Successful Completion of Phase 1/2 Part A Cystic Fibrosis Clinical Trial Announced by Discovery Laboratories
08:34 a.m. Mar 31, 1998 Eastern

DOYLESTOWN, Pa.--(BW HealthWire)--March 31, 1998--Discovery Laboratories, Inc. announced today that it has successfully completed Part A of its Phase 1/2 clinical trial, "The Treatment of Cystic Fibrosis (CF) Lung Disease by Inhalation of SuperVent(TM) Aerosol Solution."

Part A of this trial is an open-label study designed to evaluate the safety and tolerability of inhaled doses of SuperVent(TM) Aerosol Solution in twenty normal volunteers. Two groups received rising doses of SuperVent(TM), delivered by the Ventstream(TM) nebulizer. The first group of ten subjects were treated for fifteen consecutive days. That group received escalating doses of SuperVent(TM) Aerosol Solution up to either the 2.5 percent or 5 percent concentration in four or five dose increments, respectively. A second group of ten subjects were treated with SuperVent(TM) Aerosol Solution for 30 days to achieve steady-state dosing but at lower dose levels. Five of ten subjects in that group received 0.125 percent SuperVent(TM) Aerosol Solution on Day 1 followed by 29 consecutive treatments at 0.625 percent. Four of ten subjects received 0.125 percent SuperVent(TM) Aerosol Solution on Day 1, 0.625 percent on Day 2 followed by 28 consecutive treatments at the 1.25 percent concentration. One of ten subjects in the second group received 0.125 percent SuperVent(TM) Aerosol Solution on Day 1, 0.625 percent on Day 2 and 1.25 percent on Day 3 through 18 only, due to the development of a nonproductive cough.

In the 20 subjects studied, there were no statistically significant (p less than 0.05) changes in pulmonary function or other laboratory findings at any dose level studied. A number of subjects noted local symptoms (e.g. runny nose, nasal congestion, and throat irritation) which were described as minor and self-limited. One subject at the 1.25 percent dose level, two subjects at the 2.5 percent dose level and two subjects at the 5 percent dose level developed a nonproductive cough that resolved following treatment cessation. Another subject, whose cough persisted following dosing up to the 5 percent concentration, received beta-agonist puffs and corticosteroids until symptoms resolved.

This open label study was conducted at the University of Utah's Pulmonary Division under the sponsorship of John Hoidal, M.D., Division Chief and Professor of Pulmonary Medicine. Bruce Marshall, M.D., Associate Professor of Medicine and Co-director of the Intermountain CF Center at the University of Utah, is the principal investigator. David Crockford, Vice President of Clinical and Regulatory Affairs, stated, "I am happy to announce that the principal investigator and co-investigators have concluded that the safety profile of SuperVent(TM) Aerosol Solution allows for dosing up to the 1.25 percent concentration when administered to patients with obstructive airway disease such as in cystic fibrosis and chronic bronchitis. We expect to commence Part B of the Phase 1/2 clinical trial in cystic fibrosis patients in the next few months if not sooner."

SuperVent(TM) Aerosol Solution is a multidimensional therapy proposed for use in respiratory diseases characterized by inflammation, infurious oxidative effects and viscous, purulent lung secretions. The active compound in SuperVent(TM), tyloxapol, is a nonanionic alkylaryl and polyether alcohol, which is commercialized in lower concentrations in Japan for the treatment of chronic obstructive airways disease. Published in vitro pharmacologic studies by scientific consultants to the company have demonstrated tyloxapol's anti-inflammatory, anti-oxidant and mucoactive properties. David Crockford stated, "The combination of these pharmacological activities is not presently found in any drug commercialized in North America for cystic fibrosis, chronic bronchitis or emphysema."

Discovery is a Doylestown, Pa.-based bio-pharmaceutical company. Its mission is to develop and commercialize medically novel therapeutics for critical care. Presently, Discovery is developing proprietary pharmaceuticals to treat direct acute respiratory distress syndrome (ARDS), meconium aspiration syndrome (MAS), idiopathic respiratory distress syndrome (IRDS), cystic fibrosis and postmenopausal osteoporosis. Discovery plans to seek a partner for the development of ST-630. In November of 1996, Discovery completed a private financing of over $22 million. In November of 1997, Discovery merged with Ansan Pharmaceuticals Inc., a publicly traded, development stage pharmaceutical company. In February of 1998, Discovery entered into a management and merger agreement to acquire substantially its entire majority owned subsidiary, Acute Therapeutics Inc. More information about Discovery is available on the company's Web site at: www.discoverylabs.com.

To the extent that statements in this press release are not strictly historical, including statements as to future financial conditions, events conditioned on stockholder or other approval, or otherwise as to future events, such statements are forward-looking, and are made pursuant to the safe harbor provisions of the Securities Litigation Reform Act of 1995. The forward-looking statements contained in this release 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 the company's actual results and could cause results to differ from those contained in the forward-looking statements contained herein are the risk that financial conditions may change, risks relating to the progress of the company's research and development and the development of competing therapies and/or technologies by other companies. Those associated risks and others are further described in the company's filings with the Securities and Exchange Commission. (See also: http://www.businesswire.com)

Copyright 1998, Business Wire

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