| CURE
Member News Digest
454 Life Sciences (Branford), a Roche
company, announced that a team of researchers at Washington University in
St. Louis have characterized the human gut microbiome by sequencing the
microbial communities of adult twins and their mothers with the Genome Sequencer
FLX System. The work is part of the International Human Microbiome Project, an
initiative to define the role and structure of microbial communities within the
human body.
In a recent statement, Michael Kishbauch,
president and CEO of Achillion Pharmaceuticals, Inc. (New
Haven) said: "Having completed a private equity financing in August
2008, we are quite pleased to have resources available to advance our pipeline,
particularly our hepatitis C candidates, ACH-1095 and ACH-1625, forward into the
clinic. Our NS4A antagonist candidate, ACH-1095 (also known as GS-9525), which
we are developing in collaboration with Gilead Sciences, has the potential to be
both scientifically and commercially complementary with HCV protease inhibitors
in development. Our proprietary HCV compound, ACH-1625, has unique properties
from other protease inhibitors in development. We expect to see both compounds
in the clinic next year, pending successful completion of the currently on-going
preclinical studies."
Alexion Pharmaceuticals (Cheshire) said
that Soliris® (eculizumab), a terminal complement inhibitor developed by the
company, was observed by investigators to reduce blood measures associated with
undiagnosed blood clots and inflammation in patients with paroxysmal nocturnal
hemoglobinuria (PNH). A separate study found that Soliris was observed to reduce
indicators of pulmonary artery hypertension in patients with PNH. "The
common, severe, and progressive clinical consequences of PNH are becoming more
apparent as researchers gain more experience and basic knowledge with regard to
this disease," said Leonard Bell, M.D., the company's CEO.
Bayer HealthCare (Leverkusen,
Germany/West Haven) announced study results showing that patients with early
relapsing-remitting multiple sclerosis (RRMS) taking once-yearly cycles of
alemtuzumab reduced their risk of relapse by 74 percent and the risk of
sustained accumulation of disability by 71 percent compared to patients treated
with the active comparator Rebif® (high-dose interferon beta-1a). The mean
disability of patients on alemtuzumab improved from baseline, whereas the mean
disability of those on Rebif worsened.
Boehringer Ingelheim (Ingelheim,
Germany/Danbury) said that results from PRESIDE (Prevalence
of Female Sexual Problems Associated with Distress
and Determinants of Treatment Seeking), the largest survey
assessing the prevalence of female sexual problems, show that low sexual desire
is the most commonly reported sexual problem in women age 18 or older. Funding
for PRESIDE was provided by Boehringer Ingelheim.
Bristol-Myers Squibb Company (New
York/Wallingford) announced new data from studies of
IXEMPRA™ (ixabepilone) plus capecitabine compared to capectabine alone,
including a pre-specified sub set analysis demonstrating a significant increase
in progression free survival in patients with triple negative breast cancer.
Triple negative breast cancer patients are diagnosed based upon the lack of
three “receptors” – estrogen receptors, progesterone receptors and human
epidermal growth factor receptor 2 (HER2). "Patients with advanced, triple
negative breast cancer have limited treatment options and a poor
prognosis," said Hope S. Rugo, M.D., Clinical Professor of Medicine and
Director, Breast Oncology Clinical Trials Program, University of California San
Francisco Helen Diller Family Comprehensive Cancer Center. "For this
reason, it is important to explore the potential of other current and
developmental therapies to discover more and effective treatment options for
patients with this specific type of breast cancer."
Cantor Colburn LLP (Hartford)
has added two experienced intellectual property attorneys with scientific
backgrounds. David Henn has 17+ years’ experience in preparation and
prosecution of patent and trademark applications, having worked in private
practice, as in-house counsel at Xerox, in technology transfer at State
University of New York (SUNY)’s Research Foundation, and as a Patent Examiner
for the U.S. Patent and Trademark Office. Nicholas Sisti joins Cantor Colburn
LLP from Darby & Darby in New York City, where he drafted pharmaceutical,
chemical and medical device applications and amendments. Dr. Sisti has served as
patent counsel at Lundbeck Research USA in Paramus, NJ, and at Pfizer in Groton,
Conn.
Connecticut Innovations (Rocky Hill) announced
that it has made an investment of $300,000 in FMP Products Inc. (FMP) through
its Eli Whitney Fund. With operations in Greenwich and New Milford, CT, FMP is
developing laboratory automation equipment and software to help improve the
productivity of researchers in the pharmaceutical, industrial, educational, and
governmental arenas.
CuraGen Corporation (Branford) announced
preliminary data from an ongoing Phase II trial of CR011-vcMMAE, an
antibody-drug conjugate that targets GPNMB, for the treatment of patients with
unresectable Stage III or Stage IV melanoma. "The apparent prolongation in
progression-free survival of 4.5 months, compared to a historical expectation of
1.7 months, combined with clear objective responses and tumor reduction in the
majority of patients, suggests that CR011-vcMMAE has the potential to become an
important novel therapy in this patient population," commented Dr. Timothy
Shannon, president and CEO of CuraGen.
Genomas Inc. (Hartford) recently entered
a $2.5 million partnership with the Puerto Rico Economic Development Bank, the
University of Puerto Rico (UPR) School of Medical Sciences and the Puerto Rico
Industrial Development Co. (Pridco) to conduct a clinical and research study to
better understand the culturally diverse genetic makeup of the Puerto Rico
population.
GlaxoSmithKline (Research Triangle Park, NC) said
new results from a study evaluated the combination of GSK's TYKERB® (lapatinib)
plus Novartis' Femara® (letrozole) versus letrozole alone as a first-line
treatment regimen in hormone receptor positive metastatic breast cancer.
In the study, women diagnosed with post-menopausal, hormone receptor positive and metastatic breast cancer experienced a 5.2 month increase
in median progression-free survival compared to women treated with letrozole alone.
Hartford Hospital (Hartford) announced
that Dr. Stuart Lieblich has been elected secretary/treasurer of
the American Board of Oral and Maxillofacial Surgery. Dr. Lieblich has received
several honors and distinctions throughout his career, including being named to
the "Top Dentists" lists by Connecticut Magazine and Hartford
Magazine. Beyond treating trauma patients at Hartford Hospital, he
volunteers his time at its Dental Clinic.
Invitrogen (Carlsbad, CA/Branford) is
changing its name to Life Technologies following the merger of Invitrogen and
Applied Biosytems, Inc, of Norwalk, CT. Life Technologies includes the former
Protometrix located in Branford, CT.
Ipsogen (Marseille, France/New Haven)
has expanded its range of products for leukemia with the introduction of its
MPL W515L/K MutaScreen™ Kit. The
kit contains positive and negative controls, ready-to-use mixes of primers and
probes, and cut-off samples for screening of W515L and W515K mutations.
Johnson & Johnson (New Brunswick, NJ) said
that Phase 3 data demonstrate efficacy and tolerability of paliperidone
palmitate, an investigational long-acting therapy for the treatment of
schizophrenia.
Life Technologies Corporation (Carlsbad, CA/Branford)
announced that its technology for next-generation genomic
analysis, the SOLiD™ System, has been named the Life Science Innovation of the
Year for 2008 by The Scientist, a scientific publication focused on the
life science industry.
MannKind Corporation (Valencia,
CA/Danbury) announced that it has met the primary endpoints of its final two
pivotal Phase 3 studies of AFRESA™, the company's ultra rapid acting, inhaled
insulin product. "We are very pleased to announce the positive outcome of
these, the last of our three pivotal Phase 3 studies. We look forward to
presenting more complete data, including analyses of secondary endpoints, as
soon as they are available, which are expected before the end of this year.
AFRESA promises to be an important additional option for the treatment of
patients with diabetes. Our next step is to finalize a new drug application for
AFRESA, which we expect to submit to the FDA in early 2009," commented Dr.
Peter Richardson, MannKind's chief scientific officer.
Commenting on the progress of Neurogen
Corporation (Branford), Stephen R. Davis, president and CEO, said: "We
will continue to focus our resources on the development of our D2 partial
agonist, aplindore, for the treatment of Restless Legs Syndrome and Parkinson's
disease. We were very pleased to report positive Phase 2a results with Aplindore
in both of these disorders in October. Not only did we see very strong signals
of efficacy, but in both studies aplindore's partial agonist profile appeared to
be very well tolerated at the doses we plan to take forward. This offers the
potential advantage of fewer side-effects and shorter titration periods and the
possibility of no required titration in RLS."
NanoViricides, Inc. (West Haven)
announced hat they have executed a cooperative research and development
agreement with the Armed Forces Institute of Pathology (AFIP). This joint
R&D effort will enable AFIP scientists to test the effectiveness of several
NanoViricides anti-viral nanomedicines against deadly bird flu viruses (H5N1).
the company said.
Pfizer Inc. (New York, NY/Groton/New London) and
Sigma-Tau, and Italian company, announced that they have entered into a license
and supply agreement under which, following applicable regulatory submissions
and approvals, the companies will market Eurartesim®, a novel fixed dose
artemisinin-based combination therapy, in Africa. Eurartesim® aims to treat
uncomplicated Plasmodium falciparum malaria in adults and children, while
reducing the potential for re-infection.
Pharmaceutical Research and Manufacturers of
America (PhRMA) (Washington, DC) affirmed its support of responsible
direct-to-consumer advertising, stating that "in numerous studies and
surveys, DTC advertising has been shown to play a key role in educating and
empowering patients, improving patient understanding of disease and available
treatments, and fostering strong relationships between patients and their
healthcare providers."
Purdue Pharma L.P. (Stamford) announced
it has entered into a global strategic alliance with Mundipharma International
Corporation Limited and Infinity Pharmaceuticals, Inc. to advance the research,
development, and commercialization of Infinity's discovery and early clinical
programs in the areas of oncology and neuropathic pain. The alliance will focus
on supporting Infinity's pipeline of novel, small molecule oncology drug
candidates. Purdue's associated company, Purdue Pharmaceutical Products L.P.,
and Mundipharma will have the worldwide rights to assume development of
Infinity’s fatty acid amide hydrolase (FAAH) program.
Health sciences professor Ronald Beckett of Quinnipiac
University (Hamden) recently discussed the findings of his research about
smoked body mummies of the Anga people preserved in the remote New Guinea
village of Koke. Using native materials, the villagers assisted Beckett and his
crew to restore the mummy Moimango, father of the village chief Gemtasu. Some of
the native materials used included suca (tree sap), which was used as an
adhesive, and tapa (tree bark), used to reinforce Moimango's legs.
Rib-X Pharmaceuticals, Inc. (New Haven)
announced positive topline results from a Phase 2 clinical trial with the
intravenous form of its novel anionic quinolone antibiotic, delafloxacin
(RX-3341). The double-blind study showed that both doses (300mg BID and 450mg
BID) of delafloxacin were as efficacious as the FDA approved dosing regime for
tigecycline in the treatment of complicated skin and skin structure infections (cSSSI).
Additionally, when evaluated in vitro against the Gram-positive and
Gram-negative organisms isolated from patients within this trial, delafloxacin
was shown to be the more active compound overall, including its activity against
Staphylococcus aureus and methicillin-resistant S. aureus (MRSA) and quinolone-resistant
Gram-positive pathogens. "This is the third Phase 2 clinical trial showing
delafloxacin to be both efficacious and safe," said Susan Froshauer, PhD,
president and CEO of Rib-X.
Following is recent news from The University of Connecticut (Storrs) and the University of Connecticut Health Center (Farmington).
In one of the most
stringent studies to date of the popular blood
pressure-lowering drugs known as beta blockers, researchers
at the UConn/Hartford Hospital Evidence-based Practice
Center have confirmed that these drugs reduce the chances of
a heart attack following non-cardiac surgery but increase
the risk of having a stroke. Ripple Talati, an adjunct
assistant professor of pharmacy and a cardiovascular
pharmacology and outcomes fellow, authored the study. more
UConn's Office of Technology
Commercialization has launched a new website developed to increase exposure to
UCONN commercialization activities for a variety of audiences. According
to OTC Managing Director Bruce Carlson, “Commercialization of UCONN research
is a key component of the University’s new academic plan. Our goal is to
increase the involvement of alumni, faculty and students in the
commercialization process by providing information that will facilitate access
to UCONN intellectual property and other resources of interest to industry and
entrepreneurs.” Go to http://otc.uconn.edu/
to view the new site.
Johann Peter Gogarten, professor of
molecular and cell biology at UConn's College of Liberal Arts and
Sciences, will begin work in January on a new five-year project to unearth the
“roots” of the Darwin-inspired Tree of Life. The project is funded by a $2.5
million grant from the National Science Foundation. more
The UConn Health
Center is a leading partner in a state pilot program that by
next fall will have provided colorectal cancer screenings
for up to 600 uninsured or underinsured Connecticut
residents. The Connecticut Colorectal Cancer Screening
Demonstration Project, funded by a state grant, screened its
first patients in December. more
A large-scale clinical
trial underway at three sites, including UConn’s Human
Performance Laboratory, aims to pinpoint the prevalence of
statin-induced muscle pain and weakness and to better
understand how the most prescribed class of drugs in the
world exerts its potentially harmful effects on muscles.
Linda Pescatello, a professor of kinesiology in the Neag
School of Education and a principal investigator at
UConn’s Center for Health, Intervention, and Prevention,
is part of the team conducting the four-year study through a
$3 million grant from the National Institutes of Health and
the National Heart, Blood, and Lung Institute. more
Daniel Rosenberg is
trying to figure out why some early colon lesions are
suppressed by non-steroidal anti-inflammatory therapy, while
others seem to thrive under similar conditions. His research
has drawn the attention of the National Cancer Institute
(NCI), which awarded Rosenberg a $1.8 million grant and
identified his work as an “exemplar of NCI-funded
translational research.” Rosenberg is a professor of
medicine and genetics and developmental biology, an
investigator in the Center for Molecular Medicine, and
co-director of the Colon Cancer Prevention Program at the
UConn Health Center. more
UConn dramatically expanded
its nanotechnology research capabilities with the opening of
a 1,000-square-foot "clean room" that will allow
scientists to fabricate cutting-edge devices for use in
defense, industry, and medicine. The Nanobionics Fabrication
Facility – as the dust-free ‘clean room’ is formally
known – supplements state-of-the-art research technology
worth more than $20 million, ncluding high-power
electron microscopes, atomic force microscopes, and advanced
spectrometers, that is currently available at the Institute
of Materials Science (IMS) in UConn's Edward V. Gant Science
Complex. more
A study by a Health
Center researcher takes a scientific look at a therapy that
is often considered unscientific – hands-on healing.
Gloria Gronowicz, professor of surgery, found that
Therapeutic Touch performed by trained energy healers
significantly stimulated the growth of bone, tendon, and
skin cells in lab dishes. Her findings are published in the
Journal of Orthopaedic Research and the Journal of
Alternative and Complementary Medicine. more
A new major gift will
enable the UConn Health Center to offer an integrated
imaging and treatment suite. The suite will help patients
move seamlessly from diagnostics to treatment, using the
latest technology. It will be the first of its kind in the
region. Torrington natives Carole and Ray Neag made the $3.8
million pledge to upgrade the Health Center’s computed
tomography (CT) scanner with a new, more advanced model, and
to incorporate new planning and treatment tools into the
suite. more
Think outside the box.
That’s the first piece of advice Jennifer Murphy gives her
students. Murphy, who advises students majoring in ecology
and evolutionary biology in UConn's College of Liberal Arts
and Sciences, is the recipient of this year’s Outstanding
Student Advisement and Advocacy Award. more
Medical student Neena Qasba
spent most of last summer in Bolivia studying poor women’s
use of small loans for essential health services. Cheryl
Bilinski, an MD/MPH student, spent the summer in Haiti
working on a prevention and treatment program for pregnant
women and newborns with syphilis. The two students represent
the growing number of UConn Health Center students who study
abroad during their graduate school careers. more
New grants
intended to promote collaboration between researchers at
UConn in Storrs and the UConn Health Center in Farmington
have recently been awarded to 11 research teams. The
year-long grants – known as UCHC/Storrs and Regional
Campus Incentive Grants, or UCIG – are approximately
$50,000 each. They were jointly funded from the research
budgets at Storrs and the Health Center, using money derived
from indirect costs on extramural grants. more
As part of the
ongoing process to explore affiliations with regional
hospitals, University officials have released a conceptual
framework document that calls for significantly enhanced
ties between the UConn Health Center and Hartford area
hospitals. more
Dr. Cato T. Laurencin, vice
president for health affairs at the UConn Health Center and
dean of the medical school, has been named among "100
Chemical Engineers of the Modern Era" by the American
Institute of Chemical Engineers. more
Following is recent news from Yale University and the Yale School of Medicine (New Haven).
Pregnancy and surgery patients with a
serious blood disorder that causes excessive clotting have responded well to
treatment with a man-made anti-clotting protein. "This is a remarkable
technologic feat,” said study investigator Michael Paidas, M.D., associate
professor in the Department of Obstetrics, Gynecology & Reproductive
Sciences, and director of the Women and Children’s Center for Blood Disorders
at Yale. “We’ve shown that this genetically engineered protein can prevent
complications linked to antithrombin deficiency. Ours is the first team in the
United States to use the protein in a clinical trial with pregnant
patients."
Recent research at Yale opens the door to semiconductor
devices that are operated by the force of light. “While the force of light is
far too weak for us to feel in everyday life, we have found that it can be
harnessed and used at the nanoscale,” said team leader Hong Tang, assistant
professor at Yale. The research appears in the November 27 issue of
Nature.
Researchers at Yale
University have created a blueprint for artificial cells
that are more powerful and efficient than the natural cells
they mimic and could one day be used to power tiny medical
implants. The scientists began with the question of whether
an artificial version of the electrocyte – the
energy-generating cells in electric eels – could be
designed as a potential power source. "The electric eel
is very efficient at generating electricity," said Jian
Xu, a postdoctoral associate in Yale’s Department of
Chemical Engineering. "It can generate more electricity
than a lot of electrical devices."
Yale researchers have
taken the first critical steps in unraveling the mysteries
of brain aneurysms, the often fatal rupturing of blood
vessels that afflicts 500,000 people worldwide each year. An
international team — led by Murat Gunel, professor of
neurosurgery and neurobiology, and Richard Lifton, Sterling
Professor and chair of genetics, and a Howard Hughes Medical
Institute investigator — scanned the genomes of more than
2,000 individuals suffering from intracranial aneurysms
along with 8,000 healthy subjects. They discovered three
chromosome segments, or loci, where common genetic
variations can create significant risk for ruptured
aneurysms, which in turn cause strokes.
Halting a medication that
treats one ailment because it may worsen another is a
treatment trade-off decision that elderly patients with
multiple medical conditions would rather take part in,
researchers at Yale School of Medicine report in a study
published in the Journal of the American Geriatrics Society.
"Taking this kind of active role in treatment decisions
means more customized outcomes for patients," said
study author Terri Fried, M.D., professor in the Department
of Internal Medicine at Yale School of Medicine.
Yale researchers have
described how dueling brain systems may explain why you
forget to drop off the dry cleaning and may point to ways
that substance abusers and people with obsessive compulsive
disorder can overcome bad habits. In Proceedings of the
National Academy of Sciences, Christopher J. Pittenger,
M.D., and colleagues describe a sort of competition between
areas of the brain involved in learning that results in what
Pittenger calls the "dry cleaning effect." One
area of the brain called the striatum helps record cues or
landmarks that lead to a familiar destination. It is the
area of the commuter’s brain that goes on autopilot and
allows people to get to work, often with little memory of
the trip.
Rather than infer that nanotechnology is
safe, members of the public who learn about this novel science tend to become
sharply polarized along cultural lines, according to a study conducted by the
Cultural Cognition Project at Yale Law School in collaboration with the Project
on Emerging Nanotechnologies. The report is published online in the journal Nature
Nanotechnology. The determining factor in how people responded was their
cultural values, according to Dan Kahan, the Elizabeth K. Dollard Professor at
Yale Law School and lead author of the study. "People who had more
individualistic, pro-commerce values, tended to infer that nanotechnology is
safe,” said Kahan, “while people who are more worried about economic
inequality read the same information as implying that nanotechnology is likely
to be dangerous."
In the battle against obesity, Yale
University researchers may have discovered a new weapon — a naturally
occurring molecule secreted by the gut that makes rats and mice less hungry
after fatty meals. Published in the November 26 issue of the journal Cell,
a report suggests the molecule may help regulate how much animals and people
eat, according to the team headed by Gerald I. Shulman, Yale professor of
medicine and cellular & molecular physiology and a Howard Hughes Medical
Institute investigator.
Our judgment of a
person’s character can be influenced by something as
simple as the warmth of the drink we hold in our hand. In
the current issue of the journal Science, Yale University
psychologists show that people judged others to be more
generous and caring if they had just held a warm cup of
coffee and less so if they had held an iced coffee.
"When we ask whether someone is a warm person or cold
person, they both have a temperature of 98.6," said
John A Bargh, a professor of psychology at Yale and
co-author of the paper with Lawrence E. Williams of the
University of Colorado who received his Ph.D. from Yale
earlier this year. "These terms implicitly tap into the
primitive experience of what it means to be warm and
cold."
Research collaboration
among scientists working in the traditionally unrelated
fields of biology, physics and engineering will accelerate
at Yale, thanks to a gift from Dr. Raymond and Beverly
Sackler. Leading researchers from three different faculties
at Yale – the School of Medicine, the School of
Engineering and the faculty of Arts and Sciences – will be
brought together through the programs of the new Sackler
Institute for Biological, Physical and Engineering Sciences.
Dr. Lynne Regan, who holds Professorships in both Molecular
Biophysics and Biochemistry and Chemistry, has been
appointed by the Provost to be the first Director of the
Institute.
A study to help nurses hone
their heart-monitoring skills has received the largest grant
in the history of the Yale School of Nursing — $3.9
million. The funding from the National Heart, Lung, and
Blood Institute of the National Institutes of Health will
enable Yale School of Nursing Professor Marjorie Funk, and
co-investigator Barbara Drew of the University of
California–San Francisco School of Nursing, to conduct a
five-year, 16-hospital clinical trial. The study’s
long-term goal is to improve nursing practices related to
electrocardiogram (ECG) monitoring so that more accurate
diagnosis and more timely treatments lead to better outcomes
for patients.
The Yale School of Public Health is
partnering with Tsinghua University in Beijing to provide management and
leadership education for 500 underserved women in China working in the
healthcare field. The partnership, beginning in 2009, is part of the Goldman
Sachs 10,000 Women initiative.
The link between food marketing and the
growing childhood obesity epidemic is the focus of a $6.4 million grant from the
Robert Wood Johnson Foundation to the Rudd Center for Food Policy and Obesity at
Yale University. The principal investigators, Rudd Center Director Kelly D.
Brownell and Deputy Director Marlene Schwartz, will use the grant to develop a
three-year program to identify opportunities to improve the health of children
and adolescents in the United States by reducing the harm associated with food
marketing to youth.
Yale Professor Mark
Reed, whose research has contributed to nanotechnology in
areas from quantum dots to molecular electronics, has been
named a fellow of the IEEE, one of the most prestigious
honors given by this professional association for the
advancement of technology.
Among the undergraduate
offerings Yale University is making freely available by
Internet access through the Open Yale Courses are three
popular science courses in biomedical engineering, physics
and astronomy. "Frontiers of Biomedical
Engineering," taught by professor W. Mark Saltzman, is
newly added to the initial offerings of "Frontiers and
Controversies in Astrophysics" by professor Charles
Bailyn and "Fundamentals of Physics" by professor
Ramamurti Shankar. more
For more member news, see the November
2008 issue of CURE News
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