BioPharmArena.com

Eli Lilly and Company (NYSE: LLY) has announced the start of a Phase III clinical trial studying LY450139, an investigational gamma secretase inhibitor for the treatment of mild to moderate Alzheimer’s disease. LY450139 is being tested to see if it can slow the progression associated with Alzheimer’s disease by inhibiting gamma-secretase, an enzyme that can create a sticky protein called amyloid beta. Current Alzheimer’s disease theory is that subtypes of amyloid beta clump together into plaques that eventually kill off brain cells. By blocking gamma secretase, there is less amyloid beta formed, potentially slowing brain-cell death.

Slowing the rate of disease progression could preserve independent functioning and quality of life for Alzheimer’s patients in the milder stages of the disease, potentially delaying the onset of the severe stages of the disease. Currently available treatments for Alzheimer’s disease have no documented effect on amyloid beta. They provide modest improvements in symptoms but do not slow the underlying disease process.

The IDENTITY Trial - Interrupting Alzheimer’s Dementia by EvaluatiNg Treatment of AmyloId PaThologY

IDENTITY is a randomized, double-blind, placebo-controlled trial that will be conducted in the U.S. and 21 additional countries. As part of IDENTITY, 1,500 patients will be studied for 21 months, and an open-label extension will be available to all participants completing the study. Patients who are taking currently available symptomatic treatments for Alzheimer’s disease can continue treatment during their participation in IDENTITY. Because the IDENTITY study also incorporates a “randomized delayed start” design, even those subjects initially assigned to the placebo arm of the study will be started on active LY450139 treatment sometime before the end of the 21-month study period. Both the subjects and investigators will be blinded to the exact timing of this delayed start of study drug administration.

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MedicalNewsToday.com

GlaxoSmithKline (NYSE: GSK) announced that the U.S. Food and Drug Administration (FDA) has approved Rotarix® [Rotavirus Vaccine, live, oral] for the prevention of rotavirus gastroenteritis in infants. Rotarix will offer protection against the most commonly circulating rotavirus types in the U.S. and allow infants to complete the vaccination series by four months of age. The U.S. Centers for Disease Control and Prevention (CDC) currently recommends that children complete the rotavirus immunization series by six months of age. Since rotavirus disproportionately affects young children — severe rotavirus diarrhea and dehydration can occur as young as three months of age — Rotarix could help prevent many of the 55,000-70,000 hospitalizations of young children that result from rotavirus in the U.S. each year.

“Among children less than five years of age in the U.S. who are hospitalised due to rotavirus symptoms, approximately one in five is younger than six months of age,” said Barbara Howe, M.D., Vice President and Director, North American Vaccine Development, GlaxoSmithKline. “With only two doses, Rotarix allows infants to complete the vaccination series against rotavirus earlier than ever before, which may prevent many of the emergency department visits and hospitalizations that are a burden on families and the healthcare system.”

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MedicalNewsToday.com

EpiCept Corporation (Nasdaq and OMX Nordic Exchange: EPCT) today released clinical study results from the Phase I trial of EPC2407, which provided visible evidence of vascular disruptive activity. EPC2407 is EpiCept’s novel small molecule vascular disruption agent (VDA) and apoptosis inducer for the treatment of patients with advanced solid tumors and lymphomas.

EpiCept has recently analyzed the imaging data from the first eight patients enrolled in the study who had measurable Computed Tomography (CT) perfusion scans. These patients received doses of EPC2407 ranging from 4mg/kg to 13mg/kg in three different cohorts. The results indicated that the disease had stabilized in seven of the eight patients studied. The CT perfusion scan measurements indicated that overall blood perfusion in the tumor decreased with EPC2407 treatment in the second and third cohorts, indicating an effective VDA dose had been reached. These data were measured five days after the last dose in a cycle, suggesting a sustained effect after dosing. In addition, the patients with stable disease over several treatment cycles had the greatest decreases in tumor perfusion as well as results indicative of decreased blood flow and decreased blood volume to the tumor, all suggesting a potential anti-tumor response.

The anti-cancer effect of EPC2407 was seen across a wide variety of advanced tumor types including patients with: pancreatic, non-small cell lung cancer, colon, prostate, gastrointestinal, metastatic melanoma, and parotid carcinoma. Patients were treated with up to five cycles of EPC2407.

Jack Talley, President and CEO of EpiCept Corporation, stated, “These data are strong evidence of VDA activity in patients enrolled in the trial and confirm previously published animal data that demonstrated the ability of EPC2407 to inhibit tumor growth in various cancers. We look forward to sharing these data more fully at upcoming cancer meetings later this year. We also are continuing our preparations for a Phase Ib trial for EPC2407 in combination with other chemotherapeutic agents, which we anticipate will commence later this year.”

EPC2407 has shown promising vascular targeting activity with potent anti-tumor activity in pre-clinical in vitro and in vivo studies. The molecule has been shown to induce tumor cell apoptosis and selectively inhibit growth of proliferating cell lines, including multi-drug resistant cell lines. Murine models of human tumor xenografts demonstrated EPC2407 inhibits growth of established tumors of a number of different cancer types.

In October 2007, EpiCept announced the successful completion of the Phase I clinical trial for EPC2407, with all of the trial’s objectives having been met. The Company has since decided to further enroll additional patients with an extended infusion time for the drug in order to determine whether higher doses can be tolerated.

EPC2407 is one of two compounds currently in clinical trials discovered through EpiCept’s Anti-cancer Screening Apoptosis Program (ASAP). The second compound, MPC-6827, is part of the EP90745 series of apoptosis inducers licensed by EpiCept to Myriad Genetics, Inc. as part of an exclusive, worldwide development and commercialization agreement. Myriad previously announced that MPC-6827, developed under the trademark Azixa™, has a second mode of action due to vascular disruption activity. The compound is currently being evaluated in three Phase II human clinical trials, one in patients with primary brain cancer and the others in brain metastases due to melanoma and in non-small cell lung cancer. EpiCept’s licensing agreement with Myriad for Azixa includes milestone payments, and sublicensing income as well as future royalties in the event Myriad’s development of Azixa continues to progress successfully.

About EpiCept’s ASAP Technology

Cancer cells often exhibit unchecked growth caused by the disabling or absence of the natural process of programmed cell death, which is called apoptosis. Apoptosis is normally triggered to destroy a cell from within when it outlives its purpose or it is seriously damaged. One of the most promising approaches in the fight against cancer is to selectively induce apoptosis in cancer cells, thereby checking, and perhaps reversing, the improper cell growth.

EpiCept’s proprietary apoptosis screening technology can efficiently identify new cancer drug candidates and molecular targets that selectively induce apoptosis in cancer cells through the use of chemical genetics and its proprietary live cell high-throughput caspase-3 screening technology. Chemical genetics is a research approach investigating the effect of small molecule drug candidates on the cellular activity of a protein, enabling researchers to determine the protein’s function. Using this approach with its proprietary caspase-3 screening technology, EpiCept researchers can focus their investigation on the cellular activity of small molecule drug candidates and their relationship to apoptosis.

This combination of chemical genetics and caspase-3 screening technology allows EpiCept’s researchers to discover and rapidly test the effect of small molecules on pathways and molecular targets crucial to apoptosis, and gain insights into their potential as new anticancer agents. ASAP technology is particularly versatile and can be adapted for almost any cell type that can be cultured, as well as measure caspase activation inside multiple cell types e.g., cancer cells, immune cells, or cell lines from different organ systems or genetically engineered cells. This allows researchers to find potential drug candidates that are selective for specific cancer types, which may help identify candidates that provide increased therapeutic benefit and reduced toxicity.

EpiCept has identified several families of compounds with potentially novel mechanisms that induce apoptosis in cancer cells. Several compounds from within these families have progressed to lead drug candidate status with proven pre-clinical efficacies in tumor models and identified molecular targets.

About EpiCept Corporation

EpiCept is focused on unmet needs in the treatment of pain and cancer. The Company’s broad portfolio of pharmaceutical product candidates includes several pain therapies in clinical development and a lead oncology compound for AML with demonstrated efficacy in a Phase III trial; a marketing authorization application for this compound is being re-examined in Europe following a negative opinion. In addition, EpiCept’s ASAP technology, a proprietary live cell high-throughput caspase-3 screening technology, can efficiently identify new cancer drug candidates and molecular targets that selectively induce apoptosis in cancer cells. Two oncology drug candidates currently in clinical development that were discovered using this technology have also been shown to act as vascular disruption agents in a variety of solid tumors.

Forward-Looking Statements

This news release and any oral statements made with respect to the information contained in this news release, contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements include statements which express plans, anticipation, intent, contingency, goals, targets, future development and are otherwise not statements of historical fact. These statements are based on EpiCept’s current expectations and are subject to risks and uncertainties that could cause actual results or developments to be materially different from historical results or from any future results expressed or implied by such forward-looking statements. Factors that may cause actual results or developments to differ materially include: the risks associated with our need to raise additional financing to continue to meet our capital needs and our ability to continue as a going concern, the risk that Ceplene® will not receive regulatory approval or marketing authorization in the EU or that any appeal of an adverse decision will not be successful, the risk that Ceplene®, if approved, will not achieve significant commercial success, the risk that Myriad’s development of Azixa™ will not be successful, the risk that Azixa™ will not receive regulatory approval or achieve significant commercial success, the risk that we will not receive any significant payments under our agreement with Myriad, the risk that the development of our other apoptosis product candidates will not be successful, the risk that our ASAP technology will not yield any successful product candidates, the risk that clinical trials for NP-1 or EPC2407 will not be successful, the risk that NP-1 or EPC2407 will not receive regulatory approval or achieve significant commercial success, the risk that our other product candidates that appeared promising in early research and clinical trials do not demonstrate safety and/or efficacy in larger-scale or later stage clinical trials, the risk that we will not obtain approval to market any of our product candidates, the risks associated with dependence upon key personnel, the risks associated with reliance on collaborative partners and others for further clinical trials, development, manufacturing and commercialization of our product candidates; the cost, delays and uncertainties associated with our scientific research, product development, clinical trials and regulatory approval process; our history of operating losses since our inception; the highly competitive nature of our business; risks associated with litigation; risks associated with prior material weaknesses in our internal controls; and risks associated with our ability to protect our intellectual property.

These factors and other material risks are more fully discussed in EpiCept’s periodic reports, including its reports on Forms 8-K, 10-Q and 10-K and other filings with the U.S. Securities and Exchange Commission. You are urged to carefully review and consider the disclosures found in EpiCept’s filings which are available at http://www.sec.gov or at http://www.epicept.com. You are cautioned not to place undue reliance on any forward-looking statements, any of which could turn out to be wrong due to inaccurate assumptions, unknown risks or uncertainties or other risk factors.

EpiCept

Inovio Biomedical Corporation (AMEX:INO), a leader in enabling the development of DNA vaccines using electroporation-based DNA delivery, announced that the team of Dr. Christian H. Ottensmeier, MD, PhD, Cancer Research UK Senior Clinical Research Fellow at the University of Southampton, will present interim data from a clinical study of an experimental DNA-based prostate cancer vaccine at the American Association for Cancer Research meeting in San Diego, USA, April 12 - 16, 2008. The data indicates that the combination of this DNA vaccine and electroporation DNA delivery was safe and well-tolerated. Patients treated using electroporation also displayed higher levels of antibody and anti-DOM CD4 responses.This academic study is a phase I/II study in 30 HLA A2+ patients with biochemical failure of prostate cancer. The study is testing a DNA fusion vaccine developed at Southampton. The vaccine encodes an immunostimulant sequence from tetanus linked to a sequence from prostate specific membrane antigen (PSMA27). PSMA is an attractive antigen as it is found in the vast majority of prostate cancers and its expression is increased after standard anti-androgen treatment. The study is also evaluating electroporation as a novel delivery strategy for DNA vaccines compared to DNA delivered without electroporation.

The study has completed recruitment of 30 patients and vaccination is ongoing at the third (highest) dose level. Monitoring of antibody responses has been completed for the 20 patients at the first and second dose levels to week 16. Monitoring of CD4 cellular immunity has been completed for the 10 patients at the lowest dose. These 10 patients have additionally been assessed for CD8 T-cell responses. Interim results to date include:

– Vaccination with and without electroporation has been safe and well tolerated.

– The tetanus sequence induced strong antibody responses and cellular immunity. The PSMA27 antigen induced CD8+ cytotoxic T-cells in a substantial number of the patients.

- 13 of 20 patients developed increases in anti-DOM (the immunostimulant sequence from tetanus) antibody by week 16 after three vaccinations. Of these increased responses, 4 of 10 were in the DNA arm; 9 of 10 were in the electroporation arm.
- In 9 of 10 patients in the low dose cohort, increases in CD4 responses were observed.
- 6 of 10 subjects in the low dose cohort developed PSMA27-specific CD8 responses not detected before vaccination.

– Antibody responses were generally higher in patients treated using electroporation compared to those treated with the DNA vaccine alone (without electroporation). The use of electroporation-based DNA delivery appears to also increase the level of anti-DOM CD4 responses.

“We are extremely pleased with these observations that our electroporation delivery technology is enhancing the level of antibody and T-cell responses from this novel DNA vaccine against prostate cancer,” said Avtar Dhillon, MD, president and CEO of Inovio. “Apart from assessing the safety and tolerability of electroporation, being able to also detect increased levels of immune response is one of the important outcomes that we are aiming to achieve with all of our five current clinical studies for DNA-based immunotherapies and DNA vaccines that are being advanced by our partners.”

The development of this DNA vaccine was supported by the UK cancer charities the Leukemia Research Fund and Cancer Research UK, and rights to the vaccine are owned by Cancer Research Technology Limited. The study was supported by Cancer Research UK funding, the Allan Willett Foundation, Inovio Biomedical Corporation, and the Experimental Cancer Medicine Centre in Southampton. The clinical study is a collaborative project between the University of Southampton/Southampton University Hospitals and the Institute of Cancer Research/Royal Marsden Hospital, Sutton, Surrey.

An abstract of the presentation (Abstract Number 2843) including CD8+ response data for the first three patients is now available at http://www.aacr.org. The presentation during the conference will include the data from the first ten patients referenced above.

About Inovio’s Immunotherapy Products

DNA-based immunotherapy products have the potential to by-pass inherent scientific obstacles of conventional vaccines that prevent their development for cancer and chronic infectious diseases such as HIV and hepatitis C. Pre-clinical and clinical data have indicated the potential ability of Inovio’s technologies to safely and effectively deliver and significantly enhance the potency of such immunotherapies.

Inovio’s DNA-based immunotherapy products consist of DNA plasmids and its electroporation-based intratumoral and intramuscular DNA delivery systems. A DNA plasmid is designed to express an antigen that can induce an immune response specific to a cancer or infectious disease-causing organism. The plasmid is synthetically created and readily manufactured using well-established bacterial fermentation and purification technology. After a plasmid is delivered into tumor or muscle cells, production of the antigen may then induce a preventive or therapeutic immune response against the targeted disease. Inovio’s advanced electroporation devices facilitate delivery and expression of such immunotherapies and have been shown in primate and human studies to safely and efficiently generate immune responses. Breast cancer, prostate cancer, melanoma, HIV and hepatitis C virus are among the current targets of therapies employing Inovio technology.

Inovio is poised to deliver advanced DNA-based immunotherapies, devices and know-how in this rapidly advancing field. The company is actively licensing its technology to pharmaceutical and biotechnology companies and supporting early stage clinical studies arising from its own research efforts or through academic collaborations.

About the University of Southampton

The University of Southampton is a leading UK teaching and research institution with a global reputation for leading-edge research and scholarship. It is one of the UK’s top 10 research universities, offering first-rate opportunities and facilities for study and research across a wide range of subjects in humanities, health, science and engineering. The University has over 22,000 students and 5000 staff. Its annual turnover is in the region of £325 million. http://www.soton.ac.uk

About Royal Marsden Hospital

The Royal Marsden Hospital was the first hospital in the world dedicated to cancer treatment and research into the causes of cancer. Today the hospital with its academic partner, The Institute of Cancer Research, forms the largest comprehensive cancer centre in Europe with over 40,000 patients from the UK and abroad seen each year. It provides inpatient, day care and outpatient services for all areas of cancer treatment.

About Cancer Research Technology

Cancer Research Technology Limited (CRT) is a specialist commercialization and development company, which aims to develop new discoveries in cancer research for the benefit of cancer patients. CRT works closely with leading international cancer scientists and their institutes to protect intellectual property arising from their research and to establish links with commercial partners. CRT facilitates the discovery, development and marketing of new cancer therapeutics, vaccines, diagnostics and enabling technologies. CRT is wholly owned by Cancer Research UK, the largest independent funder of cancer research in the world. Further information about CRT can be found at http://www.cancertechnology.com.

About Cancer Research UK

Together with its partners and supporters, Cancer Research UK’s vision is to beat cancer. The charity carries out world-class research to improve understanding of the disease and find out how to prevent, diagnose and treat different kinds of cancer. It ensures that its findings are used to improve the lives of all cancer patients. Cancer Research UK helps people to understand cancer, the progress that is being made and the choices each person can make. The charity works in partnership with others to achieve the greatest impact in the global fight against cancer. For further information about Cancer Research UK’s work or to find out how to support the charity, visit http://www.cancerresearchuk.org.

About Leukaemia Research

Leukaemia Research is the only national UK charity devoted exclusively to improving treatments, finding cures and learning how to prevent leukaemia, Hodgkin’s lymphoma and other lymphomas, myeloma and the related blood disorders. Leukaemia Research receives no government grants and urgently needs to raise over £100 million in the next five years to commit to new research. From basic laboratory research to clinical trials with patients, Leukaemia Research is committed to saving lives by funding high quality, carefully selected research throughout the UK. Further information, including patient information booklets, is available at http://www.lrf.org.uk.

Leukaemia Research currently supports 30 Specialist Programmes in which the groups undertake long-term intensive research into relevant areas of leukaemia and the related diseases, often working closely with diagnosis and treatment; more than 200 project grants, which provides short-term funding, usually two-three years, for work on a specific problem; 25 clinical fellowships for the training of outstanding junior doctors in both the treatment and research of leukaemia and more than 20 studentships, lectureships and senior fellowships.

About Inovio Biomedical Corporation

Inovio Biomedical (AMEX: INO)is focused on developing multiple DNA-based immunotherapies and DNA vaccines. Inovio is a leader in developing human applications of electroporation using brief, controlled electrical pulses to increase cellular uptake of a useful biopharmaceutical. Human data has shown that Inovio’s electroporation-based DNA delivery technology can significantly increase gene expression and immune responses from DNA vaccines. Immunotherapy partners include Merck, Wyeth, Vical, University of Southampton, Moffitt Cancer Center, the U.S. Army, National Cancer Institute, and International Aids Vaccine Initiative. Inovio’s technology is protected by an extensive patent portfolio covering in vivo electroporation. More information is available at http://www.inovio.com.

This press release contains certain forward-looking statements relating to our plans to develop our electroporation drug and gene delivery technology. Actual events or results may differ from our expectations as a result of a number of factors, including the uncertainties inherent in clinical trials and product development programs (including, but not limited to, the fact that pre-clinical results referenced in this release may not be indicative of results achievable from testing in humans and that results from one study may necessarily not be reflected or supported by the results of other similar studies), the availability of funding to support continuing research and studies in an effort to prove safety and efficacy of Inovio’s technology as a delivery mechanism, the availability or potential availability of alternative therapies or treatments for the conditions targeted by Inovio or its collaborators, including alternatives that may be more efficacious or cost-effective than any therapy or treatment that Inovio and its collaborators hope to develop, evaluation of potential opportunities, issues involving patents and whether they or licenses to them will provide Inovio with meaningful protection from others using the covered technologies, whether such proprietary rights are enforceable or defensible or infringe or allegedly infringe on rights of others or can withstand claims of invalidity and whether Inovio can finance or devote other significant resources that may be necessary to prosecute, protect or defend them, the level of corporate expenditures, assessments of our technology by potential corporate or other partners or collaborators, capital market conditions, and other factors set forth in our Annual Report on Form 10-K for the year ended December 31, 2006, our 10-Q for the nine months ended September 30, 2007,and other regulatory filings from time to time. There can be no assurance that any product in our product pipeline will be successfully developed or manufactured, that final results of clinical studies will be supportive of regulatory approvals required to market licensed products, or that any of the forward-looking information provided herein will be proved accurate.

Inovio Biomedical Corporation

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Pfizer Inc announced the discontinuation of a Phase III clinical trial (A3671009), of single-agent tremelimumab (CP-675,206) in patients with advanced melanoma, after the review of interim data showed that the trial would not demonstrate superiority to standard chemotherapy.

Pfizer has communicated with worldwide regulatory authorities and investigators regarding the discontinuation of the trial. Investigators will work with their patients to determine if they are benefiting from treatment and therefore should continue treatment with tremelimumab. All patients are encouraged to contact their physician with questions about their treatment.

“Although this outcome is disappointing, Pfizer remains committed to investigating new treatment options for patients with melanoma, a high risk area of research with significant unmet medical need. We continue to focus on additional studies involving tremelimumab alone and in combination with other therapies which are currently ongoing in patients with several types of cancer,” said Charles Baum, M.D., Ph.D., Vice President and Oncology Therapeutic Area Head at Pfizer Global Research and Development. “We will continue to assess the study data to understand the clinical benefit seen in some patients who received tremelimumab.”

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Research, led by a Virginia Tech chemist, may someday help natural-products chemists decrease by years the time it takes to develop certain types of medicinal drugs. The research by T. Daniel Crawford, associate professor of chemistry, involves computations of optical rotation angles on chiral non-superimposable molecules

Many chiral molecules are important for medical treatment for illnesses ranging from acid-reflux to cancer. The term “chiral” means that two mirror images of a molecule cannot be superimposed onto each other. In other words, some are “left-handed” and some are “right-handed.”

“Most drugs have this handedness property,” Crawford said, “and for many of these drugs, even though both hands can cause a reaction, it is a situation where one hand does a good thing and one does a bad thing.” He used thalidomide as an example. A mixture of both hands of the drug was used in the late 1950s and early 1960s to treat morning sickness in pregnant women. Later studies revealed that, while one of the two hands acted as the desired sedative, the other hand was found to cause significant birth defects. Thalidomide was never approved by the FDA in the United States and was eventually taken off the market in Europe.

For chemists, therefore, it is often vital to determine which hand of a molecule they are using. In other words, when you have a sample of a chiral molecule, how do you distinguish between the left and right hand?

This is where a technique called polarimetry comes in to play. By shooting plane-polarized light through a sample of one hand, the chiral molecule in question will rotate to a characteristic angle either clockwise or counterclockwise, and the two hands of a chiral molecule produce opposite rotations.

“So if we figure out the direction and rotation of the light or each hand, we have a frame of reference for determining whether we have the left or right hand of a molecule,” Crawford said.

The problem with this method is that synthesizing the two hands of chiral molecules is often extremely time consuming. “It can take anywhere from weeks to years,” Crawford said.

Crawford’s research applies the theory of quantum mechanics to devise computational methods in order to eliminate having to create a synthetic molecule. “The hope is that this will allow us to calculate things like optical rotation very accurately,” he said. “So when an organic chemist has a molecule and doesn’t know if it is left- or right-handed, we can calculate that directly on the computer.”

Crawford said the ultimate goal in his research is to be able to provide organic chemists with computational tools to determine the handedness of a particular molecule they are working with. He said that such tools could speed up the drug development process by years.

The research titled, The Current State of ‘Ab Initio’ Calculations of Optical Rotation and Electronic Circular Dichcoism Spectra, by Crawford and Mary C. Tam of Virginia Tech and Mica Abrams of the University of Central Arkansas, appeared as the cover article in the November 2007 Journal of Physical Chemistry A. Get the complete article at: http://pubs.acs.org/cgi-bin/article.cgi/jpcafh/2007/111/i48/html/jp075046u.html

About the College of Science

The College of Science at Virginia Tech gives students a comprehensive foundation in the scientific method. Outstanding faculty members teach courses and conduct research in biology, chemistry, economics, geosciences, mathematics, physics, psychology, and statistics. The college is dedicated to fostering a research intensive environment and offers programs in many cutting edge areas, including those in nanotechnology, biological sciences, information theory and science, and supports the university’s research initiatives through the Institute for Critical Technologies and Applied Sciences, and the Institute for Biomedical and Public Health Sciences. The College of Science also houses programs in intellectual property law and pre-medicine.

Virginia Tech (Virginia Polytechnic Institute and State University)
Room 1, Media Bldg. (0109)
Blacksburg, VA 24061
United States
http://www.vt.edu

A patient’s willingness to participate in a clinical trial may be unaffected by the disclosure of a researcher’s financial interests in the study, unless the amount of money a researcher stands to earn depends on the results of the trial, according to a new study by researchers at the Duke Clinical Research Institute (DCRI), Wake Forest University, and the Johns Hopkins Berman Institute of Bioethics.

“We found that the patients we surveyed rated most types of financial disclosures less important in influencing their decisions to participate than other factors, like the risks and benefits of the proposed treatment,” said Kevin Weinfurt, Ph.D., deputy director of the DCRI’s Center for Clinical and Genetic Economics, and lead investigator on the study. “We also found that some patients are savvy enough to distinguish between different types of financial relationships, and they have different reactions based on these distinctions.”

The researchers published their findings in the April 2, 2008 online edition of the Journal of General Internal Medicine. The study was funded by the National Heart, Lung and Blood Institute.

More than 3,600 diabetes and asthma patients were surveyed for this study, and the researchers asked each to answer questions related to their willingness to participate in a hypothetical clinical trial. Each electronic survey contained one of five financial disclosure statements.

“The disclosure statements ranged from the generic — the doctor running the trial might benefit financially from the study — to the more specific — dealing with per capita payments, and ownership of equity on the part of the researcher or the institution,” Weinfurt said. “We found that none of the disclosures significantly affected subjects’ willingness to participate with the exception of ownership of equity on the part of the researcher.”

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Researchers at the University of Edinburgh and IBM are using powerful computing technology - including the world’s most powerful supercomputer, Blue Gene - in a new approach to designing drugs that inhibit infection by the HIV virus.

The project, which has been welcomed by First Minister Alex Salmond, is focused on how the human HIV-1 virus attaches to cells in the body. Researchers are examining a fragment of the surface protein of the virus, known as a peptide, which is crucial in stimulating the body’s immune response to viral attack. Understanding the structure and behaviour of the peptide will allow for drugs to be designed which can target this infection process.

Most HIV therapies so far have focused on the behaviour of the virus in the body after infection has taken place, when the virus multiplies and then spreads through the bloodstream. This project aims to target the infection process itself.

The project is a collaboration between the University of Edinburgh, IBM Watson Research Centre in New York and the National Physical Laboratory in Middlesex.

Jason Crain, of the University of Edinburgh’s School of Physics and Divisional Head of Science at the National Physical Laboratory, said: “This is a new approach to drug design - we are using sophisticated algorithms coupled with experimental techniques to design improved molecular therapies, and we can capitalise on enormous computing power to do this efficiently and rationally.”

The University of Edinburgh is at the forefront of advances in high performance computing and provides the widest range of supercomputer facilities of any university in Europe.

IBM Researcher Glenn Martyna said: “One of the great challenges in the medical community is to find a vaccine for the HIV virus. By combining the experimental research of the University of Edinburgh and the simulation capabilities of the world’s most powerful supercomputer, IBM’s Blue Gene, we just might get much closer to that goal.”

During Scotland Week in America, First Minister Alex Salmond said: “This life sciences collaboration, between one of Scotland’s leading universities and one of America’s biggest corporations, is a first class and positive example of the sort of connections we are trying hard to encourage and support.”

“I am delighted that through the efforts of Scottish Enterprise and Scottish Development International, we have been able to play a part in bringing this exciting project to the key stage it is at.”

University of Edinburgh is one of the top 10 Universities in Europe, one of the top 30 in the world (Times Higher World University Rankings)

University of Edinburgh

The recent “failure” of a Merck HIV/AIDS vaccine has “led to two conflicting calls for action, neither of which got it right,” a Los Angeles Times editorial says. Grant recipients “wanted the vaccine search to go on as before,” while “treatment activists wanted the money stripped from research,” the editorial says, adding that NIH at a conference last week “appeared to be taking a wiser approach” and said that it “would continue funding vaccine research” with a likely focus on “basic research and smaller, less expensive trials.”

After the Merck trial was halted, some groups “lost little time … in calling for vaccine funding to be rerouted to treatment and prevention,” according to the editorial. It adds that U.S. funding for HIV/AIDS vaccine research is less than $700 million annually — a “relative pittance compared with that for treatment and prevention, which stands at more than $15 billion annually and is expected to at least double in the next year.” It is “too easy to forget that people can develop resistance to” antiretroviral drugs and “suffer significant side effects,” the editorial says, adding that the “research effort that brought about these treatments was a tremendous achievement, but scientists still have much to learn about the virus.”

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MedicalNewsToday.com

Reps. Rosa DeLauro (D-Conn.) and Jan Schakowsky (D-Ill.) on Wednesday asked FDA to mandate that all prescription drug television advertisements include information for consumers to report serious side effects to the agency, the Los Angeles Times reports.

DeLauro and Schakowsky cited a recent Consumers Union survey that found 16% of respondents had experienced an adverse prescription drug side effect serious enough for them to seek treatment from a physician, but just 35% of respondents were aware that serious side effects could be reported to FDA. In addition, 7% of respondents named FDA as a place where they would report a serious side effect.

FDA monitors adverse events related to prescription and over-the-counter drugs through its MedWatch program. However, FDA officials said that they estimate only about one in 10 adverse events are reported to MedWatch (DuBose, Los Angeles Times, 4/3).

Last summer, Schakowsky co-sponsored an early version of legislation that required all print drug ads to contain reporting information, CQ HealthBeat reports. The measure passed in September 2007 and contained a provision that FDA conduct a study to see if it would be feasible for TV ads to contain similar information (Cooley, CQ HealthBeat, 4/2). The measure required the study to be completed by the end of March. FDA spokesperson Rita Chappelle said the study is still in progress (Los Angeles Times, 4/3). DeLauro has introduced legislation that would prohibit direct-to-consumer ads for new drugs during their first three years on the market to give time for adverse events to be reported before heavy marketing begins. DeLauro noted that spending on prescription drug ads increased from $650 million in 2001 to $1.1 billion in 2005 (CQ HealthBeat, 4/2).

Consumers Union has sent FDA a petition with more than 55,000 signatures requesting the agency require that a toll-free number and a Web site address to be included in TV ads to make it easier for people to report side effects. Chappelle said the agency has received the petition and is reviewing it (Los Angeles Times, 4/3). Comments
DeLauro said FDA “is failing to serve its most vital supervisory responsibility,” adding, “The more we know about serious drug side effects, the more we can do.”

Schakowsky said, “We’re working with and pushing the FDA” to require reporting information, adding, “The interest and signatures from consumers certainly help” (Los Angeles Times, 4/3).

A spokesperson for the Pharmaceutical Research and Manufacturers of America said that the trade group would not take a position on the petition until FDA completes the feasibility study (CQ HealthBeat, 4/2).

The survey is available online (.pdf).

Reprinted with kind permission from http://www.kaisernetwork.org. You can view the entire Kaiser Daily Health Policy Report, search the archives, or sign up for email delivery at http://www.kaisernetwork.org/dailyreports/healthpolicy. The Kaiser Daily Health Policy Report is published for kaisernetwork.org, a free service of The Henry J. Kaiser Family Foundation© 2005 Advisory Board Company and Kaiser Family Foundation. All rights reserved.

Originally published in MedicalNewsToday.com

A phase 1 clinical trial to test a novel HIV/AIDS vaccine has begun at Brigham and Women’s Hospital (BWH). This new vaccine aims to overcome the problem of preexisting immunity to common vaccine vectors, which is thought to be a major problem in the developing world.

“This study will involve 48 healthy volunteers who will receive either two or three immunizations and who will be followed to assess the safety and immunogenicity of the vaccine,” explains Lindsey R. Baden, MD, Assistant Professor of Medicine at BWH and Harvard Medical School and Protocol Chair for the study.

The vaccine consists of a replication-incompetent, recombinant adenovirus serotype 26 (rAd26) vector encoding an HIV-1 envelope gene.

“The rAd26 vaccine vector was selected for its particularly low seroprevalence in human populations and for its potent immunogenicity and protective efficacy in preclinical studies,” explains Dan H. Barouch, MD, PhD, Associate Professor of Medicine at Beth Israel Deaconess Medical Center (BIDMC) and Harvard Medical School and Principal Investigator of the Integrated Preclinical/Clinical AIDS Vaccine Development (IPCAVD) program that developed the vaccine. This program is sponsored by the Division of AIDS, National Institute of Allergy and Infectious Diseases, National Institutes of Health.

Manufactured by the Dutch biotechnology company Crucell Holland BV, the rAd26 vaccine is the first HIV-1 vaccine candidate to emerge from the IPCAVD initiative, which brings together investigators from academia and industry in an effort to accelerate the development of promising HIV/AIDS vaccine candidates. The novel strategy used in developing this vaccine enables researchers to circumvent preexisting immunity to the adenovirus serotype 5, the virus responsible for the common cold, which has recently shown limitations as an HIV-1 vaccine vector.

“The rAd26 vector does not regularly occur in the human population and human antibodies to this vector are rare,” explains Jaap Goudsmit, Chief Scientific Officer at Crucell. “The rAd26 vector therefore is efficacious in eliciting good T and B cell responses.”

AIDS remains one of the world’s most devastating health problems, with an estimated 33.2 million people living with HIV/AIDS and 2.5 million new infections reported in 2007 alone.

The House Rules Committee on Tuesday by voice vote allowed a bill (HR 5501) that would reauthorize the U.S. global HIV/AIDS program to be considered by the full House, CQ Today reports. According to CQ Today, compromises reached on the bill in the House Foreign Affairs Committee appear to be “alive and well” after the Rules Committee rejected floor consideration of several amendments (Graham-Silverman, CQ Today, 4/1).

The bill would authorize $50 billion for the President’s Emergency Plan for AIDS Relief over the next five years. The measure reflects a compromise reached between House leaders from both parties and the White House. Although it removes a provision included in PEPFAR’s original mandate that would have required one-third of HIV prevention funding to be spent on abstinence-only education, the bill includes new language requiring “balanced funding” for prevention programs that ensure that abstinence and faithfulness teachings “are implemented and funded in a meaningful way.” Under the measure, countries that spend less than 50% of funding for the prevention of the sexual transmission of HIV on abstinence and fidelity programs will be required to explain the decision to Congress.

Read more ….

MedicalNewsToday.com

Many clinical trials conducted in the U.S. exclude or underrepresent participants from numerous populations, including women, people over age 65, the disabled, rural residents and minorities, according to a report released on Tuesday, HealthDay/U.S. News & World Report reports (Mozes, HealthDay/U.S. News & World Report, 4/1). The report, “Eliminating Disparities in Clinical Trials,” was conducted by Baylor University College of Medicine’s Chronic Disease Prevention and Control Research Center and the Intercultural Cancer Council (Cooley, CQ HealthBeat, 4/1). Genentech funded the study through an “unrestricted educational grant,” HealthDay/U.S. News & World Report reports.

For the study, lead researcher Armin Weinberg, chief policy analyst Daniel Goldberg and a team of more than 300 analysts over four years reviewed policy positions held by public, private and not-for-profit clinical trial sponsors in the U.S. About 80,000 clinical trials are conducted annually, and about 2.3 million people — less than 1% of the U.S. population — participate in such trials, according to the report.

Researchers found that between 1995 and 1999, blacks, Asian-American/Pacific Islanders, Hispanics and American Indians together accounted for less than 10% of patients included in new cancer drug trials. The lack of representation of minority and other populations could lead to results that do not represent cultural, racial, religious, linguistic, age and gender differences that could impact the efficacy of drugs in the general population, researchers said (HealthDay/U.S. News & World Report, 4/1). Weinberg said, “Even if we’ve managed to see some increases in certain areas of numbers of participants in clinical trials … we have not seen the proportion of minorities increase.”

The report includes a list of recommendations to address the disparities, including a mandate requiring that all clinical trials have a minimum inclusion of underrepresented populations. The report also recommends that researchers establish more community outreach efforts, such as “navigation programs” to guide participants and encourage retention, and build a rapport with underserved communities to establish trust (CQ HealthBeat, 4/1). Other recommendations include more oversight from scientific journals of participant demographics and to guarantee insurance coverage for all costs related to trial participation (HealthDay/U.S. News & World Report, 4/1). FDA, Industry Reaction
FDA currently recommends that clinical trials include diverse populations but has no mandate on the minimum number of participants from those populations, according to CQ HealthBeat. FDA spokesperson Susan Cruzan said in a statement that a minimum inclusion mandate “would result in a massive increase in the size of such trials,” adding, “It would be likely that the benefits of setting subgroup quotas to obtain increased knowledge about subgroup responses to drugs would be outweighed by the burdens in terms of cost or drug development and delays in access to therapy.” Cruzan said, “The vast majority of drugs appear to behave similarly in all humans and do not show subgroup differences.” Meanwhile, industry representatives contend that a minimum inclusion mandate would slow the innovation process, CQ HealthBeat reports (CQ HealthBeat, 4/1).

MedicalNewsToday.com

Monogram Biosciences, Inc., (Nasdaq: MGRM) announced that it had entered into an agreement with Progenics Pharmaceuticals, Inc. (Nasdaq: PGNX) to provide resistance and tropism testing for Progenics’ clinical development program of PRO 140, an investigational CCR5 monoclonal antibody being studied for the treatment of HIV. In its ongoing phase 2 studies, Progenics is using Monogram’s Trofile(TM) tropism test to screen and monitor HIV infected individuals whose virus uses the CCR5 receptor as a portal of entry to healthy cells. Progenics is also using Monogram’s PhenoSense GT(TM) assay to measure viral resistance to drugs from other HIV-1 treatment classes.

“We are pleased to play such an important role in the development of this promising new HIV therapy,” said Chris Petropoulos, Monogram’s Chief Scientific Officer. “Monogram continues to help pave the path for many of the most highly anticipated new HIV drugs in development.”

Trofile is a patient selection co-receptor tropism assay that determines whether a patient is infected with a strain of HIV that uses the CCR5 co- receptor, the CXCR4 co-receptor, or a combination of CCR5 and CXCR4 to enter cells. Trofile is the only clinically validated tropism assay and has been used to select patients in all phase 2 and phase 3 studies of CCR5 antagonists to date.

About PRO 140

Progenics announced the start of the phase 2 program for PRO 140 in January 2008. PRO 140 is a novel monoclonal antibody that binds CCR5 and is designed to prevent HIV from entering immune system cells and thereby prevent viral replication, which occurs within the cells. CCR5 is also a receptor for chemokines, members of a family of protein molecules that are secreted by cells as part of the body’s natural inflammatory response. Unlike small- molecule CCR5 antagonists, PRO 140 inhibits HIV entry at concentrations that in vitro do not appear to block CCR5’s natural function, which includes, in part, directing the migration of immune cells towards sites of inflammation in the body.

About Progenics Pharmaceuticals, Inc.

Progenics Pharmaceuticals, Inc., of Tarrytown, NY, is a biopharmaceutical company focusing on the development and commercialization of innovative therapeutic products to treat the unmet medical needs of patients with debilitating conditions and life-threatening diseases. Principal programs are directed toward gastroenterology as well as the treatment of HIV infection and cancer. The Company, in collaboration with Wyeth, is developing methylnaltrexone for the treatment of opioid-induced side effects, including constipation (oral and subcutaneous formulations) and post-operative ileus (intravenous formulation). In March 2007, the Company submitted a New Drug Application to the United States Food and Drug Administration for the subcutaneous formulation of methylnaltrexone for patients suffering from opioid-induced constipation while receiving palliative care, followed in May 2007 by Wyeth’s submission of a Marketing Authorization Application (MAA) in Europe to the European Medicines Agency (EMEA). In the area of HIV infection, the Company is developing the viral-entry inhibitor PRO 140, a humanized monoclonal antibody targeting the HIV entry co-receptor CCR5, which has completed phase 1b clinical studies with positive results. In the area of prostate cancer, the Company is developing a human monoclonal antibody drug conjugate — a selectively targeted cytotoxic antibody directed against prostate-specific membrane antigen (PSMA), a protein found on the surface of prostate cancer cells. Progenics is also developing vaccines designed to stimulate an immune response to PSMA.

About Monogram

Monogram is a biotechnology company advancing individualized medicine by discovering, developing and marketing innovative products to guide and improve treatment of serious infectious diseases and cancer. The Company’s products are designed to help doctors optimize treatment regimens for their patients that lead to better outcomes and reduced costs. The Company’s technology is also being used by numerous biopharmaceutical companies to develop new and improved antiviral therapeutics and vaccines as well as targeted cancer therapeutics. More information about the Company and its technology can be found on its web site at http://www.monogrambio.com.

Forward Looking Statements

Certain statements in this press release are forward-looking. These forward-looking statements include references to the demand for our testing products, including our Trofile Assay, the potential use of our Trofile Assay for patient selection for the class of HIV drugs known as CCR5 antagonists, the size and timing of Progenics’ clinical trials utilizing our products, the outlook for Progenics’ investigational drug mentioned in this release and for our testing products, expected protection provided by patents, possible regulation of our products by the FDA. These forward-looking statements are subject to risks and uncertainties and other factors, which may cause actual results to differ materially from the anticipated results or other expectations expressed in such forward-looking statements. These risks and uncertainties include, but are not limited to: the risk that physicians may not use a molecular diagnostic for patient selection for CCR5 antagonists or other HIV drugs; whether larger confirmatory clinical studies will confirm the results of initial studies; risks and uncertainties relating to the performance of our products; the growth in revenues; the size, timing and success or failure of any clinical trials for HIV drugs, such as Progenics’ drug mentioned in this release; the risk that our Trofile Assay may not be utilized for patient use with CCR5 inhibitors; our ability to successfully conduct clinical studies and the results obtained from those studies; our ability to establish reliable, high-volume operations at commercially reasonable costs; expected reliance on a few customers for the majority of our revenues; the annual renewal of certain customer agreements; actual market acceptance of our products and adoption of our technological approach and products by pharmaceutical and biotechnology companies; our estimate of the size of our markets; our estimates of the levels of demand for our products; the impact of competition; the timing and ultimate size of pharmaceutical company clinical trials; whether payers will authorize reimbursement for our products and services and the amount of such reimbursement that may be allowed; whether the FDA or any other agency will decide to further regulate our products or services, including Trofile; whether the draft guidance on Multivariate Index Assays issued by FDA will be subsequently determined to apply to our current or planned products; whether we will encounter problems or delays in automating our processes; the ultimate validity and enforceability of our patent applications and patents; the possible infringement of the intellectual property of others; whether licenses to third party technology will be available; whether we are able to build brand loyalty and expand revenues; restrictions on the conduct of our business imposed by the Pfizer, Merrill Lynch and other debt agreements; the impact of additional dilution if our convertible debt is converted to equity; and whether we will be able to raise sufficient capital in the future, if required. For a discussion of other factors that may cause actual events to differ from those projected, please refer to our most recent annual report on Form 10-K and quarterly reports on Form 10-Q, as well as other subsequent filings with the Securities and Exchange Commission. We do not undertake, and specifically disclaim any obligation, to revise any forward-looking statements to reflect the occurrence of anticipated or unanticipated events or circumstances after the date of such statements.

Monogram Biosciences, Inc.
http://www.monogrambio.com

For quite some time, DNA, the stuff our genes are made of, has also been considered the building material of choice for nanoscale objects. A team led by Gunter von Kiedrowski at the Ruhr University in Bochum has now made a dodecahedron (a geometric shape with twelve surfaces) from DNA building blocks. As reported in the journal Angewandte Chemie, these objects are formed in a self-assembly process from 20 individual trisoligonucleotides, building blocks consisting of a “branching junction” and three short DNA strands.

A regular dodecahedron is a geometric shape made of 12 pentagons of equal size, three of which are connected at every vertex. This results in a structure with 30 edges and 20 vertices. In order to produce a hollow dodecahedral object from DNA, the researchers used 20 “three-legged” building blocks (three DNA strands connected together at one point). The centers of these building blocks represent the vertices of the dodecahedron. The three edges projecting from each vertex are formed when a single strand of DNA converts two neighboring bridging components into a double strand.

In order for this process to result in a dodecahedron and not some other random geometric object, all of the DNA strands must have a different sequence. Among these, there must, however, be pairs of complementary strands that can bind to each other.

By using a computer program, the researchers identified a set of 30 independent, 15-base-pair-long, double-stranded DNA sequences with similar physical properties. The double-stranded sequences were assigned to the individual edges of the dodecahedron and to specific vertices for termination. It was then determined which three single-stranded sequences needed to be attached to each three-legged junction for the predetermined structure to form.

The team synthesized the 20 computed trisoligonucleotides by means of a solid-phase synthesis. The three DNA strands were always attached by way of an aromatic six-membered carbon ring. When mixed in equal parts in a buffer solution, these building blocks do aggregate to form the expected product: regular dodecahedra. Atomic force microscopy images reveal them to be uniform particles with a diameter of about 20 nm. Under pressure, the dodecahedra are quite flexible, the can be deformed like “soft balls” without incurring any damage.

If the trisoligonucleotides are equipped with pendant “arms”, the dodecahedra can be outfitted with additional functional molecules. In this way, highly complex nanoconstructs, resembling little viruses in shape and size, should be accessible in the future. Potential applications range from medical diagnostics to nanoelectronics.

Günter von Kiedrowski
Ruhr-Universität Bochum
Germany
Angewandte Chemie International Edition

Physicians appreciate patient opinions of the care that they provide, but they oppose rating Web sites that allow users to post anonymous comments about physicians because they can damage reputations and patient relationships, according to Nancy Nielsen, president-elect of the American Medical Association, USA Today reports. Nielsen said that one “disgruntled patient” can cause problems for a physician and that “doctors are not going to want to spend their time going into a (site) and correcting a smear.”

Delia Chiaramonte, a family physician and patient adviser in Maryland, said that such Web sites — which include HealthGrades, Vitals and Angie’s List — can place physicians on the defensive and damage patient relationships, both of which can reduce quality of care. However, according to their founders, the Web sites provide important information about physicians for patients. They add that the Web sites block multiple positive or negative comments about a physician by the same user (Painter, USA Today, 3/31).

“The ‘Diagonal’ Approach to Global Fund Financing: A Cure for the Broader Malaise of Health Systems?” Globalization and Health: The study examines how the “polarization” between “vertical” financing, or funding disease-specific approaches, and “horizontal” financing, which aims to improve overall health systems, has “obscured” the prospects offered by “diagonal” financing, which aims to reach disease-specific targets through improved health systems. According to the study, the Global Fund To Fight AIDS, Tuberculosis and Malaria in April 2007 agreed to consider financing comprehensive country health programs, and the new International Health Partnership will help low-income nations to develop such programs. This “combination could lead” the Global Fund to a “much broader financing scope,” the study says. It adds that a “transformation” of the Global Fund into a “Global Health Fund is feasible, but only if accompanied by a substantial increase of donor commitments.” According to the study, the transformation of the Global Fund into a diagonal, and perhaps eventually horizontal, financer “should happen gradually and carefully and be accompanied by measures to safeguard its exceptional features” (Ooms et al., Globalization and Health, 3/25).

From MedicalNewsToday.com

Carnegie Mellon University’s Nadine Aubry and colleague Pushpendra Singh of the New Jersey Institute of Technology (NJIT) are leading a research team to develop a manufacturing strategy that could improve technologies used in tissue engineering and information technology.

Aubry, head of Carnegie Mellon’s Mechanical Engineering Department, and Singh, an engineering professor at NJIT, have developed a new way of herding nano/micro-particles into highly ordered two-dimensional lattices (monolayers) with adjustable spacing between the particles.

The team’s research, reported last month in the Proceedings of the National Academy of Sciences USA journal (http://.pnas.org/egi/content/full/105/10/3695), shows how the use of electric fields and fluid- fluid interfaces can be judiciously used to develop new materials with special properties to increase the efficiency of drug delivery patches, solar cells and the next generation of high-performance computing.

“This new manufacturing strategy could revolutionize the way we design two-dimensional nanomaterials with adaptable microscopic structures and desired properties,” said Aubry, who was recently named a fellow of the American Association for the Advancement of Science (AAAS) for her outstanding contributions to the field of fluid dynamics.

The research team found they could control the particle distribution, particularly uncharged particles, at a fluid-fluid interface by applying an electric field. Without an electric field, particles self assemble. But they self assemble under capillary action, which make particles attract one another at the free-surface of a liquid. This is the same action we experience when our cereal flakes regroup at the surface of a bowl of milk.

This self-assembly via capillary action has serious flaws. Some of those flaws include an inability to manipulate small-sized particles and adjust the porosity of the resulting material. There are also inherent defects in the particle patterns.

“What is fascinating, is that the presence of an electric field can remedy all these deficiencies,” Aubry said. “The key is that when we apply the electric field, we can expand or shrink the lattice, and we can do it dynamically. The explanation is all in the subtle interplay between the forces - both electrostatic and hydrodynamic - acting on the particles.”

The research team shows that their new technique creates forces capable of assembling micron-sized particles and theoretically predicts that the method should apply to nanoparticles as well.

“We are extremely excited about the new self-assembly method because it offers flexibility, precision and simplicity,” Aubry said.

Synvista Therapeutics, Inc. (Amex: SYI) announces data from a study of diabetic mice with the Haptoglobin 2-2 genotype that show impairment in the clearance of the Haptoglobin (Hp)-Hemoglobin (Hb) complex may result in a modification of high-density lipoprotein (HDL) structure and defective reverse cholesterol transport. These findings, which were presented at the 57th Annual Scientific Sessions of the American College of Cardiology in Chicago, suggest the value of Haptoglobin testing in people with diabetes in order to ensure more successful treatment in the prevention of cardiovascular events (such as heart attack and stroke).

“These data from a validated animal model support our belief that Haptoglobin testing may help physicians tailor optimal therapy for patients with diabetes who may be at risk for cardiovascular events. The transport of cholesterol out of atherosclerotic plaque may be an important mechanism of stroke and heart attack prevention. Characterizing the functional impairment of HDL may help us understand how to intervene in Hp2-2 diabetic patients,” said Noah Berkowitz, M.D., Ph.D., President and Chief Executive Officer of Synvista Therapeutics, which is developing a diagnostic product to identify Haptoglobin types. “As with previous studies of diabetic patients exhibiting markedly elevated cardiovascular risk, we believe that these findings support the notion of testing for Haptoglobin and treating the appropriate diabetic patients (Hp2-2) with vitamin E.”

In the study, researchers assessed clearance of Hb by Hp in diabetic mice that were also tested for Hp type. The study showed that in these mice, the combination of diabetes and the Hp2-2 genotype was associated with a two-to-three-fold increase in the half-life of the Hp-Hb complex compared to other Hp types. Further, a greater than 10-fold increase was found in the association of Hp-2-Hb and HDL in these mice. The study also demonstrated that vitamin E supplementation prevented the impairment of reverse cholesterol transport in diabetic mice with the Hp2-2 genotype.

About Haptoglobin 2-2

The Hp protein is polymorphic in humans, occurring with two alleles, 1 and 2, existing at the Hp genetic locus. Three phenotypes linked to the three genotypes, Hp 1-1, Hp 1-2 and Hp 2-2, can be identified using an ELISA assay. In multiple independent prospective longitudinal studies of more than 20,000 individuals, it has been established that the Haptoglobin genotype is an independent risk factor for cardiovascular disease, with a specific relationship to patients with diabetes mellitus. After accounting for conventional cardiovascular risk factors and diabetes characteristics in these studies, research has demonstrated that there is a 2-5 fold increased risk of cardiovascular disease in people with both diabetes and the Hp 2-2 genotype (approximately 40 percent of all diabetes patients).

About Synvista Therapeutics

Synvista Therapeutics is a biopharmaceutical company developing drugs to treat and prevent cardiovascular disease and nephropathy in people with diabetes. The Company believes it has identified several product candidates that represent novel approaches to some of the largest pharmaceutical markets. The Company’s portfolio includes orally bioavailable, organoselenium mimics of glutathione peroxidase. These compounds metabolize lipid peroxides and have the potential to limit myocardial damage subsequent to a myocardial infarction. The Company is developing a clinical diagnostic test, based on cardiovascular risk assessment, using Haptoglobin characterization, to identify patients at high risk for cardiovascular complications of diabetes.

Synvista Therapeutics also is developing alagebrium, a proposed breaker of AGEs for the treatment of diastolic heart failure. This disease represents a rapidly growing market of unmet medical need, particularly common among diabetic patients. Alagebrium has demonstrated relevant clinical activity in two Phase 2 clinical trials in heart failure, as well as in animal models of heart failure and nephropathy, among others. Alagebrium has been tested in approximately 1,000 patients in multiple Phase 1 and Phase 2 clinical trials, allowing Synvista Therapeutics to assemble a sizeable human safety database. For more information, please visit the Company’s website at http://www.synvista.com.

Any statements contained in this press release that relate to future plans, events or performance are forward-looking statements that involve risks and uncertainties including, but not limited to, the risks associated with the events described in this press release, future clinical development of Synvista Therapeutics’ product candidates, and other risks identified in Synvista Therapeutics’ filings with the Securities and Exchange Commission. Further information on risks faced by Synvista are detailed under the caption “Risk Factors” in Synvista Therapeutics’ Annual Report on Form 10-K for the year ended December 31, 2006. These filings are available on a website maintained by the Securities and Exchange Commission at http://www.sec.gov. The information contained in this press release is accurate as of the date indicated. Actual results, events or performance may differ materially. Synvista Therapeutics undertakes no obligation to publicly release the result of any revision to these forward-looking statements that may be made to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events.

Synvista Therapeutics, Inc.
http://www.synvista.com

CardioMind, Inc., a developer of stents for small, difficult-to-treat blood vessels, announced that it has begun a First-in-Human clinical trial of its drug-eluting stent. The CARE II trial, as it is called, began in February at St. Vincent’s Hospital in Melbourne, Australia, and, so far, has led to successful implantations in 12 patients.

With a .014-inch crossing profile, the CardioMind stent, known as the Sparrow(TM) Drug-Eluting Coronary Stent System, is 70% smaller in diameter than any other currently-approved stent. It targets treatment of blood vessels smaller than 2.75 mm in diameter, which currently constitute nearly 40% of all stent implants. The tightness of fit of conventional stents, as well as their inflexibility and the forces delivered by balloon expansion, however, may contribute to increased vessel trauma, which in turn leads to less favorable long term results. Beyond the range of current stenting practice, moreover, the CardioMind stent may also find use in vessels smaller than 2.25 mm and thus expand by up to 20% the worldwide market for stents, now over $4-billion annually.

“We view the Sparrow system as a platform technology for a gentler stent delivery system that will both improve safety and efficacy for currently performed procedures and also extend treatment to new areas of the coronary, neurovascular and peripheral artery system,” says Charles Maroney, President and CEO of CardioMind.

How the CardioMind Stent Works

The unique design of the CardioMind Sparrow stent permits it to travel within the guidewire lumen to the site of the lesion. There the cardiologist releases the stent and allows it to self-expand to the vessel wall. By contrast, conventional balloon-expandable stents travel over guidewires to the lesion, and thus, by their very design, occupy more volume. The Sparrow stent also offers more flexibility than current stents, making it especially adaptable to treatment of the small, tortuous blood vessels often associated with diabetes.

To coat the Sparrow stent, CardioMind has licensed the rights to the SynBiosys(TM) biodegradable polymer system from SurModics, Inc. (Nasdaq: SRDX). “The SynBiosys polymer allows the Sparrow stent to gradually return to a bare metal state, where we as an industry have 15 years of data showing no increase in late stent thrombosis,” says Maroney.

Clinical Trials

The multi-site CARE II study, which will eventually enroll 220 patients, is a randomized trial of three different stents — both bare-metal and drug-eluting versions of the Sparrow, plus a competitive stent.

According to Dr. Robert Whitbourn, associate professor and director of the Cardiovascular Research Center at St. Vincent’s Hospital and one of the study’s lead investigators: “Thus far, the first cases in this study are very encouraging. All our implanted patients are doing well, and I am impressed with the overall deliverability and performance of this new stent delivery system.” Dr. Whitbourn expects to report first full follow-up results in eight months.

Overall, says Dr. Whitbourn, “The CardioMind Sparrow System represents a promising technology in interventional cardiology. The concept of a true guidewire-delivered stent opens up the possibilities of stenting in small vessels, branch vessels and other difficult-to-access vessels. It could, thus, expand the types of lesions in coronary artery disease that can be treated in more difficult patient populations.”

Venture Funding

By reaching its First-in-Human milestone, CardioMind triggered the second tranche closing of a $33-million venture capital round raised in June 2007. That round, CardioMind’s third since it was founded in 2003, included an initial $11-million for research and development and the just-released $22-million for completion of the CARE II Study and further development. Co-leaders of the round were SV Life Sciences and De Novo Ventures, with additional funding coming from existing investors InterWest Partners, Latterell Venture Partners, Morgenthaler Ventures, and Onset Ventures.

About CardioMind

CardioMind is a developer of a unique stent delivery platform that allows interventionalists to treat very small blood vessels of 2.75 mm-diameter and less. Such vessels, often tortuous, have proven especially vulnerable to injury from conventional stent delivery systems. The small crossing profile and flexibility of the CardioMind platform promise to increase both stent safety and efficacy in such vessels and to extend the range of vessels in which stents can be deployed throughout the coronary, neurovascular and peripheral artery systems.

CardioMind, Inc.
http://www.cardiomind.com