Take a Loved One to the Doctor Day is the culmination of a six-month initiative that seeks to motivate African-Americans to become more proactive about their health and the health of their loved ones through health screenings, immunizations, blood pressure exams and more. This year, F.A.C.E. Diabetes, Stone and Anderson are joining the movement to strengthen the program’s diabetes education efforts with workshops and resources in key cities. F.A.C.E. Diabetes will be part of the seven-city Doctor Day live broadcast in Atlanta, Dallas, Detroit, Kansas City, Philadelphia, Raleigh and Washington, D.C. Stone will make a special appearance in Detroit, and Anderson in Philadelphia, where they’ll share their personal stories and inspire African-Americans to overcome key barriers to success in living with diabetes.

“Lilly and the F.A.C.E. Diabetes initiative are proud to take part in Take a Loved One to the Doctor Day to empower patients living with diabetes,” said Keith Johns, Senior Director of Marketing, Lilly Diabetes. “We hope that these events planned in cities across the country encourage African-Americans to speak with their healthcare providers about desired lifestyle changes to better manage their disease.”
As the “faces” of F.A.C.E. Diabetes, Stone and Anderson visit local communities to raise awareness of the diabetes epidemic that affects nearly 15 percent of African-American adults, and to foster the lifestyle changes that can help those with diabetes better manage the disease.(1) Research shows 3.7 million African-Americans aged 20 or older have diabetes.(1) Through community-based events such as Take a Loved One to the Doctor Day, TJMS and Lilly hope to provide valuable information and culturally-relevant solutions to help overcome the everyday challenges that many African-Americans face while living with diabetes.

“We know the statistics and now it’s time to lower them,” said Tom Joyner, whose morning show reaches over 8 million listeners. “Going to the doctor is the first step, but the follow through is just as important and that includes managing our conditions. Companies like Lilly reach out to our community and make a difference.”

The event in Detroit, featuring Stone, will be held at the Northwest Activities Center from 6 a.m. – 2 p.m. and activities in Philadelphia featuring Anderson will be at the New Covenant Church of Philadelphia from 6 a.m. – 5 p.m.

About the F.A.C.E. Diabetes Campaign

The Fearless African-Americans Connected and Empowered (F.A.C.E.) Diabetes initiative is a grassroots movement targeting African-Americans in the United States to help individuals, families, and neighborhoods overcome key barriers to success in living with diabetes. It is supported by Eli Lilly and Company, and national and local health advocacy organizations.

(1) American Diabetes Association. African Americans & Complications.

“The initiation of this clinical trial is a significant milestone that marks our continued commitment to the AIG program and to the expansion of our anthrax product franchise,” said Dr. Stephen Lockhart, Senior Vice President Product Development of Emergent BioSolutions. “AIG is an integral component of our efforts to develop safe and effective treatments for patients to be used in the event of a biological attack.”

The clinical trial will evaluate the safety and pharmacokinetics of AIG in 120 healthy adult volunteers. The study is designed to evaluate three dose levels of a single intravenous infusion of AIG compared to GAMUNEX®*, a licensed immune globulin therapy for people with primary immunodeficiency or idiopathic thrombocytopenic purpura. AIG is manufactured using the FDA-approved GAMUNEX process. In addition, a fourth cohort receiving two intravenous infusions of AIG or GAMUNEX at equivalent doses administered two days apart will be evaluated.

Emergent BioSolutions received concurrence from the FDA and approval from an Institutional Review Board on January 23, 2009 to begin this clinical trial. The clinical trial will be conducted at SNBL Clinical Pharmacology Center, a state-of-the-art clinical trial unit located in Baltimore, Maryland. This project has been funded in whole or in part with Federal funds from the Biomedical Advanced Research and Development Authority, Department of Health and Human Services, in conjunction with the National Institute of Allergy and Infectious Diseases, National Institutes of Health, Department of Health and Human Services, under Contract No HHSN272200700034.

For more information about the AIG clinical trial, visit ClinicalTrials.

About Anthrax Immune Globulin

Emergent BioSolutions’ Anthrax Immune Globulin (AIG) is being developed as an intravenous therapeutic for treatment of patients who present with symptoms of anthrax disease resulting from the release of anthrax toxins into the body. If successfully developed, AIG could be prescribed for administration in these circumstances in conjunction with antibiotics.

AIG is being developed using plasma collected from healthy donors who have been vaccinated with BioThrax® (Anthrax Vaccine Adsorbed), the only vaccine approved by the U.S. Food and Drug Administration for the prevention of anthrax infection.

About Emergent BioSolutions Inc.

Emergent BioSolutions Inc. is a biopharmaceutical company focused on the development, manufacture and commercialization of vaccines and immune-related therapeutics that assist the body’s immune system to prevent or treat disease. Emergent’s marketed product, BioThrax® (Anthrax Vaccine Adsorbed), is the only vaccine approved by the U.S. Food and Drug Administration for the prevention of anthrax. Emergent’s development pipeline includes programs focused on anthrax, botulism, typhoid, tuberculosis, hepatitis B and chlamydia. Additional information may be found at emergentbiosolutions.

Safe Harbor Statement

This press release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Any statements, other than statements of historical fact, including statements regarding our strategy, future operations, future financial position, future revenues, projected costs, prospects, plans and objectives of management, including any potential future securities offering, and any other statements containing the words “believes”, “expects”, “anticipates”, “plans”, “estimates” and similar expressions, are forward-looking statements. There are a number of important factors that could cause the company’s actual results to differ materially from those indicated by such forward-looking statements, including the success of our clinical programs; our plans to expand our manufacturing facilities and capabilities; the rate and degree of market acceptance and clinical utility of our products; the timing of and our ability to obtain and maintain regulatory approvals for our other product candidates; our commercialization, marketing and manufacturing capabilities and strategy; our estimates regarding expenses, future revenue, capital requirements and needs for additional financing; and other factors identified in the company’s annual report on Form 10-K for the year ended December 31, 2008 and subsequent reports filed with the SEC. The company disclaims any intention or obligation to update any forward-looking statements as a result of developments occurring after the date of this press release.

* GAMUNEX® is a registered trademark of Talecris Biotherapeutics, Inc.

Source
Emergent BioSolutions Inc.

Strontium 90, a major waste component, is one of the more dangerous radioactive fission materials created within a nuclear reactor. It is present in the approximately 80 million gallons of radioactive waste sludge stored in the United States alone.

The researchers are the first to show quantitatively how Closterium moniliferum, one of the bright green algae often seen in ponds, sequesters strontium (in the form of barium-strontium-sulfate crystals). They are using this understanding to think about a practical sequestration system for nuclear waste that maximizes strontium removal. The possibilities include using the algae for direct bioremediation of waste or accidental spills in the environment or designing a new process for waste treatment inspired by how the algae work.

The results are published by the journal ChemSusChem, a sister journal of Angewandte Chemie.

“Nuclear waste cleanup is a problem we have to solve,” said senior author Derk Joester, who experienced Chernobyl’s radioactive fallout when he was a teenager living in southern Germany. “Even if all the nuclear reactors were to shut down tomorrow, the existing volume of waste is great, and it is costly to store. We need to isolate highly radioactive ‘high-level’ waste from ‘low-level’ waste. The algae offer a mechanism for doing this, which we would like to understand and optimize.”

Even though strontium 90 doesn’t appear to be a significant environmental threat following the nuclear accident in Japan, the radioactive isotope will need to be dealt with during the power plant and nuclear waste cleanup, Joester said.

Joester is the Morris E. Fine Junior Professor in Materials and Manufacturing at Northwestern’s McCormick School of Engineering and Applied Science.

Strontium 90 has a half-life of about 30 years, is chemically very similar to calcium and thus is drawn to bone. The cumulative cancer risk from strontium 90 exposure when strontium is bound in bones for many years is very high.

The crescent-shaped, single-celled organism studied by Joester and his colleagues naturally makes biominerals that include non-radioactive strontium, and it can differentiate strontium from calcium — a rare feat. The researchers want to learn more about this selectivity because calcium is present in far greater abundance than strontium in nuclear waste, but calcium is harmless. By concentrating the radioactive strontium (Sr-90) in the form of solid crystals with very low solubility, the dangerous high-level waste could be isolated from the rest and dealt with separately.

“Using the algae for direct bioremediation of waste is one approach,” said Joester, who began the research years ago with his graduate student Minna Krejci, “but we also are looking at the basic mechanisms of how the algae sequester strontium so we can engineer a more selective process for waste treatment. We want to isolate and concentrate in the crystals the most strontium possible.”

The algae’s ability to separate strontium from calcium occurs when the crystals are formed inside the cells. The algae first soak up barium, strontium and calcium from their watery environment. Strontium then is sequestered along with barium in the crystals, which remain in the cells, while the calcium is excreted from the cells. (Barium must be present for the organisms to take up strontium.)

Joester and Krejci teamed up with Lydia Finney and Stefan Vogt at the Advanced Photon Source at Argonne National Laboratory to produce maps showing the distribution of barium, strontium, calcium and several other elements in the cells. At the same time, the composition of the crystals made by the cells was determined. (The crystals are located in the organism’s vacuoles, at the tips of the cells.)

The researchers varied the amount of barium and strontium in the algae’s environment and then measured the amount of strontium taken up into the cell. They found the ratio of barium to strontium in the water affected the amount of strontium incorporated into each crystal. Depending on the medium’s composition, the strontium measured in a crystal ranged from less than 1 percent up to 45 percent. This gives the researchers an avenue for making the process more strontium-selective.

“The synchrotron X-ray microscopy available at the Advanced Photon Source was absolutely critical to this study,” Joester said. “It allowed us to visualize where calcium, strontium and barium go inside the cells.” These sorts of experiments, he noted, are only possible at three synchrotron radiation facilities in the world: the Advanced Photon Source, the European Synchrotron Radiation Facility in France and the SPring-8 in Japan.

Nonradioactive strontium, which is chemically identical to the radioactive version, was used in the experiments. The researchers do not know how well the algae would survive in a radioactive environment, although the organisms have proven resistant in other harsh environments.

Joester, Krejci, Finney and Vogt all are authors of the paper, titled “Selective Sequestration of Strontium in Desmid Green Algae by Biogenic Co-precipitation with Barite.”

As this news may cause concern or confusion among people with type 2 diabetes, Takeda encourages those with questions to speak with their health care provider. Takeda has consistently emphasized the importance of physician education and patient safety in communications involving ACTOS, and has prioritized communicating the appropriate use of ACTOS in patients with type 2 diabetes.

ACTOS is an effective prescription medication used with diet and exercise to improve blood sugar (glucose) control in many adults with type 2 diabetes. Since its launch, more than 100 million ACTOS prescriptions have been written globally. ACTOS offers an established safety profile regarding the risk of cardiovascular (CV) events in people living with type 2 diabetes. Although drugs may be in the same class and have the same use, they also may have different effects due to their unique chemical structure.

Takeda remains confident in the breadth, depth and consistency of ACTOS data. Controlled clinical studies, conducted over the past 11 years in more than 20,000 patients globally, show no evidence that ACTOS is associated with an increased risk of heart attack, stroke or death.

In 2005, Takeda was the first company to complete a rigorous, randomized, placebo-controlled study, the PROactive (PROspective PioglitAzone Clinical Trial In MacroVascular Events) trial, assessing significant CV outcomes in people living with type 2 diabetes. The PROactive trial demonstrated that although there was no statistically significant difference between ACTOS and standard-of-care alone for the primary endpoint, there was no increase in mortality or total macrovascular events with ACTOS. This safety information has been included in both the FDA-approved product label and EMA-approved Summary of Product Characteristics (SPC) since 2007, providing patients and health care professionals with additional relevant information regarding the CV safety profile of ACTOS.

Takeda is the inventor and developer of ACTOS, which was launched commercially in 1999. ACTOS, as labeled, is an effective and appropriate treatment option for many people living with type 2 diabetes. Certain patients with heart failure should not start taking ACTOS. ACTOS can cause new or worsen heart failure. In clinical trials using ACTOS in monotherapy, the most common adverse events (greater than or equal to 5%) were upper respiratory tract infection, headache, sinusitis, myalgia, tooth disorder, aggravated diabetes mellitus and pharyngitis. Please see additional important safety information continued below.

About ACTOS® (pioglitazone HCl) Indications and Usage

ACTOS is a prescription medication used with diet and exercise to improve blood sugar (glucose) control in adults with type 2 diabetes. ACTOS has been studied as a monotherapy and in combination with sulfonylurea, metformin, or insulin. ACTOS should always be used according to Health Care Provider directions and its Complete Prescribing Information.

Important Safety Information

ACTOS is not for everyone. Certain patients with heart failure should not start taking ACTOS. ACTOS can cause new, or worsen, heart failure. Patients should talk to their doctor immediately if they experience unusually fast weight gain, fluid retention (swelling), shortness of breath, or unusual tiredness.

ACTOS is not for patients with type 1 “juvenile” diabetes or diabetic ketoacidosis.

ACTOS may cause low blood sugar when taken in combination with insulin or other oral antidiabetic drugs. Lightheadedness, shakiness, dizziness, or hunger may mean that a patient’s blood sugar is too low. Patients should talk to their doctor if low blood sugar is a problem for them.

Some people taking ACTOS may experience flulike symptoms, mild-to-moderate swelling of legs and ankles, anemia, and weight gain.

If a patient is of childbearing age, they should talk to their doctor before taking ACTOS, as it could increase their chance of becoming pregnant. Patients should talk to their doctor if they are pregnant, planning to become pregnant, breastfeeding, or planning to breastfeed.

A patient should not take ACTOS if they have active liver disease. A doctor should perform a blood test to check for liver problems before a patient starts ACTOS and periodically thereafter. Patients should talk to their doctor immediately if they experience nausea, vomiting, stomach pain, unusual tiredness, loss of appetite, dark urine, or yellowing of the skin or eyes.

Patients with diabetes should have regular eye exams. If a patient experiences vision problems, they should consult with their doctor immediately. Some patients have experienced visual changes while taking ACTOS. Some people, particularly women, are at higher risk of having bone fractures while taking ACTOS. Other side effects may include cold-like symptoms, headache, sinus infection, muscle pain, tooth disorder, and sore throat.

What

Experts will describe the available evidence on hydroxyurea treatment for sickle cell disease, including efficacy, effectiveness, harms, barriers to treatment, and future research needs. Following a series of scientific presentations and open public discussions, an impartial, independent panel will issue a statement of its findings on the final day of the conference, and will hold a press conference at 2:00 p.m. on Wednesday, February 27. Convened by the Office of Medical Applications of Research (OMAR) and the National Heart, Lung, and Blood Institute (NHLBI) of the NIH, this conference is free and open to the public and the media.

The conference presentations, open discussions, and the panel’s statement will focus on these questions:

1. What is the efficacy (results from clinical studies) of hydroxyurea treatment for patients who have sickle cell disease in three groups: infants, preadolescents, and adolescents/adults?

2. What is the effectiveness (in everyday practice) of hydroxyurea treatment for patients who have sickle cell disease?

3. What are the short- and long-term harms of hydroxyurea treatment?

4. What are the barriers to hydroxyurea treatment for patients who have sickle cell disease and what are the potential solutions?

5. What are the future research needs?

When

Monday, February 25, 2008 – 8:30 am – 5:30 pm
Tuesday, February 26, 2008 – 8:30 am – 12:00 pm
Wednesday, February 27, 2008 – 9:00 am – 11:00 am
Press Conference: Wednesday, February 27, 2:00 p.m.

Where

Natcher Conference Center
NIH Main Campus – Building 45
9000 Rockville Pike
Bethesda, Maryland 20892

Campus visitor information: nih/about/visitor/index.htm

The conference will also be webcast live at videocast.nih/.

Why

Sickle cell disease is an inherited blood disorder that affects between 50,000 and 75,000 people in the United States, and is most common among people whose ancestors come from sub-Saharan Africa, South and Central America, the Middle East, India, and the Mediterranean basin. Sickle cell disease occurs when an infant inherits the gene for sickle hemoglobin from both parents (Hb SS, or sickle cell anemia), or the gene for sickle hemoglobin from one parent and another abnormal hemoglobin gene from the other parent. Each year, approximately 2,000 babies with sickle cell disease are born in the United States. The condition is chronic and lifelong, and is associated with a decreased lifespan and diminished quality of life. Infections and lung problems are the leading cause of death. In addition, approximately 2 million Americans carry the sickle cell trait, which increases the public health burden as this disorder is passed on to future generations.

The red blood cells in people with sickle cell disease become deoxygenated (or depleted of oxygen), and crescent-shaped or “sickled.” The sickled blood cells become sticky, and adhere to blood vessel walls, thereby blocking blood flow within limbs and organs. These changes lead to acute painful episodes, chronic pain, and chronic damage to the brain, heart, lungs, kidneys, liver, joints, eyes, and spleen. Pain crises are responsible for most emergency room visits and hospitalizations of people with sickle cell disease. Standard treatments for acute pain crises include painkilling medications, fluid replacement, and oxygen.

In the mid-1990s, researchers began investigating the potential of hydroxyurea to reduce the number and severity of pain crises in sickle cell patients. Hydroxyurea is in a class of anti-cancer drugs and it acts to increase the overall percentage of normally structured red blood cells in the circulation. By diluting the number of cells that “sickle,” it may, if taken on a daily basis, reduce their damaging effects. Hydroxyurea was approved by the FDA for use in adults with certain forms of sickle cell anemia in 1998. However, there are a number of unresolved issues about the use of hydroxyurea, including a lack of knowledgeable providers who treat sickle cell disease, and patient and practitioner questions about safety and effectiveness, including concerns regarding potential long-term carcinogenesis.

Background

The conference is presented through the NIH Consensus Development Program. A fact sheet describing the conference process is available at consensus.nih/forthemedia.htm.

For More Information: Conference agenda, speakers, logistics, and online registration are available at consensus.nih.

The Office of the Director, the central office at NIH, is responsible for setting policy for NIH, which includes 27 Institutes and Centers. This involves planning, managing, and coordinating the programs and activities of all NIH components. The Office of the Director also includes program offices which are responsible for stimulating specific areas of research throughout NIH. Additional information is available at nih/icd/od/.

The National Institutes of Health (NIH) – The Nation’s Medical Research Agency – includes 27 Institutes and Centers and is a component of the U.S. Department of Health and Human Services. It is the primary federal agency for conducting and supporting basic, clinical and translational medical research, and it investigates the causes, treatments, and cures for both common and rare diseases. For more information about NIH and its programs, visit nih/.

Although we try to reduce fat in our diet, our bodies use it for energy. But patients with elevated levels of fat in their bloodstream nearly 10 percent of Americans are more likely to develop arthrosclerosis, or build-up of plaque in the arteries, which can lead to a heart attack or stroke.

In work with mice, researchers at the University of California, San Diego (UCSD) School of Medicine discovered a factor that could be responsible for many unexplained cases of elevated triglyceride levels.

In humans, this condition can be diabetes-related, diet-induced, or caused by drug interactions or chronic alcohol consumption. The problem can also run in families. But it turns out that another important factor is sugar a complex one produced by all cells in the body called heparan sulfate, which is related to the anti-coagulant heparin.

The UCSD team found that heparan sulfate in the liver helps the body clear triglycerides from the blood. Their study, published in the January 1 issue of the Journal of Clinical Investigation, suggests that some patients with elevated triglyceride levels could have changes in heparan sulfate in the liver. The discovery could pave the way for new therapies for a major and growing medical problem.

“The work confirms that heparan sulfate in the liver plays a crucial role in clearing fat,” said Jeffrey D. Esko, Professor of Cellular and Molecular Medicine at UCSD??™s School of Medicine. “These molecules clear triglycerides and cholesterol from the blood, working alongside the better known LDL receptors”

The UCSD researchers created a mouse model with a mutation of heparan sulfate, which resulted in elevated triglyceride levels, like those seen in many patients with diabetes. The researchers made mutations in only in the liver, because such mutations throughout all tissues would lead to the death of an embryo or death shortly after birth.

“By selectively mutating a single tissue in mice, in this case the liver, we avoided a lethal effect,” said Esko. In the lab, the researchers combined the heparan sulfate mutation with a mutation in the LDL receptor, which has long known to be responsible for clearing cholesterol from the arteries. The UCSD team showed that heparan sulfate is involved in clearing not only triglycerides, but also cholesterol, from the blood.

“The finding, that the LDL receptor plus heparan sulfate work together to clear triglyceride and cholesterol-rich particles from the blood in a healthy person is very exciting,” Esko said. The study suggests the possibility that mutations in one of 40 or so genes involved in production of heparan sulfate in the liver could result in high blood-fat levels and lead to complications such as arthrosclerosis, according to Esko.

In animal models with induced diabetes, changes in liver heparan sulfate consistent with the UCSD researchers??™ findings often appear. One of the team??™s next steps will be to induce diabetes in animals and examine the role of heparan sulfate in more detail.

“Such studies could lead to new drugs that change heparan sulfate in order to lower fat levels in patients,” said Esko.

Additional contributors to the paper include Jennifer M. MacArthur and Kristin I. Stanford, UCSD Biomedical Sciences Graduate Program; Joseph R. Bishop and Lianchun Wang, UCSD Department of Cellular and Molecular Medicine; Joseph Witztum, UCSD Department of Medicine; and Andr?© Bensadoun, Division of Nutritional Sciences, Cornell University.

Funding support was provided by the National Institutes of Health and the National Science Foundation.

University of California, San Diego
University Communications, 0938 9500 Gilman Dr.
LaJolla, CA 92093
United States
ucsd/

Since the beginning of the 20th century, scientists have postulated the existence of the “immunosurveillance” of cancer, by which the immune system recognizes cancer cells(1) as being abnormal as soon as they are produced by the body, and then eradicates them. It is only when these cells escape from the immune response that a cancer develops. However, the team led by David Klatzmann, Professor at UPMC, has just revealed that this concept is inexact: the “immunosurveillance” of cancers does exist, but in fact it protects tumor cells when they appear, in the same way as any other normal cells in the body.

When an immune response is induced by the body, two types of lymphocytes (specialized immune system cells) are particularly closely involved: regulatory T-cells and effector T-cells. The former recognize components arising from the body itself and protect tissues from attack using the immune system. By contrast, effector T-cells specifically recognize foreign components and their function is to destroy them.

Most studies focused on interactions between cancer cells and the immune system are performed once cancer development is already well-advanced, when the tumor mass is already organized and detectable. The researchers in the Laboratoire ?« Immunologie – Immunopathologies – Immunoth?©rapies ?» (UPMC / CNRS / INSERM) focused on these interactions, but during the very first few days after the appearance of tumor cells. Using animal models, they showed that appearance of the very first cancer cells triggered an immediate response by regulatory T-cells which migrated rapidly towards the tumor(2). They recognized molecules on the cancer cells that were also expressed by normal tissues in the body. These regulatory T-cells then blocked the action of effector T-cells, thus preventing them from attacking and destroying the cancer cells. Activated at all times in order to protect healthy tissues, regulatory T-cells are mobilized much more rapidly and strongly than effector T-cells, which are resting before the tumor appears. The scientists also showed that if regulatory T-cells were absent from this first encounter between the immune system and tumor cells, effector responses of the immune system indeed developed and enabled eradication of the tumor.

Regulatory T-cells are thus the first to recognize a tumor and facilitate its development by preventing its eradication by effector T-cells. This suggests that the control of regulatory T-cells should be an essential component in the development of future therapies for cancer. This discovery also opens the way to other therapeutic opportunities, such as preventive anti-tumor vaccination.

(1) A cancer (or tumor) cell is a normal cell in the body that has undergone changes, such as uncontrolled proliferation, the invasion of adjacent tissues, the colonization of distal organs, or genetic instability, etc.

(2) Generically speaking, the term “tumor” designates an abnormal proliferation of cells. When malignant, this takes the name “cancer”.

Hyperkalemia is a condition characterized by elevated serum potassium levels, which can lead to cardiac arrhythmia and sudden death. Heart failure patients are at particular risk for developing hyperkalemia, especially those patients with underlying chronic kidney disease treated with Renin-Angiotensin-Aldosterone-System (RAAS) inhibitors. RAAS inhibition in such patients provides a life-saving therapy, but has the undesirable side effect of increasing serum potassium.

The PEARL-HF Phase 2b clinical trial is a multi-center, randomized, placebo-controlled study designed to assess the efficacy, safety and tolerability of RLY5016 for the prevention of hyperkalemia in heart failure patients. The study is being conducted at clinical sites worldwide and patient enrollment is underway.

The Phase 2b clinical trial follows the successful completion of three clinical trials of RLY5016, including two Phase 1 trials and a Phase 2a trial. RLY5016 was well-tolerated in these studies. In healthy volunteers, RLY5016 demonstrated dose-related pharmacological effects. In a Phase 2a clinical trial of hemodialysis patients with hyperkalemia, RLY5016 lowered serum potassium, achieving proof-of-concept.

“We are pleased to advance our lead compound RLY5016 into Phase 2b clinical testing, following very encouraging tolerability and efficacy results observed in Phase 1 and Phase 2a clinical trials,” said Detlef Albrecht, M.D., Chief Medical Officer and Senior Vice President, Drug Development of Relypsa. “RLY5016 holds great promise in preventing and treating hyperkalemia, and thereby enhancing the use of life-saving drugs for heart failure patients. To date, we have been pleased by the interest received from clinical investigators and the positive enrollment trends observed in the first portion of the trial. We look forward to reporting interim results from the PEARL-HF Phase 2b clinical trial in the first quarter of 2010.”

Relypsa’s Chief Operating Officer, Gerrit Klaerner, Ph.D. commented, “We are proud to achieve this milestone in a capital- and time-efficient manner. Since Relypsa’s inception less than two years ago, we have made remarkable progress by advancing a preclinical asset through human proof-of-concept. We anticipate interim results from the Phase 2b trial will help us to position RLY5016 as an essential tool for cardiologists and nephrologists to optimize the use of cardiovascular agents with proven outcomes. The practice of deploying therapies that address toxicities and side effects of life-saving treatments is well established in oncology, but this will be a first in the cardiovascular field. Our goal is to establish Relypsa as one of the leading companies focused on patients with chronic cardio-renal diseases.”

Source
Relypsa, Inc.

According to a new study, individuals with heart problems have a significantly higher risk of stroke and heart attack if they take Meridia. This confirms concerns about Meridia’s safety for patients with heart disease and other heart problems (they are already warned against taking this prescription medication).

The NEJM article appears a couple of weeks before an FDA (Food and Drug Administration) advisory committee meets to discuss regulatory issues concerning Meridia. The meeting was scheduled after the publication of preliminary results from SCOUT, a study on Meridia released by the FDA in November 2009. In January 2010 the FDA asked Meridia makers, Abbot Laboratories to strengthen the warning on its label.

In January 2010 the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) concluded that the risks of these medicines (containing sibutramine) are greater than their benefits and recommended the suspension of marketing authorizations for these medicines across the European Union (Link to article).

Put simply, the SCOUT study prompted to Europeans to pull the drug off the shelves, while the FDA asked for stronger warnings only.

In this latest NEJM study, investigators monitored 10,744 obese/overweight individuals who had diabetes type 2 or heart disease and a risk factor, such as hypertension for approximately three-and-a-half years.

The researchers report that:

4.1% of the patients on Meridia had a non-fatal heart attack while 2.5% had a stroke.
3.2% of those on a placebo had a non-fatal heart attack, while 1.8% had a stroke.
In other words, those on Meridia had a 28% higher risk of having a heart attack and a 36% higher risk of developing a stroke, compared to those on the placebo.

For patients with diabetes type 2, but no history of heart disease or heart problems, Meridia did not appear to raise the risk of stroke or heart attack, the authors report.

There appeared to be no differences in fatalities – deaths from heart attack or stroke – between the patients on Meridia and those on the placebo.

The study supports current recommendations that Meridia should not be given to patients with existing heart disease or problems, the authors write.

About Meridia (sibutramine HCl monohydrate)
According to Abbot, Meridia (sibutramine hydrochloride monohydrate) is used for people who need to lose 30 pounds or more, depending on height, and should be used with a reduced-calorie diet.

The Meridia web site contains a long list of people who should not take the medication.

“Effect of Sibutramine on Cardiovascular Outcomes in Overweight and Obese Subjects”
W. Philip T. James, M.D., D.Sc., Ian D. Caterson, M.D., Ph.D., Walmir Coutinho, M.D., D.Sc., Nick Finer, M.B., B.S., Luc F. Van Gaal, M.D., Ph.D., Aldo P. Maggioni, M.D., Christian Torp-Pedersen, M.D., Ph.D., Arya M. Sharma, M.D., Ph.D., Gillian M. Shepherd, B.Sc., Richard A. Rode, Ph.D., and Cheryl L. Renz, M.D. for the SCOUT Investigators

N Engl J Med 2010; 363:905-917September 2, 2010

View drug information on MERIDIA.

UPCI and Pitt researchers presented more than 80 posters, talks and tutorials, as well as leading educational sessions and chair panel discussions during the event.

Highlights included:

ORAL PRESENTATIONS:

MONDAY, APRIL 4

Mechanisms of Complications of Multiple Myeloma Treatments

Suzanne Lentzsch, M.D., Ph.D., assistant professor of medicine and clinical director of the multiple myeloma program at UPCI, discussed her research that shows how immunomodulatory derivatives of thalidomide (IMiDs), such as lenalidomide and pomalidomide, used in multiple myeloma treatment also affect blood cell production pathways by decreasing production of a key protein needed for blood cell specialization.

“That leads to treatment complications including a reduction in the numbers of neutrophils, a kind of white blood cell, and an increase in a protein that promotes platelet clumping that in turn increases the risk for blood clots,” Dr. Lentzsch explained.

Inflammatory Mediator Drives Suppressor Cells That Cause Immune System Dysfunction in Cancer

Natasa Obermajer, Ph.D., a postdoctoral fellow, presented a project conducted in the lab of senior investigator Pawel Kalinski, M.D., Ph.D., professor of surgery and UPCI researcher, that shows a single cancer-associated inflammatory mediator called prostaglandin E2 (PGE2) drives the differentiation and stability of myeloid-derived suppressor cells that play a key role in causing immune system dysfunction and a microenvironment that allows cancer cells to thrive.

“Our findings suggest that a positive feedback loop exists between PGE2 and COX-2, which regulates PGE2 production,” Dr. Kalinski said. “When we disrupted this feedback loop in suppressor cells taken from cancer patients by blocking COX-2 or PGE2 signaling receptors, we stopped the cells’ ability to suppress cancer-killing immune cells. This might be a new avenue to explore for future cancer treatments.”

TUESDAY, APRIL 5

Cancer Vaccines Targeting Pre-Malignant Lesions

Olivera Finn, Ph.D., professor and chair, Department of Immunology, presented her work in developing vaccines that target abnormal peptides, or small pieces of protein, that are produced during the development of certain cancers. Tumor formation might be prevented with a vaccine that generates an immune response against the cells that carry these worrisome peptides.

“Vaccines that are administered as a possible treatment after cancer has already developed have not been very effective,” she noted. “But if we can help the immune system find these dangerous cells in people who are at high risk for cancer but are still healthy, we might have an intervention that could prevent many cases of disease.”

With colleagues including clinical collaborator Robert E. Schoen, M.D., professor of medicine, Dr. Finn also presented a poster of preliminary findings of a colon cancer prevention vaccine that is being tested for safety at UPMC. None of the vaccine recipients who have been evaluated had significant side effects, and half of them generated an immune response to MUC1, the vaccine target and a protein that becomes aberrant during the progression of advanced colon polyps into cancer. These early findings encourage further testing in a randomized trial to assess whether the vaccine can prevent recurrence of adenomatous polyps. Abstract 5510

POSTER PRESENTATIONS:

Novel Drug Protects Esophagus After Radiation Exposure

Mice that swallowed the experimental drug JP4-039 before they were exposed to upper body radiation were more likely to survive than untreated animals. Of the treated animals, 75 percent survived for 30 days after exposure compared to 30 percent of the untreated group. The findings could lead to drugs that prevent esophagitis, a typical side effect of radiation treatment for lung cancer. Abstract 2502

Seizure Drug Offers Protection from Radiation Exposure

In cell and mouse experiments, carbamazepine, a drug typically prescribed to treat mood disorders, epilepsy and trigeminal neuralgia, mitigated the impact of radiation exposure by increasing autophagy, a process in which the cell components are degraded and discarded. Abstract 2495