus comparator surfactants. The SELECT and STAR (a supportive Phase 3 study) trials, as well as a pooled Phase 3 analysis, have been presented at several international medical meetings and the results from the two studies were published in Pediatrics. In addition, top-line results from Discovery Lab's Phase 2 clinical trial for the prevention and treatment of BPD suggested that infants treated with up to five incremental standard doses of Surfaxin tended to have a lower incidence of death or BPD, a higher survival rate through 36 weeks post-menstrual age, and fewer days on mechanical ventilation.
Conference Call Details
Discovery Labs will hold a conference call today at 10:00 AM EDT to further discuss the foregoing. The call in number is 866-332-5218. The international call in number is 706-679-3237. This audio webcast will be available through a live broadcast on the Internet at http://investor.shareholder.com/media/eventdetail.cfm?mediaid=25849&c=DSCO&mediakey=1A992D71E1F4B3F57BBFC16C454709D0&e=0 and www.discoverylabs.com. The replay number to hear the conference call is 800-642-1687 or 706-645-9291. The passcode is 2462996.
About Discovery Labs
Discovery Laboratories, Inc. is a biotechnology company developing Surfactant Replacement Therapies (SRT) for respiratory diseases. Surfactants are produced naturally in the lungs and are essential for breathing. Discovery Labs technology produces a precision-engineered surfactant that is designed to closely mimic the essential properties of natural human lung surfactant. Discovery Labs believes that its proprietary SRT pipeline has the potential to advance respiratory medicine and address a variety of respiratory diseases affecting neonatal, pediatric and adult patients.
Discovery Labs lead product candidate, Surfaxin(r), is the subject of an Approvable Letter from the FDA for the prevention of Respiratory Distress Syndrome in premature infants. Surfaxin is also being developed for other neonatal and pediatric indications. Aerosurf(tm), Discovery Labs aerosolized SRT, is being developed to potentially obviate the need for intubation and conventional mechanical ventilation and holds the promise to significantly expand the use of surfactants in respiratory medicine. For more information, please visit our website at www.Discoverylabs.com.
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. Among the factors which could affect Discovery Labs actual results and could cause results to differ from those contained in these forward-looking statements are the risk that Discovery Labs may not profitably develop and market its products, the risk that financial market conditions may change, the risk that Discovery Labs will not be able to raise additional capital or enter into additional collaboration agreements, the risk that Discovery Labs will not be able to attract or retain qualified personnel or timely provide for a successful sales and marketing organization, risks relating to the progress of Discovery Labs research and development,, risks in the FDA or other regulatory agency review process generally, including that such regulatory authority will not approve the marketing and sale of a drug product even after acceptance of an application or that approval by such regulatory agency may be withheld, delayed and/or limited by indications or other label limitations, risks that the Chemical, Manufacturing and Controls section of Discovery Labs New Drug Application will not satisfy the FDA, risks relating to the ability of Discovery Labs or Discovery Labs third party manufacturers and development partners to manufacture or provide Discovery Labs with adequate supplies of drug substances and expertise for completion of any of Discovery Labs clinical studies, risks related to the ability of Discovery Labs and its collaborators to develop, manufacture and successfully commercialize products that combine Discovery Labs drug products with innovative aerosolization technologies, risks relating to drug manufacturing by Discovery Labs, risks relating to the significant, time-consuming and costly research, development, pre-clinical studies, clinical testing and regulatory approval process for any products that Discovery Labs may develop independently or with Discovery Labs collaboration arrangements, risks relating to the development by other companies of competing therapies and/or technologies, risks relating to reimbursement and health care reform, and risks relating to securities, product liability and other litigation. Companies in the pharmaceutical and biotechnology industries have suffered significant setbacks in advanced clinical trials, even after obtaining promising earlier trial results. Data obtained from tests are susceptible to varying interpretations, which may delay, limit or prevent regulatory approval. Those associated risks and others are further 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.