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03/23/04 -- ACCESS
PHARMACEUTICALS, INC. (Amex: AKC) 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 utilization 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. Optimization 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."
Access
Pharmaceuticals, Inc.:
Access is an
emerging pharmaceutical company focused on developing both novel low
development risk product candidates and technologies with longer-term major
product opportunities. Access markets Aphthasol®, the only FDA-approved
product for the treatment of canker sores, and is developing products for
mucositis and other dermatological indications. Access is also developing
unique polymer platinates for use in the treatment of cancer and has
developed, in conjunction with its partner Strakan, Ltd., the marketed
product Zindaclin®, which utilizes ResiDerm®, our topical zinc delivery
system that provides rapid delivery and reservoir of a drug in the skin.
This press release contains certain
statements that are forward-looking within the meaning of Section 27a of the
Securities Act of 1933, as amended, and that involve risks and
uncertainties, including but not limited to statements made relating to our
Nanoparticle Aggregate Technology and the ability to commercialize this
technology. These statements are subject to numerous risks, including but
not limited to the uncertainties associated with research and development
activities, clinical trials, our ability to raise capital, the timing of and
our ability to achieve regulatory approvals, dependence on others to market
our licensed products, collaborations, future cash flow, our ability to
perform under our plan to regain compliance with AMEX listing standards, the
timing and receipt of licensing and milestone revenues, projected future
revenue growth and our ability to generate near term revenues, the future
success of the Company's marketed product Aphthasol® and products in
development including polymer platinate, OraDisc(TM) and our mucositis
technology, our ability to develop products from our platform technologies,
our ability to manufacture
amlexanox
products in commercial quantities, our sales projections and the sales
projections of our licensing partners, and other risks detailed in the
Company's Annual Report on Form 10-K for the year ended December 31, 2002,
and other reports filed by us with the Securities and Exchange Commission.
Source: Access Pharmaceuticals, Inc.
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