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10-10-2005 (« Back to Newsroom)
MOUNT PLEASANT, Mich., Oct. 10 -- 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 STARBURSTTM dendrimers as macromolecular dendrimer-based MRI contrast agents for sensitive, non-invasive cardiovascular diagnostics. DNT's STARBURST and PriostarTM
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, VivaGelTM, 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 compatibility. 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®, 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 further
modification. 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 http://ncl.cancer.gov . About DNT
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 PriostarTM family of dendrimers, a novel dendrimer family that breaks through previous cost and manufacturing barriers.
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, VivaGelTM
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
owners.
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