MethylGene Inc.
TSX : MYG

MethylGene Inc.

December 09, 2007 18:00 ET

MethylGene and Pharmion Report Favorable Results for Phase II MGCD0103 Single-Agent Studies in Relapsed or Refractory Lymphomas at the 49th American Society of Hematology (ASH) Meeting

ATLANTA, GEORGIA--(Marketwire - Dec. 9, 2007) - MethylGene Inc. (TSX:MYG) -

- MGCD0103 Continues to Demonstrate Single-Agent Activity

- 38% Response Rate, 43% Disease Control Rate and 86% Tumor Reduction Rate in Heavily-Pretreated Patients with Relapsed or Refractory Hodgkin Lymphoma in 110mg Cohort

- Preliminary and Early Data from the 85 mg Cohort Shows Activity and Tumor Reduction

- 67% Tumor Reduction Rate in Relapsed or Refractory Non-Hodgkin Lymphoma, Including an 18% Response Rate in Evaluable Diffuse Large B-cell Patients

MethylGene Inc. (TSX:MYG) and Pharmion Corporation (NASDAQ:PHRM) today announced preliminary data from two ongoing Phase II studies with MGCD0103, the Companies' novel, isotype-selective histone deacetylase (HDAC) inhibitor, as a single-agent in the treatment of Hodgkin lymphoma (HL) and non-Hodgkin lymphoma (NHL). Data from these studies were presented today at the 49th Annual Meeting and Exposition of the American Society of Hematology (ASH).

"Data from these most recent trials continue to demonstrate the single-agent potential for MGCD0103 in a patient population that currently has few effective therapeutic options," said Donald F. Corcoran, President and Chief Executive Officer of MethylGene. "With our partners, we will continue to evaluate our current and near-term MGCD0103 clinical trials during 2008 with the goal to develop a potential registrational pathway."

"These exploratory Phase II trials show the meaningful activity of MGCD0103 in patients with differing types of lymphomas," said Patrick J. Mahaffy, President and Chief Executive Officer of Pharmion. "This is important not only for the continuing development of MGCD0103 but also because it provides further evidence for the role of epigenetic therapies in the treatment of hematologic malignancies."

Isotype Selective HDAC Inhibitor MGCD0103 Decreases Serum TARC Concentrations and Produces Clinical Responses in Heavily Pretreated Patients with Relapsed Classical Hodgkin lymphoma (HL), Abstract #2566 (Trial 010)

To date, 33 patients have been enrolled in this ongoing open-label Phase II study of refractory/relapsed classical Hodgkin lymphoma (HL). The majority of these patients have disease that has progressed following stem cell transplant as well as other subsequent therapies (100 percent of patients have undergone prior chemotherapy, 88 percent prior bone marrow or stem-cell transplant and 76 percent radiation treatment).

Of 21 evaluable patients who received the 110 mg starting dose, eight (38 percent) showed objective responses - two complete responses (CR) and six partial responses (PR). The overall disease control rate (CR+PR+stable disease (SD) greater than or equal to 6 cycles) was 43 percent. The median time to response was two cycles (one cycle equals 28 days). Tumor reductions were observed in 86 percent of patients who had CT scans and 57 percent of the patients experienced tumor shrinkages greater than 30 percent. The two CR patients have a preliminary progression-free survival (PFS) of 14 and 9 months at the time of analysis. The range of PFS from the responder group is 56 to greater than 396 days.

Adverse events (AE) associated with MGCD0103 administration of grade 3 or higher included pneumonia (15 percent), and thrombocytopenia (12 percent) and fatigue (9 percent).

Preliminary and early data from the 85 mg cohort revealed all five evaluable patients with tumor reduction of greater than or equal to 30 percent, including one PR and 2 near-PRs (49 percent and 45 percent tumor reduction). Three of these patients are ongoing in the 85 mg cohort. Enrollment in this cohort continues in order to gain additional experience at the 85 mg dose subsequent to planning potential future trials in this and other indications.

In summary, results from this ongoing trial suggest that single-agent MGCD0103 demonstrates significant anti-tumor activity in relapsed/refractory classical HL and is well-tolerated, with dose modifications used as necessary to manage toxicities. An 85 mg dose is continuing to be evaluated in this patient population.

Treatment of Relapsed or Refractory Lymphoma With the Oral Isotype-Selective Histone Deacetylase Inhibitor MGCD0103: Interim Results From a Phase II Study, Abstract 2571 (Trial 008)

To date, 50 patients have been treated in this Phase II study of MGCD0103 in non-Hodgkin lymphomas (NHL). Specific patient populations in this study included pre-treated patients with diffuse large B-cell lymphoma (DLBCL) (n equals 33) and follicular lymphoma (FL) (n equals 17). The majority of these patients have had prior treatment: 98 percent had chemotherapy, 96 percent had treatment with Rituximab®, 49 percent had prior radiation treatment and 33 percent had stem-cell transplants.

Of the 34 patients evaluable for clinical response who had completed at least one cycle of treatment and had their disease reassessed, the objective response rate (CR+PR) was 15 percent in all patients and 18 percent in the DLBCL cohort. Responses include one complete response (CR) in a patient with DLBCL, and four partial responses (PR) observed in three DLBCL patients and one FL patient. Responses were observed within two to six cycles. Of the five patients who responded to treatment, the preliminary progression-free survival (PFS) ranged from 6 cycles to 12 cycles (one cycle is equal to 28 days).

Twenty-seven patients have been reassessed for tumor size by CT scan after initiation of treatment, with 18 patients (67 percent) demonstrating tumor reduction, including 12 patients (44 percent) with equal to or greater than 30 percent shrinkage and eight patients (30 percent) with greater than or equal to 40 percent shrinkage.

Among the 50 patients evaluable for safety at time of analysis, the most common drug-related toxicities grade 3 or higher were fatigue (14 percent), neutropenia (12 percent), thrombocytopenia (10 percent) and anemia (6 percent).

In summary, the results from this ongoing trial suggest that single-agent MGCD0103 demonstrates significant anti-cancer activity in relapsed and refractory NHL (DLCBL and FL subtypes) and has a manageable side effect profile.

MGCD0103 Presentations at ASH

Oral Presentation:

- Phase I/II study of MGCD0103, an Oral Isotype-Selective Histone Deacetylase (HDAC) Inhibitor, in Combination with 5-azacitidine in Higher-Risk Myelodysplastic Syndrome (MDS) and Acute Myelogenous Leukemia (AML) (Abstract #444) - G. Garcia-Manero, M.D., MD Anderson Cancer Center; December 10, 2007, 2:45 pm; Georgia World Congress Center; Rooms A411-A412.

Poster Sessions:

- Poster #756-II: Isotype-selective HDAC Inhibitor MGCD0103 Decreases Serum TARC Concentrations and Produces Clinical Responses in Heavily Pretreated Patients with Relapsed Classical Hodgkin Lymphoma (HL) (Abstract #2566) -- A. Younes, M.D., MD Anderson Cancer Center; December 9, 2007; 10:30 am-7:00 pm; Presentation 5:00-7:00 pm; Georgia World Congress Center; Hall B4.

- Poster #761-II: Treatment of Relapsed or Refractory Lymphoma with the Oral Isotype-Selective Histone Deacetylase (HDAC) Inhibitor MGCD0103: Interim Results from a Phase II study (Abstract #2571) - A. Younes, M.D., MD Anderson Cancer Center; December 9, 2007;10:30 am-7:00 pm; Presentation 5:00-7:00 pm; Hall B4.

About MGCD0103

MGCD0103 is an orally-administered, isotype-selective HDAC inhibitor. The compound is currently in three Phase I/II clinical trials, in combination with Vidaza® for hematological malignances and with Gemzar® and Taxotere® in solid tumors; and in four Phase II monotherapy clinical trials in hematological malignancies.

About Hodgkin Lymphoma

Hodgkin lymphoma (HL) is a cancer of the lymphatic system that begins in the lymph nodes and progresses to other organs, including the lungs, liver, bone and bone marrow. It is characterized by the presence of Reed-Sternberg cells. Currently, there is no known cause of the disease, but epigenetic alterations including changes in histone acetylation, have been identified. In addition, the Epstein-Barr virus, HIV and familial history are known risk factors. The disease is slightly more prevalent in men than women, and the median age of diagnosis is 38.

About Diffuse Large B-Cell Lymphoma (DLBCL) and Follicular Lymphoma (FL)

DLBCL and FL, the two most common types of non-Hodgkin lymphoma (NHL), are cancers of the body's B-lymphocytes. These cells mature in the bone marrow and then migrate to different areas of the body. DLBCL is a relatively aggressive form of lymphoma that can spread rapidly in the body. Treatment usually requires intensive combination chemotherapy and often the addition of Rituximab. Autologous bone marrow transplantation is an option for patients who relapse, however this is only available for a select subset of patients. Retreatment with standard agents rarely results in cure for relapsed patients. FL is a less aggressive disease, but has a low cure rate and eventual progression with current therapeutic options. According to the American Cancer Society, there are approximately 59,000 new cases of non-Hodgkin lymphomas diagnosed each year in the U.S.; of these, approximately 18,000 are FL. DLBCL is the most common form of NHL lymphomas accounting for up to 30 percent of newly-diagnosed cases.

About MethylGene

MethylGene Inc. (TSX:MYG) is a publicly-traded biopharmaceutical company focused on the discovery, development and commercialization of novel therapeutics for cancer. The Company's lead product, MGCD0103, is an oral isotype-selective HDAC inhibitor presently in multiple clinical trials for solid tumors and hematological malignancies, including Phase II monotherapy and Phase 1/II combination trials with Vidaza®, Gemzar® and Taxotere®. MGCD265 is an oral kinase inhibitor targeting the c-Met, Tie-2, Ron and VEGF receptor tyrosine kinases. In addition, MethylGene has several preclinical programs: MGCD290 an HDAC inhibitor in combination with azoles for fungal infections; an HDAC program for Huntington's disease; and a sirtuins program for cancer. MethylGene's development and commercialization partners include Pharmion Corporation, Taiho Pharmaceutical and EnVivo Pharmaceuticals. Please visit our website at http://www.methylgene.com

About Pharmion

Pharmion is a leading global oncology company uniquely focused on acquiring, developing and commercializing innovative products for the treatment of hematology and oncology patients in the U.S., Europe and additional international markets. Pharmion has a number of products on the market including the world's first approved epigenetic drug, Vidaza®, a DNA demethylating agent. For additional information about Pharmion, please visit the company's website at http://www.pharmion.com.

Certain statements contained in this news release, other than statements of fact that are independently verifiable at the date hereof, may constitute forward-looking statements. Such statements, based as they are on the current expectations of management of MethylGene, inherently involve numerous risks and uncertainties, known and unknown, many of which are beyond MethylGene's control. These risks and uncertainties could cause future results, performance or achievements to differ significantly from the results, performance or achievements expressed or implied by such forward-looking statements. Such results, performance or achievements include, but are not limited to, the timing and effects of regulatory action; the continuation of collaborations; the impact of unilateral decisions and/or strategies of our collaborators; the results of clinical trials; the ability to demonstrate pharmacokinetic / bioequivalency; the timing of enrollment or completion of clinical trials; the success, efficacy or safety of MGCD0103, MGCD265 or MGCD290; the ability to scale up, formulate and manufacture sufficient GMP, clinical or commercialization quantities of MGCD0103, MGCD265 or MGCD290, and the relative success or the lack of success in developing and gaining regulatory approval and/or market acceptance for any compound or new product including MGCD0103, MGCD265 or MGCD290. Such risks include, but are not limited to, the impact of general economic conditions, economic conditions in the pharmaceutical industry, changes in the regulatory environment in the jurisdictions in which MethylGene does business, stock market volatility, fluctuations in costs, expectations with respect to our intellectual property position and our ability to protect our intellectual property and operate our business without infringing upon the intellectual property rights of others, changes in the competitive landscape including changes in the standard of care for the various indications in which MethylGene is involved, and changes to the competitive environment due to consolidation, as well as other risks, which you are urged to read, as described in MethylGene's Annual Information Form for the fiscal year ending December 31, 2006, under the heading 'risk factors,' the final prospectus filed on February 23, 2007, and all other documents filed by the Company that can be found at www.sedar.com. Consequently, actual future results may differ materially from the anticipated results expressed in the forward-looking statements. The reader should not place undue reliance on the forward-looking statements included in this presentation. These statements speak only as an update on the date they are made and MethylGene is under no obligation to revise such statements as a result of any event, circumstance or otherwise except in accordance with law.

Contact Information

  • MethylGene Inc.
    Rhonda Chiger
    Rx Communications Group, LLC
    917-322-2569
    rchiger@rxir.com
    or
    MethylGene Inc.
    Donald F. Corcoran
    President & CEO
    514-337-3333 ext. 373
    mctavishk@methylgene.com
    www.methylgene.com
    or
    Pharmion Corporation
    Breanna Burkart
    Director, Investor Relations and Corporate Communications
    720-564-9144
    bburkart@pharmion.com
    or
    Pharmion Corporation
    Anna Sussman
    Director, Investor Relations and Corporate Communications
    720-564-9143
    asussman@pharmion.com
    www.pharmion.com
    or
    Pharmion On-Site Media Contacts:
    Hal Mackins
    Ogilvy Public Relations, US
    415-994-0040
    or
    Joanne Wunder
    Ogilvy Public Relations, EU
    +44-7801-082-574