During the late 70’s and early 80’s liposomes were reengineered to circulate longer in the blood and remain intact while doing so. This was done first by grafting the liposome with glycolipids, followed by a second generation and more robust grafting of the liposome with methoxypolyethylene glycol (mPEG), otherwise referred to as stealth™ liposomes. The PEG grafted liposomes increased the in vivo liposome stability, reduced MPS uptake and provided longer plasma residence times. In short, the liposome was engineered for use in the pharmaceutical industry, but still remand difficult to produce on large scale for production.

As a result, Azaya Therapeutics has developed its Protein Stabilized Liposome (PSL™) nanotechnology that utilizes a one step manufacturing process. The liposome product is prepared in a single step that encapsulates the active drug ingredient in the lipid layer of the liposome while forming active nanoparticles in situ (100-130 nm).

Although many of the known cyctotoxic agents are poorly soluble, Azaya’s PSL technology offers a potential solution that not only addresses formulation issues of poorly soluble compounds; it can also enhance the activity (efficacy) of known drug products through targeting mechanisms.

Azaya’s single step manufacturing process incorporates key characteristics that enhance existing liposomal technology for drug delivery. To date, there have been only moderate advances and Azaya’s PSL technology is a large step towards a more efficient and economical drug delivery system. Additionally, standardized manufacturing produces uniform particles that are necessary for passive targeting of cancer tumors via the EPR effect. In addition, Azaya Therapeutics PSL™ proprietary technology targets the over expression of key proteins that are found in tumor cells. With this superior technology, Azaya Therapeutics has conducted pre-clinical studies that have demonstrated improved therapeutic potential; enhanced pharmacokinetics, enhanced inhibition of tumor xenograft models, and evidence of increased tumor uptake of active compound.

Azaya is looking to partner with companies by offering an effective proprietary process to extend marketing life of existing or new development products by enhancing therapeutic performance.

Azaya’s initial product focus is to apply its PSL™ nanotechnology to currently approved drugs, such as Taxotere (docetaxel), in order to increase the probability of regulatory approval and reduce the associated risk and cost of development.

Azaya’s lead product candidate ATI-1123 (docetaxel) has demonstrated in preclinical studies superior pharmacokinetics and efficacy compared to Taxotere. Process development and implementation of GLP toxicology studies has been initiated. Alternatively, a secondary product candidate ATI-1150 (SN-38) is currently being evaluated in confirmatory preclinical studies.