Cell Therapeutics, Inc. (CTI) Announces Pixantrone Combination Regimen Produces High Response Rates

Cell Therapeutics,
Inc. (CTI) (Nasdaq: CTIC) today announced results from a phase II study of
CPOP combination therapy with pixantrone for patients with relapsed
aggressive NHL. The results, presented at the 48th Annual Meeting of the
American Society of Hematology (ASH), showed a 73 percent overall response
rate (ORR), including 47 percent experiencing complete disappearance of
their tumors (complete response, CR). These patients had received prior
first-line regimens containing anthracyclines and due to dose limitations
for potential cardiotoxicity were not eligible to be retreated with
standard anthracyclines.

“These data suggest that in the relapsed setting where patients have
already received prior regimens containing anthracyclines, the CPOP
combination has substantial activity with a notable complete remission rate
and a low rate of serious cardiac events,” said Andreas Engert, M.D.,
Professor for Internal Medicine, Hematology and Oncology, University
Hospital of Cologne and principal investigator on the study.

Pixantrone in Combination with Cyclophosphamide, Vincristine, and
Prednisone (CPOP) in Patients with Relapsed Aggressive NHL.

In an oral session, Peter Borchmann, M.D., Ph.D., Senior Consultant,
Hematology and Oncology, University Hospital of Cologne and investigator on
the study, presented results from a phase II clinical trial of pixantrone
combination therapy, known as CPOP, in patients with relapsed aggressive
NHL — all of whom had received prior regimens containing anthracyclines.
In the CPOP regimen, pixantrone replaces doxorubicin in the standard CHOP
regimen.

Of the 30 patients evaluable for response, 73 percent (22 patients)
achieved an objective response, including 47 percent (14 patients)
experiencing a complete response (CR) and 26 percent (8 patients) achieving
a partial response (PR). The median duration response was 10.2 months (95
percent confidence interval: range 6.7 to 23 months). The predominant side
effects (grade 3/4) were hematologic including neutropenia (97 percent),
leukopenia (90 percent), lymphopenia (53 percent), anemia (30 percent),
thrombocytopenia (20 percent), and febrile neutropenia (20 percent).
Preliminary results from this study were announced in March 2006.

About the CPOP Study

This trial examined the safety and potential efficacy of pixantrone
when substituted for doxorubicin in the CHOP regimen among patients who
failed prior doxorubicin-containing CHOP therapy for aggressive NHL.
Patients received a median of six cycles of therapy (range one to 6).
Dosing for the CPOP regimen was pixantrone at 150 mg/m(2) on day l,
cyclophosphamide at 750 mg/m(2) on day l, vincristine at 1.4 mg/m(2) on day
l, and prednisone at 100 mg on days 1 through 5, each three-week cycle.

About the CHOP Regimen

The CHOP chemotherapy regimen (a combination of cyclophosphamide,
vincristine, prednisone and doxorubicin) in combination with rituximab for
CD20+ patients is the standard-of-care treatment for newly diagnosed
(first-line) aggressive NHL. Response rates following CHOP in first-line
aggressive NHL can reach 70 percent and the regimen is potentially curative
in up to 40 percent of patients. The prognosis is poor for patients who
have a recurrence of the disease (relapsed patients). Despite its
impressive anti- tumor activity, CHOP often cannot be used to retreat the
60 to 65 percent of patients who will relapse following CHOP, due to the
cumulative cardiotoxicity associated with one of its constituent agents,
doxorubicin; a chemotherapy agent which belongs to the anthracycline
family. The maximum lifetime recommended dose of doxorubicin is 450
mg/m(2). During first-line treatment with CHOP most patients receive
between 300 and 400 mg/m(2) of doxorubicin.

“The data presented at ASH suggest that in the relapsed setting for
both aggressive and indolent NHL, the use of pixantrone offers patients a
high probability of achieving a complete response with an acceptable safety
profile, even in pretreated patients,” said Scott C. Stromatt, M.D.,
Executive Vice President of Clinical Development and Regulatory Affairs at
CTI. “We look forward to further results from our ongoing pixantrone
trials.”

CTI is also studying pixantrone in two ongoing trials — a phase III
single agent study for relapsed aggressive NHL known as the EXTEND trial
and a phase II combination study (CPOP-R versus CHOP-R) for first-line
treatment of aggressive NHL, known as the RAPID trial. Interim results for
the EXTEND trial are scheduled late in the first half of 2007.

About Pixantrone

Pixantrone is an investigational agent under development for the
potential treatment of various hematological malignancies, solid tumors and
immunological disorders. It was developed to improve the activity and
safety of the anthracycline family of anti-cancer agents. Anthracyclines
have been shown to be very active clinically in a number of tumor types.
However, they are usually associated with cumulative heart damage that
prevents them from being used in a large proportion of patients. Pixantrone
has been designed to reduce the potential for these severe
cardiotoxicities, as well as to potentially increase activity and
simplified administration compared to the currently marketed
anthracyclines.

About Cell Therapeutics, Inc.

Headquartered in Seattle, CTI is a biopharmaceutical company committed
to developing an integrated portfolio of oncology products aimed at making
cancer more treatable. For additional information, please visit
cticseattle.

This press release includes forward-looking statements that involve a
number of risks and uncertainties, the outcome of which could materially
and/or adversely affect actual future results. Specifically, the risks and
uncertainties that could affect the development of pixantrone include risks
associated with preclinical and clinical developments in the
biopharmaceutical industry in general and with pixantrone in particular
including, without limitation, the potential failure of pixantrone] to
prove safe and effective for treatment of non-Hodgkin’s lymphoma,
determinations by regulatory, patent and administrative governmental
authorities, competitive factors, technological developments, costs of
developing, producing and selling pixantrone, and the risk factors listed
or described from time to time in the Company’s filings with the Securities
and Exchange Commission including, without limitation, the Company’s most
recent filings on Forms 10-K, 8-K, and 10-Q. Except as may be required by
Italian law, CTI is under no obligation to (and expressly disclaims any
such obligation to) update or alter its forward-looking statements whether
as a result of new information, future events, or otherwise.

Cell Therapeutics, Inc.
cticseattle

The Number Of People With Gout Continues To Rise

Gout rates and related cases of hyperuricema have increased over the past two decades, according to research presented this week at the American College of Rheumatology Annual Scientific Meeting in Atlanta.

Hyperuricemia is an abnormally high level of uric acid in the blood that can lead to gout a painful and potentially disabling form of arthritis that has been recognized since ancient times. Initial symptoms of gout usually consist of intense episodes of painful swelling in single joints, most often in the feet (especially the big toe). Gout occurs when excess uric acid (a normal waste product) accumulates in the body, and needle‐like crystals deposit in the joints. This may happen because uric acid production increases or, more often, the kidneys are unable to remove uric acid from the body adequately.

The prevalence of gout in the United States more than doubled between the 1960s and 1990s, but many have been unsure whether the trend continued over the past two decades. To determine if it continued, researchers recently compared the number of U.S. adults diagnosed with gout using two National Health and Nutrition Examination Surveys NHANES III 1988-1994 and NHANES 2007-2008 which are a group of surveys used to assess the health and nutrition of American adults and children. They also used the same surveys to compare prevalence of hyperuricemia and average serum urate levels between the same time periods.

The 2007-2008 survey included 5,707 participants who were at least 20 years old of which 2,797 were men and 2,910 were women to estimate the overall prevalence of gout during this time period. The prevalence was then compared to data from the 1988-1994 survey that included 18,825 participants who were at least 20 years old of which 8,816 were men and 10,009 were women. The researchers then used the same data and surveys to measure hyperuricemia (defined, for this study, as having serum urate level greater than 7.0mg/dL in men and greater than 5.7 mg/dL in women).

During the 2007-2008 timeframe, researchers identified the overall prevalence of gout among U.S. adults as 8.3 million, which corresponded to 3.9 percent of U.S. adults. This is 1.2 percent higher than the 1988-1994 timeframe figure of 2.7 percent, and researchers attribute this increase to increased gout prevalence among men and senior citizens. Over the same time period, hyperuricemia prevalence increased by 3.2 percent (from 18.2 percent to 21.4 percent), and average serum urate levels also rose by 0.15 mg/dl.

Given these findings, the researchers concluded that the number of U.S. adults with gout not only remained substantially high, but may have increased, after the 1990s. In addition, the results revealed that as gout rates went up, the rates of hyperuricemia also rose, reconfirming the connection between the two.

“These findings indicate that the prevalence of gout and hyperuricemia continue to be substantial in the new millennium,” explains Yanyan Zhu, PhD; research assistant professor at the Boston University School of Medicine and lead investigator in the study. “Factors contributing to the increase are also heightening additional risk factors including obesity and hypertension, and better management could help prevent the further rise of gout and other associated complications.”

Source: American College of Rheumatology (ACR)

Novel Use Of Mass Spectrometry Help Improve TTP Patient Outcomes

The development of a rapid and accurate assay for a life-threatening disorder relies on a novel use of mass spectrometry and proteinChip arrays. In an article in the current issue of Spectroscopy, researchers at the Ohio State University College of Medicine and Public Health describe the clinical evaluation of thrombotic thrombocytopenic purpura (TTP) using Surface Enhanced Laser Desorption/Ionization Time of Flight (SELDI-TOF) mass spectrometry.

TTP is a condition caused by a deficiency in a metalloproteinase called ADAMTS13. With a timely diagnosis, TTP patients usually respond to plasma exchange therapy. However, many patients relapse after therapy. Thus, there is a need for both a rapid diagnostic test to help clinicians start therapy and for a biomarker that can anticipate recurrence.

Without enough ADAMTS13, extensive blood clots may occur throughout the body and can cause death. ADAMTS13 prevents this by breaking apart another protein that causes the clotting process. By measuring one of the broken fragments using SELDI-TOF, the researchers found that they could determine ADAMTS13 activity levels in the patient’s blood.

SELDI-TOF mass spectrometry offers an unique property to specifically capture and concentrate the target protein in a binding array. Afterwards it becomes relatively simple to measure the analyte. In this application, an immobilized metal affinity capture (IMAC) array was chosen which could bind to a product of ADAMTS13 proteolysis, ahistidine-containing fragment. The product was then measured by the mass spectrometer. Thus, the method was used to evaluate ADAMTS13 activity in TTP patients.

Writing in the article, Haifeng M. Wu, MD, states “Since the implementation of our SELDI-TOF based method, fast turnaround time for the detection of ADAMTS13 activity has greatly helped us in making the correct diagnosis, instituting appropriate therapy, and improving patient outcomes.”

The article is “Application of SELDI-TOF mass spectrometry in clinical evaluation of thrombotic thrombocytopenic purpura” by Haifeng M. Wu, Spero R. Cataland, Michael Bissell and Ming Jin. It appears in Spectroscopy, Volume 20, Issue 5/6 (2007), published by IOS Press.

IOS Press
Nieuwe Hemweg 6b
Amsterdam 1013 BG
Netherlands
iospress.nl/

TargeGen Announces Initiation Of Clinical Trial Of JAK2 Inhibitor TG101348 In Myeloproliferative Disease Patients

TargeGen, Inc. announced that
the Company has started a multi-center Phase I/II clinical trial of
TG101348, an oral, potent, and highly selective inhibitor of JAK2 in
patients with myeloproliferative diseases.

The V617F mutation of JAK2 is implicated in the pathogenesis of certain
myeloproliferative diseases, including polycythemia vera (PV), essential
thrombocytopenia (ET) and primary myelofibrosis (PMF). In preclinical
models of myeloproliferative diseases, TG101348, administered orally, was
shown to reduce V617F-expressing cell populations in a dose-dependant
manner without adversely impacting normal hematopoeisis. The reduction of
V617F-expressing cell populations correlated with improved survival and
reduced morbidity. There are no currently approved specific therapies for
PV, ET and PMF. These disorders are estimated to affect approximately
200,000 patients in the United States and more than twice that total
worldwide.

The current clinical trial is being conducted at multiple centers in
the USA. The trial is expected to enroll between 40-80 patients. Primary
goals of this open label dose escalating protocol include identification of
a maximum tolerated dose (MTD), accumulation of safety data, measurement of
drug effect on surrogate markers, biomarkers, and presumptive clinical
endpoints.

About TargeGen, Inc.

TargeGen, Inc. is a privately held vascular biology-focused
biopharmaceutical company based in San Diego, CA. TargeGen primarily
develops small molecule kinase inhibitors that target vascular leakage
(edema), vascular proliferation (angiogenesis) and inflammation. Edema,
angiogenesis and inflammation are involved in the pathology of many major
human diseases.

TargeGen initiated operations in 2002 and has raised capital from top
tier venture capital sources. Current investors include VantagePoint
Venture Partners, Forward Ventures, Enterprise Partners, Chicago Growth
Partners, BB BIOTECH VENTURES, Innovis Investments, H&Q Capital Management,
Pappas Ventures, CTI Life Sciences and other investors.

TargeGen, Inc.
targegen

New Phase 2 Data Show Promise Of Aranesp(R) Treatment For Anemia Of Cancer

Amgen (NASDAQ:AMGN) today announced final results of a 17-week randomized, double-blind, placebo-controlled, Phase 2 study evaluating Aranesp(R) (darbepoetin alfa) administered every four weeks for the treatment of anemia in cancer patients not undergoing chemotherapy and/or myelosuppressive radiotherapy, a condition known as anemia of cancer. Patients receiving Aranesp were nearly three times more likely to achieve a hematopoietic response than patients receiving a placebo (69 percent vs. 24 percent, respectively). These results were presented at the American Society of Hematology (ASH) 48th annual meeting in Orlando, Fla.

Although anemia is increasingly recognized as the most common side effect of chemotherapy, a growing body of evidence demonstrates that as many as 475,000 cancer patients also can become vulnerable to anemia due to the cancer itself. To combat anemia symptoms, anemia of cancer patients often receive a blood transfusion, which can be a tiring and invasive procedure. Despite its prevalence, anemia of cancer in patients is under-recognized and often not treated.

“Patients with cancer who are not receiving chemotherapy or myelosuppressive radiotherapy may have infrequent clinic visits,” said David H. Gordon, M.D., clinical professor, University of Texas Health Science, and the study’s lead investigator. “This study evaluated the effectiveness of extended dosing and the results suggest that this may be a potential treatment option for such patients.”

Researchers reported results for 218 patients treated with Aranesp (n=162) or placebo (n=56) for up to 17 weeks. The study’s primary endpoint was the percentage of patients with a hematopoietic response (greater than or equal to 2g/dL hemoglobin rise from baseline or achievement of hemoglobin greater than or equal to 12g/dL without a red blood cell transfusion during the preceding 28 days). Sixty-nine percent of Aranesp-treated patients had a hematopoietic response versus 24 percent in the placebo group (p less than 0.0001). In addition, 85 percent of the patients in the Aranesp group reached the target hemoglobin of greater than or equal to 11g/dL compared to 50 percent of the placebo group (p less than 0.001). Additionally, patients with hemoglobin levels less than 10 g/dL and who were treated with Aranesp received fewer red blood cell transfusions versus those patients with hemoglobin levels less than 10g/dL in the placebo group (15 percent vs. 29 percent, respectively).

The number and type of adverse events were consistent with those previously observed in patients receiving Aranesp. Four patients (2 percent) in the Aranesp arm experienced serious thromboembolic events.

About the Phase 2 Study

This randomized, double-blind, placebo-controlled, Phase 2 study assessed the efficacy of Aranesp administered every four weeks to anemia of cancer patients not undergoing chemotherapy and/or myelosuppressive radiotherapy within 30 days of screening or during the study. Eligible patients had been diagnosed with anemia of cancer (hemoglobin levels less than 11g/dL) and non-myeloid malignancy. The primary tumor types of the patients included in the study were breast, hematologic, and prostate. Patients were randomized 3:1 to Aranesp (6.75 mcg/kg) or placebo.

About Anemia of Cancer

Anemia is a serious and under-treated condition characterized by a reduction in the normal volume of red blood cells in the blood. Major symptoms of anemia include: extreme fatigue, weakness, shortness of breath, confusion, dizziness, rapid heartbeat, extreme skin pallor, difficulty staying warm and depression. Currently, there are no U.S. Food and Drug Administration (FDA)-approved treatments for chronic anemia of cancer, which is caused by the cancer itself and is unrelated to chemotherapy.

About Aranesp

Amgen revolutionized anemia treatment with the development of Epoetin alfa, a recombinant erythropoietin (a protein that stimulates the production of oxygen-carrying red blood cells). Building on this heritage, Amgen developed Aranesp, a unique erythropoiesis-stimulating protein that can be dosed less frequently.

Aranesp was approved by the U.S. Food and Drug Administration (FDA) in September 2001 for the treatment of anemia associated with chronic renal failure (CRF), also known as chronic kidney disease (CKD), for patients on dialysis and patients not on dialysis. In July 2002, the FDA approved weekly dosing of Aranesp for the treatment of chemotherapy-induced anemia in patients with nonmyeloid malignancies and in March 2006, the FDA approved every-three-week dosing in these patients. With the addition of the every-three-week dosing, Aranesp, the only erythropoiesis-stimulating protein approved by the FDA for every-three-week administration, can allow physicians to synchronize anemia treatment with weekly and every-three-week chemotherapy, which are the majority of chemotherapy schedules. Since its introduction in 2001, more than 1.7 million CKD and chemotherapy patients with anemia have received treatment with Aranesp.

Important Safety Information

Aranesp is contraindicated in patients with uncontrolled hypertension. Erythropoietic therapies may increase the risk of thrombotic events and other serious events. The target hemoglobin (Hb) should not exceed 12 g/dL. If the Hb increase exceeds 1.0 g/dL in any 2-week period, dose reductions are recommended. In a study with another erythropoietic product, where the target Hb was 12 – 14 g/dL, an increased incidence of thrombotic events, disease progression, and mortality was seen.

Cases of pure red cell aplasia (PRCA) and of severe anemia, with or without other cytopenias associated with neutralizing antibodies to erythropoietin have been reported in patients treated with Aranesp. This has been reported predominately in patients with CRF receiving Aranesp by subcutaneous administration. A sudden loss of response to Aranesp, accompanied by severe anemia and low reticulocyte count, should be evaluated. If anti-erythropoietin antibody-associated anemia is suspected, withhold Aranesp and other erythropoietic proteins. Aranesp should be permanently discontinued in patients with antibody-mediated anemia. Patients should not be switched to other erythropoietic proteins.

The most commonly reported side effects in clinical trials were fatigue, edema, nausea, vomiting, diarrhea, fever, and dyspnea.

About Amgen

Amgen discovers, develops and delivers innovative human therapeutics. A biotechnology pioneer since 1980, Amgen was one of the first companies to realize the new science’s promise by bringing safe and effective medicines from lab, to manufacturing plant, to patient. Amgen therapeutics have changed the practice of medicine, helping millions of people around the world in the fight against cancer, kidney disease, rheumatoid arthritis, and other serious illnesses. With a deep and broad pipeline of potential new medicines, Amgen remains committed to advancing science to dramatically improve people’s lives. To learn more about our pioneering science and our vital medicines, visit amgen.

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 Amgen’s Form 10-K for the year ended December 31, 2005, and in Amgen’s 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 Amgen projects. Discovery or identification of new product candidates or development of new indications for existing products cannot be guaranteed and movement from concept to product is uncertain; consequently, there can be no guarantee that any particular product candidate or development of a new indication for an existing product will be successful and become a commercial product. Further, preclinical results do not guarantee safe and effective performance of product candidates in humans. The complexity of the human body cannot be perfectly, or sometimes, even adequately modeled by computer or cell culture systems or animal models. The length of time that it takes for Amgen to complete clinical trials and obtain regulatory approval for product marketing has in the past varied and Amgen expects similar variability in the future. Amgen develops product candidates internally and through licensing collaborations, partnerships and joint ventures. Product candidates that are derived from relationships may be subject to disputes between the parties or may prove to be not as effective or as safe as Amgen may have believed at the time of entering into such relationship. Also, Amgen or others could identify side effects or manufacturing problems with Amgen’s products after they are on the market. In addition, sales of Amgen’s products are affected by the availability of reimbursement and the reimbursement policies imposed by third 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 U.S. legislation affecting pharmaceutical pricing and reimbursement. Government regulations and reimbursement policies may affect the development, usage and pricing of Amgen’s products. In addition, Amgen competes with other companies with respect to some of Amgen’s marketed products as well as for the discovery and development of new products. Amgen believes that some of the newer products, product candidates or new indications for existing products, may face competition when and as they are approved and marketed. Amgen products may compete against products that have lower prices, established reimbursement, superior performance, are easier to administer, or that are otherwise competitive with our products. In addition, while Amgen routinely obtains patents for Amgen’s products and technology, the protection offered by Amgen’s patents and patent applications may be challenged, invalidated or circumvented by Amgen’s competitors and there can be no guarantee of Amgen’s ability to obtain or maintain patent protection for Amgen’s products or product candidates. Amgen cannot guarantee that it will be able to produce commercially successful products or maintain the commercial success of Amgen’s existing products. Amgen’s stock price may be affected by actual or perceived market opportunity, competitive position, and success or failure of Amgen’s products or product candidates. Further, the discovery of significant problems with a product similar to one of Amgen’s products that implicate an entire class of products could have a material adverse effect on sales of the affected products and on Amgen’s business and results of operations.

The scientific information discussed in this news release related to our product candidates is preliminary and investigative. Such product candidates are not approved by the U.S. Food and Drug Administration (FDA), and no conclusions can or should be drawn regarding the safety or effectiveness of the product candidates. Only the FDA can determine whether the product candidates are safe and effective for the use(s) being investigated. Further, the scientific information discussed in this news release relating to new indications for our products is preliminary and investigative and is not part of the labeling approved by the FDA for the products. The products are not approved for the investigational use(s) discussed in this news release, and no conclusions can or should be drawn regarding the safety or effectiveness of the products for these uses. Only the FDA can determine whether the products are safe and effective for these uses. Healthcare professionals should refer to and rely upon the FDA-approved labeling for the products, and not the information discussed in this news release.

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

Amgen
amgen

VIB Scientist To Receive The Hemophilia Research Award

Thierry VandenDriessche, a researcher at VIB and the Katholieke Universiteit Leuven, is to receive the Hemophilia Research Award for his research on hemophilia – a hereditary disorder affecting coagulation of the blood. The research grant, for the amount of 200,000 USD, is being presented by Bayer at a meeting of the International Society of Thrombosis & Hemostasis in Geneva. With this prize, Bayer is lending its support to research on hemophilia. Thierry VandenDriessche and his colleague Marinee Chuah are investigating the possibilities of improved treatments for hemophilia, including gene therapy.

Hemophilia

Hemophilia is a hereditary disorder in which certain coagulation factors in the blood are missing. This causes frequent bleeding in the muscles and joints, with tissue damage as a result. If the disorder is left untreated, the blood will no longer be able to coagulate, which can indirectly even lead to death. In 85% of the patients, there is a shortage of coagulation factor VIII. This condition is called hemophilia A. The rest of the patients most often have a shortage of coagulation factor IX (hemophilia B). The disorder has a frequency of 1 in 10,000. In the 20th century, hemophilia was one of the most well-known and extensively studied hereditary disorders, as it afflicted several royal families. Alexis, the only son of Russian czar Nicolas II, was perhaps the most famous hemophilia patient.

Gene therapy

Regular injection of the right coagulation factor is usually the only possible treatment for hemophilia patients. Gene therapy might well be an alternative solution. In this approach to curing the disorder, a malfunctioning gene (part of the DNA) is replaced by a properly functioning gene. VIB researchers Thierry VandenDriessche and Marinee Chuah are the first to have achieved a sustained gene therapy cure for hemophilia A in mice. In the mice with hemophilia A, the researchers succeeded in raising the concentration of coagulation factor VIII 1000 times.

Unfortunately, however, scientists ran into difficulties when testing the therapy on larger laboratory animals. After gene therapy, as is also the case with regular injections of coagulation factors, the immune system often recognizes these coagulation factors as ‘foreign’ and purges them, rendering the treatment ineffective. With the research project that has been selected to receive the award, the VIB research group will seek to identify which mechanisms are involved in the purging of this coagulation factor and how they might develop strategies to prevent this response.

Hemophilia Research Award

With its Hemophilia Research Awards Program, Bayer is supporting research on coagulation disorders in order to develop a better treatment for hemophilia patients. To be awarded such a research grant, the research project must be innovative, of high scientific caliber, and must offer added value to society. Thierry VandenDriessche’s research project was selected based on an international competition. The VIB researcher will receive 200,000 USD to carry out the project.

Promising research

With this research, the VIB scientists hope to explain the mechanisms that are responsible for causing gene therapy in hemophilia patients to ultimately fail. Knowledge of these mechanisms will play a key role in improving and developing therapeutic treatments.

VIB, the Flanders Institute for Biotechnology, is a non-profit research institute in the life sciences. Some 1000 scientists and technicians conduct strategic basic research on the molecular mechanisms that control the functioning of the human body, plants, and micro-organisms. Through a close partnership with four Flemish universities – Ghent University, the Katholieke Universiteit Leuven, the University of Antwerp, and the Vrije Universiteit Brussel – and a solid investment program, VIB unites the forces of 65 research groups in a single institute. Their research aims at fundamentally extending the frontiers of our knowledge. Through its technology transfer activities, VIB strives to convert the research results into products for the benefit of consumers and patients. VIB also develops and distributes a broad range of scientifically substantiated information about all aspects of biotechnology. More info at: vib.be

Thierry VandenDriessche and Marinee Chuah lead the ‘Gene Therapy for Bleeding Disorders and Vector Development’ research group in the VIB Department of Transgene Technology and Gene Therapy, Katholieke Universiteit Leuven, under the direction of DГ©sirГ© Collen.

Click here for more information.

vib.be

In Acute Coronary Syndromes Clopidogrel Reloading Worthwhile

Many patients who come to the cardiac catheterization laboratory for percutaneous coronary intervention (PCI) are already taking 75mg of clopidogrel daily to prevent unwanted blood clotting. Even so, an additional 600-mg “reloading” dose of clopidogrel significantly improves clinical outcomes without increasing the risk of bleeding – but only in patients with acute coronary syndromes (ACS), according to the Antiplatelet Therapy for Reduction of Myocardial Damage During Angioplasty-RELOAD (ARMYDA-RELOAD) study.

The study was presented in a Late-Breaking Clinical Trials session at the SCAI Annual Scientific Sessions in Partnership with ACC i2 Summit (SCAI-ACCi2) in Chicago. SCAI-ACCi2 is a scientific meeting for practicing cardiovascular interventionalists sponsored by the Society for Cardiovascular Angiography and Interventions (SCAI) in partnership with the American College of Cardiology (ACC).

The ARMYDA-RELOAD study found that clopidogrel reloading reduces the combined risk of death, heart attack or repeat coronary procedure by nearly two-thirds in patients with ACS, although it offers no benefit to those with stable chest pain. Until now, no study has ever specifically examined the effect of clopidogrel reloading on patients with acute coronary syndromes, a condition that encompasses both unstable angina and a form of heart attack known as non-ST-segment-elevation myocardial infarction (NSTEMI). Clopidogrel is used to prevent the formation of blood clots, or thrombi, which could block the coronary artery and cut off blood flow to the heart muscle.

“The implications of the study are self-evident: When a patient with ACS is undergoing PCI and has been taking clopidogrel before, it is a very good idea to give a further loading dose of 600 mg prior to the procedure. This will protect against ischemic complications, without fear of more bleeding,” said Germano Di Sciascio, MD, professor and chairman of cardiology at Campus Biomedico, University of Rome, Italy. “In patients with stable syndromes, ongoing preexisting clopidogrel may supply sufficient anti-platelet effect to safely undergo the procedure.”

For the study, Dr. Di Sciascio and his colleagues recruited a total of 436 patients who had been taking clopidogrel for more than 10 days before PCI. Of these, 167 (38 percent) had ACS. Patients were randomly assigned to receive an additional 600-mg loading dose of clopidogrel four to eight hours before PCI or to receive a placebo. Blood tests confirmed that platelet reactivity was significantly lower in the reload group when compared with the placebo group in patients with ACS.

After 30 days’ follow-up, the overall rates of major adverse cardiac events (MACE) – consisting of death, heart attack, or repeat PCI or bypass surgery – were the same in the two groups: 7 percent in patients who received clopidogrel reloading vs. 9 percent in the placebo group (p=0.70). A similar finding was observed in patients with stable chest pain (8 percent vs. 4 percent, respectively, p=0.23). However, in patients with acute coronary syndromes, clopidogrel reloading significantly reduced the MACE rate (7 percent vs. 18 percent, respectively; odds ratio: 0.36; p=0.035). There was no difference in the rates of bleeding (5 percent in both groups).

Fundamental differences in the cardiovascular conditions that characterize acute and stable chest pain may explain the effectiveness of clopidogrel reloading in patients with ACS, Dr. Di Sciascio said. “Patients with ACS have higher platelet reactivity, higher inflammatory status and more intracoronary thrombus,” he said. “This may make them more prone to benefit from clopidogrel reloading.”

Dr. Di Sciascio presented the results of the “Antiplatelet Therapy for Reduction of Myocardial Damage During Angioplasty-RELOAD” (ARMYDA-RELOAD) study on April 1 at 11:30 a.m. CDT in the Grand Ballroom, S100.

About SCAI

Headquartered in Washington, DC, the Society for Cardiovascular Angiography and Interventions is a 4,000-member professional organization representing invasive and interventional cardiologists in over 60 nations. SCAI’s mission is to promote excellence in invasive and interventional cardiovascular medicine through physician education and representation, and advancement of quality standards to enhance patient care. SCAI’s annual meeting has become the leading venue for education, discussion, and debate about the latest developments in this dynamic medical specialty.

About ACC

The American College of Cardiology is leading the way to optimal cardiovascular care and disease prevention. The College is a 34,000-member nonprofit medical society and bestows the credential Fellow of the American College of Cardiology upon physicians who meet its stringent qualifications. The College is a leader in the formulation of health policy, standards and guidelines, and is a staunch supporter of cardiovascular research. The ACC provides professional education and operates national registries for the measurement and improvement of quality care.

Source: Kathy Boyd David

Weber Shandwick Worldwide