Press Releases

Latest Nielsen/Oxford University Survey Finds Asian, Latin American Countries Most Concerned about Climate Change Today

Climate Scientists Viewed as Most Trustworthy Sources of Information about Environment

Global Consumers (except North Americans) believe Governments must lead Climate Change Action

NEW YORK & OXFORD, England--(BUSINESS WIRE)-- Concern for climate change has declined in the past two years with many countries recording a double digit fall, according to new research released today by The Nielsen Company and the Oxford University Institute of Climate Change. In the latest round of the survey, conducted in October 2009, 37 percent of global consumers said they were very concerned about climate change (compared to 41 percent in 2007), with the highest levels of concern expressed in Latin America (57%) and Asia Pacific (42%). However, North America lagged global regions with 25 percent of respondents saying they were "very concerned" about climate change.

Thirty five out of the fifty four countries surveyed recorded a decline in climate change concern, led by Poland (23%) and Canada (22%). Climate Change concern also fell by 18 percent in Portugal and 17 percent in Taiwan, Spain and Sweden.

"The global recession and economic woes temporarily knocked the climate change issue off the top line agenda, but as the recession is now beginning to recede, we expect the Copenhagen Summit may push this important issue to the forefront again," said Jonathan Banks, Business Insights Director Europe, The Nielsen Company. Nielsen/Oxford University research shows that concern and awareness for climate change and the environment peaked in 2007 at the time of the Live Earth concerts and the launch of Al Gore's acclaimed documentary 'An Inconvenient Truth'.

The nations most concerned about climate change were Philippines (78%), Indonesia (66%), Thailand and Mexico (62%). The Philippines posted the highest increase in climate change concern in the past two years, up 14 percent, followed by Vietnam (+9%).

"These are countries which have all experienced the direct effects of climate change through freak weather conditions and natural disasters," said Banks. Typhoon Ketsana devastated both the Philippines and Vietnam in September, while Indonesia has been struck by two earthquakes and tsunami warnings this year.

Concern for climate change in Indonesia and Brazil, the two most concerned countries in 2007, has decreased by 10 and 18 percent respectively in the most recent survey.

Globally, air and water pollution followed by climate change are the top three environmental concerns for the global population. "It's not surprising that water and air pollution top consumers' environmental concerns as these are measurable and visible to the population compared with the concept of climate change, which unfortunately many people only take seriously when human lives are endangered through freak weather patterns," said Banks.

Concern for climate change in China and India increased six and one percent respectively in the last two years. "These countries are among the world's largest emitters and this study shows that actions by their governments are responding to citizen concerns," said Timmons Roberts, Director of Environmental Studies at Brown University, USA.

GOVERNMENT VS. INDIVIDUALS: DIVIDED VIEWS ON SOLUTIONS

Globally, the majority of consumers still believe that the main responsibility for solving climate change should lie with their governments. In October 2009, 36 percent of global consumers said that governments should restrict companies' emissions of carbon dioxide and other pollution, closely followed by 34 percent who said there should be major government-led initiatives for research into scientific and technological solutions such as low emission cars, houses and renewable energy. About one in three global consumers also believe there should be government incentives (tax breaks or subsidies) to individuals for good, less or non-polluting behavior and that the population should recycle waste when possible.

"Regional differences prevail with respect to how consumers feel about the capability of their own governments to handle these issues," observed Banks. Europeans and Latin Americans feel most favourable about major government-led research into climate change solutions, while in Asia Pacific, consumers prefer that governments restrict companies' emissions of CO2 and other pollutants. Consumers in Middle East/Africa are most in favour of major government investment into improving public transport systems. North Americans, however, are the least in favour of government intervention or action towards climate change and top regional rankings for personal actions to combat climate change such as recycling waste, decreasing personal energy usage and switching to more efficient light bulbs, fixtures and electrical appliances.

WHO DOES THE PUBLIC TRUST?

Climate scientists remain the most trusted source of information about climate change, with 58 percent of global consumers believing climate scientists more than any other source. "Trust in scientists has been reported consistently and frequently across these 54 responding nations of the world. This is an important finding as the intensely policy-relevant work of climate scientists - both natural and social - informs negotiations in Copenhagen at the UN Conference of Parties meeting," said Max Boykoff, Assistant Professor of Environmental studies, University of Colorado-Boulder, USA.

The Nielsen/Oxford University Environment and Climate Change Barometer is an annual survey which measures consumer attitudes towards the environment and climate change, trust of information sources and climate change solutions among 27,548 online consumers in 54 countries.

About The Nielsen Company

The Nielsen Company is a global information and media company with leading market positions in marketing and consumer information, television and other media measurement, online intelligence, mobile measurement, trade shows and business publications (Billboard, The Hollywood Reporter, Adweek). The privately held company is active in approximately 100 countries, with headquarters in New York, USA. For more information, please visit, www.nielsen.com

The Environment Change Institute at Oxford University focuses on environmental change across the natural and social sciences with an orientation to applied and public policy. ECI plays a leading role in three of the UK Government's main climate research initiatives: the UK Climate Impacts Programmes (UKCIP), the Tyndell Centre for Climate Change Research, and the UK Energy Research Centre (UKERC). ECI increasingly engages with the public through Oxfordshire ClimateXchange, GhostForest, the Tipping Point Arts & Culture project, and media analysis. www.eci.ox.ac.uk

    Source: The Nielsen Company

SOUTH SAN FRANCISCO, CA -- (MARKET WIRE) -- 12/06/09 -- Cytokinetics, Incorporated (NASDAQ: CYTK) announced today that a poster summarizing clinical trial data regarding SB-743921 was presented at the 2009 American Society of Hematology (ASH) Annual Meeting and Exposition held December 5-8, 2009 at the Ernest N. Morial Convention Center in New Orleans, Louisiana. SB-743921 is a novel, small molecule inhibitor of kinesin spindle protein (KSP), a mitotic kinesin essential for proper cell division.

"We are pleased by the results emerging from this Phase I/II clinical trial, especially in patients with Hodgkin Lymphoma," stated Andrew A. Wolff, MD, FACC, Cytokinetics' Senior Vice President of Clinical Research and Development and Chief Medical Officer. "The clinical activity as well as the favorable tolerability profile of SB-743921 that have been observed in the Phase I portion of this clinical trial strengthen our belief that this novel drug candidate warrants further development in patients with lymphomas and we look forward to advancing this program under a potential partnership."

Poster Presentation at the 2009 American Society of Hematology (ASH) Annual Meeting and Exposition:

The poster titled, "A Phase I/II Trial of the Kinesin Spindle Protein (KSP) Inhibitor SB-743921 Dosed Q14D without and with Prophylactic G-CSF in Non-Hodgkin (NHL) or Hodgkin Lymphoma (HL)" was presented on Saturday, December 5, 2009 by Owen A. O'Connor, M.D., Ph.D., Deputy Director of Clinical Research and Cancer Treatment at The Cancer Institute and Chief of the new Division of Hematologic Malignancies and Medical Oncology in the department of Medicine, New York University Langone Medical Center, New York, NY. This poster summarized the Phase I portion of a multi-center, international Phase I/II open-label, non-randomized dose-finding clinical trial evaluating SB-743921 in patients with non-Hodgkin or Hodgkin Lymphoma who have progressed or relapsed on standard therapy. The primary objectives of this clinical trial were to determine the dose-limiting toxicities (DLTs) and the maximum-tolerated dose (MTD) of SB-743921 administered as a 1-hour infusion on days 1 and 15 of a 28-day cycle, first without and then with prophylactic granulopoietic factor support (i.e., granulocyte colony-stimulating factor or G-CSF) and to assess the safety and tolerability of SB-743921 on this schedule. The secondary objectives were to characterize the pharmacokinetics of SB-743921 administered on this schedule and to evaluate the effect of SB-743921 on biomarkers of cell proliferation in patients with accessible tumors.

The authors concluded that the MTD of SB-743921 given on this schedule with G-CSF support was 9 mg/m2. The main DLT of SB-743921 on this schedule with G-CSF support was thrombocytopenia and neutropenia. The authors noted that a greater dose-density was achieved with SB-743921 given on a once every two week schedule without prophylactic G-CSF (i.e., 6 mg/m2 = 0.43 mg/m2/day) than a once every 21 days schedule (i.e., 4 mg/m2 = 0.19 mg/m2/day). Dose-density with G-CSF on the once every two week schedule was equal to 0.64 mg/m2. Grade 3 or 4 toxicities other than myelosuppression were infrequent; in particular, there was no evidence of neuropathy or alopecia greater than Grade 1. An efficacy signal was observed at doses at or above 6 mg/m2 in Hodgkin Lymphoma patients. Of the 55 patients evaluable for efficacy, four partial responses (three patients with Hodgkin Lymphoma and one with indolent non-Hodgkin Lymphoma) were observed. The duration of the response in the patients with a partial response was between 8 weeks and 28 weeks. Best response as a percentage reduction in the sum of the product of diameters for the dominant lesion ranged from 53% to 71%. The small numbers of patients in each of the non-Hodgkin Lymphoma subtypes limited the assessment of activity in those populations. The authors concluded that further evaluation of SB-743921 in selected Hodgkin Lymphoma populations as a single agent, and in combination with other promising drug candidates, is warranted.

About Cytokinetics

Cytokinetics is a clinical-stage biopharmaceutical company focused on the discovery and development of small molecule therapeutics that modulate muscle function for the potential treatment of serious diseases and medical conditions. Cytokinetics' lead drug candidate from its cardiac muscle contractility program, omecamtiv mecarbil (formerly CK-1827452), is in Phase II clinical development for the potential treatment of heart failure. Amgen Inc. holds an exclusive license worldwide (excluding Japan) to develop and commercialize omecamtiv mecarbil and related compounds, subject to Cytokinetics' specified development and commercialization participation rights. Cytokinetics is independently developing CK-2017357, a skeletal muscle activator, as a potential treatment for diseases and conditions associated with aging, muscle wasting or neuromuscular dysfunction. CK-2017357 is in Phase I clinical development. Cytokinetics is also conducting non-clinical development of compounds that inhibit smooth muscle contractility and which may be useful as potential treatments for diseases and conditions such as systemic hypertension, pulmonary arterial hypertension or bronchoconstriction. In addition, prior Cytokinetics' research generated three anti-cancer drug candidates in Phase I clinical development: ispinesib, SB-743921 and GSK-923295. Cytokinetics is seeking a partner for ispinesib and SB-743921. GSK-923295 is being developed by GlaxoSmithKline in collaboration with Cytokinetics. All of these drug candidates and potential drug candidates have arisen from Cytokinetics' research activities and are directed towards the cytoskeleton. The cytoskeleton is a complex biological infrastructure that plays a fundamental role within every human cell. Additional information about Cytokinetics can be obtained at www.cytokinetics.com.

This press release contains forward-looking statements for purposes of the Private Securities Litigation Reform Act of 1995 (the "Act"). Cytokinetics disclaims any intent or obligation to update these forward-looking statements, and claims the protection of the Act's Safe Harbor for forward-looking statements. Examples of such statements include, but are not limited to, statements relating to Cytokinetics' and its partners' research and development activities, including clinical trial results for SB-743921, the significance and utility of such results, and the advancement of SB-743921 under a potential partnership, and the properties and potential benefits of SB-743921 and Cytokinetics' other drug candidates and potential drug candidates. Such statements are based on management's current expectations, but actual results may differ materially due to various risks and uncertainties, including, but not limited to, potential difficulties or delays in the development, testing, regulatory approvals for trial commencement, progression or product sale or manufacturing, or production of Cytokinetics' drug candidates that could slow or prevent clinical development or product approval, including risks that current and past results of clinical trials or preclinical studies may not be indicative of future clinical trials results, patient enrollment for or conduct of clinical trials may be difficult or delayed, Cytokinetics' drug candidates may have adverse side effects or inadequate therapeutic efficacy, the U.S. Food and Drug Administration or foreign regulatory agencies may delay or limit Cytokinetics' or its partners' ability to conduct clinical trials, and Cytokinetics may be unable to obtain or maintain patent or trade secret protection for its intellectual property; Amgen's and GlaxoSmithKline's decisions with respect to the design, initiation, conduct, timing and continuation of development activities for omecamtiv mecarbil and GSK-923295, respectively; Cytokinetics may incur unanticipated research and development and other costs or be unable to obtain additional financing necessary to conduct development of its products; Cytokinetics may be unable to enter into future collaboration agreements for its drug candidates and programs on acceptable terms, if at all; standards of care may change, rendering Cytokinetics' drug candidates obsolete; others may introduce products or alternative therapies for the treatment of indications Cytokinetics' drug candidates and potential drug candidates may target; and risks and uncertainties relating to the timing and receipt of payments from its partners, including milestones and royalties on future potential product sales under Cytokinetics' collaboration agreements with such partners. For further information regarding these and other risks related to Cytokinetics' business, investors should consult Cytokinetics' filings with the Securities and Exchange Commission.

Contacts:
Christopher S. Keenan
(Investors and Media)
Director, Investor Relations
(650) 624-3000

NEW ORLEANS, Dec. 6 /PRNewswire-USNewswire/ -- Sickle cell disease, a condition characterized by deformed and dysfunctional red blood cells, is one of the most common genetic blood disorders affecting millions of people around the world, including more than 70,000 Americans.(1) Research presented today at the 51st Annual Meeting of the American Society of Hematology highlights intriguing studies on the acute danger that the H1N1 pandemic presents for children with this blood disorder, evaluations of both new and standard treatments for common complications of sickle cell disease, and an expansion of the current understanding of hemoglobin expression in red blood cells that may lead to new treatments.

"Treatment for sickle cell disease consists primarily of life-long supportive care, with the only cure being bone marrow transplantation -- a risky procedure that is not readily available for most patients," said Alexis Thompson, MD, PhD, moderator of the press conference and Hematology Section Head at the Children's Memorial Hospital and Associate Professor of Pediatrics, at Northwestern University Feinberg School of Medicine, Chicago. "Therefore, research in this area is particularly important to help ensure that improved therapies continue to be developed and that patients with sickle cell disease have access to the best possible care."

This press conference will take place on Sunday, December 6, at 10:00 a.m.

NOTES:

(1) National Heart, Lung, and Blood Institute. Facts About Sickle Cell Anemia. Available at: http://www.nhlbi.nih.gov/health/public/blood/sickle/sca_fact.pdf.

Control of Hemoglobin Switching by BCL11A [Abstract #5]

As infants develop in the womb, the gamma-globin gene produces a fetal form of hemoglobin, the protein inside red blood cells that carries oxygen. Shortly after birth, a switch to beta-globin gene expression normally occurs, which leads to the production of adult hemoglobin. Both fetal and adult hemoglobin function similarly, though fetal hemoglobin has a greater affinity for binding with oxygen.

Patients with sickle cell disease have a defective form of adult hemoglobin that causes their red blood cells to become deformed and sickle shaped. As a result, the cells are unable to efficiently carry oxygen to the body's tissues and often stick together and jam vessels, causing blood flow obstruction and episodes of severe pain. If a patient with sickle cell could continue production of the fetal hemoglobin and produce less of their defective adult sickle hemoglobin, many of their complications could possibly be reduced or eliminated. A team of researchers from Harvard Medical School in Boston studied the therapeutic possibility of turning the genetic "switch" back on for the production of fetal hemoglobin to replace the defective adult hemoglobin and alleviate these devastating symptoms.

In previous studies, a gene called BCL11A was found to be involved in blocking the expression of fetal hemoglobin in adults. To test these findings in vivo and investigate the role of BCL11A in hemoglobin regulation at different developmental stages, the researchers performed genetic tests in both embryonic and adult mice that were genetically engineered to carry a complete human beta-globin gene cluster capable of producing adult hemoglobin.

In the embryonic mice, inactivation of the BCL11A gene led to a robust expression of gamma-globin (the fetal form of hemoglobin) during late gestation: more than 90 percent of the globin produced was of this type. Tissue-specific deletion of the BCL11A gene in the adult mice (8-10 weeks old) resulted in an increase of more than 1,000-fold in gamma-globin gene expression in the bone marrow erythroblasts (the precursors to red blood cells) of the experimental mice in comparison to control mice. This increase in the gamma-globin expression after inactivation of BCL11A was rapid and persisted during the course of the experiments (up until the mice were 25 weeks old).

"Currently, there are only a limited number of therapies available for patients with sickle cell disease and thalassemia, another disorder involving abnormal hemoglobin," said senior study author Stuart H. Orkin, MD, David G. Nathan Professor of Pediatrics at Dana-Farber Cancer Institute, Children's Hospital Boston, and Harvard Medical School in Boston. "This research opens up a new avenue for treatment, a way to genetically activate healthy fetal hemoglobin in the red blood cells of patients with these lifelong blood disorders."

Dr. Jian Xu will present this study in the Plenary Scientific Session on Sunday, December 6, at 3:00 p.m. in Hall F.

Hydroxyurea in Children With Sickle Cell Disease: Practice Patterns and Barriers to Utilization

[Abstract #242]

Sickle cell disease is often marked by episodes of severe and incapacitating pain called vaso-occlusive painful events, which can sometimes require hospitalization. Hydroxyurea, an oral drug that is most commonly taken once daily, was approved by the U.S. Food and Drug Administration for use in sickle cell disease patients in 1998. While hydroxyurea remains the standard of care for reducing these painful events in adults, little is known about its practice patterns in children. Researchers from the Medical College of Wisconsin and Children's Research Institute of the Children's Hospital of Wisconsin in Milwaukee investigated the patterns and barriers to hydroxyurea use in children with sickle cell disease.

In this study, researchers surveyed members of the American Society of Pediatric Hematology/Oncology about their practices and patients. Of the 1,128 surveys disseminated, 31 percent (350 surveys) were returned.

To standardize and increase the quality of care for both adults and children with sickle cell disease, the National Heart, Lung, and Blood Institute (NHLBI) provides clinical practice guidelines for the management of this blood disorder. Most of the survey respondents had heard of (87 percent) and read (78 percent) these guidelines, and provider utilization of hydroxyurea correlated with awareness of the NHLBI recommendations.

The survey found that only 8 percent of providers had half or most (50 to 90 percent) of their pediatric patients with sickle cell disease on hydroxyurea. Another 54 percent of providers had 10 to 30 percent of pediatric patients on the therapy, and 10 percent of providers had fewer than 10 percent of pediatric patients on hydroxyurea. Although a majority of providers (90 percent) felt that hydroxyurea was effective or very effective for the prevention of pain, some still did not prescribe the drug to eligible children because of apprehension about future reproductive issues (birth defects and infertility in males), despite insufficient evidence to support this concern. Low patient compliance was cited by 86 percent of providers as another reason they did not prescribe hydroxyurea. Providers reported that children and their families refused hydroxyurea because of a fear of cancer or other possible side effects, concerns that the drug would not work, compliance with required laboratory monitoring, or because they simply did not want to take medication.

The study also found that many providers prescribed hydroxyurea for reasons other than that for which it was intended, despite insufficient evidence of its efficacy for other complications of the disease.

"Our survey suggests a substantial variation in hydroxyurea utilization in children with sickle cell disease with barriers to its use found on the part of both providers and patients," said lead study author Amanda M. Brandow, DO, MS, Assistant Professor of Pediatrics at the Medical College of Wisconsin and the Children's Research Institute of the Children's Hospital of Wisconsin in Milwaukee. "To alleviate this problem, future research in the following areas may help: continued funding of studies to determine the efficacy of hydroxyurea for complications other than pain, evaluating unconfirmed toxicities of the drug that influence practice, exploring how access to care contributes to noncompliance, and research on methods to promote patient adherence to recommended medical care."

Dr. Brandow will present this study during an oral session on Monday, December 7, at 7:15 a.m. in Room 388-390.

Increased Severity of Pandemic H1N1 Influenza in Children and Young Adults With Sickle Cell Disease [Abstract #264]

Patients with sickle cell disease are more susceptible to infection than the general population. In particular, influenza, a viral disease that affects the respiratory system, is more than 50 times more frequent in children with sickle cell disease than in the general population, according to research conducted by John J. Strouse, MD, PhD, the lead author on this study, and colleagues. As H1N1 influenza, which began circulating in the United States in April 2009, has been reported to cause more severe illness in children and young adults than seasonal flu, researchers from The Johns Hopkins University School of Medicine in Baltimore sought to compare the clinical characteristics and complications associated with these infections in sickle cell disease patients under the age of 21 through a prospective analysis of patient discharge and billing records from September 1993 through July 2009.

During the study period, 99 patients who were seen at The Johns Hopkins Hospital in Baltimore were identified as having both sickle cell disease and influenza (89 with seasonal influenza and 10 with H1N1 influenza). Clinical symptoms, such as fever, cough, and runny nose, were similar between the two groups, although those with H1N1 influenza were at an estimated three-fold increased risk for life-threatening complications, such as acute chest syndrome (a severe lung illness), and nine times more likely to require intensive care, such as ventilator support.

"Our findings underscore that receiving a vaccination against H1N1 influenza, in addition to seasonal influenza, is extremely important for the health and safety of children and young adults with sickle cell disease," said lead author John J. Strouse, MD, PhD, Assistant Professor of Pediatrics and Medicine at The Johns Hopkins University School of Medicine in Baltimore.

Dr. Strouse will present this study in an oral session on Monday, December 7, at 8:15 a.m. in Room 220-222.

Safety and Efficacy of Sildenafil Therapy for Doppler-Defined Pulmonary Hypertension in Patients With Sickle Cell Disease: Preliminary Results of the Walk-PHaSST Clinical Trial [Abstract #571]

As patients with sickle cell disease have a high rate of hemolysis (red blood cell destruction), excessive amounts of hemoglobin are released into the blood stream that react with and destroy nitric oxide, a critical regulator that dilates blood vessels and inhibits clotting. This can lead to pulmonary hypertension, or abnormally high blood pressure in the arteries of lungs that also affects the heart. Approximately 10 to 30 percent of patients with sickle cell disease are suspected to have this life-threatening condition.

While the oral drug sildenafil (known as Revatio(®)) is approved to treat pulmonary arterial hypertension, it is unknown whether it is a safe and effective treatment for pulmonary hypertension in those with sickle cell disease. Therefore, a 16-week, double-blind clinical trial, known as the Walk-PHaSST study (treatment of Pulmonary Hypertension and Sickle cell disease with Sildenafil Therapy) was conducted in 10 medical centers in the United States and United Kingdom to test this application in adults and children over 12 years of age with sickle cell disease.

Before starting treatment, potential study participants were given baseline tests, including a Doppler echocardiogram and a six-minute walk test to measure heart and lung function. Seventy-four patients who had a tricuspid regurgitant jet velocity (TRV) of greater than or equal to 2.7 m/s (a sign of suspected high pulmonary blood pressure) and a six-minute walking distance of only 150-500 meters (reflecting decreased exercise capacity) were included in the study. The researchers then randomly assigned the study participants into two groups of 37 patients each. Half of the patients were treated with sildenafil at escalating doses from 20, 40, and 80 mg three times per day, and the other half received a placebo three times per day. In previous studies of patients with primary pulmonary hypertension, the highest dose of sildenafil (80 mg) had the greatest effect on blood circulation; however, to monitor for possible adverse effects associated with escalating doses, the sildenafil doses in this study were increased slowly, with dose increases made every four weeks.

The study was prematurely stopped when a significant number of the patients in the sildenafil treatment arm (46 percent) began experiencing serious side effects (primarily sickle cell pain crises requiring hospitalization), compared with only 22 percent of those in the placebo arm. Headache and blurred vision, which were expected side effects of sildenafil, were also experienced. The patients in the sildenafil group had more headaches (27 percent versus 14 percent) and more blurred vision (11 percent versus 3 percent) than the placebo group.

Prior to stopping the study, 33 patients had completed the 16-week assessment and were found to have no change in TRV value or in the walking distance test. On pain questionnaires, patients on the sildenafil treatment also reported worsening pain during walking and less enjoyment of life when compared to the patients on placebo.

"Although sildenafil is approved by the U.S. Food and Drug Administration and by the European Medicines Agency for patients with pulmonary arterial hypertension, the Walk-PHaSST study was prematurely stopped for safety concerns. However, these preliminary data should not be interpreted as implying that sildenafil may not be efficacious and safe in select sickle cell patients with documented pulmonary hypertension who are at low risk for vaso-occlusive events," said lead study author Mark Gladwin, MD, Chief of the Division of Pulmonary, Allergy, and Critical Care Medicine and Director of the Vascular Medicine Institute at the University of Pittsburgh Medical Center. "Further investigations are critically needed to find a safe and effective treatment for this patient population at high risk for death from this debilitating condition."

Dr. Gladwin will present this study in an oral session on Monday, December 7, at 2:45 p.m. in Room 220-222.

American Society of Hematology 51st Annual Meeting

The study authors and press program moderator will be available for interviews after the press conference or by telephone. Additional press briefings will take place throughout the meeting on preventing complications and improving outcomes in transplantation, advances in diagnosing and treating leukemia and myeloproliferative disorders, developments in cancer care and quality of life, and new approaches in clotting disorders. For the complete annual meeting program and abstracts, visit www.hematology.org/2009abstracts. Up-to-date annual meeting information can also be obtained by following ASH on Twitter at ASH_hematology.

The American Society of Hematology (www.hematology.org) is the world's largest professional society concerned with the causes and treatment of blood disorders. Its mission is to further the understanding, diagnosis, treatment, and prevention of disorders affecting blood, bone marrow, and the immunologic, hemostatic, and vascular systems, by promoting research, clinical care, education, training, and advocacy in hematology. ASH provides Blood: The Vital Connection (www.bloodthevitalconnection.org), a credible online resource addressing bleeding and clotting disorders, anemia, and cancer. The official journal of ASH is Blood (www.bloodjournal.org), the most cited peer-reviewed publication in the field, which is available weekly in print and online.

SOURCE American Society of Hematology

NEW ORLEANS, Dec. 6 /PRNewswire-FirstCall/ -- Onyx Pharmaceuticals, Inc. (Nasdaq: ONXX) today announced updated safety data from the pivotal Phase 2b 003-A1 study, known as the 003 trial, demonstrating that carfilzomib is well-tolerated in heavily pre-treated relapsed and refractory multiple myeloma patients. These data were presented today at the ASH/ASCO Joint Symposium at the 51st annual meeting of the American Society of Hematology (ASH) in New Orleans. Enrollment in this trial is complete (n=269), and full results, expected in 2010, could support a potential new drug application (NDA) filing by year-end 2010.

"These results show that carfilzomib is well-tolerated and can be administered at a full dose over a long period of time even in a very sick patient population for whom all available treatment options have been exhausted and who have multiple comorbidities," said lead investigator Sundar Jagannath, M.D., chief of the Multiple Myeloma Program, Bone Marrow and Blood Stem Cell Transplantation at St. Vincent's Comprehensive Cancer Center in New York. "We look forward to the full data from this trial next year."

Dr. Jagannath also presented results from the Phase 2 003-A0 study, which recruited patients whose myeloma had relapsed from two or more prior therapies and was refractory to their previous therapy. This study is the lead-in study for the current Phase 2b registrational trial in the same population. Data from this study was initially presented at the American Society for Clinical Oncology (ASCO) annual meeting in June 2009. Patients in the study had a median of five prior therapies. Previously presented efficacy data from 39 evaluable patients in the 003-A0 pilot study included an 18 percent overall response rate (partial response or better) and a 26 percent clinical benefit rate (minor response or better), median time to tumor progression of 5.1 months and a median of 7.4 months response duration.

Based on the emerging safety profile, the 003-A0 protocol was amended in 2008 to permit increased dosing of up to 27 mg/m(2). The protocol was also expanded into the 003-A1 Phase 2b trial, enrolling 269 patients with relapsed and refractory myeloma and a dose escalation from 20 mg/m(2)( )to 27 mg/m(2)( )after one cycle. The primary endpoint for the Phase 2b 003-A1 pivotal study is overall response rate, and secondary endpoints include clinical benefit response, duration of response, progression-free survival, time-to-progression, overall survival and safety.

Dr. Jagannath presented new safety data on 141 patients in the 003-A1 trial, showing that carfilzomib was well tolerated at the 27 mg/m(2) dose. Grade 3/4 hematologic events included anemia (13.5 percent), thrombocytopenia (16.3 percent), neutropenia (3.5 percent), and febrile neutropenia (0.7 percent). The rate of grade 3/4 peripheral neuropathy was 0.7 percent. The regimen was well tolerated with prolonged administration of more than 12 cycles (48 weeks) in approximately 10% of patients, and no clinically significant cumulative toxicities have been noted to date. Both portions of the trial are being conducted in collaboration with the Multiple Myeloma Research Consortium.

Investor Teleconference

Principal investigators will discuss data presentations surrounding carfilzomib in relapsed or refractory multiple myeloma, as featured at ASH. The webcast event will begin at 9:00 a.m. CT/10:00 a.m. ET on December 7, 2009. The live webcast will be available at:

http://www.onyx-pharm.com/view.cfm/32/Event-Calendar

or by dialing 847-413-3362 and using the passcode 25914947. A replay of the presentation will be available on the Onyx website or by dialing 630-652-3044 and using the passcode 25914947 later in the day. The replay will be available on the Onyx website through January 7, 2010.

About Carfilzomib

Carfilzomib is a selective, next generation proteasome inhibitor that has shown encouraging results in a broad clinical trial program in multiple myeloma. Carfilzomib is currently undergoing evaluation as a single agent in multiple Phase 2 and Phase 1 clinical trials in relapsed or refractory multiple myeloma. These trials include a Phase 2b monotherapy study in patients with relapsed, refractory multiple myeloma, the pivotal trial that could support a new drug application (NDA) filing by the end of 2010. Carfilzomib is also being evaluated in advanced solid tumors.

About Multiple Myeloma

Multiple myeloma (MM) is the second most common hematologic cancer and results from an abnormality of plasma cells, usually in the bone marrow. In the United States, more than 50,000 people are living with MM and approximately 20,000 new cases are diagnosed annually.(i) Worldwide, more than 180,000 people are living with MM and approximately 86,000 new cases are diagnosed annually.(ii)

About Onyx Pharmaceuticals, Inc.

Onyx Pharmaceuticals, Inc. is a biopharmaceutical company committed to improving the lives of people with cancer. The company, in collaboration with Bayer HealthCare Pharmaceuticals, Inc., is developing and marketing Nexavar(® )(sorafenib) tablets, a small molecule drug that is currently approved for the treatment of liver cancer and advanced kidney cancer. Additionally, Nexavar is being investigated in several ongoing trials in a variety of tumor types. Beyond Nexavar, Onyx has established a development pipeline of anticancer compounds at various stages of clinical testing, including carfilzomib, a next-generation proteasome inhibitor, that is currently being evaluated in multiple clinical trials for the treatment of patients with relapsed or relapsed/refractory multiple myeloma and solid tumors. ONX 0801, a targeted alpha-folate inhibitor, is currently in Phase 1 testing. For more information about Onyx, visit the company's website at www.onyx-pharm.com.

Nexavar(®) (sorafenib) tablets is a registered trademark of Bayer HealthCare Pharmaceuticals.

Forward Looking Statements

This news release contains "forward-looking statements" of Onyx within the meaning of the federal securities laws. These forward-looking statements include without limitation, statements regarding the anticipated benefits of the acquisition of Proteolix and the timing, progress and results of the clinical development, safety, regulatory processes, commercialization efforts or commercial potential of carfilzomib. These statements are subject to risks and uncertainties that could cause actual results and events to differ materially from those anticipated, including the risk that Proteolix's operations will not be integrated successfully into Onyx's, the risk that Onyx may not realize the anticipated benefits of the acquisition and risks related to the development and commercialization of pharmaceutical products. Any statements contained in this press release that are not statements of historical fact may be deemed to be forward-looking statements. Reference should be made to Onyx's Annual Report on Form 10-K for the year ended December 31, 2008, filed with the Securities and Exchange Commission under the heading "Risk Factors" and Onyx's Quarterly Reports on Form 10-Q for a more detailed description of such factors. Readers are cautioned not to place undue reliance on these forward-looking statements that speak only as of the date of this release. Onyx undertakes no obligation to update publicly any forward-looking statements to reflect new information, events, or circumstances after the date of this release except as required by law.

(i) National Cancer Institute, Surveillance Epidemiology and End Results, 2007 Facts and Figures

(ii) International Agency for Research on Cancer , GLOBOCAN 2002 database

SOURCE Onyx Pharmaceuticals, Inc.

CAMBRIDGE, Mass.--(BUSINESS WIRE)-- Gloucester Pharmaceuticals announced today the presentation of positive data from an analysis of ISTODAX(R) (romidepsin) in a subset of patients from Gloucester's registration study in cutaneous T-cell lymphoma (CTCL) at the 51st American Society of Hematology (ASH) Annual Meeting being held in New Orleans, LA. This analysis is an assessment of patients with CTCL who--in addition to skin disease and potential lymph node and visceral involvement--also had blood involvement. Blood involvement is characterized as having greater than five percent circulating Sezary (malignant) cells and is typically associated with advanced stage, aggressive disease. ISTODAX is a member of a new class of cancer drugs known as histone deacetylase (HDAC) inhibitors and was recently approved by the U.S. Food and Drug Administration for the treatment of cutaneous T-cell lymphoma in patients who have received at least one prior systemic therapy.

"CTCL that includes blood involvement represents a major therapeutic challenge and the results of this analysis suggest that ISTODAX may help address a treatment void for these patients," said Dr. Youn Kim, an investigator in studies of ISTODAX and Professor, Department of Dermatology and Director, Multidisciplinary Cutaneous Lymphoma Program, Stanford Cancer Center, Stanford, CA. "In this subset of 37 patients with blood involvement, the response rate is consistent with the response rate from the overall population of 96 patients in the registration trial. Additionally, the rapid and sustained reduction in Sezary counts observed in many patients with a higher blood tumor burden, which is typically associated with advanced stage, more aggressive disease, is noteworthy."

The results were described in a poster presentation entitled, "Clinically Significant Responses Achieved with Romidepsin in 37 Patients with Cutaneous T-Cell Lymphoma (CTCL) with Blood Involvement." Of the 96 patients enrolled in the registration study, 37 patients had blood involvement. In this subset of patients with blood involvement (n=37), the response rate was 32% by overall composite assessment and included 2 (5%) confirmed complete responses. In the overall study population (n=96), the response rate was 34% and included 6 (6%) confirmed complete responses. The composite assessment included measurement of skin, lymph node and visceral involvement in addition to measurement of circulating malignant T-cells (Sezary cells). The median duration of response in the 37 patients with blood involvement has not been reached; however, the current maximum duration of response is 20 months. Pruritus, intense itching, was measured in these patients using a 100mm visual analog scale (VAS). 14 of 24 patients (58%) with moderate to severe pruritus at baseline (>=30 mm VAS) had a clinically meaningful decrease (>=30 mm) in VAS. The safety profile in this subset of 37 patients was similar to the overall safety profile of ISTODAX in the registration study which was characterized principally by mild (grade 1 and 2) gastrointestinal disturbances, hematologic toxicities, clinical chemistry abnormalities and asthenic conditions. The only study-drug related serious adverse event occurring in more than one patient was tumor lysis syndrome (2 patients).

"We're pleased to see that the results in this subset of patients with more challenging disease are similar to those observed overall in the registration study," commented Jean Nichols, President and Chief Operating Officer of Gloucester Pharmaceuticals. "These data demonstrate that ISTODAX has the potential to provide sustained clinical benefit to patients with CTCL with blood involvement who have received at least one prior systemic therapy. In addition, the observed improvements in pruritus are encouraging because pruritus can be a particularly troubling symptom for this patient population."

About ISTODAX(R)

ISTODAX, a novel histone deacetylase (HDAC) inhibitor, has been approved by the U.S. Food and Drug Administration for the treatment of cutaneous T-cell lymphoma (CTCL) in patients who have received at least one prior systemic therapy. For full prescribing information, please visit www.ISTODAX.com. Gloucester is currently conducting a registration trial in peripheral T-cell lymphoma (PTCL) and additional studies of ISTODAX are being conducted in other hematologic and solid tumors. ISTODAX is not approved for the treatment of PTCL or other indications.

Important Safety Information

ISTODAX(R) is indicated for treatment of cutaneous T-cell lymphoma (CTCL) in patients who have received at least one prior systemic therapy.

Warnings and Precautions

Due to the risk of QT prolongation, potassium and magnesium should be within the normal range before administration of ISTODAX.

Treatment with ISTODAX can cause thrombocytopenia, leukopenia (neutropenia and lymphopenia), and anemia; therefore, these hematological parameters should be monitored during treatment with ISTODAX, and the dose should be modified, as necessary.

Several treatment-emergent morphological changes in ECGs including T-wave and ST-segment changes have been reported in clinical studies. The clinical significance of these changes is unknown. In patients with congenital long QT syndrome, patients with a history of significant cardiovascular disease, and patients taking anti-arrhythmic medicines or medicinal products that lead to significant QT prolongation, appropriate cardiovascular monitoring precautions, such as the monitoring of electrolytes and ECGs should be considered.

Based on its mechanism of action, ISTODAX may cause fetal harm. Woman should avoid becoming pregnant while being treated with ISTODAX and pregnant women should be advised of the potential harm to the fetus.

ISTODAX binds to estrogen receptors. Women of childbearing potential should be advised that ISTODAX may reduce the effectiveness of estrogen-containing contraceptives.

Adverse Reactions

Safety data was available and evaluated in 185 patients with CTCL in two clinical trials. Adverse reactions are presented separately for each study due to methodological differences between the studies. The most common reported adverse reactions in Study 1 were nausea (56%), fatigue (53%), infections (46%), vomiting (34%), and anorexia (23%) and in Study 2 were nausea (86%), fatigue (77%), anemia (72%), thrombocytopenia (65%), ECG T-wave changes (63%), neutropenia (57%), and lymphopenia (57%). Most of the adverse reactions were reported to be mild or moderate in severity. Most deaths in the studies were due to disease progression. Discontinuation due to an adverse event occurred in 21% of patients in Study 1 and 11% in Study 2. Serious adverse reactions reported in > 2% of patients in Study 1 were infection, sepsis, and pyrexia. In Study 2, serious adverse reactions in > 2% of patients were infection, supraventricular arrhythmia, neutropenia, fatigue, edema, central line infection, ventricular arrhythmia, nausea, pyrexia, leukopenia, and thrombocytopenia.

Drug Interactions

Prothrombin time (PT) and International Normalized Ratio (INR) should be carefully monitored in patients concurrently administered ISTODAX and Coumadin derivatives.

Co-administration of strong CYP3A4 inhibitors may increase concentrations of ISTODAX and should be avoided.

Co-administration of potent CYP3A4 inducers may decrease concentrations of ISTODAX and should be avoided.

Caution should be exercised if ISTODAX is administered with drugs that inhibit P-glycoprotein.

Use in Specific Patient Populations

Patients with moderate and severe hepatic impairment or end-stage renal disease should be treated with caution.

For additional important safety information, please see full prescribing information for ISTODAX at www.ISTODAX.com or call 1-866-223-7145.

About Gloucester Pharmaceuticals

Gloucester Pharmaceuticals acquires clinical-stage oncology drug candidates and advances them through regulatory approval and commercialization. The Company's first candidate, ISTODAX(R) (romidepsin), a novel histone deacetylase (HDAC) inhibitor, is FDA approved for the treatment of cutaneous T-cell lymphoma (CTCL) in patients who have received at least one prior systemic therapy. Gloucester is currently conducting a registration trial in peripheral T-cell lymphoma (PTCL) and anticipates data from this study in 2010. In addition, the Company is continuing further investigation of ISTODAX in other hematologic indications and solid tumors. For more information, please visit www.gloucesterpharma.com.

    Source: Gloucester Pharmaceuticals