MOUNT PLEASANT, Mich., Oct. 10 /PRNewswire/ -- DENDRITIC NANOTECHNOLOGIES
INC. (DNT), a company that is focused on the discovery, development, and
commercialization of dendrimer technologies to create a new generation of
innovative products for the identification and treatment of human diseases,
has entered into one of the first characterization collaborations with the
Nanotechnology Characterization Laboratory (NCL), an organization established
by the National Cancer Institute to foster collaboration between the
government and the private sector. The agreement with NCL will focus on the
characterization by NCL of DNT's STARBURST(TM) dendrimers as macromolecular
dendrimer-based MRI contrast agents for sensitive, non-invasive cardiovascular
DNT's STARBURST and Priostar(TM) dendrimers are "smart" biopharmaceutical
nanotechnology platforms that can be used to deliver precise quantities of a
drug or contrast agent to a specific location within the human body. DNT's
dendrimers will be subjected to an assay cascade consisting of physical
characterization, in vitro studies, and in vivo ADME/Tox protocols to
determine their absorption, distribution, metabolism, excretion, and toxicity.
DNT's proprietary dendrimer platform also serves as a targeted diagnostic and
therapeutic delivery system for a wide variety of drugs to cancer cells and
other diseases. Improved efficacy, enhanced solubility, and lower toxicity
have been demonstrated for many existing drugs.
The intent of these studies is to generate data in support of an
investigative new drug (IND) filing with the U.S. Food and Drug Agency (FDA).
It is estimated that the NCL's characterization efforts will take
approximately 12-15 months.
"Development of dendrimer-based MRI contrast agents for sensitive, non-
invasive intravascular agents is highly desired in the medical world," said
Robert Berry, DNT's chief executive officer. "DNT's STARBURST dendrimers have
demonstrated intravascular properties that increase sensitivity and image
clarity with potentially lower dosage compared to currently available general-
use contrast agents. DNT's smart nanostructures feature precise and
predictable physical properties that make them especially useful in commercial
applications requiring novel properties with nanometer precision."
The collaboration agreement with DNT is one of the first characterization
agreements entered into by the NCL and will be used to perform a preclinical
assessment of DNT's intravascular dendrimer-based MRI contrast agents. These
assessments will help provide the data necessary to enter the FDA's Phase I
clinical trials. This will be the second dendrimer-based application submitted
to FDA: Starpharma Holdings Ltd. (a DNT license holder and investor) is
currently entering Phase II clinical trials with a dendrimer-based topical
microbicide, VivaGel(TM), aimed at the prevention of HIV.
In 2005, the National Institute of Standards and Technology, the Food and
Drug Administration, and the National Cancer Institute established the
Nanotechnology Characterization Laboratory to perform preclinical efficacy and
toxicity testing of nanoscale materials. A key activity of the NCL will be to
work with FDA scientists to develop an assay cascade that can serve as the
standard protocol for preclinical toxicology, pharmacology, and efficacy of
nanoscale materials. This assay cascade will characterize a nanoscale device's
physical attributes, its in vitro biological properties, and its in vivo
Dendrimers -- an Emerging Platform for New Diagnostics
The versatility of the dendrimer architecture provides DNT and its
commercial partners with unique advantages. The ability to control the
properties of size, surface, and encapsulation are critical to any
intravascular agent product. Feasibility studies on dendrimer-based contrast
agents have demonstrated excellent carrying capacity, superior image
enhancement, and sufficient retention for imaging, with good routes of
elimination. The use of dendrimers as a platform for new therapies has already
yielded excellent results: DNT has encapsulated Magnevist(R), AG Schering's
off-patent, low molecular weight, market-leading contrast agent, within its
STARBURST and Priostar dendrimers. DNT's technology has allowed Magnevist
molecules to be contained within the dendrimer interior, resulting in the
creation of a macromolecular contrast agent with the surface available for
About the Nanotechnology Characterization Laboratory
The Nanotechnology Characterization Laboratory (NCL) performs and
standardizes the pre-clinical characterization of nanomaterials intended for
cancer therapeutics and diagnostics developed by researchers from academia,
government, and industry. The NCL serves as a national resource and knowledge
base for cancer researchers, and facilitates the development and translation
of nanoscale particles and devices for clinical applications.
The National Cancer Institute believes that the NCL's activities will
markedly speed the development of nanotechnology-based products for cancer
patients, reduce the risk of doing so, and encourage private-sector investment
in this promising area of technology development. By achieving its goals, the
NCL will provide a comprehensive set of baseline characterization parameters
that will enable cancer biologists, drug and diagnostic developers, and
clinical oncologists to apply their tools to solving problems that most affect
cancer patients. This work will also lay a scientific foundation that will
enable the FDA to make sound decisions concerning the testing and approval of
nanoscale cancer diagnostics, imaging agents, and therapeutics. See
DENDRITIC NANOTECHNOLOGIES INC. (DNT) is focused on the discovery,
development, and commercialization of dendrimer technologies to create a new
generation of innovative products for the identification and treatment of
human diseases. DNT's proprietary dendrimer platform serves as a targeted
diagnostic and therapeutic delivery system for a wide variety of drugs to
cancer cells and other diseases. Improved efficacy, enhanced solubility, and
lower toxicity have been demonstrated for many existing drugs.
DNT is committed to producing commercially viable dendrimers that can be
manufactured in large quantities, and to driving down manufacturing complexity
and costs. The company has a patent pending on its Priostar(TM) family of
dendrimers, a novel dendrimer family that breaks through previous cost and
DNT's technology development is directed by Donald A. Tomalia, Ph.D.,
president and chief technical officer. Dr. Tomalia is the inventor of
dendrimers and has led numerous commercial developments during a 25-year
management and senior scientist career with The Dow Chemical Company.
DNT is committed to developing and integrating dendrimer technologies via
corporate alliances that allow DNT scientists to use their combined expertise
to assist business partners by accelerating the pre-clinical development of
products that are significantly more effective and safer.
See http://www.dnanotech.com .
Starpharma (ASX:SPL) is an equity holder in DNT and is focused on the
development and application of dendrimer nanotechnologies as drugs against
major diseases. Starpharma's lead dendrimer product, VivaGel(TM) is currently
in U.S. FDA Phase II human clinical trials. VivaGel is a topical microbicide
gel product that has been developed for women as a preventative against the
sexual transmission of HIV.
NOTE: STARBURST and Priostar are trademarks of DENDRITIC NANOTECHNOLOGIES
INC. All other trademarks mentioned herein are held by their respective
SOURCE DENDRITIC NANOTECHNOLOGIES INC.