Press Releases

Pivotal Data on ChemGenex's Omapro(TM) Highlighted at ASH Press Conference Dec 5, 2009 10:04AM

- 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

Gloucester Pharmaceuticals' ISTODAX(R) Demonstrates Synergistic Activity with Velcade(R) in B-cell Non-Hodgkin's Lymphoma Cell Lines Dec 5, 2009 10:03AM

-- Future studies planned; data presented at ASH 2009--

CAMBRIDGE, Mass.--(BUSINESS WIRE)-- Gloucester Pharmaceuticals announced today the presentation of preclinical data demonstrating that the combination of ISTODAX(R) (romidepsin) and Velcade(R) (bortezomib) resulted in synergistic anti-tumor activity in B-cell non-Hodgkin's lymphoma cell lines. ISTODAX is a member of a new class of cancer drugs known as histone deacetylase (HDAC) inhibitors. The results were presented during a poster presentation entitled, "The Combination of Romidepsin and Bortezomib Results in Synergistic Induction of Apoptosis in Human B-Lymphoma Cell Lines" at the 51st American Society of Hematology (ASH) Annual Meeting being held in New Orleans, LA.

"The results in this in vitro combination study of ISTODAX and Velcade suggest this may be an important clinical combination to test in patients with relapsed or refractory B-cell malignancies," said Sagar Lonial, MD, Associate Professor, Hematology and Medical Oncology at Emory University School of Medicine and an author of the study. "We are currently conducting mechanistic studies with the goal of identifying predictors of response that can be validated in prospective clinical trials and look forward to presenting these results at a future scientific meeting."

"ISTODAX has been studied extensively in T-cell lymphomas and was recently approved by the FDA for the treatment of cutaneous T-cell lymphoma in patients who have received at least one prior systemic therapy," said Jean Nichols, PhD, President and Chief Operating Officer of Gloucester Pharmaceuticals. "These preclinical results in B-cell lymphoma cell lines build on previous work presented in multiple myeloma and suggest that the combination of ISTODAX and Velcade may have a potential role in the broader hematologic space and merit additional study."

Study Results:

Four B-cell lymphoma lines (Daudi, HT, Ramos and SUDHL-4) were exposed to different combinations of ISTODAX and Velcade separately, concurrently and sequentially. The combination of ISTODAX and Velcade resulted in synergistic B-cell apoptosis. Order-of-addition experiments demonstrated definite sequence specificity. When ISTODAX was administered first and followed six hours later by administration of Velcade, cell growth was arrested in the G2/M phase and cell death was increased compared to both agents being given concurrently or Velcade being administered first. Protein level expression analyses suggest that the combination affected both aggresome formation and autophagy. The observed effects of the combination of ISTODAX and Velcade on B-cell lymphoma lines at low nanomolar concentrations suggests that this may be an important clinical combination to test in patients with relapsed or refractory B-cell malignancies.

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.

Velcade(R) is a registered trademark of Millennium: The Takeda Oncology Company.

    Source: Gloucester Pharmaceuticals

Gloucester Pharmaceuticals Announces Final Results from ISTODAX(R) Phase 2 PTCL Study at ASH Annual Meeting Dec 5, 2009 10:02AM

--38% overall response rate and 10.3 month median duration of response--

CAMBRIDGE, Mass.--(BUSINESS WIRE)-- Gloucester Pharmaceuticals announced today the presentation of positive final data from a Phase 2 study of ISTODAX(R) (romidepsin) in peripheral T-cell lymphoma (PTCL) conducted by the National Cancer Institute (NCI) at the 51st American Society of Hematology (ASH) Annual Meeting being held in New Orleans, LA. Gloucester is currently conducting a registration trial in PTCL and anticipates data from this study in 2010. ISTODAX is a member of a new class of cancer drugs known as histone deacetylase (HDAC) inhibitors and 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. ISTODAX is not approved for the treatment of PTCL or other indications.

"We continue to be extremely encouraged by the results from this NCI study of ISTODAX in patients with PTCL," commented Dr. Jean Nichols, President and Chief Operating Officer of Gloucester Pharmaceuticals. "The sustained duration of response with a median of 10.3 months and the complete responses seen in the study suggests that ISTODAX may meet a significant unmet medical need in this relapsed, refractory patient population and reinforces the potential for ISTODAX to become a meaningful addition to the treatment landscape for PTCL."

"We're very pleased that the progress in the ISTODAX development program continues to be consistent with our expectations for a broader product profile," said Alan Colowick, President and Chief Executive Officer of Gloucester Pharmaceuticals. "Gloucester has reached its accrual goal in the PTCL registration trial of ISTODAX and we anticipate filing a supplemental New Drug Application for ISTODAX for the treatment of PTCL in 2010."

The Phase 2 study of ISTODAX in PTCL is sponsored by the NCI under a Cooperative Research and Development Agreement (CRADA) with Gloucester and was conducted in the United States and Australia. In a poster presentation entitled, "Final Results of a Phase 2 NCI Multicenter Study of Romidepsin in Patients with Relapsed Peripheral T-Cell Lymphoma (PTCL)" Dr. Susan Bates of the National Cancer Institute described the results for 47 patients enrolled in the study. The treatment schedule was 14 mg/m2 of ISTODAX infused on days one, eight and 15 every 28 days. The mean number of prior therapies for patients enrolled in the study is five (range one to 14) including 17 (36%) patients who had received a stem cell transplant. The overall response rate (complete response + partial response) is 38% (18/47) and the median duration of response is 10.3 months (range of 1.8 months to 72.4+ months). Five patients continue to respond to treatment at the time of this presentation. 15% (7/47) of patients experienced a complete response. Overall the adverse event profile in the study for patients with PTCL was consistent with that previously reported. The most frequent drug-related AEs were generally mild and included nausea (68%, 4% >=grade 3), cardiovascular/general other (68%, 0% >=grade 3), thrombocytopenia (66%, 28% >=grade 3), fatigue (64%, 13% >=grade 3), neutropenia (62%, 40% >=grade 3), leukocyte (total WBC decreased) (53%, 43% >=grade 3).

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

Allos Therapeutics Reports New Analyses of Data from Pivotal PROPEL Trial of FOLOTYN(TM) at 51st ASH Annual Meeting Dec 5, 2009 10:00AM

-- Overall Response Rate and Duration of Response Continue to Demonstrate the Effectiveness of FOLOTYN to Treat Patients with Relapsed or Refractory Peripheral T-cell Lymphoma --

NEW ORLEANS, La. & WESTMINSTER, Colo.--(BUSINESS WIRE)-- Allos Therapeutics, Inc. (Nasdaq: ALTH) today reported new analyses of data from the Company's pivotal PROPEL trial of FOLOTYN(TM) (pralatrexate injection) in patients with relapsed or refractory peripheral T-cell lymphoma (PTCL). In addition, the Company reported preliminary results from its Phase 1/2 study of FOLOTYN in combination with gemcitabine in patients with relapsed or refractory lymphoproliferative malignancies. These data were presented during a poster session at the 51st Annual Meeting of the American Society of Hematology (ASH) in New Orleans, LA.

In September 2009, the U.S. Food and Drug Administration (FDA) granted accelerated approval for FOLOTYN for use as a single agent for the treatment of patients with relapsed or refractory (PTCL). FOLOTYN is the first and only drug approved by the FDA for this indication and represents a new treatment option for patients with relapsed or refractory PTCL. This indication is based on overall response rate. Clinical benefit such as improvement in progression free survival or overall survival has not been demonstrated. FOLOTYN has been available to patients in the U.S. since October 2009.

The PROPEL posters included an update of overall response rate for FOLOTYN as evaluated by independent central review using International Workshop Criteria (IWC). Treatment with FOLOTYN achieved an overall response rate of 29% (32 of 109 evaluable patients). Sixty-three percent (63%) of patients responded within the first cycle of therapy. Responses were durable with a median duration of response of 10.1 months. Median overall survival was 14.5 months.

"FOLOTYN is an important new therapy for patients with relapsed or refractory PTCL and for physicians who treat patients afflicted with this very aggressive cancer," said Owen A. O'Connor, M.D., Ph.D., principal investigator in the PROPEL study of FOLOTYN; deputy director for Clinical Research and Cancer Treatment, NYU Cancer Institute; chief, Division of Hematologic Malignancies and Medical Oncology; professor of Medicine and Pharmacology at the NYU Langone Medical Center. "We continue to be encouraged by the observed responses in relapsed or refractory patients, including those whose cancer never responded to a wide range of prior therapies, including stem cell transplant therapy."

Below is a summary of conclusions and key findings from the poster presentations. To view the complete posters, go to the Company's web site and look under the "Presentations" tab of the "Investor Relations" section of the website (www.allos.com).

PROPEL Poster Presentations

Abstract #1678 Pralatrexate Induces Responses in Patients with Highly Refractory Peripheral T-Cell Lymphoma (PTCL)

A poster presentation by Dr. Kerry Savage, of the British Columbia Cancer Agency, Vancouver, BC, Canada, characterized the response to FOLOTYN among patients with peripheral T-cell lymphoma in the PROPEL study who were considered to have refractory disease, defined as no evidence of response to their most recent treatment or to any prior therapies. Patients enrolled in PROPEL were a heavily pretreated population who had a median of 3 prior systemic therapies, with the most common being CHOP-based chemotherapy and other multi-agent chemotherapy regimens. Eighteen patients (17%) received autologous stem cell transplant prior to inclusion in the study. The results of this analysis showed FOLOTYN produced durable responses in patients with relapsed or refractory PTCL who had no response to prior therapies, including the subpopulation of patients who had no response to their most recent therapy as well as patients who were refractory to all prior therapies.

    --  Of the 109 evaluable patients, 69 patients (63%) had no evidence of
        response to the most recent prior therapy.
        o According to central review, these patients achieved a 25% (17/69)
          overall response rate, with a duration of response ranging from 41 to
          673 days. A 36% (25/69) overall response rate was observed in these
          patients according to investigator review.
    --  Among the 69 patients, 26 patients (24%) had no evidence of response to
        any prior therapy before initiating FOLOTYN.
        o According to central review, 5 (19%) of these patients responded to
          FOLOTYN with a duration ranging from 54 to 306 days. Seven of these
          patients (27%) responded according to investigator review.
    --  Additionally, 76 patients (68%) received full dose FOLOTYN therapy at 30
        mg/m2 despite heavy pretreatment. Forty-six patients (67%) who had no
        response to their most recent therapy received full-dose therapy at 30
        mg/m2.

Abstract #1675 Safety and Management of Pralatrexate Treatment in Relapsed or Refractory Peripheral T-Cell Lymphoma (PTCL)

A poster presentation by Dr. Lauren Pinter-Brown, of the University of California at Los Angeles, CA, assessed the safety of the patients included in PROPEL over three clinically important parameters: duration of FOLOTYN treatment, early- and late-onset FOLOTYN toxicities, and the impact of FOLOTYN dose modification on toxicities. Overall, 115 patients were enrolled in the study. The baseline and safety population included 111 patients who received >=1 dose of FOLOTYN and excluded 4 patients not receiving therapy. In the PROPEL trial overall safety population, the safety results indicate that FOLOTYN was found to be well tolerated in patients with PTCL.

    --  The 4 most commonly observed adverse events were mucosal inflammation,
        nausea, thrombocytopenia and fatigue.
    --  Despite a median of 3 prior systemic therapies with potentially
        associated organ toxicities, the majority of patients tolerated the full
        dose FOLOTYN of 30 mg/m2.
    --  The protocol-specified dose modification schema effectively reduced the
        occurrence of mucosal inflammation. Adherence to the FOLOTYN
        dose-modification guidelines permitted continued FOLOTYN therapy.
    --  The most common Grade 3-4 AEs for patients who initiated cycle 3 were
        observed at similar or lower rates compared to those observed in cycles
        1-2. These data suggest that there is no cumulative-dose toxicity with
        FOLOTYN, which permits continued therapy for patients who derive benefit
        from FOLOTYN.

Abstract #1681 Correlation Between Baseline Methylmalonic Acid Status and Mucositis Severity in the PROPEL Study: Implications for Vitamin Prophylaxis

A poster presentation by Dr. Barbara Pro, of the University of Texas M.D. Anderson Cancer Center, Houston, TX, assessed baseline methylmalonic acid (MMA) status, homocysteine (HCY), and red blood cell (RBC) folate levels in patients enrolled in PROPEL. This baseline and safety population included 111 patients who received >=1 dose of FOLOTYN and excluded 4 patients not receiving therapy. The analysis was conducted to determine if there was an association between these values and mucosal inflammation and thrombocytopenia observed in the study.

    --  The maximum mucosal inflammation grade experienced during FOLOTYN
        therapy (Grade 0 vs Grade 1-2 vs Grade 3-4) and the baseline MMA value
        had a statistically significant linear relationship (p=0.039).
    --  The analysis revealed no other significant relationship; and baseline
        HCY and RBC folate values were not predictive of the severity of
        mucositis or thrombocytopenia in this assessment.
    --  There was also a trend toward a relationship between increasing MMA and
        increasing severity of thrombocytopenia but did not meet statistical
        significance (p=0.267).
    --  Based on these results, vitamin supplementation of folic acid and
        vitamin B12 is appropriate with FOLOTYN administration for relapsed or
        refractory PTCL.

FOLOTYN and Gemcitabine Study Poster Presentation

Abstract #1674 Pralatrexate and Gemcitabine in Patients with Relpased or Refractory Lymphoproliferative Malignancies: Phase 1 Results

A poster presentation by Dr. Steven M. Horwitz, of Memorial Sloan-Kettering Cancer Center, New York, NY, reviewed preliminary results from a Phase 1/2 study of FOLOTYN and gemcitabine in patients with B-cell lymphoma, PTCL and Hodgkin's disease. The primary objective of the Phase 1 dose finding portion of this study was to evaluate the safety and preliminary efficacy of the combination of FOLOTYN and gemcitabine. The Phase 1 evaluation determined the maximum tolerated dose (MTD) of the combination of FOLOTYN and gemcitabine on sequential days and same day schedules. Patients were administered a combination of FOLOTYN and gemcitabine according to three regimens: on the same day every two weeks (q2w), on sequential days q2w, or on sequential days once weekly for three weeks of a four week cycle.

    --  These data demonstrated that treatment with FOLOTYN and gemcitabine is
        feasible, with acceptable toxicity, when administered on a q2w schedule.
    --  The dose administered of each drug is higher when given on the same day
        schedule as compared to treating on sequential day schedule.
    --  In this dose ranging study, preliminary results showed activity of the
        combination of FOLOTYN and gemcitabine in lymphoid malignancies with a
        24% overall response rate in this heavily pretreated population.
    --  The Phase 2 expansion at the MTD will evaluate both sequential and
        same-day dosing of FOLOTYN in a q2w schedule.

About PROPEL

The open-label, single-arm, multicenter, international Phase 2 clinical trial is the largest prospective study of its type ever conducted in patients with relapsed or refractory PTCL. PROPEL enrolled 115 patients with relapsed or refractory PTCL, 109 of whom were considered evaluable for efficacy according to the trial protocol. Patients were considered evaluable if they received at least one dose of FOLOTYN, their diagnosis of PTCL was confirmed by independent pathology review, and they had relapsed or refractory disease after at least one prior treatment. Patients were treated with FOLOTYN at 30 mg/m2 once weekly by IV push over 3-5 minutes for 6 weeks in 7-week cycles until disease progression or unacceptable toxicity. In addition, patients received 1mg of vitamin B12 intramuscularly every 8-10 weeks and 1.0-1.25 mg of folic acid orally on a daily basis.

The primary efficacy endpoint was overall response rate (complete response, complete response unconfirmed and partial response) as assessed by International Workshop Criteria (IWC). The key secondary efficacy endpoint was duration of response. Response assessments were scheduled at the end of cycle 1 and then every other cycle (every 14 weeks). Duration of response was measured from the first day of documented response to disease progression or death. Response and disease progression were evaluated by independent central review using the IWC.

Important Safety Information

Warnings and Precautions:

FOLOTYN may suppress bone marrow function, manifested by thrombocytopenia, neutropenia, and anemia. Monitor blood counts and omit or modify dose for hematologic toxicities.

Mucositis may occur. If >= Grade 2 mucositis is observed, omit or modify dose.

Patients should be instructed to take folic acid (1.0 -1.25 mg orally on a daily basis) and receive vitamin B12 (1 mg intramuscularly every 8-10 weeks) to potentially reduce treatment-related hematological toxicity and mucositis.

FOLOTYN can cause fetal harm. Women should avoid becoming pregnant while being treated with FOLOTYN, and pregnant women should be informed of the potential harm to the fetus.

Use caution and monitor patients when administering FOLOTYN to patients with moderate to severe renal function impairment.

Elevated liver function test abnormalities may occur and require monitoring. If liver function test abnormalities are >= Grade 3, omit or modify dose.

Adverse Reactions:

The most common adverse reactions observed in PROPEL were mucositis (70%), thrombocytopenia (41%), nausea (40%), and fatigue (36%). The most common serious adverse events (>3%), regardless of causality, were pyrexia, mucositis, sepsis, febrile neutropenia, dehydration, dyspnea and thrombocytopenia. Forty-four percent of patients experienced a serious adverse event while on study or within 30 days after their last dose of FOLOTYN. Twenty-three percent of patients discontinued treatment due to adverse reactions.

Drug Interactions:

Co-administration of drugs subject to renal clearance (e.g., probenecid, NSAIDs, and trimethoprim/sulfamethaxazole) may result in delayed renal clearance.

Use in Specific Patient Population:

Nursing mothers should be advised to discontinue nursing or the drug, taking into consideration the importance of the drug to the mother.

For additional important safety information, please see the full prescribing information for FOLOTYN at www.allos.com.

About Peripheral T-cell Lymphoma

Peripheral T-cell lymphomas (PTCL) are a diverse group of aggressive T-cell and natural killer (NK)-cell non-Hodgkin's lymphomas (NHL) that account for approximately 10% to 15% of all newly diagnosed cases of NHL in the United States.1-3 The American Cancer Society estimates that approximately 66,000 new cases of NHL were diagnosed in the U.S. in 2009. The Company estimates the current annual incidence of PTCL in the U.S. to be approximately 5,600 patients. The outcome of patients with PTCL is poor and the majority of patients ultimately have refractory disease to a variety of agents, including multi-agent chemotherapy with CHOP (cyclophosphamide, doxorubicin, vincristine, and prednisone) or CHOP-like regimens. The 5-year overall survival rate for patients with PTCL is 25% to 40%, depending on sub-type.4-5

About Allos Therapeutics

Allos Therapeutics, Inc. (Nasdaq: ALTH) is a biopharmaceutical company committed to the development and commercialization of innovative anti-cancer therapeutics. Allos is currently focused on the development and commercialization of FOLOTYN(TM) (pralatrexate injection), a folate analogue metabolic inhibitor. FOLOTYN is the first and only drug approved in the U.S. for the treatment of patients with relapsed or refractory peripheral T-cell lymphoma. Allos is also exploring the potential of FOLOTYN in other indications. Allos retains exclusive worldwide rights to FOLOTYN for all indications. Allos is headquartered in Westminster, CO. For additional information, please visit www.allos.com.

Safe Harbor Statement

This press release contains forward-looking statements that are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements include statements regarding the potential for FOLOTYN to play a clinically meaningful role in the treatment of patients with relapsed or refractory PTCL; the potential for FOLOTYN to be an effective treatment option for patients with relapsed or refractory PTCL; and other statements that are other than statements of historical facts. In some cases, you can identify forward-looking statements by terminology such as "may," "will," "should," "expects," "intends," "plans," "anticipates," "believes," "estimates," "predicts," "projects," "potential," "continue," and other similar terminology or the negative of these terms, but their absence does not mean that a particular statement is not forward-looking. Such forward-looking statements are not guarantees of future performance and are subject to risks and uncertainties that may cause actual results to differ materially from those anticipated by the forward-looking statements. Important factors that may cause actual results to differ materially include, but are not limited to, the risks and uncertainties associated with developing adequate sales, marketing and distribution capabilities; the acceptance of FOLOTYN in the marketplace; the status of reimbursement from third party payers; the Company's dependence on third party manufacturers; the Company's compliance with applicable regulatory requirements, including the healthcare fraud and abuse laws and the Company's post-marketing requirements; and the Company's access to capital to support its future operations, including product development and commercialization plans for FOLOTYN. Additional information concerning these and other factors that may cause actual results to differ materially from those anticipated in the forward-looking statements is contained in the "Risk Factors" section of the Company's Quarterly Report on Form 10-Q for the quarter ended September 30, 2009, and in the Company's other periodic reports and filings with the Securities and Exchange Commission. The Company cautions investors not to place undue reliance on the forward-looking statements contained in this press release. All forward-looking statements are based on information currently available to the Company on the date hereof, and the Company undertakes no obligation to revise or update these forward-looking statements to reflect events or circumstances after the date of this presentation, except as required by law.

Note: The Allos logo and FOLOTYN name are trademarks of Allos Therapeutics, Inc.

References:

1. The Non-Hodgkin's Lymphoma Classification Project. A clinical evaluation of the International Lymphoma Study Group classification of non-Hodgkin's lymphoma. Blood. 1997;89(11):3909-3908.

2. Hennessy BT, Hanrahan EO, Daly PA. Non-Hodgkin lymphoma: an update [review]. Lancet Oncol. 2004;5(6):341-353.

3. O'Leary HM, Savage KJ. Novel therapies in peripheral T-cell lymphomas [review]. Curr Oncol Rep. 2008;134(5):202-207.

4. Savage KJ, Chhanabhai M, Gascoyne RD, et al. Characterization of peripheral T-cell lymphomas in a single North American institution by the WHO classification. Ann Oncol 2004;15(10):1467-75.

5. Savage KJ. Peripheral T-cell Lymphomas. Blood Rev. 2007;21:201-216.

    Source: Allos Therapeutics, Inc.

DeSmogBlog.com: Hackers Attempt to Access Canadian Government Centre for Climate Modeling and Analysis Dec 5, 2009 10:00AM

VANCOUVER, BRITISH COLUMBIA -- (MARKET WIRE) -- 12/05/09 -- On the heels of the controversial story about emails and data stolen by hackers from the Climate Research Unit at the University of East Anglia, it has now been revealed that individuals posing as network technicians attempted to infiltrate another climate data center operated by the Government of Canada.

According to sources at the University of Victoria, two people claiming to be network computer technicians presented themselves at the headquarters of the Canadian Centre for Climate Modeling and Analysis and tried to gain access to the data servers. When challenged by an employee, the two individuals hastily left. The timing of this attempted break-in is very suspicious given that it occurred so closely on the heels of the release of hacked emails and data from a similar facility housed at the Climate Research Unit at the University of East Anglia in the UK.

The story was also verified by a UVIC spokesperson in an interview yesterday with the National Post.

"This is disturbing news and it shows that there is an organized criminal campaign that is going to great lengths to infiltrate secure facilities and steal private data," said James Hoggan, author of the new book Climate Cover-Up: The Crusade to Deny Global Warming. "We don't know who is behind these criminal acts, but we hope they will eventually be unmasked by police. In the meantime, what we do know is that the individuals and organizations that quickly launched an online PR campaign to misrepresent the content of the hacked emails from the University of East Anglia are part of a decades-long confusion campaign to delay government action on the issue."

The goal of this campaign, which began around the time of the first Kyoto Protocol negotiations, was to assemble a group of like-minded "free-market" think tanks and pseudo-science experts that would call into question the scientific research on climate change, create doubt in the minds of the public and politicians, and effectively delay the introduction of clean energy policies in the United States and elsewhere.

It is no coincidence that the groups publicizing the University of East Anglia email hacking story also have a long history of taking money from oil and coal companies to attack the conclusions made by climate scientists. See attached backgrounder for more details.

BACKGROUNDER

While the culprits who stole the emails and data remain unknown for now, we have found that the individuals and organizations that are aggressively publicizing the East Anglia story are the same people at the center of the 4-plus years research we have done into the climate denial industry. Many are central characters in the new book, Climate Cover Up, written by DeSmogBlog co-founder James Hoggan.

Here's a brief summary of some of the organizations involved:

Committee for a Constructive Tomorrow: owns and operate ClimateDepot.com, which has been a main clearinghouse for the right-wing climategate echo chamber. ClimateDepot.com is managed by Marc Morano, former aide to Republican Senator James Inhofe. CFACT has received grants from Exxon Mobil, Chevron, and well-known right-wing foundations like the Carthage Foundation and the Sarah Scaife Foundation.

American Enterprise Institute: Offered to pay "experts" $10,000 to write papers that countered the IPCC reports. AEI has received close to half a million from oil-giant ExxonMobil, former Exxon Chairman Lee Raymond sits on AEI's board of directors.

Media Research Center: run by Brett Bozell, this group also operates the popular right-wing blog, Newsbusters.org. The Media Research Center has received over $257,000 from oil-giant ExxonMobil since 1998.

Cato Institute: Is the main front group for the most prolific climate denier, Patrick Michaels. Cato is the second largest recipient of funding the foundations run by Koch Industries Inc. (the largest private energy company in the United States).

Heartland Institute: Organizes a "denier conference" every year for the past three years. Used to receive funding from ExxonMobil, still receive grants from tobacco companies and are also a major recipient of grants from the foundations run by Koch Industries Inc. (the largest private energy company in the United States).

Heritage Foundation: Heritage is massive and operates on about $50 million a year. They have received significant funding from ExxonMobil, Koch Industries and other fossil fuel companies.

National Center for Policy Analysis: the NCPA is a small, but very vocal Dallas, Texas-based freemarket think tank and has received over $540,900 from oil giant ExxonMobil since 1998.

Competitive Enterprise Institute: The CEI is well-known for its public efforts to aggressively counter the scientific evidence for human-induced climate change, especially after their infamous set of television ads with the tag line "C02, We Call it Life". Since 1998, the CEI has received over $2 million in funding from oil-giant ExxonMobil.

Contacts:
Lorraine Wilson
(information or interviews)
604-349-3184
lwilson@hoggan.com