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 diagnostics.
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 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(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 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 .
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 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 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 owners.
DENDRITIC NANOTECHNOLOGIES INC.