New Type of Nano-Size Super-Magnetic Holders Capable of Carrying Different Biological Molecules without Damage Developed by Japanese Researchers

A new type of magnetic nanoparticles that are capable of constructing various types of functional proteins without damaging the activity have been developed for a wide range of applications such as analysis for gene function and research for lead compounds of medicinal products are revealed in U.S. Patent Application 20090325258.

Researchers at the Tokyo University of Agriculture and Technology (Fuchu-shi, JP) and Precision System Science Co,. Ltd (Matsudo-shi, JP) developed a process that makes it much easier to automatize a treatment with  nano-size magnetic particles . This was achieved by fitting nano-size magnetic particles (about 1 nm to several 100 nm) such as bacterial magnetic particles produced by a magnetic bacterium, to a particulate carrier having a size on the order of micrometer (ranging from about 1 .mu.m to several 100 .mu.m) in accordance with the purpose of the treatment.   

The magnetic particle holding carrier is formed of a micro-size nonmagnetic carrier and a plurality of nano-size magnetic particles bound to the carrier. Tadashi Matsunaga, Haruko Takeyama, Tomoko Yoshino and Hideji Tajima say by virtue of the structure of a magnetic particle holding carrier having a micro-size nonmagnetic particulate carrier and a plurality of nano-size magnetic particles held on the carrier, magnetism can be imparted to the nonmagnetic carrier.

Furthermore, since a plurality of nano-size magnetic particles are massively deposited onto a micro-size nonmagnetic particulate carrier, magnetic force applied to a single particle can be increased.

At the same time, since the carrier is a micro-bead and the surface of the micro-bead is covered with nano beads, the surface area of such a structure comes to be increased, with the result that a surface area/volume ratio per particle can be reduced.

As shown in FIG. 1(a), the magnetic particle holding carrier 11 according to the first embodiment has a micro-size nonmagnetic particulate carrier 12 (for example, Streptavidin Coated Beads, 1 .mu.m YG manufactured by Polysciences, Ink.), which has a particle size of about 1 .mu.m and is formed of latex whose surface is coated with streptavidin 13 serving as the receptor; a nano-size super-magnetic single domain particle(s) 14, which serves as the magnetic particles and is coated with a substance having biotin 15 serving as a ligand and an amino group; and a fluorescent dye 16 (Cy3-NHS) introduced to the amino group.

Japanese Ministry Approves EMEND® with Elan Drug Technologies NanoCrystal® for Treatment of Cancer Chemotherapy Induced Nausea & Vomiting

The Japanese Ministry of Health, Labor and Welfare has approved Elan Drug Technologies, a business unit of Elan Corporation, plc (NYSE: ELN) EMEND® (aprepitant) for the treatment of cancer chemotherapy-induced nausea and vomiting. EMEND®, which was developed by a subsidiary of Merck & Co Inc., Whitehouse Station, N.J., USA and licensed to Ono Pharmaceuticals Co., Ltd. for the Japanese market, is the first licensed product approved in Japan that incorporates Elan Drug Technologies’ NanoCrystal® technology.

NanoCrystal® technology, enables formulation of poorly water soluble compounds for all routes of administration. For EMEND®, this technology advance eliminates a food requirement and improves bioavailability by 600%. EMEND® was confirmed to be effective for both acute and delayed phases of nausea and vomiting in Japanese clinical trials, and becomes the first therapy approved for treatment of delayed phase nausea and vomiting (24 hours or later after start of cancer chemotherapy) in Japan.

“The approval of EMEND® is a significant achievement for our NanoCrystal® technology, as it marks the first Japanese approval of a product incorporating this technology in this very important market,” said Shane Cooke, Executive Vice President and Head of Elan Drug Technologies. “We hope this is the first of many products using our NanoCrystal® technology to be launched in Japan.”

In another matter, Elan Corporation, plc and Transition Therapeutics, Inc notified clinical investigators of modifications to the Phase II study AD201 and open label extension study AD251 for ELND005, a compound being developed for the potential treatment of Alzheimer's disease. The AD201 study is evaluating three dose levels of ELND005 compared to placebo in 353 patients.

Patients will be withdrawn immediately from the study in the two higher dose groups (1000mg and 2000mg dosed twice daily). The study will continue unchanged for patients who are assigned to the lower dose (250mg dosed twice daily) and placebo groups. The AD251 study will be modified to dose patients only at 250mg twice daily.

The decision by the companies to take these actions was made in concurrence with the Independent Safety Monitoring Committee (ISMC) following a review of the ongoing ELND005-AD201 study. Greater rates of serious adverse events, including nine deaths, were observed among patients receiving the two highest doses. A direct relationship between ELND005 and these deaths has not been established.

The ISMC and both companies concur that the tolerability and safety data are acceptable among patients receiving the 250mg dose and that the blinded study should continue for this dose and the placebo group.

"The “decision speaks to our strong commitment to patient safety while allowing for the continued evaluation of ELND005 at the 250mg dose, twice daily," said Menghis Bairu, M.D., EVP, Chief Medical Officer and Head of Global Development at Elan. "We continue to expect the ongoing study to provide important data to guide the next steps in the development of ELND005 for the potential treatment Alzheimer's disease."

ELND005 is an orally-administered therapeutic agent that has received fast track designation from the U.S. Food and Drug Administration (FDA) for treatment of mild to moderate Alzheimer's disease. Fast track designation can facilitate development and may expedite regulatory review of drugs that the FDA recognizes as potentially addressing an unmet medical need for serious or life-threatening conditions.

ELND005 is currently in a Phase 2 clinical study, which completed enrollment in October 2008. The study is a randomized, double-blind, placebo-controlled, dose-ranging, safety and efficacy study in approximately 353 patients with mild to moderate Alzheimer's disease. The planned treatment period for each patient is approximately 18 months.

NanoCrystal® technology is a proprietary technology developed by Elan Drug Technologies through Elan Pharma International Limited and other Elan affiliates. Five licensed products have now been approved using the NanoCrystal® technology by various health authorities including the US Food and Drug Administration (FDA). Products incorporating the NanoCrystal® technology are sold in markets worldwide.

Elan Drug Technologies (EDT), one of the world’s leading drug delivery businesses, is a business unit of Elan Corporation plc. As a fully integrated drug delivery business, Elan Drug Technologies delivers clinically meaningful benefits to patients, by using its extensive experience and proprietary delivery technologies in collaboration with pharmaceutical companies.

For 40 years, Elan Drug Technologies has been, and continues to be, a drug delivery provider of choice for a broad range of pharmaceutical companies, including many of the world’s leading pharmaceutical companies. Elan Drug Technologies offer clients drug delivery expertise with a suite of commercially launched, proprietary, technology-driven solutions, from NanoCrystal® technology for poorly water soluble compounds, to customised oral controlled release drug technologies. Products enabled by its technologies are used by millions of patients each day. For more information go to www.elandrugtechnologies.com

Alzheimer's disease, a leading cause of dementia, is a progressive brain disorder that gradually destroys a person's memory and ability to learn reason, make judgments, communicate and carry out daily activities. Alzheimer's disease may result from the build-up of toxic beta-amyloid peptides in the brain. As Alzheimer's disease progresses, individuals may also experience changes in personality and behavior, such as anxiety, suspiciousness or agitation, as well as delusions or hallucinations. It is currently estimated that more than 5 million Americans have Alzheimer's disease and more than 24 million people worldwide over the age of 60 have some form of dementia (Source: Alzheimer's Association and Alzheimer's Disease International).

Transition is a biopharmaceutical company, developing novel therapeutics for disease indications with large markets. Transition's lead products include ELND005 for the treatment of Alzheimer's disease and TT-223 for the treatment of diabetes. Transition has an emerging pipeline of preclinical drug candidates acquired externally and developed internally using its proprietary drug discovery engine. Transition's shares are listed on the NASDAQ under the symbol "TTHI" and the Toronto Stock Exchange under the symbol "TTH". For additional information about the Company, please visit http://www.transitiontherapeutics.com.

NanoCrystal® is a registered trademark of Elan Pharma International Limited, Ireland, a subsidiary of Elan Corporation plc.

EMEND® is a registered trademark of Merck & Co Inc.

Nanogate AG Acquires 25% Stake in Nanomedical Company sarastro GmbH

Nanogate AG (Göttelborn, Germany) (ISIN DE000A0JKHC9), a leading international nanotechnology enabler, is strengthening its sales potential through its equity holding in sarastro GmbH and is expanding its technical expertise to include bio-compatible solutions.

The nanotechnology company sarastro specialises in manufacturing antimicrobial and medically compatible surfaces. Nanogate and sarastro plan to enhance materials, surfaces and products for various applications with new biological properties and in doing so offer powerful solutions for a dynamically growing market. For 2009 sarastro anticipates sales in the high six-figure euros and was able to reach a sustainable level of profitability in the current financial year.

Through the transaction Nanogate is initially acquiring 25.1 % of the shares from the founders of sarastro GmbH. The purchase price is a low six-figure euro amount and is made up of cash and shares. In addition, Nanogate will soon implement a small capital increase from authorized capital. In a notarized contract, Nanogate AG has already secured the increase of its stake in the company to 51%. The option can be exercised in the coming years.

sarastro technology is already used in hearing instruments from Siemens and from a well-known Swiss manufacturer, in filtration plants for drinking water purification, and in PVC air and water hoses. Furthermore, the company produces disinfectants and other liquids using patented technology to create a particularly long-lasting disinfecting and antimicrobial effect. These are used by Wincor-Nixdorf, for example, in the maintenance of ATMs. Demand for these products is currently experiencing lively growth.

sarastro’s applications are based on the same chemical nanotechnology that Nanogate uses. The company is certified in accordance with the German Medical Devices Act. The first joint products in the Buildings/Interiors, Sport/Leisure and Automotive/Mechanical Engineering divisions are already at an advanced development stage and should come on the market next year.

According to Ralf Zastrau, CEO of Nanogate AG, “sarastro is an ideal partner for Nanogate in terms of strategy, technology and products. The demand for antimicrobially enhanced or bio-compatible surfaces and materials is growing rapidly. Consumers and industry increasingly require powerful solutions that protect against bacteria and germs. Nanogate will benefit significantly from the new equity holding. We expect it to make a positive contribution to earnings as early as 2010.”

Rainer Hanselmann, Managing Director of sarastro GmbH comments: “This partnership will enable Nanogate to increase its level of expertise and will also accelerate product development and market introduction processes at sarastro. Our skill in biological-medical applications with many well-known partners combined with Nanogate’s considerable industry expertise and broad customer base create an excellent foundation for numerous new applications and product solutions. sarastro and Nanogate will profit equally from this close collaboration.”

UF Offers Nanotechnology Licenses for Drug Detoxification Therapy and Environmental Decontamination Methods

Researchers at the University of Florida have developed novel methods of nanotechnology therapy for detoxification and decontamination. One method involves the absorption of toxic substances into or onto nanoparticles, by using molecular templating or by exploiting differences in physiochemical properties between the toxins and the nanoparticle. Another approach involves the transformation of toxic substances into inactive metabolites, by using nanoparticles as catalysts to quickly degrade the toxins using enzyme incorporation. This new technology provides highly effective techniques for reducing the free blood concentration and physiological effects of a wide range of toxic substances, including pharmaceuticals, biological and chemical toxins, and endogenous toxins produced during organ dysfunction. It is also valuable for removing toxins from skin and other surfaces, and for cleaning up environmental hazards such as chemical spills. Moreover, the technique can be tailored depending on the goal of the application and the specific properties of the toxins involved.

 The  University of Florida is seeking a company interested in commercializing novel methods of drug detoxification. Life-threatening toxicity can result from drug overdose, organ dysfunction, exposure to toxic chemicals, or biological warfare. It is a major health care problem throughout the world, affecting hundreds of thousands of patients each year. Current treatments are ineffective against most toxic substances. However, researchers at the University of Florida have developed complementary methods in medicine, particle engineering, molecular biology, and biochemistry to solve this difficult clinical problem in a broad manner. This new technology provides highly effective therapeutic techniques for reversing the physiological effects of a wide range of toxins. It is also useful for removing toxins from skin and other surfaces, and forcleaning up environmental hazards. 

Applications: Detoxification and decontamination in a wide range of applications, such as: reversing the physiological effects of toxic substances in humans and animals; eliminating toxins from organic and artificial surfaces and removing environmental hazards. 

Advantages:  Useful for a wide range of medical, veterinary, military, industrial, and environmental applications, ensuring multiple market opportunities; effective against a wide range of toxic substances, offering a broad therapeutic solution; capable of oral, intravenous, or surface use, providing flexible application; adaptable to specific applications, maximizing user acceptance. 

Current treatments are ineffective against most toxic substances. However, researchers at the University of Florida have developed complementary methods in medicine, particle engineering, molecular biology, and biochemistry to solve this difficult clinical problem in a broad manner. This new technology provides highly effective therapeutic techniques for reversing the physiological effects of a wide range of toxins. It is also useful for removing toxins from skin and other surfaces, and for cleaning up environmental hazards. 

Contact: Anthony Palmieri, Ph.D
University of Florida
Office of Technology Licensing
352/392-8929 • email: ap3@ufl.edu
Reference UF #10453; Patent pending

Endomagnetics Enters $500 Million a Year Gamma Probe Market for Breast Cancer with Simpler, Safer, Radiation Free Magnetic Tracer

Endomagnetics Ltd., an award-winning spinoff company from the University of Houston's Texas Center for Superconductivity (TcSUH) and University College London (UCL) seeks entry into the $500 million dollar a year gamma probe market for breast cancer with their radiation free, magnetic SentiMag cancer detection system.  

Based on 2007 cancer statistics and market research on the gamma probe market, of the 610,000 breast cancer and melanoma cases treated that year in North America, Western Europe, Japan and Australasia, only 153,000 were addressed using the gamma-probe. This indicates that there is a significant unmet need and a potential market worth at least $500 million, depending on the pricing and the choice of sales model.

Furthermore, the Endomagnetics solution provides a sensing platform that has applicability to other medical markets including the staging of lung, prostate and colon cancer, of which there were approximately 2,630,000 cases per year in North America, Western Europe, Japan and Australasia in 2007

The company is showcasing its SentiMag products at the 32nd Annual San Antonio Breast Cancer Symposium (Stand 142) to be held at the Henry B. Gonzalez Convention Center Dec. 9 - 13.  http://www.sabcs.org/.

Endomagnetics will showcase its pioneering technology developments in the intra-operative medical device segment by highlighting its second generation SentiMag technology, which radically alters the sentinel lymph node biopsy protocol through the use of magnetics rather than radiation in breast cancer staging. New SentiMag technology will vastly improve safety, accessibility and accuracy, and reduce treatment cost.

Endomagnetics Ltd. is an outcome of a research partnership between TcSUH and UCL that was established through the Texas/United Kingdom Bioscience Initiative - a program established in 2003 to develop intellectual property and enhance the commercialization of bioscience technologies in the UK and Texas.

The company's first product, SentiMag is an intra-operative medical device for use in the treatment of breast cancer. Globally, 1.25 million new cases of breast cancer are diagnosed each year. In most cases, surgery is required to remove the tumor. During the surgical procedure it is desirable to excise the sentinel lymph node - the node that receives drainage from the tumor - and inspect them microscopically to determine whether the cancer has spread.

Current methods of sentinel node detection present inherent and significant barriers to widespread adoption of the procedure. A key reason is that the current method is based on radiation, whereby locating the sentinel nodes involves injecting a radioactive dye into the lymph around the tumor. The dye then passes through the lymphatic system and collects in the sentinel nodes. The surgeon then uses a hand-held gamma probe to locate the node. However, the use of radioisotopes presents hospital administrators with an expensive logistical burden. There is also reluctance on the part of patients to receive a radioactive injection. Additionally, patients may not have access to hospitals or clinics with nuclear medicine facilities.
     
Furthermore, the current method is limited by the supply of radioactive isotopes that decay so quickly that they must be supplied to hospital nuclear medicine departments at least every two weeks, and which are made in only a handful of nuclear reactors worldwide. Additionally, an August 2009 issue of ScienceNews reports "...Production of the leading medical-imaging isotope is low and erratic, putting health care in jeopardy."

http://www.usnews.com/science/articles/2009/08/14/isotope-crisis-threatens-medical-care.html
       
Secondly, the handling of radioactive materials is subject to stringent regulations, requiring special staff training and segregation of the waste from the operating theater. Thirdly, the cost to the hospital of providing and handling the radioactive materials is high. Consequently, in all countries, the majority of women with breast cancer will never be offered sentinel node biopsy based on this method.
       
In contrast to the radioactive tracer, a typical magnetic tracer has a shelf life of several years. There are no staff safety issues, and therefore no regulatory burden. It is also much less expensive for the hospital than the radioactive tracer, and is, therefore, accessible to all.

Endomagnetics Ltd.'s approach to lymph node location radically alters the sentinel lymph node biopsy protocol. It uses a detection system based on magnetics rather than radiation, with the radioactive dye being replaced by an MRI contrast agent and a novel hand-held magnetic sensor replacing the gamma probe. This considerably simplifies the pre- and post-operative hospital procedures for sentinel lymph node biopsy, as hospitals and surgeons are freed from the constraints imposed by the use of radioactive materials during the staging procedure.