Early this year, New York Methodist Hospital began participating in an international clinical trial to investigate an important new, minimally invasive option for people with advanced widespread emphysema. The procedure being tested — airway bypass — creates passageways in the lung for trapped air to escape with the hope of relieving emphysema symptoms like shortness of breath.

A number of patients at New York Methodist Hospital — one of only two centers in New York City to offer the trial — have become participants. Participation ranges from 12 months to five years (depending on whether they are randomly placed in the control or the airway bypass group). Study-related medical procedures are provided for at no charge and all patients are closely monitored throughout the trial. In addition, all participants receive at least 6 weeks of pulmonary rehabilitation therapy.

Early data suggest that the airway bypass procedure holds promise for patients with emphysema. “We’re excited about the possibility of offering the investigational procedure to emphysema patients,” said Arthur Sung, M.D., director of interventional pulmonology at NYM’s Institute for Asthma and Other Lung Diseases and principal investigator for the study. “We are very hopeful that creating new passageways for airflow with the airway bypass procedure will improve lung function in patients with advanced disease.”

The opportunity to join the study is still available for qualified patients. At a minimum, participants must be over the age of 35, have advanced, widespread emphysema and must be non-smokers (or willing to stop smoking two months prior to entering the trial). Those interested in participating should call 718 780-5835 for more information.

New York Methodist Hospital

SRI International, an independent nonprofit research and development organization, announced the initiation of a tuberculosis (TB) preclinical drug evaluation program in partnership with the National Institute of Allergy and Infectious Diseases (NIAID), a component of the National Institutes of Health (NIH). The new program is part of the $56.9 million contract NIAID first awarded to SRI in 2007 to provide preclinical services for the development of drugs and antibodies as anti-infective therapeutics.

Among other preclinical TB drug development resources SRI also has the capability to test up to 30,000 compounds per year against Mycobacterium tuberculosis (Mtb) strains. Preclinical drug candidates will be provided by TB researchers via a Non-Clinical Evaluation Agreement with the NIAID. The findings will be used to guide the development of new medicines against Mtb, including multi-drug resistant (MDR) strains prevalent in many parts of the world. NIAID, by way of its portfolio of drug development contracts, will assist investigators in moving promising compounds through preclinical evaluations, including efficacy testing in animal models, pharmacokinetic analysis and toxicology studies.

“Innovative approaches to TB treatment are needed now, as new TB cases increase and Mtb bacteria become increasingly drug-resistant,” said Kristien Mortelmans, Ph.D., Director of the Microbiology Program within SRI’s Biosciences Division and Program Leader. “This project and our partnership with NIAID will help us find new cures to save lives and further SRI’s mission to help solve important global health problems.”

TB, a contagious infectious bacterial disease, is a global health threat. According to the World Health Organization (WHO), one third of the world’s population has been infected by the TB bacterium. In 2007, TB caused 1.6 million deaths. Strains that are resistant to a single drug are found in every country surveyed by the WHO, and strains resistant to all major anti-TB drugs continue to emerge, including extensively drug resistant TB (XDR-TB) that now exists in 49 countries.

As part of SRI’s strategic expansion of its TB research program, Dr. Sidharth Chopra recently joined SRI’s Microbiology Program, having recently completed a Fellowship at Stanford University, conducting research on antitubercular drug discovery. Dr. Chopra will help accelerate SRI’s antitubercular research program.

Under the 2007 contract, Services for the Preclinical Development of Therapeutic Agents, SRI has been funded to provide five years of support for the preclinical development of treatments for TB and other infectious diseases such as avian flu, SARS, West Nile virus, hepatitis and biodefense pathogens and toxins. SRI has the capability to perform medicinal chemistry, custom drug synthesis, formulation, analytical chemistry, clinical manufacturing, microbiology and virology screening, pharmacokinetics, and safety testing.

More information on the Services for Preclinical Development of Therapeutic Agents resource and how to access can be found at http://www3.niaid.nih.gov/research/resources/dmid/pretheraagents. To access the TB drug screening program, contact Dr. Robert Goldman, Program Officer, Respiratory Diseases Branch/DMID/NIAID (rgoldman@niaid.nih.gov).

About SRI International

Silicon Valley-based SRI International is one of the world’s leading independent research and technology development organizations. SRI, which was founded by Stanford University as Stanford Research Institute in 1946 and became independent in 1970, has been meeting the strategic needs of clients and partners for more than 60 years. Perhaps best known for its invention of the computer mouse and interactive computing, SRI has also been responsible for major advances in networking and communications, robotics, drug discovery and development, advanced materials, atmospheric research, education research, economic development, national security, and more. The nonprofit institute performs client-sponsored research and development for government agencies, businesses, and foundations. SRI also licenses its technologies, forms strategic alliances, and creates spin-off companies. In 2007, SRI’s consolidated revenues, including its wholly owned for-profit subsidiary, Sarnoff Corporation, were approximately $450 million.

SRI International

For patients with early stage breast cancer that has spread to the lymph nodes, adding four cycles of docetaxel (Taxotere) into a sequential regimen of epirubicin followed by cyclophosphamide, methotrexate and fluorouracil (CMF) reduces the risk of recurrence and death, updated long-term results show.

This advantage comes at the cost of an increased, but manageable, toxicity, Italian researchers report at the 33rd Congress of the European Society for Medical Oncology (ESMO) in Stockholm.

Dr. Francesco Cognetti from Istituto Oncologico Regina Elena and colleagues treated 998 patients with node-positive early stage breast cancer with one of two regimens: 486 received four months of treatment with epirubicin, followed by four cycles of treatment with CMF. The remainder received an additional docetaxel treatment between the two chemotherapy stages.

At the congress, Dr. Cognetti reports results from a median follow-up of 62 months, showing a disease-free survival rate of 74% in the docetaxel arm, compared to 68% among women treated with the other regimen.

“At a median follow-up of five years, the overall survival of patients receiving the addition of docetaxel to the standard regimen of epirubicin followed by CMF significantly improved compared to patients randomized in the control arm,” he said. “Moreover, the time of disease recurrence results significantly longer in patients enrolled in the experimental arm.”

“The trial demonstrates that the introduction of four cycles of docetaxel into a sequential epirubicin-CMF regimen reduces the risk of recurrence and death in node-positive breast cancer patients.”

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Source: ESMO Press Office
European Society for Medical Oncology

ATTRACT - the first major national trial of a catheter-based treatment for deep vein thrombosis - will evaluate the use of clot-dissolving drugs in combination with clot removal devices to prevent post-thrombotic syndrome in patients with DVT (the formation of a blood clot in a leg vein). PTS, a common irreversible complication of DVT, causes permanent damage to the veins, resulting in debilitating chronic leg pain, swelling, fatigue and/or skin ulcers. About 25 percent of DVT patients develop PTS when treated with blood thinners alone. While early treatment with blood thinners is important to prevent a life-threatening pulmonary embolism, blood thinners alone do not dissolve the existing clot, which remains in the leg. Preliminary studies have shown that interventional clot-busting treatments can - unlike standard DVT therapy - remove clots and have strong potential to prevent PTS. The outcomes of this pivotal multicenter trial - to be funded at more than $10 million by the National Institutes of Health’s National Heart, Lung and Blood Institute (NHLBI) - are likely to change the way DVT is treated in the United States.

“The ATTRACT trial could fundamentally shift the 50-year-old DVT treatment paradigm to one that includes interventional clot removal as an essential element of standard DVT care,” said interventional radiologist Suresh Vedantham, M.D., who will lead the trial. “By funding this study, the NHLBI has clearly recognized the strong potential of interventional radiology clot removal treatments for DVT to improve public health,” added the associate professor at the Washington University School of Medicine’s Mallinckrodt Institute of Radiology in St. Louis, Mo.

ATTRACT (Acute Venous Thrombosis: Thrombus Removal With Adjunctive Catheter-Directed Thrombolysis) is a multicenter, randomized trial “that will definitively determine if the newest clot-busting treatment (pharmacomechanical catheter-directed thrombolysis or PCDT) prevents post-thrombotic syndrome in patients with DVT,” said Vedantham. PCDT combines the use of a clot-dissolving drug with a catheter-mounted miniature clot removal device, allowing an interventional radiologist to break up the clot and remove it from the vein, restoring blood flow. “PTS is a serious complication of DVT that is under recognized and potentially preventable if we are able to dissolve the clots early, before permanent damage to the vein occurs,” he noted. “Established PTS is a lifelong, irreversible condition for which there are no consistently effective treatments. Its prevention is extremely important; however, physicians have historically neglected the prevention of PTS,” said Vedantham. “The groundbreaking combination of clot-busting drugs with innovative device technology - pioneered by interventional radiologists - now enables clot removal in a safer and more efficient manner, often in a single procedure session. These advances will greatly increase the use of interventional DVT treatments,” added Vedantham.

“This research is critical. The Society of Interventional Radiology Foundation initiated a DVT research consensus panel four years ago, bringing together clinicians and scientists from all disciplines and from all settings - academia, private practice, government and industry - and determining the need for the ATTRACT trial,” said Michael Darcy, M.D., chair of the board of directors for SIR Foundation, a scientific foundation dedicated to fostering research and education in interventional radiology. The SIR Foundation has been a critical partner in developing the ATTRACT trial, helping to coordinate the site selection process and partnering with the ATTRACT research team to conduct the trial, said Vedantham.

DVT is the formation of a blood clot, known as a thrombus, in a deep leg vein. This can be a very serious condition that often causes permanent damage to the leg, known as post-thrombotic syndrome. Early treatment with blood thinners is important to prevent a life-threatening pulmonary embolism, but blood thinners do not dissolve the existing clot, which remains in the leg. While many patients’ clots will slowly dissolve over time, often the vein wall and vein valves become irreversibly damaged in the process. “PTS develops as a direct result of having the blood clot stay in the vein. The blood clot continues to block the vein and permanently damages its one-way valves, resulting in the pooling of blood in the leg, chronic leg pain, swelling and fatigue and sometimes skin ulcers. It’s logical that immediate clot removal will prevent PTS,” said Vedantham.

The ATTRACT trial - the first NIH-funded multicenter, randomized trial of any interventional DVT therapy - will begin later this year. The trial will assess the presence and severity of PTS, quality of life, relief of pain and swelling, safety and costs. At least 28 U.S. clinical centers will enroll 692 patients and monitor their health for two years, said Vedantham, who is chair of the DVT Research Committee of SIR’s Venous Forum and vice chair of the Venous Disease Coalition. The Society of Interventional Radiology is a member of the Venous Disease Coalition.

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About the Society of Interventional Radiology Foundation

SIR Foundation is a scientific foundation dedicated to fostering research and education in interventional radiology for the purposes of advancing scientific knowledge, increasing the number of skilled investigators in interventional radiology and developing innovative therapies that lead to improved patient care and quality of life.

Interventional radiologists are vascular experts who invented angioplasty and the catheter-delivered stent, which were first used in the legs to treat peripheral arterial disease. They provide vascular disease management and specialize in minimally invasive treatments. Visit www.SIRfoundation.org.

Source: Maryann Verrillo
Society of Interventional Radiology

Women with recurrent ovarian cancer can be helped by an experimental therapy using a drug already touted for its ability to fight other cancers, a finding that provides hope for improved treatment of this deadly disease.

Dr. Bradley Monk, a UC Irvine gynecologic oncologist who led the worldwide phase III clinical trial, said trabectedin is the most recent addition to a short list of active drug therapies for recurrent ovarian cancer. He presents study results Sept. 15 at the 33rd Congress of the European Society for Medical Oncology in Stockholm.

“These are exciting results because positive trials in recurrent ovarian cancer are rare and have almost always led to federally approved treatments,” said Monk, an associate professor who studies and treats ovarian cancers at the Chao Family Comprehensive Cancer Center at UC Irvine. “This treatment undoubtedly will be evaluated carefully by the U.S. Food and Drug Administration and, if approved, will give women with ovarian cancer another much needed option.”

Phase III studies are multicenter trials on large patient groups designed to be the definitive assessment of a drug’s effectiveness. Such a study is often the last step before a drug is reviewed by a regulatory agency like the FDA for approval as a safe, effective treatment.

In this trial, an international group of researchers treated 672 women whose ovarian cancer had progressed after first-line treatment. Half the women received a combination therapy of trabectedin and a chemotherapy drug called pegylated liposomal doxorubicin. The other half received the chemotherapy drug alone, which is standard treatment in these cases.

In patients on the combination therapy, researchers found no progression of the cancer for an average of 7.3 months, as compared to 5.8 months for those treated with the single drug. For those who had relapsed more than six months after the first-line therapy, the median progression-free time was 9.2 months for the combination treatment, as compared to 7.5 months for the other patients.

Under the brand name Yondelis, trabectedin is approved in Europe and South Korea for treating advanced soft tissue sarcoma. In addition to the phase III ovarian cancer trial, it is being studied in smaller, phase II trials for prostate, breast and pediatric cancers.

Trabectedin is a synthetic version of a compound isolated from the sea squirt, a tubular sea animal used in a number of medical studies. It binds to the DNA of a cancer cell and blocks its ability to multiply, thus killing the cells and shrinking tumors.

When ovarian cancer is detected early - when it is confined to the ovaries - more than 90 percent of women will live at least five years, according to the American Cancer Society. Only about 20 percent of cases are detected that early. If the cancer is detected after it has spread, only about 30 percent of women survive five years. Each year, approximately 20,000 American women are diagnosed with ovarian cancer and about 15,000 die of the disease.

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About the Chao Family Comprehensive Cancer Center:

UC Irvine Healthcare’s Chao Family Comprehensive Cancer Center provides fully integrated research, prevention, diagnostic, treatment and rehabilitation programs for patients and families coping with cancer. The cancer center is one of 41 National Cancer Institute-designated Comprehensive Cancer Centers nationwide and the only one in Orange County. The designation is the highest honor given by the NCI in recognition for excellence in cancer research and treatment.

About the University of California, Irvine:

The University of California, Irvine is a top-ranked university dedicated to research, scholarship and community service. Founded in 1965, UCI is among the fastest-growing University of California campuses, with more than 27,000 undergraduate and graduate students and nearly 2,000 faculty members. The third-largest employer in dynamic Orange County, UCI contributes an annual economic impact of $3.6 billion.

Source: Tom Vasich
University of California - Irvine

A $10 million, government-funded, multicenter clinical trial of an aggressive treatment for blood clots in the leg known as deep vein thrombosis (DVT) will be led by researchers at Washington University School of Medicine in St. Louis.

Approximately 250,000 U.S. patients are diagnosed with new DVTs every year. Current clinical standards call for the patients to be treated with blood thinning agents, which prevent clot migration and formation of new clots but do not break up the original clot. Clinicians recently have realized the original clot often leads to serious, difficult-to-treat, long-term complications.

Suresh Vedantham, M.D., who is a Washington University interventional radiologist at Barnes-Jewish Hospital, is the national principal investigator for the ATTRACT (Acute Venous Thrombosis: Thrombus Removal with Adjunctive Catheter-Directed Thrombolysis) Trial, which will test the use of catheter-mounted technology that can both chew up DVTs and directly administer clot-busting drugs. The trial is funded by the National Heart, Lung and Blood Institute, part of the National Institutes of Health.

“This is the first large-scale test of these new techniques, and the potential to change clinical DVT practice on a large scale is very exciting,” says Vedantham, associate professor of radiology and surgery at the Mallinckrodt Institute of Radiology at Washington University. “If the trial is positive, it will alter the paradigm to say we don’t just prevent the next clot, we’ve got to also remove the existing clot first.”

The initial symptoms of DVT are pain and swelling in the affected leg. Associated risk factors include surgery or trauma to the leg, genetic factors, immobilization, hormonal therapies and cancer. DVTs are more common in older patients but also can occur in childhood and throughout the lifespan.

The most immediate danger from a DVT is the clot breaking loose and moving to the lungs, a condition called pulmonary embolism that kills approximately 100,000 people annually in the United States. Complications from the continued presence of the clot, known as post-thrombotic syndrome (PTS), occur in 50 percent of all DVT patients.

“PTS causes long-term chronic pain, swelling, venous ulcers and difficulty walking,” Vedantham says. “This often leads to disability, is very costly and difficult to treat and significantly impairs quality of life. By removing the clot when it is first diagnosed, we can prevent permanent damage to the leg veins and thereby prevent PTS.”

Physicians tested clot-busting drugs on DVTs as early as the 1970s, but the approach was deemed unsafe because general administration of the drugs incurred too much risk of bleeding.

Radiologists can now pinpoint the location of DVTs with X-rays and an injectable dye. Recently developed catheter technology makes it possible not only to deliver clot-busting drugs directly to the DVT but also to mash the clot to help break it up and ensure better distribution of the drugs. One such technology uses a wire in the catheter turned via a small handheld motor to break up the clot; others use ultrasound.

“The goal is to provide a safer, quicker and much more effective approach to treatment,” Vedantham says.

Plans call for 692 patients to be enrolled in the trial at 28 clinical centers nationwide, but the total number of clinical centers involved in the trial may increase to 40. Data from the trial will be analyzed at a data-coordinating center at McMaster University in Hamilton, Ontario.

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Washington University School of Medicine’s 2,100 employed and volunteer faculty physicians also are the medical staff of Barnes-Jewish and St. Louis Children’s hospitals. The School of Medicine is one of the leading medical research, teaching and patient care institutions in the nation, currently ranked third in the nation by U.S. News & World Report. Through its affiliations with Barnes-Jewish and St. Louis Children’s hospitals, the School of Medicine is linked to BJC HealthCare.

Source: Michael C. Purdy
Washington University School of Medicine

A new study has shown that an investigational drug (R207910, currently in clinical trials against multi-drug resistant tuberculosis strains) is quite effective at killing latent bacteria. This revelation suggests that R207910 may lead to improved and shortened treatments for this globally prevalent disease.

Despite numerous treatment advances, tuberculosis (TB) remains a serious disease - fueled by co-infection of HIV patients, the rise of drug-resistant strains, and the ability of Mycobacterium tuberculosis to become dormant and linger in the lungs. In fact, one third of the world population is infected, asymptomatically, with latent TB and is at risk of developing active TB disease during their life time.

Anil Koul and colleagues at Johnson & Johnson tested R207910 on dormant M. tuberculosis in three different laboratory models of latency. R207910 targets a protein (ATP synthase) essential for making cellular energy (ATP) in actively replicating TB. The researchers reasoned that even dormant bacteria, which are essentially physiologically “turned off”, still need to produce small quantities of ATP to survive. As such, a block in ATP synthesis might be an Achilles heel for killing dormant bacteria.

This reasoning proved to be correct and R207190 was able to kill dormant bacteria by greater than 95% whereas current drugs like isoniazid had no effect. Surprisingly, they found that R207910 is slightly more effective in killing dormant bacteria as compared to actively replicating ones, a unique spin as all known TB drugs are more effective on replicating bugs. Koul and colleagues hope to validate these results clinically, and note that ATP synthase should be looked at as a drug target for other persistent bacterial infections.

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From the JBC article: “Diarylquinolines are bactericidal for dormant mycobacteria as a result of disturbed ATP homeostasis” by Anil Koul, Luc Vranckx, Najoua Dendouga, Wendy Balemans, Ilse Van den Wyngaert, Karen Vergauwen, Hinrich G?hlmann, Rudy Willebrords, Alain Poncelet, Jerome Guillemont, Dirk Bald and Koen Andries

Article URL: http://www.jbc.org/cgi/content/full/283/37/25273/

Author: Anil Koul, Department of Antimicrobial Research, Johnson & Johnson, Beerse, Belgium

Source: Nick Zagorski
American Society for Biochemistry and Molecular Biology

Pluristem Therapeutics Inc. (NasdaqCM: PSTI; DAX: PJT), a bio-therapeutics company dedicated to the commercialization of non- personalized (allogeneic) cell therapy products for a variety of degenerative, ischemic and autoimmune indications, announced today the successful conclusion of its pre-clinical studies utilizing PLX-PAD prior to the initiation of human clinical trials. PLX-PAD is Pluristem’s cellular product for the treatment of critical limb ischemia (CLI), the end phase of Peripheral Artery Disease (PAD).

The final studies involved 150 animals that received single, repeated intra-muscular (IM) injections of PLX-PAD or a control substance then followed for up to 3 months post-injection. No adverse effects were noted to be caused by the PLX-PAD injections throughout the study period. Moreover, all the histology, hematology and biochemistry panels and biodistribution results support the safe administration of PLX-PAD. Previously, the Company had reported that in animals whose hind legs were rendered ischemic (reduction in blood flow) using standard industry methodologies, post-treatment evaluation using laser Doppler technology indicated revascularization (return of blood flow) of the limbs treated with PLX-PAD but not in those limbs not treated with PLX-PAD. The affected limbs’ function also improved in those animals receiving PLX-PAD.

Additionally, microscopic analyses of those limbs treated with PLX-PAD indicated a statistically significant increase in the number of new capillaries (vessels) supplying the limb, suggesting PLX-PAD has the ability to promote angiogenesis (new vessel formation). Zami Aberman, Pluristem’s President and CEO commented, “The successful completion of the PLX-PAD pre-clinical phase, in accordance with the regulatory authority’s requirements, is a major milestone. This was our final study using our PLX-PAD. We now intend to commence human trials, following receipt of the required regulatory approvals. The impressive results we have obtained in these studies give us confidence that we will be able to prove safety in our planned US and European dose escalation Phase I/II human studies, followed by proof of efficacy in our later trials.”

About Critical Limb Ischemia

In the US alone, it is estimated that 8-12 million people suffer from limb ischemia associated with PAD. The disease is characterized by narrowing and hardening of the arteries in the patient’s limb(s) caused and/or aggravated by diabetes, Buerger’s Disease, other diseases and smoking. With decreased blood flow to the affected extremity, patients can suffer a host of complications including nerve and tissue damage. In advanced stages, limb ischemia can lead to gangrene, which often requires treatment with amputation. The disease is associated with a high rate of mortality and the need for frequent hospitalization from surgical complications. Industry experts have estimated that the market for therapeutics used in the treatment of limb ischemia to be over $1 Billion. However, current therapeutic methodologies have proven ineffective for many severe limb ischemic situations and have led the medical community to call for the development of cellular therapies, such as Pluristem’s PLX-PAD, as alternative treatments.

About Pluristem Therapeutics

Pluristem Therapeutics Inc. is a bio-therapeutics company dedicated to the commercialization of non-personalized (allogeneic) cell therapy products for the treatment of several severe degenerative, ischemic and autoimmune disorders. The Company is developing a pipeline of products, stored ready-to-use, that are derived from human placenta, a non-controversial, non-embryonic, adult stem cell source. These placental adherent stromal cells (ASCs) are expanded in the Company’s proprietary PluriXTM 3D bioreactor, which imitates the natural microstructure of bone marrow and does not require supplemental growth factors or other exogenous materials. Pluristem believes that the resultant PLX (PLacental eXpanded) cells’ efficacy may be related to the secretion of cytokines or other potent immune modulators. Furthermore, PLX cells are immune privileged and possess immunomodulatory properties, thus protecting the recipient from immunological reactions that often accompany transplantations. Pluristem’s first product in development, PLX-PAD, is intended to improve the quality of life of millions of people suffering from peripheral artery disease (PAD). The Company’s products in development also include PLX-IBD, targeting Inflammatory Bowel Disease (IBD); PLX-MS, targeting Multiple Sclerosis; PLX-BMT, targeting the global shortfall of matched tissue for bone marrow transplantation (BMT) by improving the engraftment of hematopoietic stem cells (HSCs) contained in umbilical cord blood; and PLX-STROKE, targeting ischemic stroke. Pluristem has offices in the USA with research and manufacturing facilities in Israel. http://www.pluristem.com

See our product animation on YouTube.

Safe Harbor Statement

This press release contains forward-looking statements within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995 and federal securities laws. For example, when we say that this was our final study using our PLX-PAD; that we now intend to commence human trials, following receipt of the required regulatory approvals and that the impressive results we have obtained in these studies give us confidence that we will be able to prove safety in our planned US and European dose escalation Phase I/II human studies, followed by proof of efficacy in our later trials, we are using forward-looking statements. These forward-looking statements are based on the current expectations of the management of Pluristem only, and are subject to a number of factors and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. The following factors, among others, could cause actual results to differ materially from those described in the forward-looking statements: failure to obtain required regulatory approvals, changes in technology and market requirements; our technology may not be validated as we progress further and our methods may not be accepted by the scientific community; we may be unable to retain or attract key employees whose knowledge is essential to the development of our products; unforeseen scientific difficulties may develop with our process; results in the laboratory may not translate to equally good results in real surgical settings; our patents may not be sufficient; our products may harm recipients; changes in legislation; inability to timely develop and introduce new technologies, products and applications; loss of market share and pressure on pricing resulting from competition, which could cause the actual results or performance of Pluristem to differ materially from those contemplated in such forward-looking statements. Except as otherwise required by law, Pluristem undertakes no obligation to publicly release any revisions to these forward-looking statements to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events. For a more detailed description of the risk and uncertainties affecting Pluristem, reference is made to Pluristem’s reports filed from time to time with the Securities and Exchange Commission.

Pluristem Therapeutics Inc.

Two UCL academics have received prominent international awards from the European Society of Cardiology (ESC), in recognition of their work to understand and treat conditions of the heart.

Professor John Martin, Director of the UCL Centre for Cardiovascular Biology & Medicine and British Heart Foundation Professor of Cardiovascular Science, has been awarded the ESC’s Gold Medal. The only other holder of this medal in the UK is Sir James Black, Nobel Laureate. Dr Paul Riley, UCL Institute of Child Health, has been awarded the Outstanding Achievement Award 2008 of the ESC Council on Basic Cardiovascular Science.

Commenting on the ESC awards, Professor Ed Byrne, Executive Dean of the UCL Faculty of Biomedical Sciences and Head of the Medical School, said: “Heart and circulatory disease is the UK’s biggest killer and these awards demonstrate that UCL research is breaking new ground in the understanding and treatment of these conditions. I am delighted that the ESC has chosen to recognise the scientific endeavours of John and Paul and offer my sincere congratulations to them both.”

Professor Martin has pursued an active research career, examining how the manufacture of platelets in the body causes blood to clot, how arteries age, and the protective role played by the gene for vascular endothelial growth factor (VEGF). His realisation that VEGF could be used therapeutically led him to start his own company, Ark Therapeutics, which is now taking gene therapy for vascular damage through clinical trials. He has also begun a phase III clinical trial to test whether the damage of heart attack can be repaired by direct injection of a patient’s own bone marrow cells into the heart muscle.

Professor Martin also wrote the Heart Plan for Europe, a ‘tool box’ to help each country design its own bespoke prevention package for heart health, and he serves on a number of professional boards. As well as his scientific and medical endeavours, Professor Martin is a published writer and poet. He studied for his first degree in philosophy at a Spanish University and is fluent in Spanish and French, as well as being a keen artist.

The award made to Dr Paul Riley, Reader in the Molecular Medicine Unit at the UCL Institute of Child Health, recognises a landmark discovery in the field of basic cardiovascular science when his team found that a protein called Thymosin beta4 could mobilise dormant cells from the epicardium to form new blood vessels in the heart - a major step towards finding a DIY mechanism to repair injury following heart attack.

Dr Riley said: “I’m very pleased indeed that my work has attracted professional recognition from the ESC.” When not engaged in scientific pursuits, Dr Riley is a keen footballer, playing in an 8-a-side league with other scientists and clinicians close to the Institute in nearby Coram’s Fields.

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Research by Professor Martin and Dr Riley has been generously supported by the British Heart Foundation and the Medical Research Council.

About UCL

Founded in 1826, UCL was the first English university established after Oxford and Cambridge, the first to admit students regardless of race, class, religion or gender, and the first to provide systematic teaching of law, architecture and medicine. In the government’s most recent Research Assessment Exercise, 59 UCL departments achieved top ratings of 5* and 5, indicating research quality of international excellence.

UCL is in the top ten world universities in the 2007 THES-QS World University Rankings, and the third-ranked UK university in the 2007 league table of the top 500 world universities produced by the Shanghai Jiao Tong University. UCL alumni include Marie Stopes, Jonathan Dimbleby, Lord Woolf, Alexander Graham Bell, and members of the band Coldplay. http://www.ucl.ac.uk/

Source: Ruth Metcalfe
University College London

Sunshine Heart (ASX: SHC), a global medical device company focused on innovative heart assist technologies, announced that it has received conditional approval of an Investigational Device Exemption (IDE) from the U.S. Food and Drug Administration (FDA) to begin its first U.S. clinical feasibility trial for the C-Pulse(TM) device in patients with moderate heart failure. C-Pulse is an implantable aortic cuff, designed as a cost effective heart assist therapy. The device is a uniquely positioned Class III heart failure therapy that offers an innovative intervention bridging the clinical gap between heart failure pacemakers and end stage therapies which potentially creates a new market opportunity.

Enrollment is expected to begin at six premiere U.S. medical institutions by the end of 2008. The objective of the trial is to evaluate the safety and efficacy of C-Pulse in 20 patients currently suffering from moderate heart failure. William Abraham, MD, of Ohio State University, and Patrick McCarthy, MD, of Northwestern University Medical Center, will serve as national co-lead principal investigators. Each patient’s performance with C-Pulse will be closely monitored over a six month follow-up period.

Following the trial’s successful completion, the Company will request CE Mark approval to market C-Pulse in the E.U. and other international countries that honor CE Mark label claims for device safety. In addition, the Company will seek FDA approval for a larger randomized U.S. pivotal study to support the submission of a marketing application for C-Pulse in the U.S.

Malcolm McComas, Chairman of the Board commented, “We are proud to announce that Sunshine Heart is the first company to receive FDA approval to run a clinical trial evaluating a non-blood contacting heart assist device. The agency’s clinical approval of this treatment approach for moderate heart failure raises Sunshine Heart’s profile as a global development stage medical device company supported by internationally renowned trial centers and lead investigators.”

Donald Rohrbaugh, Chief Executive Officer, said, “We are very encouraged by the FDA’s IDE approval for C-Pulse and look forward to generating additional data from this study to support our global regulatory strategy. Our C-Pulse heart assist therapy offers a unique treatment to patients who are suffering from moderate heart failure and represents an important advancement in addressing this significant unmet clinical need. If left untreated, moderate heart failure is a debilitating disease that can lead to premature death. We believe that C-Pulse represents one of the most innovative therapies in development for this indication in patients who no longer receive symptom relief from medication or cardiac synchronization pacemakers. With more than five million people suffering from heart failure today and a half million more diagnosed each year, we are extremely confident in the advantages C-Pulse provides to patients as a simple, safe, less invasive, non-blood contacting implant option.”

About Sunshine Heart

Sunshine Heart (ASX: SHC) (http://www.sunshineheart.com) is a global medical device company, committed to the commercialization of C-Pulse(TM) an implantable, non-blood contacting, heart assist therapy for the treatment of people with heart failure. Through the use of counterpulsation technology, C-Pulse(TM) is designed to increase cardiac output while reducing the heart’s workload for ventricular loading. Sunshine Heart listed on the ASX in September 2004 has a presence in Australia, New Zealand and the United States of America.

Forward Looking Statements

This press release contains forward-looking statements that are based on current management expectations. These statements may differ materially from actual future events or results due to certain risks and uncertainties from time to time in the Company’s filings with the Australian Securities Exchange.

Sunshine Heart
http://www.sunshineheart.com