Cancer patients don’t have time to waste. Many go through several different treatments, however, to find one that is more effective against their particular type of tumor.

Thus, an algorithm that could help rapidly sort molecular information about a patient’s particular tumor and could help match this information to the right drug treatment would be a breakthrough of enormous value.

Dan Theodorescu, M.D., Ph.D., a University of Virginia oncologist and cancer biologist, and Jae Lee, Ph.D., a computational biologist and bioinformatics statistician, have pioneered just such a system. This work involved collaboration with colleagues at the National Cancer Institute, GeneLogic Inc. and the University of Virginia Computer Sciences Department. They published their results the week of July 23 in the Early Edition of the Proceeedings of the National Academy of Sciences, found online.

Using a panel of 60 diverse, human cancer cell lines from the National Cancer Institute (NCI-60), the researchers devised and tested an algorithm designed to match the best potential treatment(s) for a particular tumor in a particular patient.

Previously, the NCI-60 cell lines were used to screen more than 100,000 chemical compounds for their anticancer activity. These drug responses, however, were not definitely linked to clinical effectiveness in patients. Another issue is that the 60 cell lines did not include all important cancer types (for example, certain bladder cancers, lymphomas, and small cell lung cancers were not among the 60 lines studied).

The researchers investigated whether the drug sensitivity data of the 60 cancer cell lines could be extrapolated into useful information on other tumors or cancer cell lines. In fact, they found that their “coexpression extrapolation (COXEN) system” could be used to accurately predict drug sensitivity for bladder cancer cell lines to two common chemotherapies, cisplatin and paclitaxel.

“Even though this NCI cell set wasn’t an exhaustive encyclopedia of cancer cells, we found we could use the available data to draw conclusions about other cell types we were exploring. The algorithm is a Rosetta stone for translating from the NCI-studied drugs to any other cell line or human tumor,” says Dr. Theodorescu, director of the UVa Paul Mellon Prostate Cancer Institute and senior author of the study. “We believe we have found an effective way to personalize cancer therapy.” The UVa research team was able to predict the clinical responses of breast cancer patients with treated with commonly used chemotherapies, docetaxel and tamoxifen.

The most exciting aspect of this research is that in addition to predicting patient responses to therapy, the COXEN algorithm can be used to discover effective compounds in any form of cancer. By the nature of the algorithm, which examines both cancer cells and drug activity at the molecular level, these newly discovered drugs should be effective in patients. This pre-screening for effectiveness using COXEN should greatly lower the failure rate of clinical trials testing new compounds. Likewise, as the drug discovery times are decreased in research laboratories, the cost of drugs also will come down. Basically it brings the chemists making the drugs much closer to the clinic, saving time.

Because the NCI-60 set of cells has been used to screen thousands of chemically defined compounds and natural extracts for anticancer activity, “we were able to make significant predictions about what compounds might work on real patients who might have other types of cancer,” Theodorescu said. The researchers used the COXEN to screen 45,545 compounds, and they identified a several new compounds that have activity against human bladder cancer. To share this exciting capability with the scientific community, Dr. Lee is leading the development of a web-based COXEN system (coxen) where investigators with genomic profiling data from cancer cells or patient tumors can obtain chemosensitivity prediction results on FDA-approved chemotherapeutic compounds.

Dr. Theodorescu is planning clinical trials for the new compounds against bladder cancer. Another planned clinical trial would examine patients with a variety of cancers receiving COXEN personalized, second-line drug combinations to beat their cancers, using FDA-approved agents. Many new and exciting discoveries remain to be made, even more quickly and at lower costs.

University of Virginia Health System
PO Box 800795
Charlottesville, VA 22908-0795
United States
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These are the stories that will break your heart: children who are too malnourished to stay awake during class; mothers who don’t get adequate prenatal care because the clinic is a plane-ride away; the 13-year-old girl who died of a toothache when a makeshift remedy-applying a heated nail to deaden throbbing exposed nerves-went horribly wrong.

“It isn’t right for someone to die because of a toothache,” says Ivar Mendez, professor and head of Dalhousie University’s Division of Neurosurgery and chair of the Brain Repair Centre.

As busy as he is, Dr. Mendez isn’t one to shake his head and shrug his shoulders, wondering what can be done. These days, his work as a respected clinician and scientist often intersects with his humanitarian efforts. He’s generous to share his knowledge in neurosurgery, medical care and techniques-not to mention equipment-with doctors in Rwanda, Bolivia, China, Cuba and parts of Canada too. He’s pioneering the use of a remote-presence robot for medical care in the Inuit community of Nain in northern Labrador.

From Bolivia

“I feel we each have a personal responsibility to narrow the gap of inequality in the world,” he says, as he shows photographs of three places in particular where he’s directed his efforts: Aucapata, Bolivia; Nain, Newfoundland and Labrador; and Kigali, Rwanda.

“Early on I made a decision,” continues Dr. Mendez, who arrived in Toronto as a teenager with his family from Bolivia. “For every invitation I had to speak at Harvard or any other big centre, I would spend the same amount of time in a Third World country, doing what I can to contribute.”

Time and again, he returns to Bolivia, his homeland and the second poorest country in the Western hemisphere. Called “the rooftop of the world,” the landlocked South America country is breathtakingly beautiful, boasting a diversity of ecosystems, from high mountain ranges to tropical rain forests. Over 60 per cent of Bolivia’s people are indigenous, mostly Quechua or Aymara, eking out a meagre existence through subsistence farming.

On one trip, to Aucapata, an isolated village in the Andes, Dr. Mendez sat in on a class at the local school. He noticed the children were lethargic and could barely stay awake, much less respond to their increasingly frustrated teacher.

“It was nothing they could control; they just didn’t have enough food,” he says. As a brain specialist, he realized their hunger was affecting their ability to learn and retain knowledge. The solution was obvious and he immediately set about putting a school breakfast program in place using his own money.

Six years ago, the program was launched to provide a nutritious breakfast-milk, oatmeal, bread and fruit-for 60 children. Today, the program feeds 5,000 children in 24 schools. There’s been a jump in attendance at the schools for boys and girls, improved grades and more participation among the kids. It’s been easier to recruit teachers too, he notes.

Dental care

It was afterwards that Dr. Mendez heard the story of the girl and her fatal toothache. That spurred a program of dental hygiene for the children, who weren’t brushing their teeth and had mouthfuls of cavities as a result. They’ve since got into the habit of washing their hands before breakfast and brushing their teeth afterwards. As well, Dr. Mendez hired a dentist and brought in modern dental equipment and a generator. Within three months of the dentist’s arrival, she attended to almost 900 patients who hadn’t been to a dentist before.

Next, he decided to focus on those young minds, now eager to learn. He supplied the children with sturdy computers that can be hand cranked in areas where there is no electricity.

“The idea is that these children don’t need to speak the same language for some subjects, like math, art and music. But perhaps the girl in Halifax and the Inuit child in Labrador and the boy in Bolivia can get together to work on a musical composition. It’s been very exciting to see what they’ve come up with.”

Dr. Mendez’s humanitarian work is being recognized with a 2010 Humanitarian Award by the Canadian Red Cross, the same award given to Dalhousie Chancellor Fred Fountain last year. The awards dinner takes place Wednesday, November 10 at 6:30 p.m. Logan MacGillivray, the 13-year-old founder of Listen to the Children, will also be honoured. For more information or to purchase tickets, please call 424-1427.

“Making a difference to children really matters,” says Dr. Mendez. “They are the going to be the leaders of the future. They are the ones who will improve their own countries and propel them forward.”

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Study highlights:
Tiny particles of air pollution and black carbon, a marker for traffic exhaust fumes, may adversely affect heart function among heart attack survivors.

Researchers say people with recent heart attacks and even healthy people should avoid being around heavy traffic after hospital discharge.

Microscopic particles in polluted air can adversely affect the heart’s ability to conduct electrical signals in people with serious coronary artery disease, researchers reported in Circulation: Journal of the American Heart Association.

In a recent study of 48 Boston-area patients, all of whom had coronary artery disease, 24-hour Holter monitors were used to examine electrocardiograms for the conductivity change called an ST-segment depression, which may indicate inadequate blood flow to the heart or inflamed heart muscle.

The average 24-hour levels for all pollutants included in the analysis were below accepted or proposed National Air Quality Standard thresholds, meaning patients were breathing air considered healthy.

“We found that an elevation in fine particles, from non-traffic as well as traffic sources, and black carbon, a marker for traffic, predicted ST-segment depression,” said Diane R. Gold, M.D., M.P.H., the study’s senior author and an associate professor of medicine and environmental health at Harvard University in Boston, Mass. “Effects were greatest within the first month after hospitalization, and for patients who were hospitalized for a heart attack or had diabetes.”

Previous studies have documented that exposure to road traffic can trigger heart attacks, and that particulate air pollution increases the risk for cardiac death or heart attack.

“When coal sales were banned in Dublin, Ireland, and black smoke concentrations declined by 70 percent within the next 72 months, cardiovascular deaths fell by 10 percent,” said Gold, citing a study published in 2002.

The ST-segment changes Gold observed were not associated with symptoms in these patients, all of whom had experienced in-hospital procedures to examine or open up their coronary arteries.

Nevertheless, the findings expand the evidence that air pollution can affect heart health, either through inflaming the heart muscle or through reducing blood flow to the heart. It suggests the need for greater vigilance by physicians and heart patients in the weeks after discharge from the hospital, researchers said.

The American Heart Association and the American College of Cardiology recommend that some heart patients, particularly those who have had a heart attack, delay driving for two to three weeks after leaving the hospital and avoid driving in heavy traffic because of the stress it creates.

“Our study provides additional rationale to avoid or reduce heavy traffic exposure after discharge, even for those without a heart attack, since traffic exposure involves pollution exposure as well as stress,” she said.

The study’s 48 participants had been hospitalized for either a heart attack, unstable angina or worsening symptoms of stable coronary artery disease. Their median age was 57 years, 81 percent were male, 40 percent had suffered a heart attack and 25 percent had diabetes.

Researchers visited the patients two to four weeks after their discharge, and then three more times at approximately three-month intervals. At each visit, a portable electrocardiograph called a Holter monitor recorded the patients’ heart activity for 24 hours. All participants were monitored on the first visit, and 35 had monitoring on more than one visit. Researchers averaged monitor readings over each half-hour, providing 5,979 half-hour observations. They then examined the relation of these ECG measurements with levels of several pollutants, including black carbon, produced by the incomplete combustion of fossil fuels, and particulate matter (PM2.5) of less than 2.5 micrometers (about 1/10,000th of an inch) in diameter.

Researchers obtained the PM2.5 and black carbon readings at a Harvard School of Public Health monitoring site, an average distance of 10.9 miles from the participants’ homes.

Among the study’s findings:

Increased levels of particular pollution – PM2.5 and black carbon (a marker for traffic exhaust) – were associated with ST-segment depression in the study participants.

Sulfur dioxide, a pollutant that can have non-traffic sources, also was associated with ST-segment depression.

No significant correlation was found between ST-segment depression and increased levels of carbon monoxide, but levels of this pollutant were low in this study.

Patients recovering from a heart attack had greater changes in ST segment depression on electrocardiograms compared to other participants.

The key question remains – how breathing air polluted by PM2.5 and black carbon might cause ST segment depression.

“Further research is needed to evaluate whether the pollution-related ST-segment depression that we see is related to increased heart muscle inflammation, reduced oxygen flow, oxidative stress, or increased risk of arrhythmias,” Gold said.

“We think that our findings, which are definitely subclinical, may represent a process that increases clinical risk for people with symptomatic coronary artery disease,” she said.

Co-authors are: Kai Jen Chuang, Ph.D.; Brent A. Coull, Ph.D.; Antonella Zanobetti, Ph.D.; Helen Suh, Sc.D.; Joel Schwartz, Ph.D.; Peter H. Stone, M.D.; Augusto Litonjua, M.D.; and Frank E. Speizer, M.D. Individual author disclosures can be found on the manuscript.

The National Institute of Environmental Health Services, the Environmental Protection Agency, and the National Science Council funded the study.

Statements and conclusions of study authors published in American Heart Association scientific journals are solely those of the study authors and do not necessarily reflect the association’s policy or position. The association makes no representation or guarantee as to their accuracy or reliability. The association receives funding primarily from individuals; foundations and corporations (including pharmaceutical, device manufacturers and other companies) also make donations and fund specific association programs and events. The association has strict policies to prevent these relationships from influencing the science content. Revenues from pharmaceutical and device corporations are available at americanheart/corporatefunding.

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Study Results Demonstrate Aranesp Dosed Once Every Three Weeks Achieves Treatment Goals in Managing Anemia in Cancer Patients Receiving Chemotherapy.

NEW ORLEANS–June 8, 2004–Dosing Schedule Enabled Physicians to Better Coordinate Chemotherapy And Anemia Treatment.

Amgen Inc. (Nasdaq:AMGN), the world’s largest biotechnology company, announced results of a new study demonstrating that Aranesp(R) (darbepoetin alfa) dosed once every three weeks achieved and maintained the target hemoglobin levels recommended by clinical guidelines. Most patients who received Aranesp during the study achieved therapeutic goals regardless of early or late treatment. The results were presented by the study’s investigator, Glen Justice, M.D., Pacific Coast Hematology Oncology Medical, Fountain Valley, Calif., at the 40th Annual American Society of Clinical Oncology (ASCO) meeting. (Abstract #8064)

“These data demonstrate that Aranesp corrected anemia when administered once every three weeks, which can simplify the treatment of anemia and provide added benefit to patients and physicians by fitting easily into the existing chemotherapy schedule,” said Dr. Justice. “Most patients can benefit with less frequent dosing which results in less time spent receiving anemia treatment in the doctor’s office.”

The analysis includes data from a randomized, open-label multi-center study of 204 patients with chemotherapy-induced anemia. Patients were randomized into two groups: baseline hemoglobin of greater than or equal to 10.5 g/dL (early intervention) and less than or equal to 12 g/dL (observation/late intervention). The early intervention group received Aranesp every three weeks from the start of the treatment period. Patients in the observation group were not treated with Aranesp unless their hemoglobin levels dropped below 10 g/dL.

Results of this study indicate that patients with chemotherapy-induced anemia who received Aranesp 300 mcg every three weeks were able to maintain optimal hemoglobin levels between 11 and 13 g/dL (in accordance with ASH/ASCO and National Comprehensive Cancer Network (NCCN) guidelines) after early intervention as well as correct anemia in patients with hemoglobin levels below 10 g/dL. Approximately 97 percent of patients in the early intervention group attained the target hemoglobin range. After late treatment with Aranesp, mean hemoglobin improved in most patients, with 90 percent of patients achieving hemoglobin values within the target range. Greater than 90 percent of both early and late intervention patients achieve the target hemoglobin of greater than or equal to 11 g/dL with mean hemoglobin near 12 g/dL for the remainder of the study.

Two national evidence-based guidelines recommend the initiation of erythropoietic therapy at different hemoglobin levels – at greater than 10 per ASH/ASCO guidelines and at greater than 11 for NCCN guidelines; maintenance of hemoglobin near 12 g/dL during anemia therapy is recommended by ASH/ASCO guidelines and NCCN guidelines.

The number and type of adverse events were similar between the two treatment groups and were consistent with the adverse event profile for this population of anemic cancer patients receiving Aranesp.

About Aranesp

Aranesp was approved by the U.S. Food and Drug Administration (FDA) in July 2002 for the treatment of chemotherapy-induced anemia in patients with nonmyeloid malignancies. Aranesp was approved by the FDA in September 2001 for the treatment of anemia associated with chronic renal failure, also known as chronic kidney disease, for patients on dialysis and patients not on dialysis.

Aranesp is a recombinant erythropoietic protein (a protein that stimulates production of oxygen-carrying red blood cells). Amgen revolutionized anemia treatment with the discovery of recombinant erythropoietin, epoetin alfa, which is currently marketed in the U.S. by Amgen as EPOGEN(R)(1) and by Ortho Biotech Products, LP, as Procrit(R)(2). Building on this heritage, Amgen developed Aranesp(R), which contains two additional sialic acid-containing carbohydrate chains than the epoetin alfa molecule resulting in more activity with the added benefit of less-frequent administration.

Aranesp is contraindicated in patients with uncontrolled hypertension. Erythropoietic therapies may increase the risk of thrombotic and other serious events; dose reductions are recommended if the hemoglobin increase exceeds 1.0 g/dL in any two-week period. The most commonly reported side effects in Aranesp trials were fatigue, edema, nausea, vomiting, diarrhea, fever, and dyspnea.

About Amgen

Amgen is a global biotechnology company that discovers, develops, manufactures and markets important human therapeutics based on advances in cellular and molecular biology.

FORWARD LOOKING STATEMENT

This news release contains forward-looking statements that involve significant risks and uncertainties, including those discussed below and others that can be found in our Form 10-K for the year ended December 31, 2003, and in our periodic reports on Form 10-Q and Form 8-K.

Amgen is providing this information as of the date of this news release and does not undertake any obligation to update any forward-looking statements contained in this document as a result of new information, future events or otherwise.

No forward-looking statement can be guaranteed and actual results may differ materially from those we project. The Company’s results may be affected by our ability to successfully market both new and existing products domestically and internationally, sales growth of recently launched products, difficulties or delays in manufacturing our products, and regulatory developments (domestic or foreign) involving current and future products and manufacturing facilities. In addition, sales of our products are affected by reimbursement policies imposed by first party payors, including governments, private insurance plans and managed care providers, and may be affected by domestic and international trends toward managed care and healthcare cost containment as well as possible US legislation affecting pharmaceutical pricing and reimbursement. Government regulations and reimbursement policies may affect the development, usage and pricing of our products. Furthermore, our research, testing, pricing, marketing and other operations are subject to extensive regulation by domestic and foreign government regulatory authorities. We, or others could identify side effects or manufacturing problems with our products after they are on the market. In addition, we compete with other companies with respect to some of our marketed products as well as for the discovery and development of new products. Discovery or identification of new product candidates cannot be guaranteed and movement from concept to product is uncertain; consequently, there can be no guarantee that any particular product candidate will be successful and become a commercial product. In addition, while we routinely obtain patents for our products and technology, the protection offered by our patents and patent applications may be challenged, invalidated or circumvented by our competitors. Further, some raw materials, medical devices, and component parts for our products are supplied by sole first party suppliers.

Aranesp prescribing information can be accessed by calling 800-772-6436 or by logging onto aranesp.

(1) EPOGEN(R) is a registered trademark of Amgen Inc.
(2) Procrit(R) is a registered trademark of Ortho Biotech Products, L.P.

CONTACT:
Amgen
Kelly Stoddard, 805-447-4587 (media)
Investor Relations, 805-447-1060 (investors)

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During this National Cancer Control Awareness Month, The Cancer Institute of New Jersey (CINJ) is highlighting its clinical trial program and the importance of patients having access to quality information about these cancer studies right at their fingertips. CINJ is a Center of Excellence of UMNDJ-Robert Wood Johnson Medical School.

As New Jersey’s only National Cancer Institute-designated Comprehensive Cancer Center, CINJ currently enrolls more than 1,000 patients in prevention, treatment and supportive care trials, including approximately 15 percent of all new adult cancer patients and approximately 70 percent of all pediatric cancer patients. Enrollment in clinical trials nationwide is fewer than five percent of all adult cancer patients.

Among the exciting trials at CINJ is an effort to see whether combining the FDA-approved drugs Celebrex® and Lipitor®, used respectively for arthritis pain and lowering cholesterol, might slow or stop the growth of prostate cancer. Information on this trial and many others being offered at CINJ, can be found at the New Jersey Cancer Trial Connect (NJCTC) website.

NJCTC is a web-based, comprehensive resource in English and Spanish that allows patients to cross-reference tumor sites, targeted drugs and other information, then matches them with cancer clinical trials available throughout New Jersey. The site (njctc) — which is operated by CINJ with assistance from the state — was launched in 2003 and has received more than seven-million hits since.

Susan Goodin, PharmD, FCCP, BCOP, is the associate director of clinical trials and therapeutics at CINJ and professor of medicine at UMDNJ-Robert Wood Johnson Medical School. As the driving force behind the creation of New Jersey Cancer Trial Connect, she can discuss how the need for such a resource tool was identified, and what impact the website has had on patients. Dr. Goodin can also provide an overview of CINJ’s clinical trial program as well as discuss aspects of supportive care, clinical pharmacology and drug interactions. She is also the lead investigator on the aforementioned Celebrex®/Lipitor® trial.

Cancer Institute of New Jersey
195 Little Albany St.
New Brunswick
NJ 08903-2681
United States
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If you have trouble keeping weight off and you’re wondering why – the surprising answer may well be the cheeseburgers you ate – when you were a toddler.

Surprising new research by University of Calgary, Faculty of Kinesiology researcher Dr. Raylene Reimer, published in an international journal, indicates a direct connection between an adult’s propensity to put on weight and our early childhood diet.

Reimer is a leader in a growing field of study that examines the developmental origins of health and disease. Researchers in this area believe our pre-natal and early childhood environment influences our future risk of developing conditions like cardio vascular disease, obesity and diabetes.

“My research has shown that the food we eat changes how active certain genes in our body are – what we call genetic expression. In particular we believe that our diet has a direct influence on the genes that control how our bodies store and use nutrients,” says Reimer. “There’s a growing body of work that indicates a relationship between our health as adults and our early diet, and even our mother’s diet. This research shows for the first time that our early childhood diet may have a huge impact on our health as adults.”

Reimer’s study published in the current Journal of Physiology (London,) compares three groups of rats. At a very young age the rats were weaned onto three separate diets. One group was fed a high protein diet; one group was fed a high fibre diet and a third group was fed a control diet. When the rats became adults, they were switched to a high fat, high sugar diet, which reflects the reality of the typical western diet.

The results were astonishing. The group of rats who were reared on the high protein diet packed on much more weight and body fat than the rats who had ‘grown up’ eating the high-fibre diet, who put on the least amount of weight and body fat.

“I believe this study clearly shows that the composition of early childhood diet may have a direct lifelong impact on genes that control metabolism and obesity risk,” says Reimer. “This study clearly indicates that diet composition alone can change the trajectory of circulating satiety hormones and metabolic pathways that influence how we gain weight or control blood sugar as adults.”

The 2005 Canadian Community Health Survey conducted by Statistics Canada revealed that a majority of Canadians are now overweight. 36.1% of the population is officially overweight and an additional 23.1% of the population is officially obese (BMI of 30 or more.)

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Schering-Plough
Corp., (NYSE: SGP) announced that a study published in the November
2008 issue of the medical journal, Anesthesiology (Vol. 109, No. 5)(1)
demonstrated that sugammadex produced a significantly more rapid recovery
from profound rocuronium-induced muscle relaxation than the conventional
reversal agent neostigmine. Importantly, this is the first comparative
study to demonstrate that rapid reversal of profound rocuronium-induced
muscle relaxation is possible. In the study, the median time to recovery
was 2.7 minutes in the sugammadex group versus 49.0 minutes in the
neostigmine group.

Sugammadex is a novel selective relaxant binding agent that works in an
entirely new and unique way to encapsulate the muscle relaxant molecule and
render it inactive. Sugammadex is approved and marketed in the European
Union as BRIDION(R).

“This study demonstrates that sugammadex is the first agent to permit
rapid reversal of a profound level of rocuronium-induced neuromuscular
blockade,” said lead author R. Kevin Jones, M.D., attending
anesthesiologist, Saddleback Memorial Medical Center, Laguna Hills, Calif.
“This finding with sugammadex will likely have important clinical
implications for how muscle relaxation is managed, providing
anesthesiologists with greater control in maintaining the level of blockade
necessary during surgery, while allowing for rapid recovery once surgery is
completed.”

The study, known as the Signal trial, was a Phase III, multicenter,
randomized, parallel-group, safety-assessor blinded study that compared the
efficacy and safety of sugammadex versus neostigmine/glycopyrrolate in the
reversal of profound rocuronium-induced neuromuscular blockade.
Traditionally, reversal of nondepolarizing neuromuscular blocking agents
(NMBAs) such as rocuronium or vecuronium has been achieved by using
acetylcholinesterase inhibitors, such as neostigmine. However, these older
agents cannot rapidly reverse profound neuromuscular blockade.

Neuromuscular blockade plays several critical roles in general
anesthesia. Anesthesiologists use muscle relaxation to improve surgical
conditions and to facilitate intubation and mechanical ventilation.
Reversal agents reverse the effects of muscle relaxants, enabling patients
to regain normal muscle function sooner and breathe on their own again.

Studies have shown that in clinical practice, patients are often
extubated before complete recovery has occurred, leaving the patients at
risk of associated postoperative complications such as airway obstruction
or pulmonary complications. Residual neuromuscular blockade, which is an
important cause of NMBA-associated morbidity in surgical patients, was not
reported in any patient in this study.

“These results demonstrate the efficacy of sugammadex in rapidly
reversing profound rocuronium-induced neuromuscular blockade, an option
that is not possible with conventional reversal agents,” said Robert J.
Spiegel, M.D., chief medical officer and senior vice president,
Schering-Plough Research Institute. “This study shows that sugammadex
offers advantages over neostigmine and may help improve anesthesia
management in the millions of surgeries where muscle relaxation agents are
used.”

Key Findings

In the Signal study, sugammadex or neostigmine was administered at
reappearance of 1-2 post-tetanic counts (profound neuromuscular blockade).
The primary efficacy endpoint of the study was time from sugammadex or
neostigmine/glycopyrrolate administration to return of the train-of-four
(TOF) ratio to 0.9. Profound neuromuscular blockade reversal with
sugammadex 4 mg/kg was about 17 times faster than with neostigmine 70
mcg/kg (geometric mean times were 2.9 minutes versus 50.4 minutes,
respectively [P Continue reading →

Dental experts from around the world are meeting in Liverpool for the Eighth World Congress on Preventative Dentistry (WCPD).
The congress brings together internationally renowned speakers including Professor Lois Cohen – one of the world’s leading authorities on preventative dentistry. The congress will be attended by Chief Dental Officers from across Europe as well as dental experts from 28 countries including Beijing and Australia.

The event will focus on the need for international joint policies in oral health promotion and oral disease prevention and build on earlier themes from previous meetings of the World Congress, particularly promoting equity and reducing health inequality.

Professor Cynthia Pine, Dean of Dental Studies at the University said: “I am delighted the University of Liverpool has been chosen to host such a prestigious international conference. This is an ideal opportunity to promote Liverpool’s dental expertise to international policy makers and world leading researchers in the field of preventative dentistry.

“Our dental colleagues will be discussing oral health promotion activities taking place in their individual countries, so the congress will provide an exciting opportunity to develop new strategies by combining best practice ideas and experiences.”

Chief Dental Officer at the World Health Organisation, Professor Poul Petersen, will be awarded an honorary degree by the University during the conference. Professor Petersen is being honoured for his contributions in improving social and behavioural aspects of oral health internationally.

The conference is being held at St George’s Hall, Liverpool from Wednesday, 7 September to Saturday 10 September 2005. The degree ceremony takes place on Thursday, 8 September.

Joanna Robotham
joanna.robothamliv.ac
44-015-179-42026
University of Liverpool
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Rosetta Genomics, Ltd. (NASDQ: ROSG), a leader in
the development of microRNA-based diagnostic and therapeutic products,
announced the initiation of a clinical validation study with The
University of Texas M. D. Anderson Cancer Center (MDACC). The study will
focus on Rosetta Genomics’ microRNA-based test that identifies the primary
site of cancer of unknown primary (CUP). The study will include one hundred
patients who are diagnosed with CUP at MDACC, and who meet the eligibility
criteria. Rosetta Genomics expects this test to be submitted for regulatory
approval in the second half of 2008.

“The initiation of this validation study is an integral part of the
commercialization roadmap for our diagnostic tests, as we advance them
towards use in a clinical setting,” said Amir Avniel, President and CEO of
Rosetta Genomics. “We believe the initiation of this study for our CUP
assay with a leading cancer research center such as M. D. Anderson attests
to the critical unmet need this test addresses.” CUP is a heterogeneous
group of cancers that constitutes 3-5% of all cancers with a poor median
survival of 6-10 months(1). Each year, approximately 70,000 patients in the
United States are diagnosed with CUP. A patient is typically diagnosed with
CUP only after undergoing a wide range of tests, including various imaging
tests such as x-ray, CT, MRI, and PET, which often fail to identify the
origin of the cancer.

Presently, the choice of treatment for metastatic cancer is largely
dependent on the nature of the primary tumor. Patients with CUP pose a
therapeutic dilemma and treatment is often empiric with a “trial and error”
approach. In the era of rapidly growing effective cytotoxic and targeted
therapies for known cancers, quicker and more accurate methods of
identifying the tissue of origin of CUP cases would permit the use of these
therapies, thereby improving the chances of achieving a response and
possibly extending the patient’s survival.

“The current gold standard diagnostic evaluation for CUP consists of a
careful history and physical examination, laboratory tests, imaging
studies, invasive studies when necessary, and thorough pathologic
evaluation. This process is lengthy and exposes the patient to unnecessary
toxicities,” noted Dr. Gauri Varadhachary (M.D. Anderson – Please insert
title). “Rosetta Genomics’ microRNA-based CUP assay may present an
alternative test to current diagnostic practices. This study aims to
validate their assay as well as compare its performance with current tests
for CUP.”

About microRNAs

MicroRNAs (miRNAs) are recently discovered, naturally occurring, small
RNAs that act as master regulators and have the potential to form the basis
for a new class of diagnostics and therapeutics. Since many diseases are
caused by the abnormal activity of proteins, the ability to selectively
regulate protein activity through microRNAs could provide the means to
treat a wide range of human diseases. In addition, microRNAs have been
shown to have different expression in various pathological conditions. As a
result, these differences may provide for a novel diagnostic strategy for
many diseases.

About Rosetta Genomics

Rosetta Genomics (Nasdaq: ROSG) is a leader in the field of microRNAs.
Founded in 2000, the company’s integrative research platform combining
bioinformatics and state-of-the-art laboratory processes has led to the
discovery of hundreds of biologically validated novel human microRNAs.
Building on its strong IP position and proprietary platform technologies,
Rosetta Genomics is working on the application of these technologies in the
development of a full range of microRNA-based diagnostic and therapeutic
tools, focusing primarily on cancer and various women’s health indications.
The first microRNA diagnostic test applying Rosetta Genomics’ technology
has been approved for clinical use by the State of New York, and the
company expects it will be launched by licensed clinical laboratories in
the United States in 2008.

Forward Looking Statement Disclaimer

Various statements in this release concerning Rosetta’s future
expectations, plans and prospects, including without limitation, statements
relating to the role of microRNAs in human physiology and disease, the
potential of microRNAs in the diagnosis and treatment of disease and the
Company’s ability to successfully develop CUP diagnostic tests, constitute
forward-looking statements for the purposes of the safe harbor provisions
under The Private Securities Litigation Reform Act of 1995. Actual results
may differ materially from those indicated by these forward-looking
statements as a result of various important factors, including risks
related to: Rosetta’s approach to discover and develop novel diagnostics
and therapeutic tools, which is unproven and may never lead to marketable
products or services; Rosetta’s ability to fund and the results of further
pre-clinical and clinical trials; Rosetta’s ability to obtain, maintain and
protect the intellectual property utilized by Rosetta’s products; Rosetta’s
ability to enforce its patents against infringers and to defend its patent
portfolio against challenges from third parties; Rosetta’s ability to
obtain additional funding to support its business activities; Rosetta’s
dependence on third parties for development, manufacture, marketing, sales,
and distribution of products; Rosetta’s ability to successfully develop its
candidate tools, products and services, all of which are in early stages of
development; Rosetta’s ability to obtain regulatory clearances or approvals
that may be required for its products and services; the ability to obtain
coverage and adequate payment from health insurers for the products and
services comprising Rosetta’s technology; competition from others using
technology similar to Rosetta’s and others developing products for similar
uses; Rosetta’s dependence on collaborators; and Rosetta’s short operating
history; as well as those risks more fully discussed in the “Risk Factors”
section of Rosetta’s Annual Report on Form 20-F for the year ended December
31, 2007 as filed with the Securities and Exchange Commission. In addition,
any forward-looking statements represent Rosetta’s views only as of the
date of this release and should not be relied upon as representing its
views as of any subsequent date. Rosetta does not assume any obligation to
update any forward-looking statements unless required by law.

References

(1) Bugat, R., et al., Summary of the Standards, Options and
Recommendations for the management of patients with carcinoma of unknown
primary site (2002). Br J Cancer, 2003. 89 Suppl 1: p. S59-66.

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Mardil, Inc. announced positive interim data from a pilot study investigating the safety and efficacy of its novel cardiac device – BACE (Basal Annuloplasty of the Cardia Externally) — in treating mitral valve regurgitation. The condition arises when the heart’s mitral valve leaks blood backward into the heart, causing a range of severe and debilitating symptoms.

The first 11 patients implanted with BACE demonstrated a significant reduction in the severity grade of their mitral regurgitation, from a baseline mean grade of 3.32 to a mean grade of 0.61 post implantation, the data demonstrate. Mitral regurgitation severity is graded on a scale from 0 to 4, with 4 representing the most severe condition. The improvements in mitral valve function were sustained at 6 months, as demonstrated by follow-up echocardiograms conducted in the 3 of the 11 patients. No device related adverse events were reported.

Interim results of the 20-patient pilot study were presented today at the annual Transcatheter Cardiovascular Therapeutics (TCT) conference in San Francisco.

“While the data are preliminary, they represent a level of improvement that is extremely encouraging,” said Jai Raman, MD, PhD, professor of surgery and director of adult cardiac surgery and cardiothoracic surgical research at the University of Chicago. “BACE represents a novel modality for treating functional mitral valve regurgitation because it addresses the root cause of the condition – a heart muscle that is enlarged and weakened – whereas current devices on the market attempt to replace or repair valves that are structurally normal.”

About the study

The pilot study of 20 patients was designed to assess the safety and efficacy of the BACE Device, a less invasive cardiac device that sits outside the heart and supports the weakened ventricular muscle while treating valvular dysfunction. Eleven patients with moderate to severe ischemic mitral regurgitation underwent implantation with BACE, along with coronary artery bypass grafting (CABG) on a beating heart; seven of them underwent surgery without a heart-lung bypass machine. Three patients had left ventricular reconstructive procedures. One patient died of complications related to insertion of a mechanical support device that was placed pre-operatively. No device-related adverse reactions were reported in the trial.

The pilot study is being conducted in India. Mardil is seeking an investigational device exemption (IDE) through the U.S. Food and Drug Administration to begin clinical trials in the U.S. next year.

About BACE

The BACE Device serves as a tension band that encircles the exterior of the heart, supporting the left ventricular wall and the mitral valve annulus. Gentle pressure and support from the BACE Device allow the leaflets of the mitral valve to close properly, thereby preventing blood from leaking backward when the heart pumps. BACE is the only device that can be adjusted and fine-tuned after implantation and in an office setting. The device was designed to reduce the significant mortality and morbidity rates associated with current treatments for mitral valve repair and replacement. The device sits outside the heart, negating the need for open-heart surgery or the use of a heart-lung bypass machine, both of which pose serious risks and side effects.

ABOUT MARDIL INC.

Mardil Inc. is a medical device company whose mission is to design, develop and market new and innovative patented technologies in the cardiac medical device field. The company’s first product, BACE (Basal Annuloplasty of the Cardia Externally), is a minimally invasive device that treats functional mitral valve regurgitation. The device is currently undergoing human trials in India, and human trials in the U.S. are pending. Mardil Inc. has been largely funded by Ventureast, India, an early stage venture capital company based in Hyderabad with a focus on life sciences.

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