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MethylGene Presents Clinical Data on Mocetinostat at the 2013 American Society of Clinical Oncology Annual Meeting


6/3/2013 9:54:26 AM

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Montreal, Canada, June 3, 2013 – MethylGene Inc. (TSX:MYG) today announced that clinical data for mocetinostat, the spectrum selective histone deacetylase (HDAC) inhibitor, was presented at the 2013 ASCO Annual Meeting in Chicago, Illinois.

Abstract #7116 – Poster – A Phase II Study of Mocetinostat, An Oral Isotope-Specific Histone Deacetylase (HDAC) Inhibitor, in Combination with 5-Azacitidine in Patients with Myelodysplastic Syndrome (MDS)

Data was presented from an open-label phase II combination trial in patients with MDS or acute myeloid leukemia (AML). The population included twenty-eight MDS patients who were categorized as relatively poor risk and thirty-eight AML patients. The Objective Response Rate (ORR) (defined as Complete Response (CR) + Complete Response with incomplete blood count recovery (CRi) + Hematological Improvement (HI)) was 61% in the MDS cohorts and 32% in the AML patients and the disease control rate (ORR + stable disease) was 93% in the MDS group and 84% in the AML patients. Two thirds of both MDS and AML patients remained progression free while on study. Among the confirmed highest-risk category of MDS patients, 64% achieved a best response of CR or CRi. Reductions in bone marrow blasts that continued to improve in successive treatment cycles were achieved in MDS and AML patients treated with the combination of mocetinostat and 5-azacitidine. The most common drug-related toxicities of grade 3 or higher were fatigue, thrombocytopenia, anemia and gastrointestinal events.

Abstract #8535 – Poster – A Phase II Study of Single Agent Mocetinostat, An Oral Isotype-Selective Histone Deacetylase (HDAC) Inhibitor, In Patients With Diffuse Large B-Cell (DLBCL) And Follicular (FL) Lymphomas:

In a poster discussion session, data was presented from an open label multicenter mocetinostat monotherapy trial in a population of seventy-two patients treated with 70 mg – 110 mg mocetinostat monotherapy on a 3x/week schedule. The ORR was 17% in the DLBCL cohort and 10% in the FL group. The disease control rate (defined as ORR plus patients with stable disease at first scan) was 49% in the DLBCL patients and 61% in the FL cohort. The most common drug-related toxicities of grade 3 or higher were fatigue, neutropenia, thrombocytopenia, anemia and hypophosphatemia.

“The data generated from 13 clinical trials with 440 patients treated, support the view that mocetinostat has clinical activity as monotherapy and in combination and that further evaluation is warranted” said Dr. Charles Baum, President and Chief Executive Officer. “I believe there is untapped value in the program and we are working with our investigators and the FDA to establish the optimal path forward for mocetinostat.”

The ASCO posters are available on our website at http://methylgene.com/pipeline-myg/mocetinostat/mocetinostat-posters-publications.

About Mocetinostat

Mocetinostat is an orally available, isoform selective histone deacetylase, or HDAC, inhibitor that has been evaluated over 400 patients in multiple Phase I and Phase II clinical trials for the treatment of hematological malignancies and solid tumors. Based on the promising early phase single agent responses in patients with Hodgkin’s disease we are evaluating Phase II study designs in these patients. In addition, we are evaluating plans for development of this agent in combination with azacitidine for the treatment of patients with intermediate and high risk myelodysplastic syndromes, or MDS. Prognosis for the intermediate and high-risk category of MDS patients is poor and there is a need for treatments that will improve clinical outcomes. Mocetinostat is partnered with Taiho Pharmaceutical for selected Asian Territories.

About MethylGene

MethylGene is a publicly-traded biopharmaceutical company engaged in the development and commercialization of novel therapeutics for the treatment of cancer. Our compounds result from internal chemistry efforts targeting the active sites of enzymes that are key drivers of tumor growth. Our clinical development programs are focussed on treating selected tumor types that express high levels of these targets in order to most effectively address unmet patient needs. Our lead program in clinical development is MGCD265, a multi-targeted small molecule kinase inhibitor for treatment of oncology patients with solid tumors. We are also evaluating development opportunities in oncology for mocetinostat, a spectrum-selective HDAC inhibitor and MGCD516, a kinase inhibitor with a distinct target profile.

Investor Relations Contact:

MethylGene, Inc.

Mark J. Gergen

Executive Vice President & COO

Phone: 858-546-2902

Tracey Rowlands, Ph.D.

Manager Business and Corporate Development

Phone: 514-337-3333 ext. 512

ir@methylgene.com

www.methylgene.com

Michael Wood

Managing Director

LifeSci Advisors

Phone: 646-597-6983

mwood@lifesciadvisors.com

www.lifesciadvisors.com

Notice to Investors

This news release is for informational purposes only and is not an offer to buy or the solicitation of an offer to sell any securities.

Forward Looking Statements

Certain statements contained in this news release, other than statements of fact that are independently verifiable at the date hereof, may constitute forward-looking information and forward-looking statements (collectively “forward-looking statements” within the meaning of applicable securities laws). Such statements, based as they are on the current expectations of management of MethylGene and upon what management believes to be reasonable assumptions based on information currently available to it, inherently involve numerous risks and uncertainties, known and unknown, many of which are beyond MethylGene’s control. Such statements can usually be identified by the use of words such as “may”, “would”, “believe”, “intend”, “plan”, “anticipate”, “estimate” and other similar terminology, or state that certain actions, events or results “may” or “would” be taken, occur or be achieved. Any such forward-looking statements are based on information currently available to us, and are based on assumptions and analyses made by us in light of our experience and our perception of historical trends, current conditions and expected future developments, as well as other factors that MethylGene believes are appropriate in the circumstances.

However, whether actual results and developments will conform with our expectations and predictions is subject to a number of risks, assumptions and uncertainties, many of which are beyond our control, and the effects of which can be difficult to predict. In evaluating any forward-looking statements in this news release, MethylGene cautions readers not to place undue reliance on any forward-looking statements. Readers should specifically consider the various factors which could cause actual events or results to differ materially from those indicated by our forward-looking statements. Unless otherwise required by applicable securities laws, MethylGene does not intend, nor does it undertake any obligation, to update or revise any forward-looking statements contained in this news release to reflect subsequent information, events, results or circumstances or otherwise.



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