Alliance Pharmaceutical Corp. Announces Plans to Re-Initiate LiquiVent Clinical Trials.

SAN DIEGO--(BW HealthWire)--Aug. 28, 1997--Alliance Pharmaceutical Corp. (NASDAQ:ALLP) announced today that it has completed an analysis of the Phase III LiquiVent(R) pediatric clinical trial for which enrollment was temporarily suspended in April.

Based on this analysis and results from previous studies, Alliance is planning to re-initiate North American clinical trials with LiquiVent by the end of the year. LiquiVent is being co-developed worldwide with Hoechst Marion Roussel.

LiquiVent is a unique oxygen-carrying liquid (perflubron) that is administered via a proprietary "partial liquid ventilation" (PLV) technique directly into the lungs of a patient who is being supported by a mechanical ventilator. The goal of PLV therapy with LiquiVent is to reduce the patient's exposure to the harmful effects of conventional mechanical ventilation.

The Phase III study involving pediatric patients with acute respiratory distress syndrome (ARDS) commenced in January 1996, and a protocol amendment was implemented in December 1996. The amendment included a number of study design modifications, including an adjustment of the criteria for patient inclusion in the trial.

After the modifications were implemented, there was an unexplained decrease in the mortality rate of the control group. Enrollment in the trial was suspended in April 1997, after the inclusion of approximately 200 patients, in order to evaluate the study design and to identify potential factors that contributed to the change in the control group mortality.

The analysis of the data indicated that there were changes in the patient demographics (age and disease etiologies) after implementation of the protocol amendment. Patients in the post-amendment control group were substantially younger and had different risk factors for ARDS, compared to the pre-amendment control group.

The post-amendment control group was also treated differently than the other patients in regard to the application of additional therapies such as extracorporeal membrane oxygenation, high frequency oscillatory ventilation, nitric oxide, or surfactants.

The post-amendment control patients received these therapies more frequently, earlier, and for a longer duration, compared to both the pre-amendment control group and the LiquiVent-treated patients. The disproportionate application of these therapies and the imbalance in the risk factors for ARDS following the amendment confounded attempts to compare responses between the PLV and control groups.

The study analysis also supported previous reports that PLV therapy with LiquiVent is a safe procedure. No deaths were attributed to LiquiVent by the clinical investigators. The favorable outcome for patients who received authorized extended dosing for up to ten days (five days beyond the protocol-specified five-day limit) provides a further confirmation of the safety of LiquiVent.

In addition to the Phase III pediatric trial, LiquiVent has been administered to adult patients with encouraging results.

As reported in February 1997, a randomized, controlled, Phase II clinical trial with adult acute hypoxemic respiratory failure (AHRF) patients demonstrated that, compared to conventional mechanical ventilation, PLV with LiquiVent resulted in an increase in survival and significant improvement in "ventilator-free days" for 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 assessment of patients who were older than 55 years could not be made due to the small number of control patients in this age group.)

Based upon these results, Alliance intends to initiate a study with adult patients before the end of the year. Adults represent approximately 80-90% of the patients who require mechanical ventilator support, and they are therefore the primary patient population who may benefit from PLV treatment.

Alliance and its development partner, Hoechst Marion Roussel, are evaluating the strategy for the development of partial liquid ventilation with LiquiVent in light of the data accumulated from the Phase II and III trials, and the information obtained regarding study design, patient demographics, and the application of additional therapies. A plan for the continuation of the development program is expected to be refined shortly.

Alliance is a pharmaceutical research and development company focusing on transforming novel scientific discoveries into innovative drug products.

In addition to LiquiVent, it has two other products based on its perfluorochemical technologies currently in clinical development: Oxygent(TM) (perflubron emulsion), an intravascular oxygen delivery system to temporarily augment oxygen delivery in surgical and other patients at risk of acute tissue hypoxia (oxygen deficiency), which is being co-developed with affiliates of Johnson & Johnson; and Imagent(R) US, an intravenous contrast agent for enhancement of ultrasound images to assess cardiac function and detect blood flow abnormalities (perfusion defects).

On July 21, 1997, Alliance announced an agreement in principle with Schering AG, Germany, for the worldwide co-development of Imagent US.

Except for historical information, the matters set forth in this release are forward-looking statements that are subject to risks and uncertainties that could cause actual results to differ materially from those set forth herein, including the uncertainties associated with the conduct of pre-clinical or clinical studies and the timing or ability to investigate scientific data.

The Company refers you to cautionary information contained in documents the Company files with the Securities and Exchange Commission from time to time, including the last Form 10-K and Form 10-Q, and those risk factors set forth in the recent registration statement on Form S-3 (Registration Number 333-06739).

CONTACT: Alliance Pharmaceutical

Gwen Rosenberg, 619/558-4375