Clinical Trials

LiquiVent®

Alliance Pharmaceutical Corporation's product, LiquiVent®, is currently the only product being used in the FDA clinical trials. The FDA also has given this product a "fast-track" status because of its potential to treat life-threatening ARDS. It is currently in Phase 3 clinical trials at various research facilities around the country, including The University of Kansas Medical Center in Kansas City, Kansas. Other facilities that have documented information regarding their studies are The University of Michigan and The University of Washington. LiquiVent® has been administered to over 270 humans during the trials thus far.

Update: Results of the clinical trials were disappointing and Alliance is no longer pursuing partial liquid ventilation application for patients with ARDS. A clinical trial statement from Alliance, through its wholly owned subsidiary, PFC Therapeutics, states that the company plans to pursue development and commercialization of Oxygent, a synthetic therapeutic oxygen carrier to be used as a temporary red blood cell substitute.

Mr. Robert Koshinskie, President of Seahorse Medical, Inc. informs us that "...Seahorse Medical is currently (2002) the only firm committed to bringing liquid ventilation to the healthcare provider. The mission of Seahorse Medical is to commercialize the total liquid ventilation technology that has been developed at Temple University over the last 20 years".

For additional information about LiquiVent® or Alliance Pharmaceuticals, please visit their web site.

Preliminary reports say that with the administration of PFCs, ventilator days are decreased in patients under the age of 55 years-old. The decrease in ventilator days has not shown a great improvement in the mortality rate. Hopefully the mortality rate will decrease in the future. Current mortality rate for ARDS patients using lung protective strategies or partial liquid ventilation are 15% and 19% respectively. Lung protective strategies have dropped the mortality rate of ARDS from 40-50% to less than 20%.

PFCs are not only used for acute respiratory failure. They are being studied for their properties to decrease inflammation that would prevent disruption, leakage, and injury to the lungs. Also with the opacification of lung tissue, they have been used to determine lung deformities. PFCs have many properties that we don't fully understand.

We would like to thank Alliance Pharmaceutical Corporation for the many resources that they provided.

 

The following is an example of the inclusion and exclusion criteria for some of the clinical trials currently underway.

Inclusion criteria for patients to be started on PLV trials:
• Subject is between 15 and 75 years of age
• Subject is intubated and on a ventilator
• Subject has pulmonary parenchymal disease identified by bilateral infiltrates on CXR
• Subject has impaired oxygenation as evidenced by PaO2/FiO₂ ratio 70 to 300 on FiO₂ >= 50%
• A second physician familiar with the patient must confirm eligibility

Exclusion Criteria
• Ventilator support for more than 5 days
• Tidal volume < 4 ml/kg
• Neuromuscular respiratory failure or cardiac failure causing respiratory failure
• Lung surgery in past 30 days
• Status asthmaticus or severe chronic COPD
• Systolic BP < 90
• Intubated for chronic interstitial lung disease
• Active air leak into pleural space
• Refractory seizures
• High risk of mortality within 3 months
• Known hypersensitivity to perfluorocarbons
• Pregnancy
• Other experimental drug within 30 days
• Creatinine > 3.0
• Total bilirubin > 2.0 and albumin < 2.5
• PT > 3 sec above control (if not on anticoagulants)
• Platelets < 75,000
• WBC < 1000
• DIC
• APACHE II score > = 30