Nov. 6, 2014, 12:35 PM
- Thinly-traded micro cap Epizyme (EPZM -17.4%) gets the rude treatment today in response to its report of preliminary Phase 1 results for EPZ-5676, a selective inhibitor of the DOT1L histone methyltransferase, for the treatment of acute leukemia with alterations in the MLL gene (MLL-r) or partial tandem duplications within MLL.
- Of the 28 subjects evaluable for efficacy, two MLL-r patients in the 54 mg/m2 cohort achieved complete responses. These were the same two patients Epizyme reported on in January.
- Biological activity was observed in several patients who experienced resolution of cutaneous leukemia or leukemia cell differentiation effects. The majority of subjects did not exhibit an observable therapeutic effect from the drug.
- Chief Development Officer Peter Ho, M.D., Ph.D,, says the company is pleased with the safety profile of EPZ-5676 and the two complete responses.
Jan. 7, 2014, 12:46 PM
Jan. 7, 2014, 9:16 AM
Jan. 7, 2014, 8:02 AM
- Epizyme (EPZM) rallies 32% (low volume) in premarket action.
- Monday evening, the company reported that it has achieved the "POC milestone in the EPZ-5676 DOT1L inhibitor clinical program," an event which triggers a $25M payment from partner Celgene (CELG).
- Objective responses in patients with translocations of the MLL-r observed in the fourth dose cohort of an ongoing Phase 1 study were the triggering event.
- Additionally, the company says "a development candidate milestone has been achieved for one of the three HMT targets included" in the GlaxoSmithKline (GSK) partnership, triggering another $4M milestone payment.
- 2013 end-of-year cash now seen at $145M versus $115M previous. (PR)
Nov. 14, 2013, 12:45 PM
Nov. 14, 2013, 10:20 AM
- Shares of Epizyme (EPZM -34.3%) sink after the company outlines initial findings from a Phase 1 study of EPZ-5676 in heavily pre-treated advanced hematological malignancies.
- EPZM says the treatment has been well-tolerated with no dose-limiting toxicities. There was one adverse event-related treatment discontinuation, but the company says it wasn't related to the drug.
- Treatment effect observed in four of eight MLL-r acute leukemia patients.
- No treatment effects observed in non-MLL-r patients.
- The company now plans to initiate a Phase 1 "MLL-r only expansion stage with an 80 mg/m2/day administration schedule without a drug holiday and with possible continued dose escalation." (PR)
Aug. 16, 2013, 12:03 PM
- Epizyme (EPZM +3.3%) receives an FDA orphan drug designation for EPZ-5676, its treatment for acute leukemia.
- EPZ-5676 is a small molecule inhibitor of DOT1L created to treat acute leukemias in which the MLL gene is rearranged due to a chromosomal translocation.
- Due to the translocation, DOT1L is routed to specific locations in the chromosome where it wouldn't normally be present. As a result, it causes inappropriate methylation at these locations, which results in the increased expression of genes causing leukemia.
Jul. 16, 2013, 12:41 PM
Jun. 27, 2013, 11:13 AMEpizyme (EPZM +2.4%) trades higher after Wedbush's Greg Wade ramps up coverage with an Outperform rating and a $37 price target. Wade says that advances in genetically defining sub-sets of cancer patients have led to identifying certain histone methyltransferase proteins as key malignant drivers, and EPZM's small molecule drug discovery platform is key to marrying these antagonists with the genetically definable malignancy. | Comment!
Jun. 13, 2013, 11:20 AMEpizyme (EPZM -3.6%) announces that its first patient has been enrolled in a Phase 1/2 clinical trial of EPZ-6438, an orally administered, small molecule inhibitor for non-Hodgkin lymphoma. The drug is being developed in partnership with Eisai (ESALY.PK), and as a result of EPZM's first patient enrollment, it's earned a $6M milestone payment from Eisai. | Comment!
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