454 Life Sciences (Branford) announced the publication of the 250th peer-reviewed study using the Genome Sequencer System. The studies span a diverse group of sequencing applications: 82 whole genome sequencing papers including de novo sequencing and re-sequencing for comparative genomics; 54 small RNA studies; 37 papers in the fast growing field of metagenomics; 27 studies in transcriptome profiling, including whole transcriptome assembly and expression profiling; 13 studies examining chromosome structure and epigenetics; 10 studies in the new field of ultra-deep sequencing for rare variant detection; 11 studies examining ancient DNA. The remaining papers focus on the technology and informatics of the 454 Sequencing System.

Achillion Pharmaceuticals, Inc. (New Haven) announced the appointment of Nicholas Simon to its Board of Directors. "Nick Simon has a tremendous corporate development and marketing background, as well as a unique breadth of experience gained from guiding the development of numerous life science companies," commented Michael Kishbauch, President and Chief Executive Officer of Achillion. "I welcome Nick to the Achillion Board and look forward to his contributions as we advance our product pipeline in the near term, with the potential for three drug candidates to enter clinical trials in 2009."

Alexion Pharmaceuticals, Inc. (Cheshire) has received a Prix Galien USA 2008 Award for Best Biotechnology Product for Soliris® (eculizumab). See story in this issue.

Bayer HealthCare (Leverkusen, Germany/West Haven) announced that new data from its BENEFIT (BEtaseron in Newly Emerging multiple sclerosis For Initial Treatment) study confirm that early initiation of Betaseron® (interferon beta-1b) treatment in patients with a first event suggestive of multiple sclerosis (MS) significantly delayed the onset of clinically-definite MS (CDMS) by 37 percent (p=0.003) and McDonald MS by 45 percent (p<0.0001) over five years compared to delayed treatment. The results confirm a continued benefit of initiating treatment with Betaseron shortly after the first event.

Boehringer Ingelheim (Ingelheim, Germany/Danbury) said results of its UPLIFT® (Understanding Potential Long-term Impacts on Function with Tiotropium) trial, showed that SPIRIVA® HandiHaler® (tiotropium bromide inhalation powder), sustained improvements in lung function for up to 4 years as measured by FEV1 (p<0.001) versus placebo in Chronic Obstructive Pulmonary Disease (COPD) patients.

Bristol-Myers Squibb Company (New York/Wallingford) commented on Eli Lilly's recent acquisition of ImClone Systems Incorporated. “We are pleased to have initiated a process that has resulted in the substantial increase of ImClone’s value for all of its stockholders,” said James M. Cornelius, Chairman and Chief Executive Officer, Bristol-Myers Squibb. “Looking ahead, we will work closely with Eli Lilly and Company, a company I know well, to continue to bring to patients not only ERBITUX®, the important cancer therapy we co-commercialize in the U.S. and Canada with ImClone, and co-develop in Japan with Merck KGaA and ImClone, but other compounds, including IMC-11F8, under development by ImClone to which Bristol-Myers Squibb holds long-term marketing rights.”

Cara Therapeutics (Shelton) announced completion of a Phase I clinical trial for its second-generation, peripherally acting kappa opioid agonist, CR845, under development for the treatment of acute and chronic pain. The drug candidate was safe and well-tolerated after intravenous infusion, and resulted in plasma levels of CR845 expected to be associated with clinical analgesic activity. In addition, CR845 infusion triggered a quantitative endocrine biomarker of peripheral kappa opioid receptor activation at the lowest dose tested.

CuraGen Corporation (Branford) announced that it has completed the enrollment of patients into its Phase 2 trial evaluating CR011-vcMMAE for the treatment of advanced melanoma.

Danbury Hospital (Danbury) announced that it is participating once again in the American College of Surgeons National Surgical Quality Improvement Program (NSQIP). “The data management system compiled by the American College of Surgeons (ACS) enables us to continuously monitor and improve the quality of surgical care. It’s a powerful tool that allows for continuous quality performance improvement,” said Pierre Saldinger, MD, FACS, chairman of the Department of Surgery at Danbury Hospital, who serves as “surgeon champion” for the hospital’s NSQIP process.

GlaxoSmithKline (Research Triangle Park, NC) reported that new research shows how nicotine withdrawal creates functional changes in the brains of smokers trying to quit, causing cognitive performance deficits (such as ability to concentrate) that may make it more difficult to quit, and could be a driver of smoking relapse. The company says that brain imaging technology shows that when treatment with its Commit® 4 mg nicotine lozenge is introduced, symptoms of nicotine withdrawal can be reversed.

Hartford Hospital (Hartford) said that two leading surgical oncologists had joined its Helen & Harry Gray Cancer Center. The hospital welcomed Dr. Ramon E. Jimenez and Dr. Robert J. Piorkowski. Drs. Jimenez and Piorkowski are experts in the surgical management of patients with breast cancer, skin cancer (including melanoma), sarcomas (tumors of soft tissue origin), intra-abdominal tumors and gastrointestinal malignancies. In addition, Dr. Piorkowski has expertise in treating patients with head and neck tumors. They offer oncology and radiation oncology consultations when appropriate, providing multi-disciplinary disease management.

Johnson & Johnson (New Brunswick, NJ) said new findings from a Phase 3 multicenter, randomized head-to-head study comparing ustekinumab and Enbrel® (etanercept) for the treatment of moderate to severe psoriasis showed ustekinumab superior to Enbrel according to primary and major secondary efficacy endpoints. Ustekinumab is a new, investigational human monoclonal antibody with a novel mechanism of action that targets the cytokines interleukin-12 (IL-12) and interleukin-23 (IL-23), naturally occurring proteins that are important in the body’s regulation of immune responses and that are believed to play a role in immune-mediated inflammatory disorders, including psoriasis.

MannKind Corporation (Valencia, CA/Danbury) released preliminary top-line results from a Phase 3 clinical study of the Technosphere® Insulin System in patients with type 1 diabetes. Dr. Peter Richardson, MannKind's Chief Scientific Officer, commented, "We are very pleased with the results of this study, the first of our three completed pivotal Phase 3 studies. These observations confirm the results of earlier studies and build on the important differentiating features of this product, including its positive effects on fasting glucose levels." Separately, the company announced that it has proposed to the United States Food and Drug Administration to use AFRESA™ as the trade name for its Technosphere® Insulin System.

Pfizer Inc. (New York, NY/Groton/New London) announced that MannKind Corporation will transition certain Exubera patients with a continuing need for inhaled insulin to MannKind’s inhaled insulin product, Technosphere® Insulin. Technosphere® Insulin, which MannKind seeks to market under the trade name AFRESA™, is an investigational product that has recently completed Phase 3 clinical trials.

Pharmaceutical Research and Manufacturers of America (PhRMA) (Washington, DC) said it applauds the introduction of the Intellectual Property Protection and Enforcement Act of 2008, sponsored by Senators Max Baucus (D-Mont.) and Orrin Hatch (R-Utah). "This critical legislation will help in the battle to reduce the theft of intellectual property around the world and also help American firms fight piracy, the counterfeiting of American-designed products and other violations of U.S. intellectual property rights," PhRMA said.

Purdue Pharma L.P. (Stamford) and Mallinckrodt Inc. of Hazelwood, Missouri have agreed to end the OxyContin® (oxycodone HCl controlled-release) Tablets patent infringement lawsuit between them in the United States District Court for the Southern District of New York. According to the agreement, Mallinckrodt acknowledges the validity and enforceability of Purdue's patents and admits that marketing generic versions of OxyContin under its Abbreviated New Drug Application (ANDA) without a license from Purdue would infringe these patents. In exchange, Purdue has agreed to grant Mallinckrodt a royalty-bearing license, ending in 2009, to sell limited quantities of generic versions of 10 mg, 20 mg, 40 mg, and 80 mg extended-release oxycodone tablets.

Quinnipiac University (Hamden) ranked first among northern universities with master's degree programs as having made the most promising and innovative changes in academics, faculty, campus or facilities, according to the 2009 "Best Colleges" issue of U.S. News.

Rib-X Pharmaceuticals, Inc. (New Haven) announced formation of a clinical advisory board. Dr. Robert C. Moellering, Jr., M.D., will serve as chairman. From 1999 to 2005, Dr. Moellering was the Herrman L. Blumgart Professor of Medicine at Harvard Medical School and Chairman of the Department of Medicine at Beth Israel Deaconess Medical Center, Boston.

SBIR - Connecticut (East Hartford) will host the 2008 National SBIR Conference Novermber 12-14 at the Connecticut Convention Center in Hartford. more

Following is recent news from The University of Connecticut (Storrs) and the University of Connecticut Health Center (Farmington).

Geoffrey G. Dellenbaugh, a patent and licensing attorney experienced in the pharmaceutical and biotechnology fields, has joined the UConn Intellectual Property and Entrepreneurship Law Clinic. The Clinic provides free intellectual property services to small businesses in Connecticut. more

A simple blood test can indicate whether a patient’s heart is failing, according to doctors at the Health Center’s Pat and Jim Calhoun Cardiology Center. Evidence from a continuing clinical research study being conducted at the Health Center suggests that a failing human heart releases the peptide, or protein fragment, identified as Caspase-3 p17. Rather than use an invasive surgical procedure to confirm suspicions about a deficiency in the heart’s ability to circulate blood to the rest of the body, cardiologists can check a blood sample for the peptide, believed to be a marker, or indicator of heart failure. more

The Pat and Jim Calhoun Cardiology Center added five physicians this summer, including two electrophysiologists to run the Heart Rhythm Program. Drs. Heiko Schmitt and Christopher Pickett are co-directors of the Heart Rhythm Program. Drs. Anjanette Ferris Senatus, Erick Avelar, and Jason Ryan specialize in non-invasive cardiology. more

A new Center for Implant and Reconstructive Dentistry has opened at the UConn Health Center, with a team of nationally-recognized experts who provide a full range of dental implant services to improve health and enhance smiles with natural-looking replacement teeth. Dr. Donald Somerville, an accomplished prosthodontist who trained at some of the best dental programs in the country, has been appointed director. more

Students at the UConn Health Center who wish to carry on a long institutional tradition of studying global health issues may now have private financial support to do so, thanks to a scholarship funded by a School of Medicine alumnus. Dr. Edward Hargus, M.D. ’73, and his wife Maria have made a gift to provide assistance for students participating in global health education activity through the Center for International Community Health Studies in the School of Medicine. more

Following is recent news from Yale University and the Yale School of Medicine (New Haven).

Yale University scientists have found tiny snippets of RNA are crucial to the formation of blood vessels - a process called angiogenesis that is crucial to everything from early development to heart disease and the spread of cancer. "The role of small RNAs in blood vessels is a new area of research.  Our findings really point towards novel approaches to either choke off the blood supply to tumors or to promote the growth of blood vessels when needed," said William C. Sessa, professor of pharmacology and director of the vascular biology & therapeutics program at the Yale School of Medicine and senior author of the study.

Yale researchers have identified an unusual molecular process in normal tissues that causes RNA molecules produced from separate genes to be clipped and stitched together. The discovery that these rearranged products exist in normal as well as cancerous cells potentially complicates the diagnosis of some cancers and raises the possibility that anti-cancer drugs like Gleevec could have predictable side effects. The work is reported in the journal Science. "Our findings are surprising because we identified in normal cells certain types of gene products- so called chimeric RNAs and proteins-thought to be found only in cancerous cells or in cells on their way to becoming cancerous," said Jeffrey Sklar, professor of pathology and laboratory medicine at Yale School of Medicine, and senior researcher on the study.

Yale molecular and evolutionary biologists in collaboration with Department of Energy scientists produced the full genome sequence of Trichoplax, one of nature's most primitive multicellular organisms, providing a new insight into the evolution of all higher animals. "Trichoplax placozoans are animals that have only four body cell types and no structured organs. They represent descendents of the oldest multi-celled animal, perhaps older even than sponges," said author Stephen Dellaporta, professor of molecular, cellular and developmental biology at Yale.

Researchers at Yale University and the University of Chicago showed that mice exposed to common stomach bacteria were protected against the development of Type 1 diabetes. The findings, reported in the journal Nature, support the so-called “hygiene hypothesis” – the theory that a lack of exposure to parasites, bacteria and viruses in the developed world may lead to increased risk of diseases like allergies, asthma, and other disorders of the immune system. teams led by Li Wen at Yale and Alexander V. Chervonsky at the University of Chicago showed that mice deficient in innate immunity were protected from diabetes in normal conditions.

Out of the 3 billion genetic letters that spell out the human genome, Yale scientists have found a handful that may have contributed to the evolutionary changes in human limbs that enabled us to manipulate tools and walk upright. "Our study identifies a potential genetic contributor to fundamental morphological differences between humans and apes," said James Noonan, Assistant Professor of Genetics in the Yale University School of Medicine and the senior author of the study.

Yale researchers have shown that the origin and evolution of the placenta and uterus in mammals is associated with evolutionary changes in a single regulatory protein, according to a report in Proceedings of the National Academy of Sciences. "Many past studies have shown that genes are regulated and altered by changes within their own structures. This is the first work suggesting that the evolution of transcription factors — separate regulatory proteins — may play an active role in the origin and evolution of structural innovations like the placenta and uterus," said senior author Gunter Wagner, the Alison Richard Professor of Ecology & Evolutionary Biology at Yale.

Intelligence offers some protection against succumbing to immediate gratification, but psychologists have been unsure why. Yale University researchers report that they may have found the first clue to the mystery in an area of the brain that governs abstract problem solving and goal management. "How do you juggle what you desperately want to do right now versus what you know to be best for yourself long term? Its not easy for anyone," said Jeremy Gray, assistant professor of psychology and co-author of the study. "We found that a part of prefrontal cortex that helps integrate goals and values appears to contribute to both self-control and to performance on tests of abstract reasoning and problem solving, helping to explain why self-control and intelligence are related."

Yale School of Medicine researchers reported today that the chemical bisphenol-A (BPA), a building block for polycarbonate plastics found in common household items, causes the loss of connections between brain cells. "Our goal was to more closely mimic the slow and continuous conditions under which humans would normally be exposed to BPA," said study author Csaba Leranth, M.D., professor in the Department of Obstetrics, Gynecology & Reproductive Sciences and in Neurobiology at Yale.

Patients may receive poor or delayed care after sign-out—the transfer of a patient from one doctor to another during a shift change—Yale School of Medicine researchers report in an Archives of Internal Medicine study. “We spend a great deal of time in medical school teaching students how to present a patient, but no time at all on sign-out, which occurs more frequently and is high risk,” said the study’s lead author Leora Horwitz, M.D., assistant professor of internal medicine at Yale School of Medicine. “Closing safety gaps at sign-out could help patients and doctors by reducing duplicative, inefficient care.”

Yale University's Center for Interdisciplinary Research on AIDS (CIRA) has received an $11 million grant to support another five years of HIV prevention and health services research. CIRA is one of eight HIV research centers in the United States funded by the National Institute of Mental Health (NIMH). "We are very excited about the new award because it will allow us to build on CIRA's historic strengths and forge new programs that are responsive to changes in both the pandemic and the scientific community," said Paul Cleary, director and principal investigator for CIRA and dean of the Yale School of Public Health.

Yale University's Pasko Rakic, one of the world's top neurobiologists, received the inaugural Kavli Foundation Prize for Neuroscience. The Kavli Prizes are designed to bring recognition to top scientific enterprises not covered by Nobel prizes. They were created and endowed by Fred Kavli, Norwegian born entrepreneur and philanthropist.

For more member news, see the September 2008 issue of CURE News