Press Releases

NEW ORLEANS, Dec. 5 /PRNewswire-USNewswire/ -- There have been significant scientific advances in the field of blood cancers, and leading experts continue to gain a better understanding of how certain diseases progress in order to discover new treatment options and provide patients with the best care. Research presented today at the 51st Annual Meeting of the American Society of Hematology explores optimal induction therapies for managing multiple myeloma, the importance of advance care planning for improved quality of life, and a potential new first-line therapy for patients with non-Hodgkin lymphoma.

"Studies such as these are designed to improve the quality of evaluation, diagnosis, and treatment of various blood cancers," said moderator of the press conference Richard A. Van Etten, M.D., Ph.D., Director of Tufts Medical Center Cancer Center in Boston. "The results of these studies not only give hematologists a better understanding of disease progression, but also direct them to the measures that are safer and more effective in treating their patients."

This press conference will take place on Saturday, December 5, at 10:00 a.m.

A Prospective, Multicenter, Randomized Trial of Bortezomib/Melphalan/Prednisone (VMP) Versus Bortezomib/Thalidomide/Prednisone (VTP) as Induction Therapy Followed by Maintenance Treatment With Bortezomib/Thalidomide (VT) Versus Bortezomib/Prednisone (VP) in Elderly Untreated Patients With Multiple Myeloma Older Than 65 Years [Abstract #3]

Multiple myeloma is a type of blood cancer that affects white blood cells known as plasma cells and is common among the elderly. In the United States, the incidence of this disease is increasing at an alarming rate with 13,000-15,000 new cases diagnosed each year.(1) Over the last few years the treatment of elderly patients older than 65 years with multiple myeloma has changed, mainly due to the introduction of novel agents such as thalidomide, bortezomib, and lenalidomide. According to results from the Velcade as Initial Standard Therapy in Multiple Myeloma: Assessment With Melphalan and Prednisone (VISTA) trial, the combination of bortezomib, melphalan, and prednisone is significantly superior to melphalan and prednisone alone, which has been the current standard of care for multiple myeloma patients who cannot receive a stem cell transplant. However, research has not yet confirmed whether an alkylating agent (chemical compound) or an immunomodulatory therapy (drug that suppresses or stimulates the body's immune response) is the optimal partner for bortezomib. Researchers from the Spanish Myeloma Group designed a study to better determine if melphalan or thalidomide should be used as part of induction therapy (the initial treatment given to patients) in combination with bortezomib. The study showed that elderly patients were able to receive less aggressive treatment regimens of induction therapy by supplementing them with a maintenance treatment.

In order to evaluate whether the induction therapy regimen could be further optimized by decreasing toxicity while maintaining efficacy, the intensity of both treatment regimens was reduced as compared with the VISTA regimen, but supplemented with maintenance therapy. In this study, 260 patients with a median age of 75 years were randomized to receive a modified induction schedule of six cycles of bortezomib, melphalan, and prednisone (VMP) or bortezomib, thalidomide, and prednisone (VTP) as induction therapy followed by maintenance therapy with bortezomib and thalidomide (VT) or bortezomib and prednisone (VP) for up to three years.

Study results indicate that modified induction schedules for both VMP and VTP were highly effective with similar overall response rates (80 percent for VMP and 81 percent for VTP), which were determined using the European Group for Blood and Marrow Transplantation (EBMT) criteria, and complete remission rates (20 percent for VMP and 27 percent for VTP), but there was a clear difference in the toxicity profile of each group. In the VMP regimen there was a higher incidence of neutropenia (abnormally low count of white blood cells) and infections, but VTP resulted in the development of cardiac toxicity. The frequency of grade 3-4 peripheral neuropathy (PN) was 5 percent in the VMP group. Maintenance therapy with either VT or VP also markedly improved the quality of patient responses with a good safety profile, increasing complete response from 23 percent up to 42 percent, with no significant differences in response rates between the VT and VP treatment arms. In addition, both maintenance regimens resulted in an acceptable toxicity profile.

"Melphalan with prednisone has been the gold standard for the treatment of elderly multiple myeloma patients for the past 40 years, but novel combination therapies have emerged as superior options," said lead author Maria-Victoria Mateos, M.D., Ph.D., Attending Physician, Hematology Department at the Hospital Universitario de Salamanca in Spain. "In this study, we demonstrate that the combination of a reduced dosage for induction therapy followed by maintenance therapy may be a novel approach for treating this patient population."

Dr. Mateos will present this study at the Plenary Scientific Session on Sunday, December 6, at 2:30 p.m. in Hall F.

(1) Cleveland Clinic. Education: Prevalence and Incidence of Multiple Myeloma. Available at: http://my.clevelandclinic.org/myeloma/education/multiple_myeloma.aspx. Accessed November 20, 2009.

Psychological Correlates of Having Advance Care Planning in Patients With Hematological Malignancies [Abstract #72]

Advance care planning (ACP) provides patients with the opportunity to communicate with their family and health-care provider about their end-of-life choices. Patients who participate in ACP usually have a living will and a health-care proxy, a person who carries out their health-care choices in the event that they become incapable of making medical decisions. However, according to previous studies, only 50 percent of patients with blood cancers who are undergoing a high-risk procedure, such as a stem cell transplant, participate in ACP. Moreover, the group that lacked ACP had a higher mortality rate, suggesting that the group least likely to have ACP is the group most in need of it. While there is a need to increase engagement in ACP, many argue that discussing possible death with patients adds to their stress level. Researchers from the University of Nebraska Medical Center in Omaha and Fred Hutchinson Cancer Research Center in Seattle compared the psychological well-being of patients with blood cancers who did or did not have ACP to help understand how best to design interventions that may increase patient engagement in ACP.

This study analyzed data from the HEMA-COMM (Hematology Communications) study cohort, an observational study that evaluated doctor-patient communication. The study included 293 patients with blood cancers who have ACP - that is, have a designated health-care proxy and a living will - or who did not have ACP - that is, they lacked a health-care proxy or a living will, or both. The two groups were compared according to socio-demographic characteristics, diagnosis, previous treatments, patient and physician estimates of cure and life expectancy, discussions of wishes for life support, and various measures of psychosocial well-being including coping, depression/anxiety, denial, social support, and quality of life.

The study found that both patients who engage and who do not engage in ACP have similar psychosocial well-being except for patterns of coping. Patients who have ACP use more problem-focused coping patterns (e.g., taking advice, active coping, seeking moral support or discussing feelings with others, planning, and having a positive outlook) as opposed to emotion-focused coping patterns (e.g., denial, behavioral or mental disengagement, turning to religion, self-blame, and substance abuse). Problem-focused coping is defined as problem solving by doing something to alter the source of stress and predominates when a person feels that something constructive can be done to affect the outcome of events. In addition, patients with ACP were more likely to be older (56 years versus 52 years), have higher income, have leukemia or myelodysplastic syndrome, and have received prior cancer treatment. The majority of patients with ACP discussed wishes for the use of life support with family (62 percent), while only 30 percent had discussed their wishes with a physician with or without family, and just 8 percent of patients had not discussed their wishes at all.

"While advance care planning may be more relevant for someone who has a life-threatening disease, it really is important to all individuals, and we hope that more people engage in this important process," said lead author Fausto R. Loberiza Jr., M.D., Associate Professor at the University of Nebraska Medical Center. "In order to increase engagement in ACP, it is important to focus on the practical importance of ACP regardless of prognosis and de-emphasize the emotional aspects of ACP. This approach may be more appealing to our patients regardless of coping style."

Dr. Loberiza will present this study in an oral presentation on Sunday, December 6, at 5:45 p.m. in Room 393-396.

Bendamustine Plus Rituximab is Superior in Respect of Progression-Free Survival and Complete Remission Rate When Compared to CHOP Plus Rituximab as First-Line Treatment of Patients With Advanced Follicular, Indolent, and Mantle Cell Lymphomas - Final Results of a Randomized Phase III Study on StiL (Study Group indolent Lymphomas, Germany) [Abstract #405]

About half of all blood cancers are those of the lymphatic system, which are classified as either Hodgkin or non-Hodgkin lymphoma. There are many types of non-Hodgkin lymphoma, including follicular lymphoma (the second most common type) and mantle cell lymphoma (a rare and difficult-to-treat cancer). While the current standard of care for patients with non-Hodgkin lymphoma is a chemotherapy regimen called CHOP (cyclophosphamide, hydroxydaunorubicin, oncovin, and prednisone) plus the immunotherapy rituximab, it has been linked to high toxicity rates. However, promising results have been observed in two phase II studies evaluating a new combination treatment consisting of a chemotherapy agent called bendamustine plus rituximab in patients with relapsed or refractory indolent (slow-growing) or mantle cell lymphoma. In order to further investigate the role of bendamustine and rituximab combination therapy, researchers from the German Study Group Indolent Lymphoma (StiL) initiated a multicenter, randomized, phase III study to compare the efficacy and safety of bendamustine plus rituximab versus CHOP plus rituximab as a potential first-line therapy for patients with follicular, indolent, and mantle cell lymphoma.

Five hundred forty-nine patients were randomized to receive one dose of rituximab (375 mg/m2) plus two doses of bendamustine (90 mg/m2) every 28 days or the standard CHOP regimen every 21 days for a maximum of six cycles. The types of non-Hodgkin lymphoma were equally distributed between the two treatment regimens (55 percent and 56 percent for follicular lymphoma, 18 percent and 19 percent for mantle cell lymphoma, and 27 percent and 24 percent for other indolent lymphomas, respectively). The primary objective of the study was to improve progression-free survival for patients with non-Hodgkin lymphoma.

Study results revealed that bendamustine and rituximab combination therapy significantly improved progression-free survival and complete remission rates while showing less toxicity as compared with the current standard treatment. The median progression-free survival for bendamustine and rituximab combination therapy was 54.8 months compared with 34.8 months for CHOP and rituximab combination therapy. The complete remission rate of 40.1 percent for bendamustine and rituximab combination therapy was significantly higher than the 30.8 percent achieved with CHOP and rituximab combination therapy. As predicted, a higher frequency of serious adverse events was seen with the CHOP and rituximab combination therapy, such as neutropenia (10.7 percent versus 46.5 percent) and leukocytopenia (12.1 percent versus 38.2 percent). The bendamustine and rituximab combination therapy was better tolerated by patients as evidenced by lower rates of treatment side effects such as hair loss (15 percent versus 62 percent), infectious complications (95 versus 121 patients), nerve damage (18 versus 73 patients), and episodes of inflammation in the mucous lining of the mouth (16 versus 47 patients).

"While the CHOP and rituximab combination is the current standard of care, it is frequently associated with serious adverse events and more side effects, as was further shown in this study," said lead author Mathias J. Rummel, M.D., Ph.D., Head of the Department for Hematology at the University Hospital in Giessen, Germany. "These promising results suggest that the combination of bendamustine and rituximab has the potential to become the new standard, first-line treatment option for patients with these non-Hodgkin lymphoma entities."

Dr. Rummel will present this study on Monday, December 7, at 11:00 a.m. in Room 208-210.

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 new approaches in clotting disorders, preventing complications and improving outcomes in transplantation, advances in diagnosing and treating leukemia and myeloproliferative disorders, and new trends and treatment options for sickle cell disease. 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

MIAMI--(BUSINESS WIRE)-- In a joint report on expanding broadband opportunity, entitled Toward Access, Adoption and Inclusion: A Call For Digital Equality and Broadband Opportunity, state legislative caucuses representing communities of color today called the broadband status quo "unacceptable" and released a set of policy recommendations for spreading high-speed Internet service to every American.

"We firmly believe that ubiquitous broadband access, adoption and use stand to be great equalizers in our society," the lawmakers said in the report. "For our organizations and, most significantly, for the communities and people we represent, the broadband status quo is unacceptable."

"We seek broadband for all because it creates opportunities, breaks down barriers and promotes access by opening doors in areas of job creation, education, and health care. Broadband can help reduce the inequalities that have historically hampered communities of color, and provide those same communities with better opportunities to build their lives based on their individual merit, ambition, and talents," the report declared.

Digital Divide Threatens Sustainability of Communities of Color

Writing in "Towards Access, Adoption & Inclusion: A Call for Digital Equality and Broadband Opportunity," the groups said that broadband Internet adoption and use must become the norm for all communities. They urged policymakers to make broadband connectivity available, accessible, and affordable for every American; to incentivize broadband adoption; and to foster investment in broadband as a way to stimulate job creation and economic opportunity.

The report was issued jointly by the National Black Caucus of State Legislators, the National Hispanic Caucus of State Legislators, The National Caucus of Native American State Legislators, and the National Pacific American Caucus of State Legislators. The Hispanic Institute and the Joint Center for Political and Economic Studies provided substantive data for the report and reiterated the need to collect better data about the digital divide and why people of color are less likely to subscribe to broadband service.

The report noted the persistence of a digital divide that separates people of color and low wage earning groups from more affluent Americans. It said the divide "threatens the future sustainability of our communities and our country."

"Broadband can and must be a vehicle for expanded opportunity for all Americans," said study co-author Dr. Nicole Turner Lee, VP and Director, Media and Technology Institute, Joint Center for Political and Economic Studies. "But if we tolerate a status quo in which some Americans have broadband and some don't, the gaps that separate one American from another will become institutionalized."

The report identified the inability of large numbers of citizens to subscribe to broadband as the major reason the United States is falling short of its broadband goal, and traced that failure in large part to problems of affordability, and in some instances to access.

Affordability is A Key Barrier That Prevents Many Citizens From Embracing Broadband

"Even where service is available, if the proposition of adopting broadband is too expensive, people will not use it," the report said. It urged policymakers to address affordability through a combination of government initiatives, programmatic reforms, incentives for private sector action, and public-private partnerships.

It warned against policies that might shift costs to the poor or "over-burden low-volume broadband users with the costs of maintaining services for high-volume users."

"Before any new policy regime is implemented, we must fully understand the potential socio-economic implications of its implementation," the report added. The lawmakers also called for "a system of checks and balances that encourages, rather than dissuades, private investment in broadband deployment and innovation."

"The issue isn't funding, its commitment," noted study co-author Gus West, Chairman of the Board, The Hispanic Institute. "Broadband is one more opportunity for America to bring people of color into the economic mainstream at the beginning by making sure that every citizen has the same access to the Internet and the opportunities it provides."

The Hispanic Institute is a 501 (c) 3 designated nonprofit organization. The Hispanic Institute's mission is sharply focused: THI provides an effective education forum for an informed and empowered Hispanic America. The Hispanic Institute manages ongoing projects including the study of Hispanic economic contributions; media monitoring; consumer fraud protection; citizenship education; and technology and telecommunication research.

The Joint Center for Political and Economic Studies is one of the nation's leading research and public policy institutions and the only one whose work focuses primarily on issues of particular concern to African Americans and other people of color. The Joint Center will mark its 40th Anniversary of service in 2010. To learn more, please visit www.jointcenter.org.

Photos/Multimedia Gallery Available: http://www.businesswire.com/cgi-bin/mmg.cgi?eid=6114425&lang=en

    Source: The Hispanic Institute and The Joint Center

BALTIMORE, MD -- (MARKET WIRE) -- 12/05/09 -- Brower Piven, A Professional Corporation announces that a class action lawsuit has been commenced in the United States District Court for the Northern District of California on behalf of purchasers of the securities of SunPower Corporation ("SunPower" or the "Company") (NASDAQ: SPWRA) (NASDAQ: SPWRB) during the period between April 17, 2008 and November 16, 2009, inclusive (the "Class Period").

No class has yet been certified in the above action. Members of the Class will be represented by the lead plaintiff and counsel chosen by the lead plaintiff. If you wish to choose counsel to represent you and the Class, you must apply to be appointed lead plaintiff no later than January 19, 2010 and be selected by the Court. The lead plaintiff will direct the litigation and participate in important decisions including whether to accept a settlement and how much of a settlement to accept for the Class in the action. The lead plaintiff will be selected from among applicants claiming the largest loss from investment in the Company during the Class Period. You are not required to have sold your shares to seek damages or to serve as a Lead Plaintiff. You may contact Brower Piven (through hoffman@browerpiven.com or 410/986-0036) to answer any questions you may have in that regard.

The complaint accuses the defendants of violations of the Securities Exchange Act of 1934 by virtue of the Company's failure to disclose during the Class Period that the financial statements and information issued by SunPower in its press releases, quarterly reports for 2008 and 2009 and annual report for the fiscal year 2008 were false and misleading because defendants included unsubstantiated accounting entries related to cost of goods sold in SunPower's Philippines operations and false and misleading certifications, required by the Sarbanes-Oxley Act of 2002, attesting to the accuracy of SunPower's financial statements and the adequacy of its internal controls over financial reporting. According to the complaint, on November 17, 2009, after the Company filed a report on Form 8-K with the SEC stating that because of accounting improprieties, the Company's previously issued interim financial statements for each of the 2009 quarterly periods, the previously reported financial results for the fiscal year ending December 28, 2008, the financial information in its 2009 quarterly reports on Form 10-Q and its 2008 annual report on Form 10-K, and the guidance provided by the Company for the 2009 fiscal year, should no longer be relied upon, the value of SunPower's stock declined significantly.

If you have suffered a net loss for all transactions in SunPower Corporation securities during the Class Period, including shares or possibly calls purchased during, but not sold until after the end of the Class Period or possibly put options sold but not covered until after the end of the Class Period, you may obtain additional information about this lawsuit and your ability to become a lead plaintiff by contacting Brower Piven at www.browerpiven.com, by email at hoffman@browerpiven.com, by calling 410-986-0036, or at Brower Piven, A Professional Corporation, The World Trade Center-Baltimore, 401 East Pratt Street, Suite 2525, Baltimore, Maryland 21202. Attorneys at Brower Piven have combined experience litigating securities and class action cases of over 40 years. If you choose to retain counsel, you may retain Brower Piven without financial obligation or cost to you, or you may retain other counsel of your choice. You need take no action at this time to be a member of the class.

CONTACT:
Charles J. Piven
Brower Piven, A Professional Corporation
Baltimore, Maryland
410/986-0036
Email Contact

BALTIMORE, MD -- (MARKET WIRE) -- 12/05/09 -- Brower Piven, A Professional Corporation announces that a class action lawsuit has been commenced in the United States District Court for the Western District of Washington on behalf of purchasers of the securities of Northwest Pipe Company ("Northwest Pipe" or the "Company") (NASDAQ: NWPX) during the period between April 23, 2008 and November 11, 2009, inclusive (the "Class Period").

No class has yet been certified in the above action. Members of the Class will be represented by the lead plaintiff and counsel chosen by the lead plaintiff. If you wish to choose counsel to represent you and the Class, you must apply to be appointed lead plaintiff no later than January 19, 2010 and be selected by the Court. The lead plaintiff will direct the litigation and participate in important decisions including whether to accept a settlement and how much of a settlement to accept for the Class in the action. The lead plaintiff will be selected from among applicants claiming the largest loss from investment in the Company during the Class Period. You are not required to have sold your shares to seek damages or to serve as a Lead Plaintiff. You may contact Brower Piven (through hoffman@browerpiven.com or 410/986-0036) to answer any questions you may have in that regard.

The complaint accuses the defendants of violations of the Securities Exchange Act of 1934 by virtue of the Company's failure to disclose during the Class Period that defendants overstated the Company's revenues and earnings by failing to recognize revenues in accordance with Generally Accepted Accounting Principles. According to the complaint, on November 12, 2009, after the Company announced that it was delaying the filing of its Quarterly Report for the quarter ended September 30, 2009, pending the conclusion of an ongoing internal investigation of certain accounting matters, the value of Northwest Pipe's stock declined significantly.

If you have suffered a net loss for all transactions in Northwest Pipe Company securities during the Class Period, including shares or possibly calls purchased during, but not sold until after the end of the Class Period or possibly put options sold but not covered until after the end of the Class Period, you may obtain additional information about this lawsuit and your ability to become a lead plaintiff by contacting Brower Piven at www.browerpiven.com, by email at hoffman@browerpiven.com, by calling 410-986-0036, or at Brower Piven, A Professional Corporation, The World Trade Center-Baltimore, 401 East Pratt Street, Suite 2525, Baltimore, Maryland 21202. Attorneys at Brower Piven have combined experience litigating securities and class action cases of over 40 years. If you choose to retain counsel, you may retain Brower Piven without financial obligation or cost to you, or you may retain other counsel of your choice. You need take no action at this time to be a member of the class.

CONTACT:
Charles J. Piven
Brower Piven, A Professional Corporation
Baltimore, Maryland
410/986-0036
Email Contact

- Highest Response Rates Yet for T315I + CML Clinical Trial -

- Findings Suggest Omapro Represents a New Potential Therapy for CML Patients with the T315I Resistance Mutation -

MELBOURNE, Australia, & MENLO PARK, Calif.--(BUSINESS WIRE)-- ChemGenex Pharmaceuticals Limited (ASX: CXS) announced today updated clinical data showing that Omapro(TM) (omacetaxine mepesuccinate) produced durable hematologic and cytogenetic responses in chronic myeloid leukemia (CML) patients who have failed treatment with imatinib and who have developed the Bcr-Abl T315I mutation. New data was presented at a pre-conference press showcase at the 51st Annual American Society of Hematology Annual Meeting in New Orleans, Louisiana.

At the press conference titled "Advances in Diagnosing and Treating Leukemia and Myeloproliferative Disorders" Dr. Jorge Cortes, MD, Professor of Medicine and Deputy Chair in the Department of Leukemia at The University of Texas, MD Anderson Cancer Center, a lead investigator in the study, presented data on behalf of a team including investigators from ChemGenex and leading U.S. and European clinical research centers. Completing his presentation, Dr Cortes concluded that Omapro represents a new potential therapy for patients with T315I+ CML.

Data were presented from 81 CML patients: 49 in chronic phase, 17 in accelerated phase and 15 in blast phase. Highlights of the data were:

    --  Complete hematologic responses (CHR) in 86% of chronic phase patients,
        median response duration 9 months
    --  Total cytogenetic response rate of 41% in chronic phase patients, with
        major cytogenetic response (MCyR) rate of 27%
    --  Overall hematologic responses in 35% of accelerated phase patients
        (median duration 7 months)
    --  Overall hematologic responses in 47% of blast phase patients (median
        duration 2 months)
    --  Investigators reported that omacetaxine is safe for self-administration,
        is well tolerated, and that reversible and manageable myelosuppression
        is the most common side effect

"We are delighted with the positive data presented today that continues to show that Omapro can provide clinical benefit to patients in this very difficult to treat sub-set of CML where there are no other approved treatment options," said Greg Collier, Ph.D., Managing Director and Chief Executive Officer of ChemGenex. "We would like to thank Dr. Cortes and all of our investigators for their efforts to produce this data. These results support our regulatory filings, and we look forward to working with the agencies in the U.S. and Europe over the next several months as we seek approval for Omapro in 2010."

Applications for marketing approval for Omapro are currently under review by the U.S. Food & Drug Administration (priority review), and the European Medicines Evaluation Agency.

The complete oral presentation by Dr. Cortes detailing this study will take place:

Date/Time:      Monday, December 7, 2009 at 4:45 p.m., U.S. Central Time

                #644: Safety and Efficacy of Subcutaneous-Administered
Abstract/Title: Omacetaxine Mepesuccinate in Imatinib-Resistant Chronic Myeloid
                Leukemia (CML) Patients Who Harbor the Bcr- Abl T315I Mutation -
                Results of An Ongoing Multicenter Phase 2/3 Study

Oral Session:   Chronic Myeloid Leukemia - Therapy: Managing Resistance and
                Residual Disease

Location:       Conference Auditorium AB (Ernest N. Morial Convention Center)

About the Study

The study was designed to evaluate the safety and efficacy of subcutaneously (SC) administered omacetaxine in patients with imatinib resistant T315I+ Philadelphia chromosome positive CML. Eligible patients include adult CML Patients in chronic, accelerated, or blast disease phase (CP, AP, BP) with a confirmed Bcr-Abl T315I mutation and resistance to imatinib therapy. Patients were given 1.25 mg/m2 SC omacetaxine twice daily for 14 days every 28 days until hematologic response for induction therapy. For maintenance therapy, patients were dosed 1.25 mg/m2 SC omacetaxine twice daily for 7 days every 28 days. Eighty one patients were described in this presentation (49 CP, 17 AP and 15 BP). The median age was 58 years (19-83) with a median CML disease duration of 54 months (5-286). All patients had failed prior imatinib therapy, and 79% had failed two or more prior TKIs. The presence of baseline T315I mutation was confirmed in all patients.

About Omapro(TM) (omacetaxine mepesuccinate)

Omacetaxine mepesuccinate is administered subcutaneously and acts differently from TKIs. It may have a therapeutic advantage for patients who have failed TKIs. Omacetaxine is currently in global phase 2/3 clinical trials for CML and has been granted Orphan Drug designations by the U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMEA) as well as Fast Track status by the FDA.

Omacetaxine is a first-in-class cetaxine with demonstrated clinical activity as a single agent in a range of hematological malignancies. Omacetaxine has a novel mechanism of action, specifically binding to the ribosomal A-site cleft and inhibiting protein translation of short-lived oncoproteins that are upregulated in leukemic cells (particularly Cyclin-D1, Mcl-1 and c-Myc). In addition, pre-clinical research presented at the 14th Congress of the European Hematology Association (EHA) in Berlin, Germany this summer, demonstrated that omacetaxine kills human CML stem cells that are known to be insensitive to TKIs.

About Chronic Myeloid Leukemia (CML) and the Bcr-Abl T315I Mutation

Chronic myeloid leukemia (CML) is a cancer of the bone marrow with a worldwide prevalence of approximately 200,000 patients. The bone marrow is responsible for the production of specialized cells that constitute blood; these cells include red blood cells (to carry oxygen around the body), thrombocytes (to help stop bleeding) and certain white cells (part of the body's defense system against infection). In patients with CML the cell production system is diseased and defective. Cells multiply uncontrollably and do not fully develop (differentiate) into functional blood cells.

The majority of CML patients initially respond well to treatments with drugs called tyrosine kinase inhibitors (TKIs). However, a significant proportion of patients fail, or become intolerant to, one or more TKIs. In many of these situations the cause of failure can be traced to the emergence of Bcr-Abl mutations. A common mutation called T315I renders CML resistant to all currently approved TKIs, and has created a significant unmet medical need in the management of CML.

About ChemGenex Pharmaceuticals Limited

ChemGenex is an oncology focused biopharmaceutical company developing small molecules with new mechanisms of action to treat malignancies with significant unmet medical needs. The company is developing omacetaxine, its lead product candidate, for the treatment of patients with Chronic Myeloid Leukemia (CML), Acute Myeloid Leukemia (AML), and Myelodysplastic Syndrome (MDS). A New Drug Application has been accepted by the U.S. Food and Drug Administration and a Marketing Authorisation Application has been validated by the European Medicines Agency for CML patients with the Bcr-Abl T315I mutation. The corporate strategy for ChemGenex is to commercialize omacetaxine independently in North America and to establish commercial partnerships in the rest of the world. ChemGenex currently trades on the Australian Stock Exchange under the symbol "CXS" For additional information on ChemGenex Pharmaceuticals, please visit the company's website at http://www.chemgenex.com.

Details on the clinical trials can be accessed from the following websites: http://www.clinicaltrials.gov/ct2/show/NCT00375219?term=homoharringtonine&rank=9 and http://www.tkiresistantcmltrials.com.

Omapro(TM) is a trademark of ChemGenex Pharmaceuticals Limited

Safe Harbor Statement

Certain statements made herein (including for this purpose sites to which a hyperlink has been provided) that use the words "estimate", "project", "intend", "expect", "believe" and similar expressions are intended to identify forward-looking statements within the meaning of the US Private Securities Litigation Reform Act of 1995. These forward-looking statements involve known and unknown risks and uncertainties which could cause the actual results, performance or achievements of the company to be materially different from those which may be expressed or implied by such statements, including, among others, risks or uncertainties associated with the development of the company's technology, the ability to successfully market products in the clinical pipeline, the ability to advance promising therapeutics through clinical trials, the ability to establish our fully integrated technologies, the ability to enter into additional collaborations and strategic alliances and expand current collaborations and obtain milestone payments, the suitability of internally discovered genes for drug development, the ability of the company to meet its financial requirements, the ability of the company to protect its proprietary technology, potential limitations on the company's technology, the market for the company's products, government regulation in Australia and the United States, changes in tax and other laws, changes in competition and the loss of key personnel. These statements are based on our management's current expectations and are subject to a number of uncertainties that could change the results described in the forward-looking statements. Investors should be aware that there are no assurances that results will not differ from those projected.

    Source: ChemGenex Pharmaceuticals Limited