NMT2

Pacylex Granted FDA Fast Track Designation for PCLX-001 for the Treatment of Relapsed or Refractory Acute Myeloid Leukemia

Retrieved on: 
Tuesday, November 22, 2022

Edmonton, Alberta--(Newsfile Corp. - November 22, 2022) - Pacylex, a clinical-stage N-myristoyltransferase (NMT) inhibitor company developing first-in-class therapies for leukemia, lymphoma, and solid tumor cancers, today announced that the U.S. Food and Drug Administration (FDA) has granted PCLX-001 Fast Track Designation for the treatment of adult patients with relapsed or refractory acute myeloid leukemia (AML).

Key Points: 
  • Edmonton, Alberta--(Newsfile Corp. - November 22, 2022) - Pacylex, a clinical-stage N-myristoyltransferase (NMT) inhibitor company developing first-in-class therapies for leukemia, lymphoma, and solid tumor cancers, today announced that the U.S. Food and Drug Administration (FDA) has granted PCLX-001 Fast Track Designation for the treatment of adult patients with relapsed or refractory acute myeloid leukemia (AML).
  • PCLX-001 is a first-in-class N-myristoyltransferase inhibitor which inhibits signaling necessary for cancer cell proliferation and survival in leukemia and lymphoma.
  • PCLX-001 is currently in clinical studies at 4 hospitals in Canada in non-Hodgkin Lymphoma and solid tumor patients.
  • Pacylex is developing PCLX-001 in the form of a once-a-day pill initially to treat leukemia and lymphoma.

Pacylex Will Present Phase 1 Clinical Experience with PCLX-001 and Rationale for Expanding into Acute Myeloid Leukemia Patients at ASH 2022

Retrieved on: 
Thursday, November 3, 2022

The ongoing study is in Non-Hodgkin's Lymphoma and solid tumor patients and the company will present the non-clinical evidence that AML patients may benefit as well.

Key Points: 
  • The ongoing study is in Non-Hodgkin's Lymphoma and solid tumor patients and the company will present the non-clinical evidence that AML patients may benefit as well.
  • Pacylex non-clinical data which strongly supports expanding clinical investigations of PCLX-001 to acute myeloid leukemia (AML) will be presented at the American Society of Hematology Annual Meeting.
  • PCLX-001 safety experience in 17 lymphoma and solid tumor patients provides confidence to proceeding with a second clinical indication in AML.
  • Pacylex initiated clinical studies in Canada in the fall of 2021 in non-Hodgkin lymphoma and solid tumors and will soon initiate clinical studies in the US in acute myeloid leukemia patients.

Pacylex Announces FDA Clearance of IND Application for PCLX-001 to Treat Acute Myeloid Leukemia

Retrieved on: 
Wednesday, November 2, 2022

Edmonton, Alberta--(Newsfile Corp. - November 2, 2022) - Pacylex, a clinical-stage NMT inhibitor company developing first-in-class therapies for leukemia, lymphoma, and solid tumor cancers, today announced that the U.S. Food and Drug Administration (FDA) has cleared the Investigational New Drug (IND) application for PCLX-001 for the treatment of acute myeloid leukemia (AML).

Key Points: 
  • Edmonton, Alberta--(Newsfile Corp. - November 2, 2022) - Pacylex, a clinical-stage NMT inhibitor company developing first-in-class therapies for leukemia, lymphoma, and solid tumor cancers, today announced that the U.S. Food and Drug Administration (FDA) has cleared the Investigational New Drug (IND) application for PCLX-001 for the treatment of acute myeloid leukemia (AML).
  • The company received FDA Orphan Drug Designation for PCLX-001 in AML and will launch its Phase 1 study in the next quarter.
  • Pacylex is developing PCLX-001 in the form of a once-a-day pill initially to treat leukemia and lymphoma.
  • Pacylex is a pharmaceutical company headquartered in Edmonton, Alberta, Canada, targeting hematologic and solid cancers with a new first-in-class therapeutic, PCLX-001.

Pacylex Announces Orphan Drug Designation Granted to PCLX-001 for the Treatment of Acute Myeloid Leukemia

Retrieved on: 
Friday, October 14, 2022

Edmonton, Alberta--(Newsfile Corp. - October 14, 2022) - Pacylex today announced that the U.S. Food and Drug Administration (FDA) granted PCLX-001 Orphan Drug Designation for "treatment of patients with acute myeloid leukemia."

Key Points: 
  • Edmonton, Alberta--(Newsfile Corp. - October 14, 2022) - Pacylex today announced that the U.S. Food and Drug Administration (FDA) granted PCLX-001 Orphan Drug Designation for "treatment of patients with acute myeloid leukemia."
  • PCLX-001 is currently being studied in non-Hodgkin lymphoma (NHL) and solid tumor cancer patients at 4 sites in Canada.
  • Pacylex has filed an IND to study PCLX-001 in the U.S. in AML patients.
  • PCLX-001 is the lead drug in a new class of NMT inhibitors, enabling Pacylex to exploit NMTs as new clinical targets for cancer treatment.

Major Grant Awarded to Study PCLX-001 in Acute Myeloid Leukemia Patients

Retrieved on: 
Tuesday, October 11, 2022

PCLX-001 is being studied in non-Hodgkin lymphoma (NHL) and solid tumor cancer patients at 4 clinical sites in Canada.

Key Points: 
  • PCLX-001 is being studied in non-Hodgkin lymphoma (NHL) and solid tumor cancer patients at 4 clinical sites in Canada.
  • This investigation will be the first of an N-myristoyl transferase (NMT) inhibitor, PCLX-001, in AML patients.
  • This clinical study is the culmination of work done in AML (Acute Myeloid Leukemia) animal models for years combining insights on the role myristoylation may play in cancer with an NMT inhibitor Pacylex licensed for exclusive development.
  • This study in AML patients at MD Anderson will be the first clinical study of PCLX-001 in the US.

Pacylex Presents Evidence Supporting Advancement of PCLX-001 for Treatment of AML at AACR 2022

Retrieved on: 
Friday, April 8, 2022

The poster details are below:

Key Points: 
  • The poster details are below:
    To view the full announcement, including downloadable images, bios, and more, click here .
  • New data on PCLX-001 being presented at American Association for Cancer Research (AACR) Annual Meeting.
  • Pacylex is a pharmaceutical company targeting hematologic and solid cancers with a new first-in-class therapeutic, headquartered in Edmonton, Alberta, Canada.
  • PCLX-001 is the lead drug in a new class of NMT inhibitors, enabling Pacylex to exploit NMTs as new clinical targets for cancer treatment.

Pacylex Pharmaceuticals Announces Publication in Current Oncology of First Clinical Experience with an N-myristoyltransferase (NMT) inhibitor in a Patient with Diffuse Large B-cell Lymphoma (DLBCL)

Retrieved on: 
Monday, March 14, 2022

This Phase 1 study is primarily intended to determine the safety of PCLX-001 at escalating doses.

Key Points: 
  • This Phase 1 study is primarily intended to determine the safety of PCLX-001 at escalating doses.
  • Pacylex is developing PCLX-001 in the form of a once-a-day pill initially to treat leukemia and lymphoma.
  • Pacylex is a pharmaceutical company targeting hematologic and solid cancers with a new first-in-class therapeutic, headquartered in Edmonton, Alberta, Canada.
  • Pacylex initiated clinical studies in Canada in the fall of 2021 in diffuse large B-cell lymphoma and solid tumors.

Pacylex Presented Initial Clinical Experience With PCLX-001 in Patients at ASH 2021

Retrieved on: 
Monday, December 13, 2021

Edmonton, Alberta--(Newsfile Corp. - December 13, 2021) - Pacylex today announced that data from the first ever clinical trial of an N-myristoyltransferase (NMT) inhibitor was presented at the American Society of Hematology (ASH) Annual Meeting and Exposition from 11-14 December 2021.

Key Points: 
  • Edmonton, Alberta--(Newsfile Corp. - December 13, 2021) - Pacylex today announced that data from the first ever clinical trial of an N-myristoyltransferase (NMT) inhibitor was presented at the American Society of Hematology (ASH) Annual Meeting and Exposition from 11-14 December 2021.
  • This update included the design of the first clinical trial with PCLX-001 in Non-Hodgkin's Lymphoma and solid tumor patients and an update on the first dose cohort.
  • This presentation included the design of the first clinical trial with PCLX-001 in Non-Hodgkin's Lymphoma and solid tumor patients and an update on the first dose cohort.
  • Pacylex initiated clinical studies in Canada in the fall of 2021 in diffuse large B-cell lymphoma and solid tumors.

NobleStitchâ„¢ EL Again Expands Global Base With New Center In Ireland

Retrieved on: 
Thursday, October 11, 2018

BELFAST, Ireland, Oct. 11, 2018 /PRNewswire/ --NMT2 is excited to announce its expansion of NobleStitch EL into the Irish market with first series of PFO closure cases in Belfast, Ireland.

Key Points: 
  • BELFAST, Ireland, Oct. 11, 2018 /PRNewswire/ --NMT2 is excited to announce its expansion of NobleStitch EL into the Irish market with first series of PFO closure cases in Belfast, Ireland.
  • After becoming aware of the NobleStitch EL suture-based technology, he reached out to Professor Anthony Nobles, the Inventor of the NobleStitch EL and Chairman, CEO and Chief Clinical Officer of NMT2, to arrange the first cases to be performed in Ireland.
  • The NobleStitch EL offers an alternative to using an umbrella-type device in the heart."
  • They were very enthusiastic about the NobleStitch EL and have already scheduled their next set of cases.