CAMBRIDGE, Mass., April 26, 2011 /PRNewswire/ -- Tarix Pharmaceuticals (www.tarixpharma.com) today announced enrollment of the first patient in a Phase 1 clinical study of TXA127, a pharmaceutical grade formulation of a naturally occurring peptide known to stimulate early hematopoietic precursor cells in the bone marrow. The study will evaluate the safety of TXA127 following double cord blood stem cell transplant (DCBT) in adult patients with hematological cancers. The study will also compare the time to engraftment for patients receiving TXA127 to that of historical controls in order to assess the efficacy of TXA127 in speeding up the engraftment process.
Umbilical cord blood-derived stem cells offer increased flexibility in the degree of human leukocyte antigen (HLA) matching required for transplantation and are a critical source of donor cells for patients for whom a source of immunologically compatible donor cells are not readily available. Following transplantation, the rate at which the infused stem cells are able to repopulate patients' blood with platelets and other mature blood cells (engraftment) determines the risk of developing serious complications such as infection and bleeding. There are currently no drugs available that speed up the engraftment process.
"Initiation of our Phase 1 clinical program in DCBT marks another significant milestone in the development of TXA127 for enhancing engraftment following stem cell transplantation," stated Rick Franklin, CEO of Tarix Pharmaceuticals. "This program complements our ongoing placebo-controlled Phase 2 clinical study in adults receiving autologous peripheral blood stem cell transplant. We are excited to advance these programs in order to address the unmet needs of the full spectrum of patients undergoing hematopoietic stem cell transplants."
TXA127 is unique because it directly stimulates transplanted stem cells to replenish circulating platelets, white blood cells and red blood cells, potentially reducing the time it takes for blood cell counts to return to safe levels following stem cell transplant, which may accelerate the recovery process and reduce some of the health risks associated with stem cell transplant.
TXA127 was granted Orphan Drug designation from the U.S. Food and Drug Administration (FDA) as a treatment to enhance engraftment in patients receiving a stem cell transplant. TXA127 has also received Orphan Drug designation for the treatment of Myelodysplastic Syndrome (MDS).
About the Phase 1 Program
Tarix expects to conduct multiple open-label Phase 1 clinical studies of TXA127 designed to evaluate the safety and efficacy of TXA127 in the acceleration of engraftment following double cord blood stem cell transplant, involving adult and pediatric patients. The first Phase 1 study described above is expected to enroll approximately 10 adult patients with acute myelogenous leukemia (AML), myelodysplastic syndrome (MDS), acute lymphocytic leukemia (ALL), chronic myelogenous leukemia (CML), chronic lymphocytic leukemia (CLL), Hodgkin's lymphoma (HL), or non-Hodgkin's lymphoma (NHL) at The MD Anderson Cancer Center. For more information, please visit http://clinicaltrials.gov/ct2/show/NCT01300611.
For more information about the ongoing Phase 2 double-blind, placebo-controlled multi-center study evaluating the safety and efficacy of TXA127 in the acceleration of engraftment following autologous peripheral blood stem cell transplant, please visit http://clinicaltrials.gov/ct2/show/NCT01121120?term=tarix&rank=2.
About Tarix Pharmaceuticals
Tarix Pharmaceuticals is a clinical stage biopharmaceutical company developing peptide drugs to address significant unmet medical needs. The Company's lead product, TXA127, is a pharmaceutical formulation of the naturally occurring peptide, Angiotensin (1-7). TXA127 is currently in a Phase II clinical trial for the treatment and prevention of thrombocytopenia (reduced platelet count) associated with cancer chemotherapy, and a Phase II trial for peripheral blood stem cell engraftment. Tarix is preparing additional clinical trials with TXA127 in acute respiratory distress syndrome (ARDS), cord blood stem cell engraftment, and myelodysplastic syndrome (MDS). TXA127 is also being developed, under grants from the US government, as a treatment for radiation exposure.
Tarix's second product, PanCyte, is a synthetic, long-acting analogue of Angiotensin (1-7). PanCyte is in pre-clinical development focused on chemotherapy-induced thrombocytopenia and neutropenia, as well as combination treatment with low dose erythropoietin in chemotherapy-induced anemia.
SOURCE Tarix Pharmaceuticals