San Carlos, CA December 5, 2014 - Cellerant Therapeutics Inc., announced that data from the Phase 1 clinical trial for CLT-008, a first-in-class, allogeneic, cell-based therapy for use in patients with acute myeloid leukemia (AML), will be presented at the 2014 American Society of Hematology (ASH) Annual Meeting and Exposition in San Francisco, December 6-9, 2014.
"We look forward to the opportunity to present clinical data on CLT-008 at ASH," said Ram Mandalam, Ph.D., President and Chief Executive Officer of Cellerant Therapeutics. "For AML patients with severe neutropenia, human myeloid progenitor cells (CLT-008) can proliferate and differentiate into myeloid effector cells with a potential to treat or prevent infection. Data from the study show clear evidence of safety. Efficacy signals are also present in the Phase 1 data with respect to reduction in mucositis and fever in patients receiving myeloablative chemotherapy for the treatment of AML."
Based on these positive Phase 1 results, Cellerant is initiating a multi-center, prospective, randomized Phase 2 clinical trial to demonstrate a decrease in risks of febrile episodes and infections related to chemotherapy treatment in AML. If successful, CLT-008 may also be applicable in many other clinical settings where chemotherapy-induced severe neutropenia is present.
The abstract and timing of the presentation is provided below:
Date: Sunday, December 7, 2014, 6:00 PM-8:00 PM
Location: North Building, Hall E (Moscone Center)
Abstract number: 2268
Presentation Title: Phase 1 Clinical Investigation of Human Myeloid Progenitor Cells (CLT-008) As a Supportive Care Measure during Chemotherapy for Acute Myeloid Leukemia (AML)
Presenting Author: Matthew J. Wieduwilt, MD, PhD, University of California, San Diego
Program: Oral and Poster Abstracts
Session: 613. Acute Myeloid Leukemia: Clinical Studies: Poster II
Abstract Link: https://ash.confex.com/ash/2014/webprogram/Paper67487.html
CLT-008 is a unique, off-the-shelf, cryopreserved, cell-based therapy that contains human myeloid progenitor cells derived from adult hematopoietic stem cells that have the ability to mature into functional granulocytes, platelets and red blood cells in vivo. In nonclinical models, cryopreserved, allogeneic mouse myeloid progenitor cells have been shown to be highly effective in providing protection from lethal radiation, preventing infection, facilitating stem cell engraftment and improving overall survival. Cellerant is developing CLT-008 as a treatment for severe neutropenia associated with chemotherapy in oncology patients, cord blood transplantation, and acute radiation exposure.
Cellerant Therapeutics is a clinical stage biotechnology company focused on developing human stem cell and antibody therapies for oncology applications and blood-related disorders. Cellerant's lead product, CLT-008, will be entering a Phase 2 clinical trial in patients with hematological malignancies. The Company also has a cancer stem cell (CSC) antibody discovery program focused on therapies for acute myeloid leukemia, multiple myeloma and myelodysplastic syndrome.
For more information on Cellerant, please contact:
Cellerant Therapeutics, Inc.
Vice President, Corporate Development
Andrew McDonald Ph.D.
LifeSci Advisors LLC
(646) 597 6979