Linguamatics Ltd, a leader in enterprise text mining for the life science and other markets, announced that it has joined the Microsoft BioIT Alliance, an association of life science organizations and informatics companies whose focus is to enhance collaboration and accelerate the pace of drug discovery and development.

"As the amount of textual information impacting drug discovery and development programs grows exponentially each year, the ability to extract and share decision-relevant knowledge is crucial to streamline the process and raise productivity," said Roger Hale, COO and Co-founder of Linguamatics. "Linguamatics is delighted to be part of Microsoft's BioIT Alliance. As a leader in knowledge discovery from text, we look forward to working with other alliance members to explore new ways in which the immense value of text mining can be exploited across complex, multidisciplinary organizations like pharmaceutical companies."

"We are very pleased to welcome Linguamatics to the BioIT Alliance," said Rudy Potenzone, Worldwide Industry Technology Strategist for Pharmaceuticals at Microsoft and BioIT Alliance Coordinator. "Their commitment to innovation coupled with world-class experience and expertise in discovering and extracting relevant facts and relationships from text across the enterprise complements the capabilities of other Alliance members."

The BioIT Alliance is designed to enable collaboration among organizations in the life sciences field in order to shorten the time between discovery of new biological data and the application of that knowledge to human health.

About The Bioit Alliance

Formed in 2006, the BioIT Alliance is a cross-industry group working to integrate science and technology in order to accelerate the pace of drug discovery and realize the potential of personalized medicine. Founding members include Accelrys Software Inc., Affymetrix, Inc., Agilent Technologies Inc., Amylin Pharmaceuticals, Inc., Applied Biosystems, The BioTeam Inc., Digipede Technologies LLC, Discovery Biosciences Corporation, Geospiza Inc., Hewlett-Packard Development Company, L.P., Illumina Inc., InterKnowlogy, Microsoft Corporation, Sun Microsystems Inc., The Scripps Research Institute, VizX Labs LLC and other key companies in the pharmaceutical, biotech, hardware and software industries. Additional information about the BioIT Alliance can be found on the BioIT Alliance Web site at bioitalliance.

About Linguamatics

Linguamatics helps organizations to maximize the value derived from information resources through effective deployment of innovative natural language processing (NLP) based technology. The versatile interactive information extraction system, I2E, helps organizations to do much more than simply cope with vast quantities of information. Its unique combination of search and text mining helps organizations to turn this information into a competitive advantage. From life sciences and healthcare to business intelligence, from media analysis to security, users mine large collections of documents, extracting relevant facts, relationships and quantitative data from content such as scientific papers, news feeds, patents, or internal reports. Linguamatics has a rapidly growing user community with I2E deployed at most top-10 pharma companies. The company was founded in 2001, and has headquarters in Cambridge, UK.

Linguamatics

The International Vaccine Institute (IVI) announced the launch of the Dengue Vaccine Initiative (DVI), in collaboration with the Sabin Vaccine Institute (Sabin), the Johns Hopkins University (JHU), and the World Health Organization (WHO), to support development of vaccines to control dengue fever, a widespread and expanding hemorrhagic fever that is endemic in most tropical and subtropical regions of the world.

Through a $6.9 million grant from the Bill & Melinda Gates Foundation, DVI will accelerate the development and utilization of safe, affordable and broadly protective vaccines to combat dengue, a mosquito-borne infection which causes severe flu-like symptoms, and its potentially lethal complication dengue hemorrhagic fever, characterized by bleeding, plasma fluid leakage, and in severe cases shock and death. Each year, an estimated 2 million people with dengue hemorrhagic fever require hospitalization representing a significant burden on the fragile healthcare systems of developing and endemic nations.

"We are extremely grateful for the Gates Foundation's continued support of our critical work to promote the development of life-saving dengue vaccines and ensure their effective introduction. Dengue is an infection whose burden has increased sharply around the world," said Dr. John Clemens, Director-General of IVI. "The global dengue community is on the eve of many important breakthroughs in dengue research and development, and I believe that we'll make significant progress in controlling dengue within the decade."

An estimated 3.6 billion individuals (55% of the world's population) are at risk of contracting dengue, an infection caused by four distinct, yet closely related viruses. Recovery from one strain of dengue confers lifelong immunity against the infecting strain but increases the risk for development of hemorrhagic fever, shock, and death following infection from the other three strains.

"Development and use of a dengue vaccine represents the best hope of preventing cases, deaths and economic losses," said Dr. Ciro de Quadros, Executive Vice President of Sabin. "There are very few places that dengue does not impact. The infection is endemic in more than 100 countries across the globe and incidence of infection in typically unexpected places is increasingly common."

Current methods are limited to vector control, which have been largely ineffective at controlling dengue with the number of cases and geographic reach of the infection increasing dramatically each year. According to the WHO, the incidence of dengue has increased 30-fold over the last 50 years with 50 million dengue infections now occurring worldwide each year.

To contribute to raising the priority and support for new dengue vaccines likely to be licensed in a few years, DVI will undertake concentrated work in two countries-Colombia and Thailand-to generate data on the burden of disease, potential private demand, cost of illness and seroprevalence of dengue infection. In addition, DVI will carry out private demand and cost of illness studies in Brazil and Vietnam.

"Dengue is high on the agenda of many countries, so are the expectations into a dengue vaccine," said Dr. Joachim Hombach, Acting Head of WHO's Initiative for Vaccine Research. "Activities conducted under DVI will not only promote the development of safe and effective vaccines but ensure that products will be accessible and affordable to impoverished communities where the infection is endemic."

"In many cases, insufficient planning and financing for new vaccines has significantly slowed uptake in countries that need them most" said Dr. Orin Levine, Executive Director, International Vaccine Access Center (IVAC), Johns Hopkins Bloomberg School of Public Health. "At IVAC, we look forward to overcoming the economic obstacles to dengue vaccine use as part of DVI and to paving the way for rapid uptake of vaccines as early as 2015."

Source:
Dengue Vaccine Initiative
International Vaccine Institute
Sabin Vaccine Institute
International Vaccine Access Center (IVAC)
World Health Organization (WHO)

Tanabe Seiyaku Co., Ltd. has received approval for anti tumor necrosis factor (TNF)-a monoclonal antibody preparation REMICADE(R) for Drip Infusion 100 (generic name: infliximab) for extended indication of treating "Behcet's disease complicated with refractory uveoretinitis which does not respond to conventional therapies", for the first time in the world.

Behcet's disease is refracatory systemic inflammatory disease characterized by repeated episodes of relapses and recoveries, such as oral ulcer on the mucous membrane, dermatitis, uveoretinitis, and ulcer on the vulva. It is sometimes associated with inflammatory symptoms in the intestines, nerve, and vessel. As vision loss due to repeated ocular attacks is QOL (quality of life)-threatening, and suppression of frequency of ocular attacks is primarily important in the therapy.

It has been known from the recent researches that TNF-a, proinflammatory cytokine, is involved deeply in ocular attacks in uveoretinitis. REMICADE(R) produces a dramatic therapeutic effect in TNF-a involved inflammatory diseases by binding specifically to TNF-a and inhibiting its action, and it is expected to be highly effective also in uveoretinitis. As a result of the clinical study, it is proved that administration of REMICADE(R) in patients with Behcet's disease with refractory uveoretinits suppressed the frequency of ocular attacks.

Bechet's disease develops much in Japan, and nationwide, about 17,000 people are suffering from the disease. Tanabe Seiyaku will contribute to improve the patients' QOL through the proper use of REMICADE(R) by conducting post-marketing surveillance on all patients, and providing reliable safety information, as we have successfully completed in Rheumatoid Arthritis and Crohn's disease.

About Tanabe Seiyaku Co., Ltd.

Tanabe Seiyaku Co., Ltd. (TSE: 4508) is a manufacturer and distributor of pharmaceuticals for cardiovascular system, circulatory system, central nervous system, respiratory system and gastrointestinal system, tonics, antibiotics, chemotherapeutics, hormones, vitamins, diagnostic agents and mediums, as well as other products such as food additives and cosmetics. Operations are carried out through various divisions: prescription drugs, OTC drugs, diagnostic agents, animal drugs, chemicals, food additives, and dies/pigments.

Corporate Communications Division
Tanabe Seiyaku Co., LTD.
Corporate Communications Division

A team of scientists at JILA, a joint institute of the National Institute of Standards and Technology (NIST) and the University of Colorado (CU) at Boulder, has shown that by sampling a person's breath with laser light they can detect molecules in the breath that may be markers for diseases like asthma or cancer. While many studies have been done to showcase the potential of optical technologies for breath analysis, the JILA approach takes an important step toward demonstrating the full power of optics for this prospective medical application. Their findings are published in the latest issue of the Optical Society of America's open-access journal Optics Express.

The technique, called cavity-enhanced direct optical frequency comb spectroscopy, may one day allow doctors to screen people for certain diseases simply by sampling their breath. "This technique can give a broad picture of many different molecules in the breath all at once," says Jun Ye, who led the research. He is a fellow of JILA, a fellow of NIST and a professor adjoint at CU-Boulder's Department of Physics.

Optical frequency comb spectroscopy was developed in the 1990s by Ye's JILA colleague John L. Hall and Theodor W. Hänsch of Germany's Max-Planck Institute (they shared the 2005 Nobel Prize in Physics with Roy J. Glauber for their invention). In the paper, Michael Thorpe, a graduate research assistant, Ye, and their colleagues describe the novel application of this technique to breath analysis. Optical comb spectroscopy is powerful enough to sort through all the molecules in human breath, Ye says, but it is also sensitive enough to find those rarest molecules that may be markers of specific diseases.

Every time we breathe in, we inhale a complex mixture of gasses mostly nitrogen, oxygen, carbon dioxide, and water vapor, but also traces of other gasses, such as carbon monoxide, nitrous oxide, and methane. Each time we exhale, we blow out a slightly different mixture with less oxygen, more carbon dioxide, and a rich collection of more than a thousand types of other molecules most of which are present only in trace amounts.

Some of these tracer breath molecules are biomarkers of disease. Just as bad breath may indicate dental problems, excess methylamine can be used to detect liver and kidney disease, ammonia on the breath may be a sign of renal failure, elevated acetone levels in the breath can indicate diabetes, and nitric oxide levels can be used to diagnose asthma. When many breath molecules are detected simultaneously, highly reliable and disease-specific information can be collected. For instance, asthma can be detected much more reliably when carbonyl sulfide, carbon monoxide, and hydrogen peroxide are all detected in parallel with nitric oxide. The reported approach offers exactly this kind of potential.

In the experiments performed by Ye and his colleagues, optical frequency comb spectroscopy was used to analyze the breath of several student volunteers. They showed that they could detect trace signatures of gasses like ammonia, carbon monoxide, and methane on their breath. In one of these measurements, they detected carbon monoxide in a student smoker and found that it was five times higher when compared to a non-smoking student.

The researchers had the students breathe into an optical cavity a space between two standing mirrors. The optical cavity was designed so that when they aimed a pulsed laser light into it, the light bounced back and forth so many times that it covered a distance of several kilometers by the time it exited the cavity. This essentially allowed the light to sample the entire volume of the cavity, striking all the molecules therein. In addition, this lengthens the light-molecule interaction time thereby increasing the sensitivity. By comparing the light coming out of the cavity to the light that went in, Ye and his colleagues could determine which frequencies of light were absorbed and by how much. This information told them which molecules were present in the breath from the start. The remarkable combination of a broad spectral coverage of the entire comb and a sharp spectral resolution of individual comb lines allows them to sensitively identify many different molecules, as they show in their paper.

While the efficacy of this technique has yet to be evaluated in clinical trials, monitoring the breath for such biomarkers is an attractive approach to medicine because breath analysis is the ultimate non-invasive and low-cost procedure. Existing approaches to breath analysis are limited, because the equipment is either not selective enough to detect a diverse set of rare biomarkers, or it is not sensitive enough to detect trace amounts of the molecules exhaled in human breath. The biggest shortcoming of existing approaches is their inability to provide rapid and reliable breath measurements for many biomarkers. The new technique addresses these problems with its capability to rapidly, simultaneously, sensitively, and accurately detect many breath biomarkers. The results can qualitatively change the field of breath analysis, realizing its real potential as a low-cost, rapid, robust, and non-invasive method for health screening.

Funding for this work was provided by the Air Force Office of Scientific Research, Agilent Technologies Foundation, the Defense Advanced Research Projects Agency, NIST, the National Science Foundation, and a University of Colorado proof of concept grant.

Paper: "Cavity-enhanced optical frequency comb spectroscopy: application to human breath analysis," Michael J. Thorpe et al., Optics Express, Vol. 16, Issue 4, February 18, pp. 2387-2397; abstract at opticsinfobase/abstract.cfm?URI=oe-16-4-2387.

About OSA

Uniting more than 70,000 professionals from 134 countries, the Optical Society of America (OSA) brings together the global optics community through its programs and initiatives. Since 1916 OSA has worked to advance the common interests of the field, providing educational resources to the scientists, engineers and business leaders who work in the field by promoting the science of light and the advanced technologies made possible by optics and photonics. OSA publications, events, technical groups and programs foster optics knowledge and scientific collaboration among all those with an interest in optics and photonics. For more information, visit osa.

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The targeted agent nilotinib (AMN107) appears to offer striking benefits in patients with chronic myelogenous leukemia (CML) who are resistant to Gleevec, the standard therapy for this cancer, say researchers at The University of Texas M. D. Anderson Cancer Center.

Results of a 119-patient, phase I dose-escalation study, published June 15 in The New England Journal of Medicine, show that nilotinib offers a relatively favorable safety profile and obvious activity, researchers say, even though the study was not designed to measure the agent's effectiveness.

"We are very excited about this drug," says the study's lead investigator, Hagop Kantarjian, M.D., professor and chair of the Department of Leukemia. "With it, I believe we are going to make another quantum leap in the treatment of CML, allowing us to treat our patients according to their cancer's distinct molecular signature."

Nilotinib is the younger sibling of Gleevec, both of which were developed by Novartis Pharmaceuticals Corporation, which also funded the study. Preclinical studies have shown that nilotinib, which is administered in pill form, is up to 50 times more potent than Gleevec because it was designed to more efficiently bind to, and shut down, the protein enzyme responsible for the disease.
v The June 15 NEJM also includes a report on a phase 1 clinical trial for dasatinib, a medication developed by Bristol-Myers Squibb for CML and acute lymphoblastic leukemia, and an editorial noting the importance of both papers' findings for CML patients and for swift, targeted drug development based on an understanding of cancer at the molecular level.

While Kantarjian notes that nilotinib seems to have fewer side effects than Gleevec, which is considered a safe drug, some patients in this trial were found to have abnormal electrical activity in their hearts, and one patient experienced two cardiac events. "We believe this issue is manageable with the right dose of nilotinib and with careful monitoring, but of course we want to test the agent further to make sure it is 100 percent safe," he says.

"At this point, Gleevec should remain the standard of care," Kantarjian says. "For CML patients who respond to Gleevec, and most of them do, 93 percent are doing well five years after treatment."

The study, which included researchers and patients from M. D. Anderson, the University of Frankfurt and Heidelberg University in Germany, and the H. Lee Moffitt Cancer Center, tested nilotinib in Gleevec-resistant patients who had little or no other treatment options available to them.

The participants had either CML or "Philadelphia-positive" acute lymphocytic leukemia (ALL). These diseases are caused by the swapping of genetic material in bone marrow stem cells, which results in an abnormality called the Philadelphia chromosome, and creation of a new gene. This gene produces the fusion protein, BCR-ABL, which leads to development of leukemia. Gleevec and nilotinib both bind to, and inactivate, BCR-ABL.

In the trial, researchers continually increased the dose of nilotinib from a low of 50 mg. to as much as 1,200 mg. daily in some patients.

Nilotinib improved outcomes in all three forms of CML, and was most effective in treating chronic phase CML, Kantarjian says. Of the 12 patients in this category, 11 had a complete hematological remission of their cancer, meaning a disappearance of all findings consistent with advanced stage CML, and return of blood counts to normal.

A total of 13 of 33 patients in the blastic phase of the disease disease - the most advanced stage - had a hematological response (defined as control of white blood cell counts), and 9 had a cytogenetic response (elimination of cells with the cancer-causing defect). Of 46 patients in the accelerated phase, 33 had a hematological response and 22 had a cytogenetic response.
The agent had less activity than expected in patients with ALL. Only 2 of 13 patients responded, and that may be because the cancer was too advanced to be affected by a single drug, Kantarjian said.

The researchers also found that nilotinib's side effects were quite tolerable, and different than those seen with Gleevec. They included myelosuppression (a reduction in the ability of the bone marrow to produce blood cells), transient increases in bilirubin due to breakdown of red blood cells, and skin rashes.

Kantarjian adds that occasional patients experienced an abnormally long "QTcF" interval, a measurement of the time between the onset and the end of electrical activity in the heart's ventricular chamber. Prolongation of this interval is considered a marker of a cardiac arrhythmia. One patient had two adverse cardiac events that were associated with use of nilotinib, and one sudden death was reported in a patient beyond the follow-up time analysis, he says, but the cause of that death is unknown.

"This finding indicates the need for careful monitoring for cardiac events and arrhythmias in all patients who are receiving nilotinib, and a strict avoidance of medications that may prolong the QTcF interval," the researchers write in their paper.

"We would like to see, in the long run, if there are any unusual side effects to nilotinib, and then directly compare it with Gleevec in newly diagnosed CML patients," Kantarjian says. "In the future, nilotinib could possibly emerge as the standard of care."

Co-authors of the study include, from M. D. Anderson: Francis Giles, M.D., Susan O'Brien, M.D., and Jorge Cortes, M.D.; from J. W. Goethe Universitat, Frankfurt: Oliver G. Ottmann, M.D., Lydia Wunderle, M.D., Barbara Wassmann, M.D., and Dieter Hoelzer, M.D.; from Novartis Pharmaceuticals: Chiaki Tanaka, M.D., Paul Manley, M.D., Patricia Rae, William Mietlowski, Ph.D., Kathy Bochinski, Margaret Dugan, M.D., and Leila Alland, M.D.; Andreas Hochhaus, M.D., from the Univeristate Heidelberg; Kapil Bhalla, M.D., from Moffitt Cancer Center; Maher Albitar, M.D., Ph.D., from Quest Diagnostics; and James D. Griffin, from the Dana Farber Cancer Center.



From M. D. Anderson, Kantarjian reports having received lecture fees from Bristol-Myers Squibb and Novartis Pharmaceuticals and research grants from Bristol-Myers Squibb, Novartis Pharmaceuticals and MGI Pharma. Giles and Cortes reports having received research grants from Bristol-Myers Squibb and Novartis Pharmaceuticals. These arrangements are managed by M. D. Anderson in accordance with its conflict of interest policies.

Contact: Scott Merville

University of Texas M. D. Anderson Cancer Center

View drug information on Gleevec.