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METHYLGENE INITIATES PHASE II CLINICAL TRIAL WITH PROPRIETARY HDAC INHIBITOR, MGCD0103, IN B-CELL LYMPHOMA
Montreal, Quebec. September 15, 2006 - MethylGene Inc. (TSX: MYG), a biopharmaceutical company focused on developing products for the treatment of cancer, along with its partner Pharmion Corporation (NASDAQ: PHRM) today announced the initiation of a Phase II clinical trial with its lead histone deacetylase (HDAC) inhibitor product candidate, MGCD0103, in patients with relapsed or refractory B-cell lymphomas. Specific patient populations include patients with diffuse large B-cell lymphoma (DLBCL) and follicular lymphoma, two tumor types that are classified as non-Hodgkin’s lymphomas (NHL). The first patient was enrolled at MD Anderson Cancer Center, where Dr. Anas Younes is the principal investigator.
This open-label, single-agent trial (Trial 008) will enroll up to 82 patients with DLBCL or follicular lymphoma for whom other treatments have failed or whose disease has relapsed. The trial will be conducted at several leading cancer centers in North America. MGCD0103 will be given orally, three times per week without interruption at a flat dose of 110 mg. This dose was determined based on safety and efficacy data from the companies’ Phase I hematologic malignancy study. Key objectives of the study will be to determine the effectiveness of MGCD0103 as a treatment option for these patients. Secondary objectives include determining the safety profile, as well as assessing biomarkers and predictive markers for MGCD0103. The trial is expected to last up to 24 months.
Many cases of DLBCL and follicular lymphoma exhibit disrupted HDAC-dependent epigenetic regulation of cancer-related genes. Small molecule HDAC inhibitors are thought to have anticancer activity by regulating aberrant gene expression and restoring gene expression to normal levels. In addition, recent scientific literature has reported clinical activity against DLBCL as a result of HDAC inhibition.
“The initiation of this trial further expands our HDAC program in cancer,” said Donald F. Corcoran, President and Chief Executive Officer of MethylGene. “MGCD0103 is currently being evaluated in several clinical trials for solid tumors and hematological cancer as a single-agent or in combination with approved agents. With our partners Pharmion and Taiho, we look forward to initiating several additional clinical trials with the compound by the end of the year.”
“HDAC inhibition represents a novel mechanism for treatment of non-Hodgkin's lymphoma since key targets such as BCL-2 and BCL-6 have been shown to be regulated by HDAC,” commented Dr. Michael Crump, Associate Professor of Medicine, University of Toronto Lymphoma Site Leader at Princess Margaret Hospital and principal investigator for this trial. “Preclinical and clinical data support the use of HDAC inhibitors in lymphoma. In addition, because of the difficulty in treating non-Hodgkin’s lymphoma, there is a need for novel oral agents that could be used either alone or possibly in combination with current treatments."
About MGCD0103, an Oral HDAC Inhibitor
MGCD0103 is a rationally designed, oral, isotype-selective HDAC inhibitor. In addition to the clinical trial noted above, MethylGene and Pharmion continue to enroll patients in a Phase I single-agent trial evaluating MGCD0103 on a twice weekly oral schedule (Trial 004), a Phase I/II combination trial with demethylating agent Vidaza® (azacitidine for injectable suspension, marketed by Pharmion) in patients with advanced myelodysplastic syndrome (MDS) or acute myelogenous leukemia (AML) (Trial 005), and in a Phase II single-agent trial in patients with refractory or relapsed Hodgkin’s lymphoma (Trial 010). The Companies previously completed enrollment in three Phase I trials (Trials 001, 002, 003) with MGCD0103 in solid tumors or MDS/AML and expect to embark on additional single-agent and/or combination trials in solid and hematological cancers.
About Diffuse Large B-Cell Lymphoma (DLBCL) and Follicular Lymphoma
Lymphoma occurs when there is DNA damage to a lymphocyte (white blood cell) that causes an increased production of proteins that prevents the cells from dying when they should (programmed cell death) or, causes rapid cell division. These malignant cells can accumulate to form tumors or spread to other areas of the body via the lymphatic system. Lymphomas are grouped into two categories: Hodgkin’s lymphoma and non-Hodgkin’s lymphoma. DLBCL and follicular lymphoma, the two most common types of non-Hodgkin’s lymphoma, 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, which fails for approximately 50 percent of patients within two years. 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.
Follicular lymphoma is a less aggressive disease, but has a low cure rate and eventual progression with current therapeutic options. Because of this, many physicians delay treatment until a patient is symptomatic. Standard therapy includes IV treatment with rituximab with or without an agent such as fludarabine or 2-chlorodeoxyadenosine. Combination intraveneous chemotherapy or oral alkylating agents have also been used. According to the American Cancer Society, there are approximately 58,870 new cases of non-Hodgkin’s lymphomas diagnosed each year in the U.S; of these, approximately 18,300 are follicular lymphoma. DLBCL is the most common form of NHL accounting for about 30% of all lymphomas.
About MethylGene
MethylGene is a publicly-traded biopharmaceutical company focused on the discovery, development and commercialization of novel therapeutics in cancer. Two cancer product candidates are currently in clinical trials: MGCD0103, partnered with Pharmion Corporation and Taiho Pharmaceutical Co., Ltd., and MG98, partnered with MGI Pharma, Inc. MethylGene has an exclusive license agreement with Merck & Co. for the development and commercialization of small molecule beta-lactamase inhibitors to overcome antibiotic resistance. MethylGene has partnered its non-oncology HDAC program for neurodegenerative diseases with EnVivo Pharmaceuticals. MethylGene has a portfolio of preclinical programs for its multi-targeted kinase and histone deacetylase (HDAC) inhibitors for both oncology and non-oncology indications, and continues to seek partnering opportunities in these areas. Please visit our website at www.methylgene.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 results of clinical trials; the timing of enrollment or completion of clinical trials; the success, efficacy or safety of MGCD0103 or MG98; 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 and MG98. 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, 2005, under the heading "risk factors,” 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.
Investor Relations Contacts
Rhonda Chiger
Rx Communications Group, LLC
Phone: 917-322-2569
rchiger@rxir.com
Donald F. Corcoran
President & CEO
MethylGene Inc.
Phone: 514-337-3333 ext. 373
mctavishk@methylgene.com
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