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LONDON, UK / ACCESSWIRE / October 31, 2017 / Pro-Trader Daily takes a look at the latest corporate events and news making the headlines for Epizyme, Inc. (NASDAQ: EPZM), following which we have published a free report that can be viewed by signing up at http://protraderdaily.com/optin/?symbol=EPZM. The Company presented positive data from the dose escalation portion of the Company's ongoing Phase-1 clinical trial of tazemetostat in pediatric patients with relapsed or refractory INI1-negative molecularly defined solid tumors at the 2017 AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics. For immediate access to our complimentary reports, including today's coverage, register for free now at:
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Phase-1 Clinical Trial of Tazemetostat
Phase-1 clinical trial of tazemetostat is an open-label, multi-dose, multi-center study comprising of dose escalation and expansion parts. The dose escalation study was conducted in 46 patients aged six months to 21 years with INI1-negative tumors including epithelioid sarcoma, poorly differentiated chordoma, atypical teratoid rhabdoid tumors, malignant rhabdoid tumors, renal medullary carcinoma or relapsed/refractory synovial sarcoma. The oral suspension of tazemetostat was administered twice daily in continuous 28-day cycles in various doses.
Results of the Study
Tazemetostat was generally well-tolerated at all explored doses. Adverse events like vomiting, pyrexia, headache, and nausea were reported. Only one patient experienced a dose-limiting toxicity event at the dose level of 300mg/m2. One patient discontinued the study due to treatment-related adverse effects and five patients had dose reductions. Tazemetostat showed encouraging anti-tumor activity across a range of INI1-negative cancers in pediatric patients.
Epizyme is Encouraged by the Potential of Tazemetostat
Peter Ho, M.D., Ph.D., Chief Medical Officer of Epizyme, stated that the results from the dose escalation portion of the study support the potential of tazemetostat to treat INI1-negative cancers, in both the pediatric and adult treatment settings. Peter added that the Company is encouraged by the potential of tazemetostat to benefit a patient population with such a significant unmet medical need.
FDA Granted Fast Track Designation to Tazemetostat for Treatment of Patients with Relapsed/Refractory Follicular Lymphoma
On April 25, 2017, the US Food and Drug Administration (FDA) granted Fast Track designation to tazemetostat for the treatment of patients with relapsed or refractory follicular lymphoma, either wild type EZH2 or with EZH2 activating mutations.
FDA also granted Orphan Drug designation to tazemetostat, for the treatment of patients with soft tissue sarcoma (STS) on June 21, 2017.
About Tazemetostat Clinical Trial Program
Tazemetostat is currently being studied in ongoing Phase-2 programs in both follicular lymphoma and diffuse large B-cell lymphoma (DLBCL) forms of non-Hodgkin lymphoma, certain molecularly defined solid tumors, including epithelioid sarcoma and other INI1-negative tumors, and mesothelioma as well as in combination studies in DLBCL.
What is Tazemetostat?
Tazemetostat is an orally administered, first-in-class small molecule EZH2 inhibitor for the treatment of multiple types of hematological malignancies and genetically defined solid tumors. In early clinical development, tazemetostat has demonstrated clinical activity and well-tolerated safety profile in both patients with hematological malignancies and genetically defined solid tumors.
About Epizyme, Inc.
Founded in 2007, Epizyme is a clinical stage biopharmaceutical Company creating novel epigenetic therapies for people with cancer. The Company is broadly developing its lead product candidate, tazemetostat, with studies underway in both solid tumors and hematological malignancies, as a monotherapy and combination therapy and in relapsed and front-line disease. Epizyme is headquartered in Cambridge, Massachusetts.
Last Close Stock Review
At the closing bell, on Monday, October 30, 2017, Epizyme's stock rose slightly by 0.90%, ending the trading session at $16.80. A total volume of 428.11 thousand shares have exchanged hands. The Company's stock price skyrocketed 40.00% in the last three months and 83.61% in the previous twelve months. Moreover, the stock soared 38.84% since the start of the year. The stock currently has a market cap of $1.10 billion.
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