Targazyme said today that it will begin enrolling patients in a Phase II clinical study to evaluate TZ101-fucosylated bone marrow stem cells in cancer patients, after the FDA granted the San Diego-based company investigational new drug clearance.
The treatment is designed to use blood-forming stem cells from bone marrow to restore the body’s ability to make blood and immune cells in patients with leukemia, lymphoma and some types of anemia. Targazyme is studying the modification of stem cells from haplo-identical donors – someone who is a 50% match to the recipient. Targazyme’s product, TZ101, modifies stem cells to improve their ability to home, adhere and engrant into the bone marrow. The company hopes this will accelerate hematopoietic recovery, reduce infection and lessen a cancer patient’s time in the hospital after the haplo-identical transplant.
“Enhancing bone marrow stem cell engraftment with a product like TZ101 will improve clinical outcomes for patients with serious, life-threatening cancers and other disorders for which hematopoietic stem cell transplant is prescribed,” Dr. Gheath Alatrash, of Houston’s University of Texas MD Anderson Cancer Center, said in prepared remarks.
“This FDA IND clearance for a Phase II TZ101 haplo-identical transplant study is an important clinical milestone to help us drive towards our initial target product label of accelerating hematopoietic recovery post hematopoietic stem cell transplantation,” added CEO Lynnet Koh. “This clinical study builds on available clinical data that TZ101 improves time to absolute neutrophil count and platelet recovery in patients undergoing hematopoietic stem cell transplants and, together with our second product TZ102, provides proof of concept that our pipeline of products are enabling technologies for improving efficacy outcomes for various cells such as T cells, natural killer cells, and hematopoietic, cardiac and neural stem cells, that are used to prevent and treat a variety of different diseases for which there is a high unmet medical need.”
