Sign in Subscribe
Pharmaceutical industry

CuraGen and TopoTarget Initiate Clinical Trial of PXD101 for Advanced Hematologic Malignancies

Strategic Insights

— 1 min read

CuraGen Corporation and TopoTarget A/S have initiated a Phase I clinical trial to evaluate the safety and tolerability of PXD101, a small molecule histone deacetylase (HDAC) inhibitor, in combination with azacitidine for the treatment of advanced hematologic malignancies. The trial is sponsored by the National Cancer Institute under a Clinical Trials Agreement with CuraGen, and aims to establish the maximum tolerated dose (MTD) and safety profile of PXD101 in combination with azacitidine for patients with advanced hematologic cancers.

Key Takeaways:

  • The Phase I trial is an open-label, dose-escalation study enrolling up to 15 patients with advanced hematologic cancers, including relapsed or refractory acute myelogenous leukemia (AML), acute lymphoblastic leukemia (ALL), chronic myelogenous leukemia (CML), or myelodysplastic syndromes (MDS).
  • Patients will receive PXD101 and azacitidine in continuous four-week cycles until disease progression.
  • The study will determine whether there is additive or synergistic activity of PXD101 in combination with azacitidine by evaluating pharmacodynamic endpoints.
  • PXD101 is a promising small molecule HDAC inhibitor being investigated for its role in treating a wide range of solid and hematologic malignancies.
  • The HDAC inhibitors represent a new mechanistic class of anti-cancer therapeutics that target HDAC enzymes and have been shown to induce apoptosis, promote differentiation, inhibit angiogenesis, and sensitize cancer cells to other anti-cancer agents.
  • PXD101 is currently being evaluated in multiple clinical trials as a potential treatment for multiple myeloma, T-cell lymphoma, and colorectal and ovarian cancers.

Statistics:

  • Up to 17 patients will be enrolled in the study, including the initial 15 with advanced hematologic cancers and 18 additional patients with MDS or AML.
  • The trial aims to establish the maximum tolerated dose (MTD) of PXD101 in combination with azacitidine.
  • PXD101 is being investigated as a potential treatment for multiple myeloma, T-cell lymphoma, and colorectal and ovarian cancers.

Sources:

  • Health & Medicine Week editors, via NewsRx.com, "CuraGen and TopoTarget Initiate Phase I Clinical Trial of PXD101" (2006)
  • CuraGen Corporation press release, "CuraGen and TopoTarget Announce Initiation of Clinical Trial Evaluating PXD101 and Azacitidine in Combination" (undated)

Read more