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Tarix Pharmaceuticals Enrolls First Patient in Phase 2 Clinical Study of TXA127 Following Autologous Peripheral Blood Stem Cell Transplant



2/24/2011 7:36:54 AM

CAMBRIDGE, Mass., Feb. 23, 2011 /PRNewswire/ -- Tarix Pharmaceuticals (www.tarixpharma.com) today announced enrollment of the first patient in a Phase 2 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 is currently enrolling patients undergoing autologous peripheral blood stem cell transplant to evaluate the safety and efficacy of TXA127 in accelerating engraftment following transplant.

Following a stem cell transplant, it can typically take several weeks for the stem cells to repopulate the patient's blood with platelets and other mature blood cells. During this time the patient is at increased risk of serious infection and bleeding. There are currently no drugs available that speed up the engraftment process.

"TXA127 has the potential to reduce 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," stated Rick Franklin, CEO of Tarix Pharmaceuticals. "TXA127 is unique because it directly stimulates transplanted stem cells to replenish circulating platelets, white blood cells, and red blood cells."

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 2 Program

The double-blind, placebo-controlled multi-center Phase 2 study will evaluate the safety and efficacy of TXA127 in the acceleration of engraftment following autologous peripheral blood stem cell transplant in patients with Hodgkin or non-Hodgkin lymphomas or multiple myeloma undergoing limited reinfusion of CD34+ cells. The study is expected to enroll a total of 74 patients at eight leading U.S. medical centers. For more information, please visit http://clinicaltrials.gov/ct2/show/NCT01121120?term=tarix&rank=2.

TXA127 will also be evaluated in two clinical trials in cord blood transplantation. One conducted at M D Anderson will involve adult patients, while the other at Duke University, will enroll pediatric patients.

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


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