Access Pharmaceuticals Inc. Enters Research Collaboration on Nanoparticle Aggregate Drug Delivery Technology

Access Pharmaceuticals, Inc. today provided an update of progress in the development of its proprietary Nanoparticle Aggregate Drug Delivery System (“Nanoparticle Aggregate Technology.”) The Company also disclosed that it has entered into a research collaboration with a US major drug delivery company to assess the Nanoparticle Aggregate Technology. Due to confidentiality provisions in the Agreement, Access cannot disclose the name of the strategic partner.

The goal of the collaboration is to evaluate the utilisation of Access’ versatile Nanoparticle Aggregate Technology for the delivery of therapeutic proteins. The focus of the initial development project is to formulate proteins which are susceptible to degradation in the presence of solvents. The Nanoparticle Aggregate Technology is being developed primarily for the controlled release of water-soluble proteins. Access has demonstrated that these proteins can be incorporated into the aggregate in a simple cost effective manufacturing process using aqueous solutions at room temperature and that release of the protein from the nanoparticle aggregate can be tailored to meet the desired profile, allowing delivery lasting from several days, up to a projected six-month period.

Commenting on the collaboration, Kerry P. Gray, President and CEO of Access stated, “We are very pleased to be working with a highly regarded company in the field of drug delivery. Through this collaboration it is anticipated that the development of our exciting technology will be accelerated, as the partner company has significant experience developing drug delivery systems.”

Drug delivery from nanoparticle aggregates is based on several independent variables including nanoparticle size and chemical composition of the particle. The nanoparticle aggregate technology allows remarkable versatility in protein loading and subsequent release. Optimisation of a formulation can be achieved in a relatively short time for a given protein drug. Importantly, Access’ Nanoparticle Aggregate Technology can substantially reduce the “burst release” of the protein, which occurs with other delivery systems. In preclinical animal studies the ability to control the release of the protein for periods of 3-months and greater has been established. Additional preclinical animal studies have shown that the materials used to produce the aggregates, which are included in several FDA approved products, are biocompatible and therefore suitable for use in a drug delivery system.

Mr. Gray further commented “Access’ Nanoparticle Aggregate Technology represents one of the simplest delivery systems with great versatility for incorporating and delivering proteins. The ability to load the protein in a cost-effective manufacturing process without using solvents or polymerization and to tightly control the drug release profile are potentially very significant competitive advantages over other protein delivery technologies. Protein delivery represents an exciting and rapidly expanding market as they are being increasingly used to treat a wide variety of disease including cancer, infections, rheumatoid arthritis and autoimmune disease.”

Posted March 23^rd, 2004