BDSI has already conducted animal studies with aspirin encapsulated using its cochleate technology and found that the tendency of the drug to cause gastrointestinal side effects is greatly reduced, while its efficacy is unaffected and may even be enhanced.
Aspirin is a member of the non-steroidal anti-inflammatory drug (NSAID) class, one the most commonly used medications taken by 14 million people in the US alone on a daily basis. All drugs in this class cause inflammation and ulcers in the GI tract, to a greater or lesser extent, and this massive exposure takes its toll. Each year, around 100,000 people are hospitalised and 10,000-20,000 die each year from NSAID-related complications.
Defiante, a subsidiary of Sigma-Tau Finanziaria, is interested in using BDSI's Biroal drug delivery technology into a new formulation of aspirin for use in humans. It is currently a stockholder in BDSI.
The cochleate encapsulation aims to get around this problem by incorporating the NSAID molecules in a matrix comprised of cochleates, a naturally occurring material based on calcium-phospholipid structures. Last year, the company presented preliminary data suggesting that aspirin delivered in this matrix did not cause GI inflammation in animals, and seemed to improve the delivery of the drug to target cells.
BDSI and Defiante are still in talks on the details of a licence agreement, and particularly on whether this will be on an exclusive or non exclusive basis. If no licence is taken out by the end of July, BDSI said, it will be free to approach other potential licensors of the technology.