454 Life Sciences (Branford) announced that, using 454 sequencing technology, researchers at Columbia University and Victorian Infectious Disease Laboratory have discovered a new virus responsible for the deaths of three organ transplant recipients. Earlier the company announced new products and software for its ultra-high throughput Genome Sequencer FLX System.

Achillion Pharmaceuticals, Inc. (New Haven) announced the appointment of Dr. Elizabeth A. Olek as vice president and chief medical officer. Dr. Olek joins Achillion as a member of the executive management team and will lead the clinical development of Achillion's product development candidates. Dr. Olek joins Achillion from Novartis Pharmaceuticals Corporation.

Alexion Pharmaceuticals (Cheshire) and The Oklahoma Medical Research Foundation announced that Alexion has agreed to acquire from OMRF all rights to certain patents related to complement-inhibition technology. The patents cover inventions made by OMRF in the 1980s relating to the treatment of complement system mediated disorders, to which Alexion has had limited rights as a licensee since the inception of the company. In the 1990s, Alexion began programs to create and develop monoclonal antibodies capable of blocking the body's complement system. One result of these Alexion programs was the development of Soliris®, which was approved for marketing by the U.S. Food and Drug Administration and by the European Commission during 2007. Soliris® (eculizumab) is a complement inhibitor product developed and marketed by Alexion for the treatment of paroxysmal nocturnal hemoglobinuria, a rare, debilitating and life-threatening disease.

Commenting on the company's 2007 results, Leonard Bell, M.D., CEO, said: “Alexion's regulatory and commercial success in 2007 is a direct result of breakthrough science, compelling clinical data and a steadfast commitment to patients. During 2007, Alexion became a global commercial organization and started to fulfill its mission of improving the lives of people with serious and life-threatening disease. Physicians are developing a new sense of urgency in detecting and treating patients with PNH as early as possible. We greatly appreciate the confidence and support we have received from physicians, employees, and shareholders since Alexion was founded.”

Applied Spine Technologies (New Haven) announced the appointment of Michael J. Giordano, M.D., M.B.A. as chief medical officer. He will oversee an ongoing, randomized, controlled, national clinical study comparing the company's Stabilimax NZ® device to traditional fusion surgery.

Bayer HealthCare (Leverkusen, Germany/West Haven) announced that its partner, ZymoGenetics Inc., received FDA approval of RECOTHROM™ for use as a topical hemostatic product. Bayer acquired the product rights for all markets outside the US in 2007 and will provide US sales support for a three-year period as part of a co-promotion agreement.

Boehringer Ingelheim (Ingelheim, Germany/Danbury) announced completion of the enrollment phase of its RE-LY™ study, which is comparing two blinded doses of oral dabigatran etexilate with the current standard therapy, warfarin (target INR 2.0-3.0) in patients with non-valvular atrial fibrillation who are at moderate to high risk of stroke. Currently, over 10,000 patients have been treated for at least 6 months with final study results expected to be reported in early 2009.

Bristol-Myers Squibb Company (New York/Wallingford) has named Togo D. West, Jr., to its board of directors, where he will will serve as a member of the compensation and management development committee and the committee on directors and corporate governance. West, 65, is currently chairman of TLI Leadership Group and of Noblis, Inc. He has been U.S. Secretary of the Army and U.S. Secretary of Veterans Affairs.

Carigent Therapeutics (New Haven) announced that the National Science Foundation has awarded the company a six-month, $97,000 Phase I Small Business Innovation Research (SBIR) grant to engineer long-circulating nanoparticles that target delivery and enable controlled release of paclitaxel to ovarian cancer tumors. Paclitaxel, a widely used chemotherapy drug sold under various brand names, including Taxol®, is a potent anticancer natural product used to treat patients with leukemia, lymphoma, and a number of solid-tumor malignancies including ovarian cancer, breast cancer, lung cancer, and brain cancer.

Cognate BioServices (Baltimore/New Haven) has taken 7,550 square feet of laboratory and office space at the Long Wharf Maritime Center in New Haven. Established in 2002 and founded by Toucan Capital, Cognate is an international research and development company with an established track record of of successfully developing and providing a broad range of cell-based products and services for research, drug discovery, and clinical applications. Richard Gold of O,R&L represented the company in the lease negotiations.

CuraGen Corporation (Branford) announced the appointment of Sean Cassidy as vice president and CFO. David W. Wurzer is stepping down to pursue other opportunities. Previously Cassidy served as controller of 454 Life Sciences Corporation. 

Danbury Hospital (Danbury) has announed the appointment of Jessica L. Dodge, M.D., to the Department of Laboratory Medicine. Board certified in Anatomic and Clinical Pathology, Dr. Dodge earned her medical degree from the Medical College of Pennsylvania, and was an intern at the Johns Hopkins Hospital in Baltimore, MD. She also completed a residency and Surgical Pathology Fellowship at Johns Hopkins Hospital.  She was previously employed at the Cayuga Medical Center at Ithaca (NY) and St. Vincent Hospital at Worcester Medical Center in Massachusetts.

GlaxoSmithKline (London/Research Triangle Park, NC) and XenoPort, Inc. announced positive top-line results from a placebo-controlled Phase 3 clinical trial designed to evaluate the potential of XP13512 (GSK1838262) to maintain efficacy over the course of nine months in patients with moderate-to-severe primary Restless Legs Syndrome. “The results of this study strengthen our belief that XP13512 has potential as an effective and well tolerated treatment for primary RLS,” said Ronald W. Barrett, Ph.D., chief executive officer of XenoPort.

The newest satellite facility of Hartford Hospital (Hartford) is the Helen & Harry Gray Cancer Center in Avon. The new center, on Fisher Drive just a short distance from the hospital's Wellness Center on Rte. 10, is slated to open in July, 2008.

HistoRx (New Haven) named Rana K. Gupta CEO. Gupta had been serving as interim CEO since August 2006. During that time, the company advanced its proprietary AQUA® tissue biomarker analysis technology platform, increased its revenue stream to fund product development, and completed a $6 million Series B equity financing round.

Ipsogen (Marseille, France/New Haven) has entered into a pilot agreement with AstraZeneca to evaluate molecular services and products in cancer research. Ipsogen will provide AstraZeneca with JAK2-based products for initial evaluation and will conduct quantitative analysis in its Marseille laboratories on samples provided by AstraZeneca. The study will help determine the viability of a test which could potentially be utilized by AstraZeneca in future clinical trials. Ipsogen is the exclusive worldwide licensee of the intellectual property on the JAK2 V617F mutation.

The company also announced the a license agreement with Université Libre de Bruxelles (ULB), Belgium for the worldwide and exclusive rights on the Genomic Grade™,  a genomic index invented by Pr. Christos Sotiriou & Pr. Martine Piccart, from the Bordet Institute, Brussels and Dr. Mauro Delorenzi from the Swiss Institute for Cancer Research (ISREC), Lausanne, two leading European cancer research institutes.

Reporting on 2007 results, William C. Weldon, chairman and CEO of Johnson & Johnson (New Brunswick, NJ), said, “Despite challenges in certain markets, our broad base of businesses allowed us to achieve solid results, building on our foundation of long-term profitable growth. It was a year of significant progress in our pipeline; the successful integration of Pfizer Consumer Healthcare; and the creation of new organizational structures focused on future growth.”

Commenting on 3Q results, Alfred Mann, chairman and CEO of MannKind Corporation (Valencia, CA/Danbury), said, “While Exubera [inhalable insulin] was withdrawn from the marketplace, our Technosphere Insulin is very different and continues to be well received by patients and physicians in our clinical trials. Our Phase III program is on track and our readiness for commercial operations is proceeding according to schedule. As data becomes available in 2008, we will be able to share more of this progress with our investors. In the meantime, the recently announced positive Phase I data for our Technosphere/GLP-1 product were encouraging. More than ever, there is a need for improved and innovative diabetes therapies. We at MannKind remain committed to bringing such therapies to the enormous number of diabetes patients who suffer from this disease.”

NanoViricides, Inc. (West Haven) reported that they are on course with the development of nanoviricides™ drug candidates against highly pathogenic avian influenzas (HPAI) including H5N1 bird flu, and common influenza. “We are now ready to begin animal studies on H5N1 at a renowned federal agency,” said Dr. Eugene Seymour, MD, MPH, CEO of the Company. Earlier, the Company had delayed these studies in search of suitable facilities. The work is expected to begin once the contracts are finalized.

Neurogen Corporation (Branford) announced Feb 4 that its president, Stephen R. Davis, has been appointed chief executive officer. William Koster has retired but remains on the company's board. The company announced Feb 6 that it is reducing its workforce as part of a restructuring intending to focus its resources on its advancing clinical assets.

Earlier, the company announced that it has completed the follow-up component of a Phase I multiple ascending dose (MAD) study with NGD-4715, an MCH-1 receptor antagonist being investigated for the treatment of obesity. Results suggest that the effect of MCH-1 receptor antagonism on caloric regulation and sleep architecture requires further study in humans. Based on the results, Neurogen has determined that it will not advance the compound into Phase II testing at this time, but will consider out-licensing its MCH program for potential development with a partner.

Commenting on 2007 results, Jeff Kindler, chairman and CEO of Pfizer Inc. (New York, NY/Groton/New London), said: “In 2007, we delivered solid performance, and made structural and operational changes to enhance the future performance of our company. With strong product performance, cost reductions, improved productivity and the benefits of foreign exchange, we achieved both revenue and adjusted diluted EPS growth ... . Our new products  —  Lyrica, Chantix, and Sutent  —  are performing well. We are continuing to strengthen our senior leadership team and enhance accountability. We are shifting investments into high-priority therapeutic areas, revamping our R&D operations and acquiring new compounds and technologies that we believe are especially promising. These actions taken together have made Pfizer a stronger company than it was a year ago, and we look forward to continued progress in 2008.”

Pharmaceutical Research and Manufacturers of America (PhRMA) (Washington, DC) has joined a nationwide workplace wellness effort in becoming CEO Cancer Gold Standard™ accredited, certifying their commitment to the health of their employees and their families by meeting an exceptionally high standard of cancer prevention, screening and health care. The CEO Cancer Gold Standard™, calls for companies to evaluate their benefits and culture and take extensive, concrete actions in five key areas of health and wellness to fight cancer in the workplace. To earn accreditation, a company must establish programs to reduce cancer risk by discouraging tobacco use; encouraging physical activity; promoting a healthy diet; providing appropriate screening to detect cancer at its earliest stages and providing access to quality care, including cancer clinical trials.

Purdue Pharma L.P. (Stamford) said it had achieved an important victory in its patent infringement litigation relating to Purdue's patents covering the pain medicine OxyContin® (oxycodone HCl controlled-release) Tablets when the United States District Court for the Southern District of New York rejected claims that the patents in suit were unenforceable because of alleged inequitable conduct by Purdue in obtaining them from the United States Patent and Trademark Office. In an Opinion and Order dated January 7, 2008, the Court stated, “[T]he weight of the equities before this Court does not warrant the extreme sanction of holding the patents in suit unenforceable. ...[D]efendants have failed to show by clear and convincing evidence that the Purdue committed inequitable conduct before the PTO, and therefore the patents-in-suit will not be held unenforceable on that basis.”

RainDance Technologies (Guilford) was selected as a World Economic Forum Technology Pioneer and invited to participate in the World Economic Forum Annual Meeting in Davos, Switzerland, in January 2008. Technology Pioneers are companies that have been identified as developing and applying highly transformational and innovative technologies in the areas of energy, biotechnology and health, and information technology. According to the Forum, to be selected as a Technology Pioneer, a company must be involved in the development of life-changing technology innovation and have the potential for long-term impact on business and society. In addition, it must demonstrate visionary leadership, show all the signs of being a long-standing market leader  —  and its technology must be proven.

Rib-X Pharmaceuticals, Inc. (New Haven) announced the enrollment of the first patients in two separate Phase II clinical trials. The studies will evaluate the safety and efficacy of RX-1741 in the treatment of Community-Acquired Pneumonia, and separately in the outpatient treatment of Uncomplicated Skin and Skin Structure Infections. RX-1741 is the Company’s first antibiotic program developed using its proprietary technology platform. RX-1741 is an oxazolidinone antibiotic that exhibits activity against methicillin-resistant Staphylococcus aureus (MRSA) and other Gram-positive organisms, and has demonstrated both greater spectrum and potency of activity than the currently marketed product of the same class. Rib-X believes that RX-1741, discovered using proprietary knowledge of the three dimensional structure of a key area of the ribosome, the 50S subunit,  will demonstrate a high level of effectiveness against resistant microbes.

Vion Pharmaceuticals, Inc. (New Haven) announced that the FDA has lifted the clinical hold on the Phase III trial (Vion Study CLI-037) of its lead anti-cancer agent, Cloretazine® (VNP40101M), in combination with cytarabine in relapsed acute myelogenous leukemia (AML). Alan Kessman, CEO, said, “We are pleased with the FDA's decision ... and are now poised to move ahead with clinical development.”

Webster Bank (Waterbury) announced the appointment of Jeffrey A. Klaus as regional president for its greater New Haven region. Klaus has 25 years of experience in the Connecticut banking industry.

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

Six proposals from researchers in the sciences and engineering won a total of $2 million of equipment funding in the recent Provost’s Research Equipment Competition at UConn. more

A new automated clinical laboratory is adding another level of patient protection at the Health Center, as well as cost-savings and safety benefits for staff. more

The second annual New England Musculoskeletal Institute Research Day was held recently at the UConn Health Center. The event is an opportunity for scientists and clinicians to present their latest research findings. more

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

Bioengineers at Yale and Cornell have created a modified chemotherapy that more effectively reaches and remains at the site of brain tumors — by adding a water-soluble polymer to the anti-cancer drug, according to a report in the November-December issue of Bioconjugate Chemistry. “This approach has the potential to increase treatment distances to more than a centimeter, which may be sufficient to prevent the recurrence of human brain tumors,“ said Mark Saltzman, Goizueta Foundation Professor of Chemical and Biomedical Engineering at Yale and senior author on the paper.

Boosting an exercise-related gene in the brain works as a powerful anti-depressant in mice-a finding that could lead to a new anti-depressant drug target, according to a Yale School of Medicine report in Nature Medicine. “The VGF exercise-related gene and target for drug development could be even better than chemical antidepressants because it is already present in the brain,” said Ronald Duman, professor of psychiatry and senior author of the study.

An antibody used to treat certain cancers and rheumatoid arthritis appears to greatly delay type 1 diabetes in mice, Yale School of Medicine researchers report in the Journal of Clinical Investigation. “Our paper shows, for the first time, that after successful B cell depletion, regulatory cells emerge that can continue to suppress the inflammatory and autoimmune response even after the B cells return,” said Li Wen, senior research scientist in the division of endocrinology. “Even more strikingly, we found that these regulatory cells include both B and T cells.”

Yale School of Medicine researchers have shown for the first time that it is possible to suppress the development of epilepsy in genetically predisposed animals — which could open the door to treating epilepsy as a preventable disease. “Current treatments for epilepsy may control seizures, but they do nothing to alter the underlying disease,” said Hal Blumenfeld, M.D., associate professor of neurology and lead author of the study. “These findings are important because they set the stage for prevention of epilepsy in genetically susceptible people.”

A genetic mutation expands lesions in the aorta and promotes coronary atherosclerosis, more commonly known as hardening of the arteries, according to a study by Yale School of Medicine in Cell Metabolism. “Mice engineered without the Akt1 gene and fed a high cholesterol diet had many more signs of aortic atherosclerosis compared to their littermates,” said William Sessa, senior author of the study, professor of pharmacology, and director of Yale's vascular biology and therapeutics program.

Yale School of Medicine researchers have isolated a gene that helps protect newborns from the most common respiratory cause of infant death in the United States — respiratory distress syndrome. “The finding is important because prematurity is not only the most common respiratory cause of infant mortality in the U.S., it also tends to be a more serious problem in inner city neighborhoods,” said Richard Bucala, M.D., professor of medicine and pathology, professor of epidemiology at Yale School of Public Health, and senior author of the study.

Researchers at Yale School of Medicine have found that a low concentration of vitamin E in the blood is linked with physical decline in older persons. Published in the January 23 issue of Journal of the American Medical Association, the study included 698 people age 65 or older who were randomly selected from the population registry in two municipalities close to Florence, Italy. The researchers, led by first author Benedetta Bartali of Yale, collected blood samples to measure the levels of micronutrients including folate, iron and vitamins B6, B12, D and E.

The New Haven City Plan Commission unanimously approved a site plan for a garage to be used by the Smilow Cancer Center at Yale-New Haven Hospital. Plans call for retail shops to surround the garage. Besides the garage, a new medical lab on Park Street accompanies development of the cancer center, which is expected to open in 2009.

Research projects by two Yale School of Medicine investigators — one studying global healthcare disparities, the other, depression — have been given a boost with five-year, $600,000 awards from the Patrick and Catherine Weldon Donaghue Medical Research Foundation for Health-Related Research. The Investigator Awards to Jennifer Prah Ruger, assistant professor in the Division of Global Health at Yale School of Public Health, and Alexander Neumeister, M.D., director of the Molecular Imaging Program in psychiatry, are intended to support particularly promising and highly talented medical researchers holding academic appointments at Connecticut institutions.

Tim Corson, a Yale postdoctoral fellow in the Department of Molecular, Cellular & Developmental Biology, received two top fellowship honors from the Canadian Institutes of Health Research (CIHR) in Ottawa on November 20 for his proposal of a research project to target and destroy a protein commonly active in cancer. Corson received the Jean-François St-Denis Fellowship in Cancer Research for the top-ranked proposal in the field of cancer research in the 2006-2007 competition, and a Bisby Fellowship for submitting the overall top-ranked post-Ph.D. proposal in February 2007 competitions.

Even though current guidelines advocate colorectal cancer screenings for those with severe illnesses, they may bring little benefit and may actually pose harm, according to a recent study by Yale School of Medicine researchers published in the Archives of Internal Medicine. First author R. Scott Braithwaite, M.D., and his colleagues developed a new method of evaluating medical screening tests like colonoscopy, called the “payoff time,” which is the minimum amount of time it takes for the benefits from a test to exceed its harms (i.e., its complications and side effects).

The largest, most comprehensive study of young women with heart attacks — VIRGO (Variation in Recovery: Role of Gender on Outcomes in Young AMI patients) — was recently launched at Yale School of Medicine with a $9.7 million National Institutes of Health grant. “This is the first study to focus on this high risk-and highly unstudied-group.” said Yale School of Public Health Associate Professor Judith Lichtman, co-principal investigator of the study. “There have been no large, prospective studies of this population, even though the death toll is comparable to that from breast cancer.”

The adage “It's not what you say but how you say it” — was confirmed by a Yale study, which shows that playing up the benefits of quitting smoking is more effective in getting people to quit than emphasizing the problems associated with continuing to smoke. The difference is substantial enough that consideration should be given to rewriting the warning labels on packs of cigarettes to emphasize the benefits of quitting smoking rather than the risk of continuing, said first author Benjamin Toll, assistant professor of psychiatry at Yale School of Medicine.

Children learn by imitating adults-so much so that they will rethink how an object works if they observe an adult taking unnecessary steps when using that object, according to a Yale study today in Proceedings of the National Academy of Sciences. “Even when you add time pressure, or warn the children not to do the unnecessary actions, they seem unable to avoid reproducing the adult's irrelevant actions,” said Derek Lyons, doctoral candidate, developmental psychology, and first author of the study. “They have already incorporated the actions into their idea of how the object works.”

Black patients are significantly less likely than their white counterparts to receive therapy for various kinds of cancer, despite recent efforts to close gaps in treatment, according to a study by researchers at Yale School of Medicine published in the January 7 online issue of the journal Cancer. Cary P. Gross, M.D., associate professor of medicine at Yale School of Medicine, and colleagues studied the Surveillance, Epidemiology, and End Results (SEER)-Medicare database to evaluate whether greater attention and investment in access to care for all individuals have led to any reduction in cancer treatment disparities.

For more member news, see the December 2007 issue of CURE News