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Nomir Medical Technologies, a leader in the development of optical energy technologies for anti-infective medical applications, announced that the Company will present an abstract detailing positive in vitro and in vivo human data from its study of onychomycosis (toe nail fungus) using Noveon®, a novel dual wavelength optical energy device. Noveon is designed to effect near-infrared photo-inactivation of fungi and bacteria at energies and temperatures that are safe to normal and healthy tissue.

The detailed data will be presented in a digital session at the New Cardiovascular Horizons "Wound Management of the Diabetic Foot and Wound Healing" conference in New Orleans, September 10-13, 2008.

In May 2008, Nomir initiated a pivotal product registration trial for Noveon for the onychomycosis indication.

About Nomir

Nomir Medical Technologies, Inc. is a medical device company with a product pipeline of optical energy therapeutics being developed for multiple clinical applications. Nomir’s light-based systems target the elimination of bacterial and fungal infections, while also promoting healthy tissue recovery. This potential therapy-altering technology may enhance the effectiveness of, or even reduce the need for antibiotics and antifungal agents, and may be associated with fewer treatment side-effects. Nomir has a broad patent portfolio with pending systems, methods and unique photobiological mechanism claims for near infrared photodamage to bacterial and fungal pathogens. http://www.nomirmedical.com

Forward-looking statements

Certain statements contained in this press release containing words like believe, intend, may, expect, project and other similar expressions are forward-looking statements involving a number of risks and uncertainties. Factors that can cause actual results to differ materially from those projected in the Company’s forward-looking statements include the following: market acceptance of our technologies, therapies, and products; our ability to obtain financing; our financial and technical resources relative to those of our competitors; our ability to keep up with rapidly changing technologies; government regulations of our technologies; our ability to assert and enforce our intellectual property rights and protect our proprietary technologies; the ability to attract and retain key employees; the ability to obtain and develop partnership opportunities; the timing of commercial product launches; the ability to achieve key milestones in key products and other risks factors from time to time in the Company’s announcements.

Nomir Medical Technologies, Inc.

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Ninety years after the sweeping destruction of the 1918 flu pandemic, researchers at Monroe Carell Jr. Children’s Hospital at Vanderbilt have recovered antibodies to the virus - from elderly survivors of the original outbreak.

In addition to revealing the surprisingly long-lasting immunity to such viruses, these antibodies could be effective treatments to have on hand if another virus similar to the 1918 flu breaks out in the future.

The study, led by James Crowe Jr., M.D., professor of Pediatrics and director of the Vanderbilt Program in Vaccine Sciences, Christopher Basler, Ph.D., at the Mount Sinai School of Medicine, and Eric Altschuler, M.D., Ph.D., at the University of Medicine and Dentistry of New Jersey-New Jersey Medical School, is published online in the journal Nature.

The influenza pandemic of 1918 killed nearly 50 million people worldwide, many of whom were young, healthy adults. With fears of another looming flu pandemic stoked by the emergence of "bird flu" in Asia, researchers have wanted to study the 1918 virus and the immune response to it.

In 2005, researchers from Mount Sinai and the Armed Forces Institute of Pathology in Washington, D.C., resurrected the 1918 virus from the bodies of people killed in the outbreak. The bodies, and the virus, had been preserved in the permanently frozen soil of Alaska.

When the investigators approached Crowe, whose lab had developed methods of making antibodies, to try to make antibodies to the 1918 flu, he was skeptical, but agreed to try.

The researchers collected blood samples from 32 survivors age 91-101 years and found that all reacted to the 1918 virus, suggesting that they still possessed antibodies to the virus.

Crowe’s team was then able to isolate exceedingly rare B cells - the immune cells that produce antibodies - from eight of those samples and grow them in culture. Seven of those samples produced antibodies to a 1918 virus protein, suggesting that their immune systems were waiting on standby for a long-awaited second outbreak.

"The B cells have been waiting for at least 60 years - if not 90 years - for that flu to come around again," Crowe said. "That’s amazing…because it’s the longest memory anyone’s ever demonstrated."

Crowe’s team then fused cells showing the highest levels of activity against the virus with "immortal" cells to create a cell line that secretes monoclonal (or identical) antibodies to the 1918 flu. The antibodies reacted strongly to the 1918 virus and cross-reacted with proteins from the related 1930 swine flu but not to more modern flu strains.

To test if these antibodies still work against 1918 flu in a living animal, Crowe’s collaborators at the Centers for Disease Control and Prevention infected mice with the 1918 flu and then administered the antibodies at varying doses. Mice receiving the lowest dose of 1918 antibody - and those receiving a non-reactive "control" antibody - died. All mice given the highest doses of 1918 antibodies survived.

Although aging typically causes immunity to weaken, "these are some of the most potent antibodies ever isolated against a virus," Crowe said. "They’re the best antibodies I’ve ever seen."

The findings suggest that B cells responding to a viral infection - and the antibody-based immunity that results - may last a lifetime, even nine or more decades after exposure.

These antibodies could be used as potential treatments for future outbreaks of flu strains similar to the 1918 virus. And the technology could be used to develop antibodies against other viruses, like HIV.

Most importantly, said Crowe, "the lessons we are learning about the 1918 flu tell us a lot about what may happen during a future pandemic."

Researchers at the Scripps Research Institute in La Jolla, Calif., also contributed to the study. The work was supported by grants from the National Institutes of Health.

Source: Craig Boerner
Vanderbilt University Medical Center

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Spectrum Pharmaceuticals, Inc., (NasdaqGM: SPPI) launched FUSILEV™ (levoleucovorin) for injection.

"The launch of FUSILEV establishes the foundation of Spectrum’s commercial oncology franchise," said Rajesh C. Shrotriya, M.D., Chairman, Chief Executive Officer, and President of Spectrum Pharmaceuticals. "We believe the market potential of FUSILEV, as a replacement for leucovorin, could be significant. In the U.S., there are more than 500 million milligrams of leucovorin prescribed every year. Our sales, under the currently approved indications, are expected to ramp up slowly until the full range of indications and formulations are approved. We have built a team of highly seasoned sales and marketing professionals with a record of success in launching and marketing oncology drugs."

The Company recently filed an amendment to its pending New Drug Application (NDA) for FUSILEV Tablets. The Oncologic Drugs Advisory Committee (ODAC) has already voted affirmatively that the oral formulation is safe and effective when used in the rescue of high dose methotrexate. The Company continues to work on the supplemental NDA for use of the parenteral formulation in combination with 5-FU containing regimens in advanced metastatic colorectal cancer. As a result of pre-NDA consultation, FDA has recommended a more comprehensive scope of data analysis as the basis for registration in this indication. The Company anticipates filing the supplemental NDA for colorectal cancer by the end of October 2008.

About FUSILEV (levoleucovorin) for injection

FUSILEV, a novel folate analog, is available in 50-mg vials of freeze-dried powder. It is the pharmacologically active isomer of leucovorin. FUSILEV rescue is indicated after high-dose methotrexate therapy in osteosarcoma. FUSILEV is also indicated to diminish the toxicity and counteract the effects of impaired methotrexate elimination and of inadvertent overdosage of folic acid antagonists. FUSILEV (levoleucovorin or (6S)-leucovorin) is the only commercially available formulation comprised only of the pharmacologically active isomer of leucovorin.

Important FUSILEV (levoleucovorin) for injection Safety Considerations

FUSILEV is contraindicated for patients who have had previous allergic reactions attributed to folic acid or folinic acid. Due to calcium content, no more than 16-mL (160-mg) of levoleucovorin solution should be injected intravenously per minute. FUSILEV enhances the toxicity of fluorouracil. Concomitant use of d,l-leucovorin with trimethoprim-sulfamethoxazole for pneumocystis carinii pneumonia in HIV patients was associated with increased rates of treatment failure in a placebo-controlled study. Allergic reactions were reported in patients receiving FUSILEV. Vomiting (38%), stomatitis (38%) and nausea (19%) were reported in patients receiving FUSILEV as rescue after high dose methotrexate therapy. FUSILEV may counteract the antiepileptic effect of phenobarbital, phenytoin and primidone, and increase the frequency of seizures in susceptible patients.

Full prescribing information can be found at http://www.fusilev.com .

About Spectrum Pharmaceuticals

Spectrum Pharmaceuticals is a biopharmaceutical company that acquires, develops and commercializes a diversified portfolio of drug products, with a focus mainly on oncology and urology. Our strategy is comprised of acquiring and developing a broad and diverse pipeline of late-stage clinical and commercial products; establishing a commercial organization for our approved drugs; continuing to build a team with people who have demonstrated skills, passion, commitment and have a track record of success in developing drugs and commercialization in our areas of focus; and, leveraging the expertise of partners around the world to assist us in the execution of our strategy. For more information, please visit our website at http://www.spectrumpharm.com .

Forward-looking statement

This press release may contain forward-looking statements regarding future events and the future performance of Spectrum Pharmaceuticals that involve risks and uncertainties that could cause actual results to differ materially. These statements include but are not limited to statements that relate to our business and its future, Spectrum’s ability to identify, acquire, develop and commercialize a broad and diverse pipeline of late-stage clinical and commercial products, establishing a commercial organization for our approved drugs, continuing to build our team, leveraging the expertise of partners around the world to assist us in the execution of our strategy, the safety and efficacy of FUSILEV, the market potential of FUSILEV, the sales growth of FUSILEV, that the filing of the supplemental NDA for colorectal cancer will occur by the end of October 2008, that FUSILEV shall be approved in the full range of indications and formulations, and any statements that relate to the intent, belief, plans or expectations of Spectrum or its management, or that are not a statement of historical fact. Risks that could cause actual results to differ include the possibility that our existing and new drug candidates, may not prove safe or effective, the possibility that our existing and new drug candidates may not receive approval from the FDA, and other regulatory agencies in a timely manner or at all, the possibility that our existing and new drug candidates, if approved, may not be more effective, safer or more cost efficient than competing drugs, the possibility that our efforts to acquire or in-license and develop additional drug candidates may fail, our lack of revenues, our limited marketing experience, our dependence on third parties for clinical trials, manufacturing, distribution and quality control and other risks that are described in further detail in the Company’s reports filed with the Securities and Exchange Commission. We do not plan to update any such forward-looking statements and expressly disclaim any duty to update the information contained in this press release except as required by law.

Spectrum Pharmaceuticals

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When entrepreneurial geneticist Craig Venter sailed around the world on his yacht sequencing samples of seawater, it was an ambitious project to use genetics to understand invisible ecological communities. But his scientific legacy was disappointing - a jumble of mystery DNA fragments belonging to thousands of unknown organisms.

Now a team led by a University of Washington scientist has studied lake mud, which contains microbial communities even more complex than those in seawater, and homed in on bacteria that perform the ecological task of eating methane. The study, published Sunday (Aug. 17) in the journal Nature Biotechnology , shows a way to sequence unidentified life.

"This work demonstrates that we can get a complete genome for a totally unknown organism," said lead author Ludmila Chistoserdova, a UW research scientist in chemical engineering. "We extracted a complete genome from a very complex community, and this is something novel."

Only 1 percent of microbes survive in the laboratory, Chistoserdova said, and the remaining 99 percent are undiscovered. Genetics can bypass the laboratory to help reveal microscopic communities, but most genetic tools use short stretches of known genetic code. Researchers look for these short stretches and copy, or amplify, them from the environment.

"You can only use amplification when you know what you’re trying to get. And that’s the problem," Chistoserdova said. "When you want to discover something unknown, amplification is a very deficient technique because you keep discovering the things you already know. So how can you discover the unknown?"

The researchers targeted a particular ecological function, in this case eating single-carbon compounds such as methane. First they collected samples of mud from the bottom of Lake Washington, a typical freshwater lake of moderate temperature and average levels of compounds such as methane, produced by decomposing organisms, in the sediment. Then they mixed the mud with five different samples of food labeled with carbon-13, a heavier isotope of carbon. Over time, organisms that ate the lab food incorporated the heavy carbon into their cells and their DNA. For five different single-carbon food sources, the scientists then separated the DNA by weight, knowing that the heavier pieces must belong to organisms that ate the lab-catered food.

Chistoserdova estimates the original mud sample contained about 5,000 different microbes, but the five batches of enriched DNA each contained only a dozen or so organisms. Researchers then were able to piece together carbon-13 DNA fragments to create one entire genome for Methylotenera mobilis, a microbe that eats methylamine, a form of ammonia. (This microbe was already known, though the team did not use that knowledge to create the sequence.) They also produced a partial genome for Methylobacter tundripaludum, a methane-eating microbe that so far resists cultivation in the lab.

The project was funded by the National Science Foundation and the Department of Energy.

Discovering an organism’s entire genetic sequence has many uses. For example, the genetic code may produce clues for growing the microbe in the lab, which would allow scientists to study it and perhaps harness it for practical applications. Other research groups could look for the DNA in the environment as a telltale sign that the same microbe is present elsewhere. And knowing the identity of the most ecologically important organisms would help understand ecological cycles and monitor microbial population shifts, for instance due to climate change.

Chistoserdova’s team was looking at methylotrophs, organisms that eat single-carbon compounds. Methane in the atmosphere, generated by decomposing plants and animals, is a greenhouse gas 25 times more potent than carbon dioxide. Unseen methylotrophs on land and in water keep the amount of methane reaching the atmosphere in check.

"These are the bacteria that maintain the Earth’s health. Some of the methane escapes - in some parts of the lake you can see the bubbles. But whatever doesn’t escape as bubbles, these bacteria do a very good job of eating it," Chistoserdova said.

Her group will continue to study the role of methane-eating freshwater bacteria.

Click here for the full list of authors.

Click here for more information on the project.

Source: Hannah Hickey
University of Washington

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Understanding the form and function of certain proteins in the human body is becoming faster and easier, thanks to the work of researchers at the University of Illinois.

By combining custom-built spectrometers, novel probe designs and faster pulse sequences, a team led by Illinois chemistry professor Chad Rienstra has developed unique capabilities for probing protein chemistry and structure through the use of solid-state nuclear magnetic resonance spectroscopy.

The researchers’ recent results represent significant progress toward atomic-scale resolution of protein structure by solid-state NMR spectroscopy. The technique can be applied to a large range of membrane proteins and fibrils, which, because they are not water-soluble, are often not amenable to more conventional solution NMR spectroscopy or X-ray crystallography.

"In our experiments, we explore couplings between atoms in proteins," Rienstra said. "Our goal is to translate genomic information into high-resolution structural information, and thereby be able to better understand the function of the proteins."

Solid-state NMR spectroscopy relaxes the need for solubility of the sample. In solution NMR spectroscopy, molecules are allowed to tumble randomly in the magnetic field. In solid-state NMR spectroscopy, molecules are immobilized within a small cylinder called a rotor. The rotor is then spun at high speed in the magnetic field.

"With increased speed and sensitivity, we can obtain very high resolution spectra," Rienstra said. "And, because we can resolve thousands of signals at a time - one for each atom in the sample - we can determine the structure of the entire protein."

To improve sensitivity and accelerate data collection, Rienstra’s group is developing smaller rotors that can be spun at rates exceeding 25,000 rotations per second. The faster rotation rate and smaller sample size allows the researchers to obtain more data in less time, and solve structure with just a few milligrams of protein.

The determination of protein structure benefits not only from improvements in technology, but also from the researchers’ novel approach to refining geometrical parameters.

Structure determination is normally based upon distances between atoms. Rienstra discovered a way of measuring both the distance between atoms and their relative orientations with very high precision.

"Using this technique, we can more precisely define the fragments of the molecule, and how they are oriented," Rienstra said. "That allows us to define protein features and determine structure at the atomic scale."

Rienstra will describe his group’s latest findings and techniques at the national meeting of the American Chemical Society, to be held in Philadelphia, Aug. 17-21. Rienstra and his collaborators described their work - creating the highest resolution protein structure solved by solid-state NMR - in the March 25 issue of the Proceedings of the National Academy of Sciences .

The work was funded by the National Science Foundation and the National Institutes of Health.

Source: James E. Kloeppel
University of Illinois at Urbana-Champaign

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