Clinical Trial Data (Phase 2a) Regarding Inhaled Amikacin Will Be Presented at American Thoracic Society International Conference
WHO: Dr. Michael S. Niederman, MD, Chairman, Department of Medicine, Winthrop-University Hospital, Professor of Medicine; Vice Chairman, Department of Medicine, SUNY at Mineoloa. Dr. Jean Chastre, Professor of Medicine, University of Paris. WHAT: Four posters detailing the results of a Phase 2a clinical trial evaluating the pharmacokinetic, serum and tracheal aspirate concentration, safety and antibiotic reduction properties of NKTR-061. Data will be presented and discussed at this ATS session to show a reduction in the use of IV antibiotics in mechanically ventilated patients during treatment of gram-negative pneumonia with NKTR-061. Further, the data indicate that the administration of NKTR-061 resulted in high tracheal aspirate concentrations and high epithelial lining fluid concentrations of amikacin in gram-negative pneumonia in intubated mechanically ventilated patients. Finally, data will be presented indicating that NKTR-061 achieves safe serum concentrations following multiple dosing in intubated mechanically ventilated patients with gram-negative pneumonia. WHEN: Monday, May 21st, 2007, 8:15-11:00 am (PT) WHERE: The American Thoracic Society (ATS) International Conference at the San Francisco Marriott Hotel.
NKTR-061 (inhaled amikacin) is being tested to evaluate the safety and tolerability of amikacin formulated for inhalation for the adjunctive treatment of gram-negative pneumonia in ventilated patients diagnosed with hospital or ventilator associated pneumonia. This new inhaled antibiotics product candidate leverages Nektar's proprietary Aerosol Generator that is designed to rapidly deliver aerosolized antibiotics to the deep lungs, both within and outside of a ventilator system. The result is a potentially faster-acting, potentially more effective treatment modality which provides key advantages over traditional pneumatic or ultra-sonic nebulizer.
ABOUT HOSPITAL-ACQUIRED GRAM-NEGATIVE PNEUMONIA:
Hospital-acquired, gram-negative bacterial pneumonia is a serious problem which afflicts patients even in the world's most advanced clinical settings. It is most commonly acquired by patients in intensive care units who have been put on ventilators for breathing assistance. Current treatment involves the administration of intensive antibiotics, supplemental oxygen, and intravenous fluids. Some 25-50% of those who acquire gram-negative bacterial pneumonia will die from it.
Nektar Therapeutics is a biopharmaceutical company with a mission to develop and enable differentiated therapeutics with its industry-leading pulmonary and PEGylation technology platforms. Nektar pulmonary and PEGylation technology, expertise, manufacturing capabilities and know-how have enabled nine approved products for partners, which include the world's leading pharmaceutical and biotechnology companies. Nektar also develops its own products by applying its pulmonary and PEGylation technology platforms to existing medicines with the objective to enhance performance, such as improving efficacy, safety and compliance.
This press release contains forward-looking statements regarding NKTR-061 and the company's pulmonary technology. These forward-looking statements involve risks and uncertainties, including but not limited to: (i) preclinical testing and clinical trials are long, expensive and uncertain processes, (ii) because the NKTR-061 program is in the early phases of clinical development, the risk of failure is high and can occur at any stage of development, (iii) the company's ability to obtain regulatory approval of NKTR-061 and (iv) there can be no assurance that the company's patent applications for NTKR-061 will issue; patents that have issued will be enforceable; or that intellectual property licenses from third parties may not be required in the future. Other important risks and uncertainties are detailed in the company's reports and other filings with the SEC, including its most recent Annual Report on Form 10-K and Quarterly Report on Form 10-Q. Actual results could differ materially from the forward-looking statements contained in this press release. The company undertakes no obligation to update forward-looking statements, whether as a result of new information, future events, or otherwise.
Posted: May 2007