By Mary Welch
Alliance Pharmaceutical Corp. said results of two Phase III studies of Imagent, its intravenous contrast agent, showed a highly statistical improvement in visualizing the walls of the heart over the standard ultrasound imaging.
The San Diego-based company intends to file a new drug application (NDA) in the next few months.
The multicenter study involved about 500 patients who had been referred to cardiologists by their doctors. ¿The cardiologists believed that a visual evaluation of the heart was necessary,¿ said Mark Walters, project director, contrast agent development, adding that the evaluation ¿could be necessary for a variety of reasons.¿
In addition, all the patients had previously undergone the standard echocardiography (ultrasound) procedures, which had not resulted in optimal images of the heart.
¿Again, there could be a number of reasons why a good ultrasound picture could not be taken, such as obesity, the ribs are too close or they may be smokers and have a lot of junk in their lungs,¿ Walters said. ¿Whatever the reason, the end result is that doctors had a hard time distinguishing the heart¿s image, especially the walls,¿ he said.
Imagent consists of microscopic bubbles derived from Alliance¿s perfluorochemical and surfactant technologies. The product was developed to enhance images using gray scale, color Doppler and harmonic imaging techniques.
The agent is injected into the blood, where it enhances cardiac ultrasound images and helps detect abnormal blood flow. Doctors can see the contrast between the bubbles and the surrounding tissues, which may reveal previously unseen vessels and heighten the visualization of blood supply to organs, tissues and tumors.
¿Wherever the blood goes, the bubbles follow,¿ Walters said.
These Phase III trials were designed to compare the endocardial border delineation (heart walls) of the two imaging processes. The company may expand the imaging agent¿s use to improve detection of myocardial perfusion, blood flow abnormalities and sold tumors in the liver, kidney, breast and prostate.
The trials, begun in September 1997, involved taking ultrasound images of the heart as well as Imagent and nuclear images. All were then sent to independent laboratories, where cardiologists who knew nothing about the patients evaluated the images in terms of border definition and wall motion.
¿That¿s why it took so long,¿ Walters said. ¿We had to have all these images read ¿ more than 1,000. What was found was that Imagent provided clearer ultrasound images, which allows for a potentially more accurate diagnosis.¿
Alliance expects Imagent could reach the market next year. Imagent is being developed jointly with Schering AG, of Berlin. The two formed their partnership in 1997, with Schering agreeing to pay up to $65 million, excluding royalties, to develop the product. Alliance did not receive a milestone for Phase III results.
Last month, the company said it hoped to raise $20 million by selling up to 10 million shares of common stock. The funding would be used to underwrite Imagent¿s NDA filing as well as the development of two other products now in Phase III trials. (See BioWorld Today, April 16, 1999, p. 1.)
One of the other products is Oxygent, an intravascular oxygen carrier, or ¿blood substitute,¿ that carries oxygen to tissues through the bloodstream. The other is LiquiVent, a liquid ventilation agent that carries 20 times more oxygen than water, which currently is being tested in adults on mechanical ventilation with acute lung injury from such things as drowning, pneumonia and burns.
Any leftover money will be used to pay for the preclinical development of its new PulmoSpheres drug delivery system. PulmoSpheres are dry spheres that can encapsulate antibiotics, peptides and proteins as well as other drugs for use with a wide variety of inhalation devices.
The company¿s stock (NASDAQ:ALLP) closed Tuesday at $2.687, down $0.046.
Gwen Rosenberg, vice president of corporate communications for Alliance, said the lukewarm Wall Street reception is not unusual. ¿Whenever you¿re in the midst of a stock offering, you tend not to get the same reaction to good news as you would otherwise,¿ she said. n