Alliance Pharmaceutical Corp. announces Phase II LiquiVent results in adult AHRF patients.
LiquiVent is being co-developed worldwide by Alliance Pharmaceutical Corp. (NASDAQ:ALLP) and Hoechst Marion Roussel. Ronald B. Hirschl, M.D. (University of Michigan), a principal investigator in the Phase II trial, presented the findings of the study, which enrolled 90 adult patients, 65 of whom received LiquiVent in the partial liquid ventilation (PLV) technique, and 25 of whom were treated by conventional mechanical ventilation (CMV).
The patients ranged in age from 15 to 75 and varied markedly in the cause and severity of their underlying disease. The study evaluated the safety of the PLV procedure, dosing and ventilator management strategies, and the effect of LiquiVent therapy on patients of different demographic and disease classifications.
Hirschl reported that PLV with LiquiVent was a safe procedure in this adult population and that, compared to CMV, a significant reduction in the number of days on mechanical ventilation support and improved survival were observed in the 58 patients who were 55 years of age or younger and who met the study definition of AHRF, regardless of their underlying injury or disease.
An imbalance between study groups in the number of patients greater than age 55 resulted in insufficient control patients (2) vs. LiquiVent-treated patients (18) to allow assessment of the effect of the drug in the older sub-population.
Hirschl reported that older AHRF patients generally have more severe disease, often involving multiple organs, and therefore have a poorer prognosis.
He suggested that the greater number of older patients in the LiquiVent treatment group was the probable explanation for the fact that the study was unable to demonstrate an overall difference in results between treated and control subjects.
Results of the study were shared recently with the U.S. Food and Drug Administration, and preparations are now under way for a larger, pivotal adult Phase II/III study.
In addition, LiquiVent is under development for use in pediatric AHRF patients, and large, pivotal clinical traits in this population are ongoing in the United States and Canada. Physician-sponsored clinical trials using LiquiVent to treat premature and neonatal infants with acute respiratory failure are also under way in the United States.
In collaboration with Hoechst Marion Roussel, preparations are being made to expand the LiquiVent clinical development program outside North America.
AHRF is a life-threatening pulmonary disorder than can result from many causes, including serious infections, traumatic shock, severe burns or inhalation of toxic substances. Patients with this disorder frequently have inflammation in their lungs, which leads to blockage of the small airways and collapse of alveoli (air sacs), resulting in inadequate exchange of oxygen and carbon dioxide.
To improve their blood oxygenation and to support life until the underlying cause can be resolved, these patients are placed on mechanical ventilators. The high ventilator pressure needed to force air into the lungs and the continuous administration of high concentrations of oxygen can, however, further damage a patient's lungs.
LiquiVent is a unique oxygen-carrying liquid drug that is being co-developed by Alliance and Hoechst Marion Roussel for use in the proprietary PLV technique, which involves administering the drug directly into the lungs of a patient who is being supported by a mechanical ventilator.
The goal of LiquiVent therapy is to reduce a patient's exposure to the harmful effects of CMV. Animal studies have demonstrated that LiquiVent opens collapsed alveoli and improves gas exchange, allowing a reduction in ventilator pressure and oxygen concentration.
PLV with LiquiVent may also offer a means of lavaging (washing) the lungs to remove mucus and debris, and could be effective in reducing alveolar inflammation.
Alliance is a pharmaceutical research and development company focusing on transforming novel scientific discoveries into innovative drug products.
In addition to LiquiVent, two other drug products based on Alliance's perfluorochemical technologies are currently in clinical studies: Oxygent (perflubron emulsion), an intravascular oxygen carrier to reduce or eliminate the need for allogeneic (donor) blood transfusions during elective surgery, which is being co-developed with affiliates of Johnson & Johnson; and Imagent US, an intravenous contrast agent for enhancement of ultrasound images to detect blood flow abnormalities (perfusion defects).
CONTACT: Alliance Pharmaceutical Corp., San Diego
Gwen Rosenberg, 619/558-4375
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|Date:||Feb 10, 1997|
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