NewYork-Presbyterian Performs Lifesaving Liver Transplant On Premature Infant

A 5-month-old New York infant received a lifesaving liver transplant for advanced liver failure diagnosed following her birth 10 weeks premature. One of the smallest babies ever to successfully receive a liver transplant, she weighed 4 pounds at the time of the surgery.

The surgery was performed in February and was led by Dr. Tomoaki Kato, surgical director of liver and intestine transplant programs at NewYork-Presbyterian Hospital/Columbia University Medical Center, and chief of abdominal organ transplantation and professor of surgery at Columbia University College of Physicians and Surgeons.

“Performing a transplant in a premature infant this size is a major challenge where any technical issue would have been fatal, but it was the only option,” says Dr. Kato. “Most babies born with her condition would not have the chance to grow up. This surgery shows that transplantation is possible — although only at an academic medical center with appropriate resources and only with focused teamwork and dedication.”

In the weeks after being born on Dec. 3, the patient was referred to NewYork-Presbyterian/Morgan Stanley Children’s Hospital where she was diagnosed with an irreversible liver injury of unknown origin. Cared for in the neonatal intensive care unit, she was on a ventilator and had dangerous fluid buildup in her abdomen and difficulty feeding. After being on the organ waitlist for two weeks, a replacement liver became available in Florida.

“The donor organ wasn’t a matching blood type and it was substantially larger than her diseased organ, but it was critical that we proceed. To accommodate its size we created an artificial abdominal wall using a Gore-Tex mesh,” explains Dr. Kato. “Unlike other organs, the liver has the unique ability to adapt itself to the patient’s body. In this case the organ is making itself smaller. As she grows, her new liver will grow with her.”

In the weeks following the surgery, the patient started recognizing her mother and responding to her by smiling. The child has also gained the ability to get nutrition through a feeding tube rather than intravenously. Her liver function normalized, and soon after the Gore-Tex mesh was removed and her abdomen closed.

Her medical care has been overseen by Dr. Steven Lobritto, medical director of pediatric liver transplantation at NewYork-Presbyterian/Morgan Stanley Children’s Hospital and associate clinical professor of pediatrics and medicine at Columbia University College of Physicians and Surgeons.

“While she is on immunosuppressant medication and received a blood-type mismatched organ, rejection is usually not a major issue in babies, whose bodies can more easily accept an organ than someone who is full grown,” says Dr. Lobritto.

Collaboration With the Neonatal Intensive Care Unit

According to Drs. Kato and Lobritto, the success of this transplant was a direct result of a novel transplant collaboration with the neonatal intensive care unit.

The patient’s tiny size and medical issues related to prematurity meant that she may not have received optimal treatment in the pediatric intensive care unit, where childhood transplant patients are normally treated. “Accommodating the patient in a NICU setting required thorough on-the-spot training for clinicians and caregivers at every level,” says Dr. Lobritto.

Dr. Ulana Sanocka, the neonatologist in charge of caring for this transplanted child at NewYork-Presbyterian/Morgan Stanley Children’s Hospital and an associate clinical professor of pediatrics at Columbia University College of Physicians and Surgeons, says: “It was a very rewarding collaborative experience. Everyone worked around the clock to ensure she received the best care possible.”

Special Note to the Media: NewYork-Presbyterian physicians and surgeons are available for interviews about the surgical procedure. At the parents’ request, the patient is not available for media interviews.

Organ Transplantation at NewYork-Presbyterian Hospital

The organ transplantation program at NewYork-Presbyterian Hospital — which includes NewYork-Presbyterian Hospital/Weill Cornell, NewYork-Presbyterian Hospital/Columbia and The Rogosin Institute — is the most active program of its kind in the nation, offering comprehensive and personalized care for the heart, liver, pancreas, kidney and lung. With outcomes ranked among the nation’s best, the Hospital is dedicated to improving quality of life for its patients. NewYork-Presbyterian’s dedicated teams of surgeons and physicians are responsible for many significant advances made over the past several decades in transplant surgery and the maintenance of healthy organs. The Hospital has been on the forefront of developing and improving anti-rejection medications (immunosuppressants), minimally invasive surgery for living donors, genetic methods to detect transplant rejection, strategies to increase opportunities for donor matching, islet cell transplantation, and the FDA-approved Left Ventricle Assist Device (LVAD) that functions as a bridge to transplantation for those waiting for a new heart.

NewYork-Presbyterian/Morgan Stanley Children’s Hospital

NewYork-Presbyterian/Morgan Stanley Children’s Hospital, located in New York City, offers the best available care in every area of pediatrics — including the most complex neonatal and critical care, and all areas of pediatric subspecialties — in a family-friendly and technologically advanced setting. Building a reputation for more than a century as one of the nation’s premier children’s hospitals, Morgan Stanley Children’s Hospital is affiliated with the Department of Pediatrics at Columbia University College of Physicians and Surgeons, and is Manhattan’s only hospital dedicated solely to the care of children and one of the largest providers of children’s health services in the tri-state area with a long-standing commitment to its community. It is also a major international referral center, meeting the special needs of children from infancy through adolescence worldwide. NewYork-Presbyterian Hospital also comprises NewYork-Presbyterian Hospital/Columbia University Medical Center, NewYork-Presbyterian Hospital/Weill Cornell Medical Center, NewYork-Presbyterian Hospital/Westchester Division and NewYork-Presbyterian/The Allen Hospital. NewYork-Presbyterian is the #1 hospital in the New York metropolitan area and is consistently ranked among the best academic medical institutions in the nation, according to U.S.News & World Report.

Source: NewYork-Presbyterian Hospital

FDA Approves FRAGMIN(R) As First Low-Molecular-Weight Heparin For Extended Treatment To Reduce The Recurrence Of Blood Clots In Patients With Cancer

The U.S. Food and Drug Administration (FDA) has approved a new indication
for FRAGMIN(R) (dalteparin sodium injection), for the extended treatment of
symptomatic venous thromboembolism (VTE) [proximal deep vein thrombosis
(DVT) and/or pulmonary embolism (PE)] to reduce the recurrence of VTE in
patients with cancer.

VTE is the formation of a blood clot that can travel from a leg vein to
the lung, with potentially fatal results. FRAGMIN is the first
low-molecular- weight heparin (LMWH) approved in the U.S. for the extended
treatment of recurrent VTE in patients with cancer.

“Cancer treatments and the disease itself put this patient population
at significantly higher risk than non-cancer patients for developing DVT or
PE, the two conditions described as VTE,” said Frederick Rickles, MD, FACP,
clinical professor of medicine at George Washington University Medical

VTE is a frequent medical complication for patients with cancer.
Patients with cancer have an increased risk of VTE compared to those
without cancer. Additionally, patients with cancer may be immobilized,
which predisposes the patient to this condition.

Today’s FDA approval is based on data from the CLOT study, which
evaluated the safety and efficacy of FRAGMIN in reducing the recurrence of
DVT/PE in patients with cancer, compared to an oral anticoagulant. Patients
diagnosed with acute DVT, PE or both were randomized into two groups of 338
patients each. One group received FRAGMIN for six months. The other group
received FRAGMIN for five to seven days, followed by warfarin for six
months. Warfarin is an oral anticoagulant that has been used for many years
as the standard drug in the long-term treatment of VTE.

The CLOT study showed that, during a six-month period, nearly twice as
many patients (53) treated with warfarin experienced at least one episode
of DVT or PE compared to those treated with a once-daily administration of
FRAGMIN (27). Most of the difference occurred during the first month of
treatment. The benefit was maintained over the six-month study period.
Mortality rates were similar between the study groups at the end of the
study. The safety findings were numerically higher for the FRAGMIN group
versus the warfarin group for major bleeding, thrombocytopenia (drop in
platelet count) and liver enzyme elevations. Results from the CLOT study
were published in the July 10, 2003 issue of the New England Journal of

“The CLOT study provides clinical evidence that FRAGMIN is more
effective than traditional oral anticoagulant therapy in reducing risk of
recurrent VTE in patients with cancer,” said Dr. Rickles. “Physicians now
have an FDA- approved low-molecular-weight heparin specifically for
extended treatment to reduce the recurrence of blood clots in patients with

Eisai licensed exclusive U.S. rights to promote FRAGMIN from Pfizer Inc
in September 2005, and has assumed responsibility for product distribution.
This agreement for FRAGMIN is aimed at strengthening Eisai’s position in
oncology and critical care in the United States. Eisai and Pfizer currently
have three product alliances.

Additional Indications

In the United States, FRAGMIN is also indicated for prevention of DVT,
which may lead to PE, in patients undergoing hip replacement surgery, in
at- risk patients undergoing abdominal surgery and in at-risk acutely ill
patients whose mobility is severely restricted. FRAGMIN is also approved
for prophylaxis of ischemic complications resulting from unstable angina
and non- Q-wave myocardial infarction (heart attack), when used with

Important Safety Information


When neuraxial anesthesia (epidural/spinal anesthesia) or spinal
puncture is employed, patients anticoagulated or scheduled to be
anticoagulated with low molecular weight heparins or heparinoids for
prevention of thromboembolic complications are at risk of developing an
epidural or spinal hematoma which can result in long-term or permanent

The risk of these events is increased by the use of indwelling epidural
catheters for administration of analgesia or by the concomitant use of
drugs affecting hemostasis such as non steroidal anti-inflammatory drugs
(NSAIDs), platelet inhibitors, or other anticoagulants. The risk also
appears to be increased by traumatic or repeated epidural or spinal

Patients should be frequently monitored for signs and symptoms of
neurological impairment. If neurological compromise is noted, urgent
treatment is necessary.

The physician should consider the potential benefit versus risk before
neuraxial intervention in patients anticoagulated or to be anticoagulated
for thromboprophylaxis (also see WARNINGS, Hemorrhage and PRECAUTIONS, Drug

FRAGMIN is contraindicated in patients with active major bleeding or
with known hypersensitivity to the drug, heparin, or pork products, or with
thrombocytopenia associated with a positive anti-platelet antibody test. It
should be used with extreme caution in patients with a history of heparin-
induced thrombocytopenia.

Patients undergoing regional anesthesia should not receive FRAGMIN for
unstable angina or non-Q-wave myocardial infarction, and patients with
cancer undergoing regional anesthesia should not receive FRAGMIN for
extended treatment of symptomatic VTE, due to an increased risk of bleeding
associated with the dosage of FRAGMIN recommended for these indications.

FRAGMIN cannot be used interchangeably (unit for unit) with
unfractionated heparin or other low-molecular-weight heparins.

FRAGMIN, like other anticoagulants, should be used with extreme caution
in patients who have an increased risk of hemorrhage; bleeding can occur at
any site during therapy. An unexpected drop in hematocrit or blood pressure
should lead to a search for a bleeding site.

The most commonly reported side effect is hematoma at the injection site.

Please see FRAGMIN for full prescribing information.

FRAGMIN is a registered trademark of Pfizer Health AB and is licensed
to Eisai Inc.

About Eisai Inc.

Eisai Inc. is a U.S. pharmaceutical subsidiary of Eisai Co., Ltd., a
research-based human health care (hhc) company that discovers, develops and
markets products throughout the world. Eisai focuses its efforts in three
therapeutic areas: neurology, gastrointestinal disorders and
oncology/critical care. Established in 1995, Eisai Inc. began marketing its
first product in the United States in 1997 and has rapidly grown to become
an integrated pharmaceutical business with sales of approximately $2.2
billion in fiscal year 2005 (year ended March 31, 2006).

About Pfizer Inc

Founded in 1849, Pfizer is the world’s largest research-based
pharmaceutical company taking new approaches to better health. We discover
and develop innovative medicines to treat and help prevent disease for both
people and animals. Through consistent, high-quality manufacturing and
distribution operations, our medicines reach patients in 180 nations. We
also partner with healthcare providers, governments and local communities
around the world to expand access to our medicines and to provide better
quality healthcare and health system support. At Pfizer, our colleagues
work every day to help people stay happier and healthier longer and to
reduce the human and economic burden of disease worldwide.

Eisai Inc.; Pfizer Inc.


View drug information on Fragmin; Warfarin Sodium tablets.

Nightcap Before Bed May Affect Quality Of Sleep

While numerous studies have linked alcohol abuse to sleep disruption, especially in males, there has been little research on alcohol and its effects on sleep in females. Now, a new study shows that a moderate amount of alcohol, taken before bed, can impact the quality of sleep for young women.

“We found that a moderate dose of alcohol consumed by a young woman an hour before bed is associated with increased sleep intensity in the first couple hours of the sleep episode,” says author Mary A. Carskadon, PhD, with the Bradley Hospital Sleep and Chronobiology Laboratory and Brown Medical School.

This phenomenon was observed in well-slept women using an alcohol dose of 0.49 g/kg, equivalent to two to three standard drinks (in the form of vodka tonics), in the hour before bedtime, or 0.5 g/% below the legal limit for driving while intoxicated in many states.

Appearing in the June 2006 issue of the journal Alcoholism: Clinical and Experimental Research, this study looked at the sleep habits of young women (between ages 22 to 25) who drank alcohol before bed, over the course of three nights. Researchers monitored the women’s sleep and sleep electroencephalograms (EEGs), a graphic record of the electrical activity of the brain – a technique that can analyze the “microarchitecture” of sleep.

Researchers found few, but noteworthy differences between sleep and sleep EEG with alcohol versus placebo. When alcohol had been consumed, rapid eye movement (REM) sleep decreased, while stage 4 sleep (the deep sleep early in the night) was slightly increased. In addition, spectral analysis of the EEG showed signs of increased sleep intensity during non-REM (NREM) sleep after alcohol compared with placebo.

“Whether this sleep pattern is beneficial or harmful is unknown at this point. Although it may signal an initial consolidation of sleep, it might also be associated with difficulty waking in the event of an emergent problem, such as a fire or medical emergency,” says author Eliza Van Reen, a psychology graduate student at Brown University.

More work is needed to examine other alcohol doses, sex differences and vulnerability that may occur with a positive family history of alcoholism, the authors conclude.


Founded in 1931, Bradley Hospital (www.bradleyhospital) was the nation’s first psychiatric hospital operating exclusively for children. Today, it remains a premier medical institution devoted to the research and treatment of childhood psychiatric illnesses. Bradley Hospital, located in Providence, RI, is a teaching hospital for Brown Medical School and ranks in the top third of private hospitals receiving funding from the National Institutes of Health. Its research arm, the Bradley Hasbro Children’s Research Center (BHCRC), brings together leading researchers in such topics as: autism, colic, childhood sleep patterns, HIV prevention, infant development, obesity, eating disorders, depression, obsessive-compulsive disorder (OCD) and juvenile firesetting. Bradley Hospital is a member of the Lifespan health system.

Contact: Carol L. Vieira


Long-Term Care Insurance: Most Need It But Few Understand Why

When you think about your plans for
retirement, a nice place to live, traveling, playing golf and leaving an
inheritance for loved ones may all be part of your plan. Sounds lovely. But
what will happen to your plan if you become unable to care for yourself due
to an illness, accident or maybe just the effects of getting older? You’ll
need some type of long-term care, and that won’t come cheap.

“The reality is that 60 percent of Americans who reach age 65 will
someday need long-term care services and in many parts of this country,
these services can cost more than living in a five-star hotel,” said David
F. Woods, CLU, ChFC, president of the LIFE Foundation. “People need to
learn more about long-term care insurance and understand the chance they’re taking by not insuring themselves against the risk of one day needing assistance with the tasks of daily living. Delaying or avoiding the
decision to buy a long-term care insurance policy can mean the difference
between living your retirement years on your own terms or facing some very difficult financial realities.”

To encourage people to evaluate their long-term care insurance needs,
the nonprofit LIFE Foundation urges Americans to avoid five common excuses
people give for putting off a long-term care insurance purchase. As with
any insurance decision, LIFE advises that consumers meet with an agent to
learn more.

Excuse #1 – I can’t afford it

This is the most common reason given for not owning long-term care
insurance. Yet according to LIMRA International, a market research
organization, people who have never shopped for policies overestimate the
cost by as much as five to 10 times. Start evaluating coverage options when you first start thinking seriously about retirement, which experts say
should be in your 40s or early 50s at the latest. Long-term care insurance
can be quite affordable, especially if you buy at a relatively young age.
LTC Consultants estimate that $1,800 a year in premiums would buy a 40-year old couple three years of benefits at a daily payout of $140. If that same couple waited until they were 50 to buy, they would be paying $3,900 a year.

Excuse #2 – I won’t need it

According to the Centers for Medicare and Medicaid Services, about 10
million people of all ages already need help with the basic tasks of daily
living, and that number is projected to increase sharply as the population
continues to age. “Aging can be a steep emotional hurdle to face, however
people need to recognize that today’s long-term care environment isn’t the
same as what their grandparents experienced,” said LIFE Board Member Deb Newman, CLU, ChFC, LTCP, President of Newman Long Term Care.

“Most people will need long-term care and there are wonderful care options today, but only to those with the means to pay for them and that’s where long-term care insurance can be so essential.”

Excuse #3 – My health insurance, Medicare or Medicaid coverage will pay
for my care

Don’t count on it! Health insurance only pays for doctor and hospital
bills and maybe your prescription costs. Medicare only covers short-term
rehabilitative care that you receive after being hospitalized for at least
three days. Medicaid, on the other hand, does pay for long-term care
services but will only pay for care if you have very limited assets and
meet federal poverty guidelines. Moreover, having Medicaid pay for your
care also means you may not have much of a say in choosing the facility
that will provide your care.

Excuse #4 – My family will take care of me

Family members are often the first line of defense for loved ones who
need long-term care services, but this is often not a permanent or wise
solution. “Most people don’t want to depend on their loved ones to care for
them for the long-term,” said Newman. “Those in the ‘sandwich generation’
especially, who are currently taking care of both their aging parents and
their growing children, know the emotional and financial burden caring for
loved ones can bring. People should take steps now to make sure that when
the time comes, not all the responsibility of caring for them will fall on
the shoulders of their children or siblings.”

Excuse #5 – The buying process is too complicated

Long-term care policies do have a multitude of options and features,
which is why it is important to seek assistance from a qualified insurance
professional who specializes in these products. When you meet with an
advisor, pay particular attention to these five key product features:

— Daily benefit – This is how much the policy will guarantee to pay you
for covered services once your claim is approved. The amount of
coverage you will need is largely based on the average cost of care in
your area.

— Elimination period – This is the amount of time required before the
policy will begin making payments. Most policies have zero, sixty,
ninety, or even one-hundred and eighty day elimination periods. The
longer you’re willing to wait before benefits begin to be paid out, the
cheaper the premiums will be.

— Maximum benefit – This is the total amount the policy will pay once the elimination or waiting period has been satisfied. Many policies will
pay benefits for one, two or three years, and some will pay for a
lifetime. The length of your benefit your purchase usually comes down
to what you can afford. The longer the better.

— Types of facilities covered – Today, most policies will pay for care
rendered in a range of settings such as at home by a health aide, or in
an assisted living facility or nursing home. You’ll want to make sure
that all these choices will be available to you, especially the option
of receiving care at home, where most people prefer to live for as long
as they can.

— Inflation protection – Experts strongly recommend this because it
protects your policy from rising costs for care, due to inflation. Most
companies offer either 5% compound or 5% simple inflation. If you can afford it, the compound-interest option can make a big difference in
helping your benefit keep pace with the rapidly rising cost of care.

For additional information and helpful tips, visit the section of
LIFE’s website dedicated to long-term care insurance at

About LIFE

The Life and Health Insurance Foundation for Education (LIFE) was
founded in 1994 in response to the public’s growing need for information
and education on life, health, disability and long-term care insurance.
LIFE also seeks to remind people of the important role insurance
professionals perform in helping families, businesses and individuals find
the insurance products that best fit their needs. To learn more about these
topics, please visit life- line.

The Life Foundation

Kidney Drugs Hampered By High Blood Phosphate Levels

High blood phosphate levels can set chronic kidney disease (CKD) patients on a rapid path to kidney failure, according to a study appearing in an upcoming issue of the Journal of the American Society Nephrology (JASN). To make matters worse, phosphate appears to interfere with the effectiveness of important kidney medications.

The kidneys of patients with CKD cannot efficiently get rid of wastes such as excess phosphate in the blood. As a result, the kidneys become overloaded with phosphate. Carmine Zoccali, MD (CNR-IBIM, Clinical Epidemiology and Physiopathology of Renal Diseases and Hypertension of Reggio Calabria, Italy) and his colleagues wondered how this phosphate overload affects the kidneys of patients with CKD. They also wondered whether phosphate overload alters the effects of ramipril, a drug prescribed to slow the progression of kidney disease. (The use of ramipril and other drugs in its class represents the current standard of care for patients with CKD.)

The researchers studied health information from 331 CKD patients, dividing patients into four groups based on their phosphate levels.

Among the major findings:

– Even though their blood phosphate was still normal or near normal, patients in the two highest phosphate groups progressed more quickly to serious kidney dysfunction or kidney failure than patients with lower phosphate levels.

– Higher phosphate levels blunted ramipril’s benefits.

These results suggest that phosphate levels can predict which CKD patients are in serious trouble of developing kidney failure. They also show that high phosphate levels block the beneficial effects of important kidney medications.

Future studies should test whether reducing phosphate improves kidney health and optimizes patients’ medications. “Our study opens the exciting possibility that reducing phosphate, either by diet or drug treatment, may enhance CKD patients’ response to certain drugs,” said Dr. Zoccali. “If our findings are replicated in a new clinical trial, interventions aimed at reducing phosphate will be a relevant step forward in the fight against these dangerous kidney diseases,” he added.

Source: American Society of Nephrology (ASN)

Women Who Sleep Badly In More Danger Than Men

Researchers at Duke University Medical Center say they may have figured out why poor sleep does more harm to cardiovascular health in women than in men.

Their study, appearing online in the journal Brain, Behavior and Immunity, found that poor sleep is associated with greater psychological distress and higher levels of biomarkers associated with elevated risk of heart disease and type 2 diabetes. They also found that these associations are significantly stronger in women than in men.

“This is the first empirical evidence that supports what we have observed about the role of gender and its effects upon sleep and health,” says Edward Suarez, an associate professor in the department of psychiatry and behavioral sciences at Duke and the lead author of the study. “The study suggests that poor sleep – measured by the total amount of sleep, the degree of awakening during the night, and most importantly, how long it takes to get to sleep – may have more serious health consequences for women than for men.”

Suarez says that while women are twice as likely as men to report problems with sleep, most sleep studies in the past have focused on men, a phenomenon that has been slowly changing in recent years.

Researchers studied 210 apparently healthy, middle-aged men and women without any history of sleep disorders. None smoked or took any medications on a daily basis and investigators excluded any women who were on hormone therapy, which has been shown in some studies to alter sleep patterns in some women.

Using a standardized sleep quality questionnaire, participants rated various dimensions of their sleep during the previous month. Additional measures assessed the extent of any depression, anger, hostility and perceived social support from friends and family.

Blood samples taken from the volunteers were measured for levels of biomarkers associated with increased risk of heart disease and diabetes, including insulin and glucose levels, fibrinogen (a clotting factor) and two inflammatory proteins, interleukin-6 and C-reactive protein.

The researchers found that about 40 percent of the men and the women were classified as poor sleepers, defined as having frequent problems falling asleep, taking 30 or more minutes to fall asleep or awakening frequently during the night. But while their sleep quality ratings were similar, men and women had dramatically different risk profiles.

“We found that for women, poor sleep is strongly associated with high levels of psychological distress, and greater feelings of hostility, depression and anger. In contrast, these feelings were not associated with the same degree of sleep disruption in men,” says Suarez.

Women who reported higher degree of sleep disruption also had higher levels of all the biomarkers tested. For women, poor sleep was associated with higher levels of C-reactive protein and interleukin-6, measures of inflammation that have been associated with increased risk of heart disease, and higher levels of insulin. The results were so dramatic that of those women considered poor sleepers, 33 per cent had C-reactive protein levels associated with high risk of heart disease, says Suarez.

“Interestingly, it appears that it’s not so much the overall poor sleep quality that was associated with greater risk, but rather the length of time it takes a person to fall asleep that takes the highest toll,” says Suarez. “Women who reported taking a half an hour or more to fall asleep showed the worst risk profile.”

The study was supported by a grant from the National Institutes of Health.

Suarez says he’s planning further studies to understand the complex relationship between health risk and poor sleep in men and women. He believes that the gender differences may be due, in part, to variation in the activity of a number of naturally occurring substances in the body, such as tryptophan, an amino acid; serotonin, a neurotransmitter; and melatonin, a neurohormone. “All of these substances are known to affect mood, sleep, onset of sleep, inflammation and insulin resistance,” he says.

“Good sleep is related to good health. More research needs to be done to define gender-linked responses to poor sleep, including the role that sex hormones play over a lifetime and how sleep needs and responses change from childhood to maturity,” says Suarez.


Source: Michelle Gailiun

Duke University Medical Center

Grant For Rice’s Global Health Program Renewed By HHMI

The Howard Hughes Medical Institute (HHMI) today awarded a $1.2 million, four-year grant to continue Rice University’s successful undergraduate global health program Beyond Traditional Borders (BTB).

BTB, which began with a $2.2 million HHMI grant in 2006, challenges students to come up with practical solutions to real-world problems in the developing world. The program has captured the imagination of Rice’s students; more than 10 percent of the university’s undergraduates have taken a BTB class since 2006, and several dozen students have traveled to developing nations to test their designs in local clinics.

“Our program aims to open students’ eyes to the challenges of global health and to help them use the tools of science and engineering to design solutions that are affordable, effective and culturally appropriate,” said BTB creator Rebecca Richards-Kortum, Rice’s Stanley C. Moore Professor of Bioengineering. “HHMI’s continued support will allow us to expand our undergraduate and K-12 initiatives.”

The technologies BTB students have created include:
A low-cost fluorescence microscope that makes malaria and tuberculosis diagnosis easier.
A “lab-in-a-backpack” full of diagnostic tools – including a microscope, centrifuge and rapid tests – that nurses in the developing world can use to accurately determine what is making a patient sick.
A tiny clip that pharmacists can attach to a syringe to help parents and other caregivers deliver the proper dose of medicine to children.

BTB students take global health courses and work in teams to solve challenging health problems. In their first BTB class, students get an introduction to biomedical engineering and design a simple solution to a real-world global health problem. From there, they can enroll for a global health minor – which includes four additional BTB classes and two related electives – and tackle progressively more difficult design problems.

The new HHMI grant will allow Rice to expand BTB to a national scale. BTB’s annual outreach workshop for high school teachers plans to recruit the best science and engineering teachers from across the country. Rice will also invite students from other universities and from high schools whose teachers were trained in the K-12 workshop to participate in an international health-technologies design conference and competition.

“I’m excited about the opportunity for students nationwide to be a vital part of the process of designing a new technology and seeing the impact that it has,” Richards-Kortum said. “I think we’re creating a generation of students who can design solutions to important global health problems.”

Rice is one of 50 research universities in 30 states and the District of Columbia that are receiving a total of $70 million from HHMI to strengthen undergraduate and precollege science education nationwide.

Jade Boyd
Rice University

Osiris Therapeutics Completes Enrollment Of Stem Cell Trial For The Treatment Of Heart Attacks

Osiris Therapeutics, Inc. (NASDAQ: OSIR), announced that it has successfully completed enrollment in a Phase 2 clinical trial evaluating Prochymal (remestemcel-L), an adult mesenchymal stem cell therapy, in patients experiencing their first heart attack. The double-blind, placebo-controlled trial enrolled a total of 220 patients from 33 leading clinical centers in the United States and Canada.

“We appreciate the participation of our outstanding team of clinicians and would like to offer our special thanks to the patients who are taking part in this exciting trial,” said Lode Debrabandere, Ph.D., Senior Vice President of Therapeutics at Osiris. “We look forward to following their progress and collecting high quality data on the safety and efficacy of Prochymal in this significant indication.”

In 2009, Osiris completed a Phase 1 double-blind, placebo-controlled study in 53 patients that demonstrated the safety of Prochymal in cardiac patients suffering from their first heart attack. Additionally, treatment with Prochymal significantly improved cardiac function, patient global assessment and reduced cardiac arrhythmias (irregular heartbeat) when compared to placebo.

About the Phase 2 Acute Myocardial Infarction Trial

The Phase 2 double-blind, placebo-controlled trial will evaluate the safety and efficacy of Prochymal in conjunction with standard of care in improving heart function in patients who experienced their first heart attack. The trial is being conducted at leading institutions and academic research centers in the United States and Canada. The focus is on patients who have suffered a severe myocardial infarction. To be classified as severe, the patient’s left ventricular ejection fraction, or LVEF, must have been between 20% and 45% at baseline. LVEF, which reflects the fraction of blood pumped out of a ventricle with each heart beat, is a common measurement of overall heart function and typically declines after a heart attack. Patients were randomized to either Prochymal or placebo at 1:1. Efficacy endpoints determined from cardiac MRI include end systolic volume, LVEF and the ability of Prochymal to preserve functional heart tissue and limit scar formation following a heart attack. In addition, functional and quality of life assessments will be performed.


Osiris Therapeutics, Inc.

Global AIDS Alliance Thanks Congress For Increasing Funding For AIDS, TB And Malaria Programs

Today the Global AIDS
Alliance thanked the US Congress for agreeing to a major increase in funds
to combat AIDS, tuberculosis and malaria in Africa and other regions for
fiscal year 2007. Congress will increase funding by $1.3 billion, for a
total of $4.5 billion. This will raise the U.S. contribution to the Global
Fund to Fight AIDS, Tuberculosis and Malaria, a cost-effective
international partnership, to $724 million.

Congress has recognized that global disease is a true emergency in
which bold US leadership can be truly effective. The AIDS epidemic is still
spreading, with 4.3 million new infections this past year. Extremely drug-
resistant TB is a major new threat, especially in southern Africa. Malaria
is a major killer of children and a contributing factor in the spread of

Dr. Paul Zeitz, Executive Director of the Global AIDS Alliance, made
the following statement:

“This funding increase will save millions of lives and provide urgently
needed care and support for millions of orphaned and vulnerable children.
We thank all members of Congress responsible for this funding increase, in
particular Senate Majority Whip Richard Durbin (D-IL), Senator Patrick
Leahy (D-VT), Senator Robert Byrd (D-WV), Speaker Nancy Pelosi (D-CA),
Representative David Obey (D-WI), House Majority Leader Steny Hoyer (D-MD),
and Representative Barbara Lee (D-CA). These legislators are putting the US
on the right side of history by fully backing the fight against disease.
This is exactly the kind of bold leadership we need in the US Congress.

“With the increase for the Global Fund, the US is much better placed to
go to other countries and urge them to increase their contributions to the
Fund. We will need Germany, Japan and others to now reciprocate by upping
their contributions; otherwise the global goal of universal access to
AIDS-related services by 2010 will remain out of reach.

“A new, extremely dangerous form of TB has emerged, and much more US
funding will be required to combat it, and quickly. Extremely
drug-resistant tuberculosis (XDR-TB) threatens to undermine much of our
progress in fighting HIV/AIDS. The emergency is so great that the Congress
should use the upcoming Supplemental Budget for 2007 to channel $300
million to address this disease threat.

“A wide range of humanitarian, student and religious groups worked
together to urge Congress to provide the funding agreed to this week.
People across the United States also appealed to Congress to provide this
funding, and Congress responded with vision and leadership.

“Increases are also urgently needed for other global poverty programs,
as well as the response to AIDS in the United States, and we hope Congress
provides these as a part of the FY 2008 appropriations process.”

Global AIDS Alliance

FDA Gives TCA Cellular Therapy Green Light To Proceed With First ALS Adult Stem Cell Trial Using Patient’s Own Stem Cells

TCA Cellular Therapy, LLC (TCA-CT) announced that the U.S. Food and Drug Administration (FDA) has approved its adult stem cell protocol to conduct Phase I clinical trials to treat Amyotrophic Lateral Sclerosis (ALS or Lou Gehrig’s disease).

This is the second FDA-approved protocol for the treatment of ALS using stem cells in the country; and the first using adult stem cells from the same patient. The aim of the Phase I study will assess safety.

ALS afflicts approximately 30,000 Americans. More people die of ALS than Huntington’s disease; and the fatalities nearly equal Multiple Sclerosis. The life expectancy of a patient diagnosed with ALS is two to five years.

“I hope that our trial, along with the combined efforts of scientists and patients, will pave the way to breaking the chains of this devastating disease,” stated Gabriel Lasala, M.D., president and CEO of TCA Cellular Therapy.

About the Trial

Under the scientific guidance of cellular biologist, Jose J. Minguell, Ph.D., the adult stem cells will be taken from the patient’s bone marrow in a simple outpatient procedure. The cells will then be processed in TCA-CT’s GMP laboratory and administered to the patient by spinal tap in one of TCA-CT’s facilities.

Recruitment for trial patients will commence in the next few weeks. The company anticipates moving into Phase II within a year.

TCA Cellular Therapy