CURE
Member News Digest
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Salute to new member
Health Sciences International, Inc.
is a clinical research organization established in 1997 that comes to
Connecticut with expertise in the conduct of Phase I-IV clinical trials. HSI
says it has a unique business model that assures that Phase I-IV clinical
trials, in multiple therapeutic areas, meet milestone timelines while adhering
to enforceable SOPs, GCP, Standards of the Industry, and CFR/ ICH Guidelines. More at
http://www.hsiresearch.org/
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454 Life Sciences (Branford) reports
that in a study of the Mimivirus, the world's largest known virus, a research
team from the Structural and Genomic Information Laboratory at the Mediterranean
Institute of Microbiology in Marseille, France, used the Genome Sequencer FLX
System from 454 Life Sciences to perform the first ever viral transcriptome
analysis by deep sequencing RNAs expressed by infected amoebas throughout the
Mimivirus replication cycle. Unexpectedly, the analysis revealed 75 new genes,
including 26 producing non-coding RNAs. The existence, and so far unknown
function, of these additional genes in the already plethoric Mimivirus genome
could radically change the current understanding of the way large viruses
operate.
Roche (parent company of 454
Life Sciences) and IBM announced an agreement to develop a
nanopore-based sequencer that will directly read and decode
human DNA quickly and efficiently. The novel technology,
developed by IBM Research, offers true single molecule
sequencing by decoding molecules of DNA as they are threaded
through a nanometer-sized pore in a silicon chip. The
approach holds the promise of significant advantages in
cost, throughput, scalability, and speed compared to
sequencing technologies currently available or in
development, Roche says.
Achillion
Pharmaceuticals,
Inc. (New Haven) has received a Phase 1 Small Business Innovation
Research Grant from the National Institute of Allergy and Infectious Disease
branch of the National Institutes of Health for the further study and
characterization of a back-up series of compounds related to its novel
antibacterial, ACH-702. The new compounds in the series to be studied
demonstrate excellent inhibition of the essential bacterial enzyme DNA gyrase,
and have improved metabolic stability. In particular, preliminary data show
potent target inhibition of the Mycobacterium tuberculosis gyrase enzyme which
translated in vitro to good antibacterial activity against drug-resistant
tuberculosis.
Alexion
Pharmaceuticals (Cheshire) said it is accelerating by three months to the third quarter
the introduction of its Soliris® blood disorder treatment
in Japan, a move that enhances the Cheshire drug maker's
2010 financial outlook. With
the Japan sales stream coming on line sooner than expected,
Alexion raised its revenue guidance for 2010 to $515 million
to $530 million $10 million more than the previous upper
and lower limits.
Earlier the company announced that it has completed enrolling
patients in all four previously announced prospective, open-label clinical
studies being conducted in North America and multiple European countries
investigating Soliris© (eculizumab) as a potential treatment for patients with
atypical Hemolytic Uremic Syndrome (aHUS). "Given the potential for rapid
and life-threatening deterioration observed in patients with aHUS, and the
inability to predict sudden worsening in an individual, we are increasingly
focused on diligently advancing our development efforts. We look forward to
presenting preliminary results from these studies later in 2010," said
Leonard Bell, M.D., Chief Executive Officer of Alexion. "In addition,
because a significant number of patients with aHUS are children, we are
committed to expanding our aHUS program to include studies of Soliris in
pediatric patients with aHUS."
Amarin Corp
(Mystic) said its two
clinical trials for a heart-disease treatment are moving
ahead of schedule, adding that its $44 million in cash on
hand as of March 31 is more than enough to support the
trials. The trials will test Amarin's AMR101 treatment for
reducing high levels of triglycerides, the bloodstream's
fatty chemical linked to clogged and hardened arteries.
Meanwhile, the company,
originally based in Ireland, has moved the majority of its
operations to Mystic. The consolidation in Mystic comes
after the company secured $70 million in new financing last
year.
Applied Spine Technologies, Inc. (Rocky
Hill) has been awarded a new patent titled "Spinal Stabilization Device
with Weld Cap." U.S. patent No. 7,699,875, issued by the U.S. Patent and
Trademark Office on April 20, 2010, claims geometry for a spring based spinal
stabilization device including members to mechanically connect the spring to
other structural components. "One of the documented clinical benefits of
our Stabilimax device is its allowance of significant interpedicular travel,”
said Craig Corrance, president and CEO. "The issuance of this patent
recognizes the uniqueness associated with our device and adds yet another layer
to our patent portfolio."
Bayer HealthCare (Leverkusen,
Germany/West Haven) reports that an orphan drug designation has been granted by
the U.S. Food and Drug Administration for ciprofloxacin dry powder inhaler (DPI)
for management of pulmonary infection due to Pseudomonas aeruginosa in
cystic fibrosis (CF) patients. A similar designation has already been granted by
the European Medicines Agency. Ciprofloxacin DPI is an investigational
drug–device combination that combines ciprofloxacin dry powder formulated
using Novartis' Proprietary PulmoSphere® technology with a delivery inhaler.
Ciprofloxacin DPI is in Phase 2 development and is being studied for its safety
and potential to improve lung function, as measured by the forced expiratory
volume in 1 second (FEV1), in patients with CF.
BioRelix, Inc. (New Haven)
and Dalton Medicinal Chemistry have jointly announced an
expansion and renewal of their exclusive worldwide
collaboration and agreement to discover and develop new
therapeutics. Dalton will apply their proprietary insights
to the design and synthesis of new classes of compounds
against selected Riboswitch targets. BioRelix will advance
these compounds with their array of biological assays and
knowledge of Riboswitch drug discovery and development, the
companies said.
Boehringer Ingelheim
(Ingelheim,
Germany/Ridgefield) continued to grow in 2009,
increasing its net sales by 9.7% to EUR 12.7 billion. Even without taking into
account positive currency effects, growth was once again above the average
growth for the worldwide pharmaceutical market, at 6.7%. This means, the company
said, that for the tenth consecutive time Boehringer Ingelheim grew faster than
the pharmaceutical market and in 2009 was the fastest growing company of the
world’s 15 largest pharmaceutical companies.
Boehringer Ingelheim received the CURE Award
for Education at the CURE Annual Meeting April 27 in New Haven. (See
story is this issue).
Bristol-Myers Squibb Company
(New
York/Wallingford) has authorized the repurchase of up to $3 billion of its
common stock. The decision reflects the company’s strong financial position,
the company said, including cash and marketable securities of $9.8 billion at
the end of the first quarter, its positive outlook on its future cash position,
and its focus on increasing shareholder value.
CMD Bioscience
(Orange) announced that the US Patent Office has issued a notice of allowability
for the provisional applications 60/785,232 and 60/878,217. "The key to
successful structure-based peptide drug discovery is a rapid and accurate method
for estimating and scoring protein-peptide binding affinities. The just granted
Affinity Score 1.0 patent clearly affirms the innovativeness of the
CMDBioscience methodology and confirms our leadership in computational peptide
drug design and discovery," said CMDBioscience cofounder and CEO Dr. Joseph
Audie.
Connecticut Innovations (Rocky
Hill) announced that it has accepted NovaTract Surgical LLC of Guilford into its Pre-Seed Support Services Program. NovaTract is developing
a medical device that will be used in single-incision laparoscopic surgery and
natural orifice transluminal endoscopic surgery. Separately, CyVek of
Wallingford said it had accepted $802,500 from Connecticut Innovations. The
company is developing a platform to measure substances under chemical analysis
in clinical diagnostic settings. Earlier, Connecticut Innovations announced it
had invested $500,000 in Soft Tissue Regeneration of Stamford.
GlaxoSmithKline plc
(Research Triangle Park, NC) and Human Genome Sciences, Inc. announced
topline secondary endpoints from BLISS-76, the second of two pivotal Phase 3
trials of Benlysta™ (belimumab) in seropositive patients with systemic lupus
erythematosus. Carlo Russo, M.D., Senior Vice President, Biopharm
Development, GSK, said, “Based on the totality of data in BLISS-52 and
BLISS-76, we believe that belimumab could deliver a significant therapeutic
option for patients with lupus, a chronic condition which has a devastating
effect on the lives of patients living with the disease.”
Hartford Hospital
(Hartford) said that Anthem Blue Cross and Blue Shield of Connecticut has
designated Hartford Hospital as a Blue Distinction Center for Spine SurgerySM
and a Blue Distinction Center for Knee and Hip ReplacementSM. These
designations are awarded to medical facilities that have demonstrated expertise
in delivering quality health care.
HistoRx (New Haven) received a $1.5
million loan from Connecticut Innovations. The funding will be used to help
HistoRx build out laboratory space and purchase laboratory equipment.
Ipsogen (Marseille, France/New
Haven) said that Corinne Danan has joined the company as Vice President
Commercial Operations. Prior to joining Ipsogen, she was European Director for
Monogram Biosciences, a California company specializing in individualized
medicine.
Johnson & Johnson (New
Brunswick, NJ) said that the SEDASYS® System, the first computer-assisted
personalized sedation system, was granted a CE Mark for the European Union for
routine colonoscopy and screening of the upper gastrointestinal tract; and
Health Canada granted regulatory approval for the SEDASYS® System for use by
healthcare professional teams during routine colonoscopy.
MannKind Corporation (Valencia,
CA/Danbury) completed Study 117, an efficacy study in
patients with type 1 diabetes, and reports that the company's AFREZZA™ product
met the primary endpoint of non-inferiority in HbA1C levels compared to standard
insulin therapy.
MannKind received the CURE New Operations Award
at the CURE Annual Meeting April 27 in New Haven. (See story is
this issue).
MiraDx Inc. (New Haven) received $1 million from the
Connecticut Innovations Eli Whitney Fund as part of a $4
million Series A round that also involved individual
investors. MiraDx
is applying microRNA (miRNA) discoveries licensed
from Yale University to develop gene-based laboratory tests
that will provide individualized information on the
likelihood of disease occurrence and response to certain
types of therapy. MiRNAs are small genetic regulators that
control cell development, cell cycle, cell differentiation
and cell death; they have also been linked to certain
cancers and other disease states.
NanoVircides (West Haven) announced that its anti-Dengue drug
candidates demonstrated significant efficacy in recently
completed preliminary cell culture studies. The studies were
performed in the laboratory of Dr. Eva Harris, Professor of
Infectious Diseases at the University of California,
Berkeley (UC Berkeley).
Separately,
the company said its anti-HIV drug candidates demonstrated
efficacy in recently completed cell culture studies using
two distinctly different HIV-1 isolates. The studies were
performed in the laboratory of Carol Lackman-Smith at the
Southern Research Institute, Frederick, Maryland.
Earlier
the company said it has received $5
million from Seaside 88, a Florida limited partnership that
has financed several bio-pharma companies. "This
financing positions us for meeting the listing standards of
major exchanges," said Eugene Seymour, MD, MPH, who is
CEO of the Company. "We now have sufficient cash in
hand to meet our operating needs for the next eighteen
months at the current rate of expenditure."
Pfizer Inc. (New York,
NY/Groton/New London) and the World Bank announced they will collaborate to
improve the healthcare infrastructure, specifically the supply chain, in
developing countries, starting with Africa.
Pfizer received the CURE
Award for Excellence at the CURE Annual Meeting April 27 in
New Haven. (See story is this issue).
Vascular Insights LLC (Madison) said it
has won approval for use of the CE Mark on its ClariVein®-OC catheter, paving
the way for marketing of the device in Europe. ClariVein®-OC is an infusion
catheter system intended for endovascular occlusion of incompetent veins in
patients with superficial venous reflux. Infusion is through an opening at the
distal end of the catheter and fluid delivery is enhanced by the use of a
rotating dispersion wire to mix and disperse the infused fluid in the blood
stream and on the vessel wall.
Following is recent news from The
University of Connecticut (Storrs) and the University of
Connecticut Health Center (Farmington).
Plans to renovate John
Dempsey Hospital and build a new patient care tower at the
UConn Health Center have won approval from the Connecticut
legislature. "This is a significant legislative victory
for the Health Center and the entire University," said Dr.
Cato T. Laurencin, the Health Center’s vice president for
health affairs and dean of the UConn School of Medicine. more
Dr. Justin Radolf, a
professor in the Departments of Medicine and Genetics and
Developmental Biology at UConn, has published a paper that
evaluates the major protective antioxidant systems of the
bacterium that causes syphilis. more
Amy Anderson and Dennis
Wright, both associate professors of medicinal chemistry in
the School of Pharmacy, are fighting a small, but potent
enemy – methicillin-resistant Staphylococcus aureus,
better known as MRSA. The research of this husband and wife
research team focuses on the development of new drugs to
treat MRSA infections as well as other infectious diseases. more
Improving care for patients
at risk for osteoporosis; minimizing pain for patients with
sickle cell disease; preventing central line infections for
critically ill patients: these are the quality-improvement
goals that fueled the work of three Health Center nurse
practitioners who recently completed a rigorous new
doctorate program in nursing practice. more
Dr. William B. White, professor of medicine
and division chief of hypertension and pharmacology at the UConn Health
Center’s Calhoun Cardiology Center, has published an expert commentary about
the impact of the increase in blood pressure that occurs when we awake. more
When Kelci Stringer was
looking for a home for a research institute honoring her
late husband – All-Pro NFL lineman Korey Stringer – the
University of Connecticut and its renowned kinesiology
department were her first choice. Korey Stringer died from
complications due to an exertional heat stroke he suffered
during a Minnesota Vikings pre-season training camp in 2001.
more
The University of
Connecticut Neag School of Education, with the support of
the National Football League and Gatorade, is opening a new
institute on the Storrs campus to further research,
education, and advocacy for the prevention of heat stroke
and sudden death in sport. more
Following is recent news from Yale
University and the Yale School of Medicine (New Haven).
Prions, not plaques, appear to be the
cause of memory loss in mice with Alzheimer's, says Stephen Strittmatter, the
Vincent Coates Professor of Neurology and professor of neurobiology at Yale. He
is senior author of a new study; other Yale authors of the study are David
Gimbel, Haakon Nygaard, Erin Coffey, Zachary Gimbel, and Erik Gunther.
A Yale-led team of scientists, using
advanced DNA sequencing technology, has for the first time pinpointed individual
variations of where, along the chain of 3 billion letters that make up the human
genome, important gene regulatory elements do their jobs. Maya Kasowski, an
M.D./Ph.D. candidate in Yale’s Department of Molecular, Cellular and
Developmental Biology is co-lead author of the paper with Fabian Grubert,
formerly a postdoctoral researcher at Yale now a post-doc at Stanford.
A team of Yale University scientists has
discovered a previously unknown type of "molecular scissors" that can
tailor micro-RNAs, tiny snippets of genetic material that play a key role in
regulating many of life’s functions. "We are still just beginning to
scratch the surface in our understanding of small RNAs,” said Antonio J.
Giraldez, the Lois and Franklin H. Top, Jr. Yale Scholar in the genetics
department of the Yale School of Medicine and senior author of the study."
A single, very unusual family with
Tourette syndrome (TS) has led Yale School of Medicine researchers to identify a
rare mutation in a gene that is required to produce histamine. The finding
provides a new framework to understand many years of data on the role of
histamine function in the brain and points to a potentially novel approach to
treatment of tics and Tourette. The team was led by Matthew State, M.D., the
Donald J. Cohen Associate Professor in the Yale Child Study Center and in the
Departments of Psychiatry and Genetics, and co-director of the Yale
Program on Neurogenetics.
A Yale-led study reveals, for the first
time, the process by which a particular genetic mutation causes seizures and
ataxia, the neurodegenerative disorder believed to have afflicted Abraham
Lincoln. Senior author is Jon S. Morrow, M.D., Ph.D., professor of pathology and
molecular, cellular and developmental biology.
Telomeres — the repeat sequences of DNA
at the end of chromosomes — are much more likely to be damaged by UV radiation
than are other common cellular structures, Yale researchers report. Douglas
Brash, professor of therapeutic radiology, genetics and dermatology, and a
researcher for the Yale Cancer Center, is senior author of the study.
Yale University engineers have found that
the defects in carbon nanotubes cause T cell antigens to cluster in the blood
and stimulate the body’s natural immune response. Their findings could improve
current adoptive immunotherapy, a treatment used to boost the body’s ability
to fight cancer. Tarek Fahmy, associate professor of chemical engineering and
biomedical engineering, is senior author of the paper.
Researchers at Yale School of Medicine
have discovered that exposure during pregnancy to Bisphenol A (BPA), a common
component of plastics, causes permanent abnormalities in the uterus of
offspring, including alteration in their DNA. Led by Hugh S. Taylor, M.D.,
professor in the Department of Obstetrics, Gynecology & Reproductive
Sciences at Yale, the study is the first to show that BPA exposure permanently
affects sensitivity to estrogen.
A Yale team compared the evolution of
organisms and computer operating systems by analyzing the control networks in
both a bacterium Escherichia coli and the Linux operating system. Mark Gerstein,
the Albert L. Williams Professor of Biomedical Informatics is senior author of
the paper.
Depression among low-income mothers could
last well beyond the postpartum period and become a chronic condition, suggests
a new study by researchers at Yale School of Medicine. Lead author is Carol C.
Weitzman, M.D., associate professor of pediatrics.
Children with asthma are more likely to
develop a range of health and social problems as they enter into adulthood, new
research by the Yale School of Public Health has found. Lead author is Jason M.
Fletcher, an assistant professor in the division of Health Policy and
Administration.
Jon Soderstrom of Yale's Office of Cooperative
Research received the CURE Atlas Award for Venture Capital Achievementat the
CURE Annual Meeting April 27 in New Haven. (See story is this
issue).
For more member news, see the April
2010
issue of CURE News
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