CuraGen and TopoTarget Initiate Phase I Trial of PXD101 in Patients with Hematologic Cancer
Wednesday June 30, 6:30 am ET
NEW HAVEN, Conn., June 30 /PRNewswire-FirstCall/ -- CuraGen Corporation (Nasdaq: CRGN - News) and TopoTarget A/S announced today the initiation of a Phase I clinical trial to evaluate PXD101, one of the most advanced histone deacetylase (HDAC) inhibitors in development, in patients with hematologic cancer. Given that PXD101 may play a role as a treatment for hematologic as well as solid cancers, this Phase I trial complements the ongoing Phase I study in cancer patients with solid tumors initiated in 2003.
"We are excited by the initiation of a second Phase I for PXD101 as we look to explore the full potential of this promising cancer treatment," stated Timothy M. Shannon M.D., Executive Vice President of Research and Development and Chief Medical Officer at CuraGen.
Jonathan M. Rothberg, Ph.D., CuraGen's Chief Executive Officer, President and Chairman further added, "CuraGen is undergoing a value inflection as we continue to build clinical momentum to transition PXD101 and CG53135 to Phase II, CR002 to Phase I, and advance additional products from our pipeline toward clinical development."
This PXD101 Phase I trial in patients with hematological cancer is a dose- escalating, open-label study and is expected to enroll approximately 15 patients. The trial will be conducted under the supervision of Peter Gimsing, M.D., in the Department of Hematology at Copenhagen University Hospital. The study will evaluate the safety and potential activity in patients with hematologic malignancies. The initial Phase I trial has similar study objectives but is focused in patients with solid tumors.
About PXD101
PXD101 is a Phase I HDAC inhibitor being investigated for the treatment of various solid and hematologic cancers. PXD101 is one of the most advanced HDAC inhibitors in development and has been shown in preclinical studies to have a favorable therapeutic window based on PXD101's targeted activity on cancer cells versus normal cells. PXD101 will be investigated for its role in the treatment of a wide range of solid and hematologic malignancies either as a monotherapy, or in combination with other active anti-cancer agents.
An initial multicenter Phase I trial of PXD101 is ongoing at The Royal Marsden Hospital (London and Surrey, UK) and the Beatson Oncology Centre (Glasgow Scotland). A total of 24 to 36 patients with advanced solid tumors may be enrolled in this study in order to evaluate the safety, pharmacokinetic, and pharmacodynamic response to PXD101.
About HDAC inhibitors
A growing body of research highlights the role of HDAC in regulating gene expression, particularly the expression of cancer-related genes. HDAC inhibitors represent a new mechanistic class of anti-cancer therapeutics that target HDAC enzymes, and have been shown to: arrest growth of cancer cells (including drug resistant subtypes); induce apoptosis, or programmed cell death; promote differentiation; inhibit angiogenesis; and sensitize cancer cells to overcome drug resistance phenotype when used in combination with other anti-cancer agents. HDAC inhibitors are believed to play a role in a wide range of solid malignancies such as breast, colon, lung and ovarian cancers, and hematological malignancies, such as lymphomas, leukemias and myeloma. The current global oncology therapeutic market is estimated to be worth over $20 billion.
About TopoTarget
TopoTarget is a British/Danish biopharmaceutical company dedicated to the discovery, development and clinical progression of new and improved therapeutics for the cancer patient. The Company results from the merger of TopoTarget A/S, the Danish oncology company and Prolifix Ltd, the UK-based cell cycle company. TopoTarget develops and markets novel pharmaceuticals and aims to identify new indications for existing compounds. It applies its precise and in-depth understanding of the molecular mechanisms of cancer with its wide experience in clinical oncology practice to develop new and effective medicines to combat the disease. TopoTarget has three products in its clinical pipeline including: TopoTect® which is currently in Phase III clinical trials for the prevention of severe tissue damage following accidental chemotherapeutic extravasation, TopoTect®/etoposide as co-therapy for treating brain metastasis, and PXD101, one of the leading HDAC inhibitors in clinical development. The Company recently received the City of Copenhagen Enterprise Award in recognition of its work to develop TopoTect®. TopoTarget is based in Copenhagen, Denmark and Oxford, UK. For more information refer to topotarget.com. |
