AI-850™
Our Reformulation of Paclitaxel and Potential Bioequivalent of Abraxane®
AI-850, our initial product candidate utilizing our Hydrophobic Drug Delivery System or HDDS™ Technology, is a readily dissolving formulation of the hydrophobic drug, paclitaxel, the active ingredient in the cancer drug, Taxol™. It also appears to have a comparable pharmacokinetic profile with Abraxane, based upon human data available in publications on each drug. Paclitaxel is the active ingredient in Abraxane for Injectable Suspension,one of the fastest growing cancer drugs on the market today. Drug products that are confirmed to have equivalent pharmacokinetics in a human study may be eligible for regulatory approval as a bioequivalent and the development timeline is abbreviated, since Phase 2 and 3 clinical trials are usually not required.
To dissolve paclitaxel, Taxol contains Cremophor®, which is believed to cause severe hypersensitivity reactions, such as an extreme allergic reaction called anaphylaxis. Taxol is typically administered using pre-medications and by long infusions to patients with cancer.
By putting nanoparticles of paclitaxel into our sponge-like microspheres, we have created a paclitaxel formulation that is free of Cremophor and consists of paclitaxel nanoparticles in a porous, hydrophilic matrix, composed primarily of a sugar that has been proven to be innocuous in other injectable drugs.
Potential benefits include:
- No Cremophor-related adverse events
- No pre-medications
- Faster injections
- Cheaper and easier administration
AI-850 has completed Phase 1 human safety clinical trials. This study provides human proof-of-concept of our HDDS technology.
AI-850 appears to be bioequivalent to Abraxis Bioscience’s Abraxane®, a leading cancer drug that some analysts expect will reach peak sales of $1 billion a year. Acusphere has licensed its HDDS technology for oncology therapeutics applications, as well as the rights to AI-850, to Cephalon Inc.