Stem Cell Therapeutics Advances CD47 Antagonist Program Into IND-Enabling Phase

TORONTO, Canada I September 9, 2013 I Stem Cell Therapeutics Corp. (TSX VENTURE:SSS)(SCTPF), a biopharmaceutical company developing cancer stem cell- related therapeutics, today announced that it has advanced its CD47 antagonist program into an Investigational New Drug (IND) enabling phase. In collaboration with a contract manufacturing organization, Stem Cell Therapeutics (SCT) will begin the manufacturing process to generate drug for formal toxicology studies and a subsequent phase I clinical study, which is anticipated to begin in H2/2015.

SCT's program targets the activity of CD47, a molecule upregulated on many leukemias and solid tumors. CD47 delivers a "do not eat" signal that suppresses macrophage phagocytosis, allowing cancer cells, including cancer stem cells, to escape immune-mediated destruction. SCT has chosen to block the CD47 protein using a modified version of its natural ligand, SIRPα, fused to an immunoglobulin Fc region. The SIRPaFc fusion protein has shown excellent anti-leukemic activity both in vitro and in human xenograft models, and exhibits a unique binding profile compared to other CD47 blocking agents. These results, as well as encouraging safety data emerging from a recently completed non-human primate study, will be reported at a future scientific conference.

"We believe that SIRPaFc, through its ability to activate the innate immune response and eliminate cancer stem cells, holds great promise as a novel immunotherapy," commented Dr. Niclas Stiernholm. "The transition from the research to the IND-enabling phase is a key milestone for the SIRPαFc program, and we will continue on the path towards clinical testing."

About Cancer Stem Cells:

The cancer stem cell (CSC) concept postulates that the growth of tumors is driven by a rare population of dedicated cells that have stem cell-like properties, including self-renewal. While the bulk of a tumor consists of rapidly proliferating cells and differentiated cells, neither of which is capable of self-renewal, a small population of CSCs provides for long-term maintenance of the cancer. Although the CSC concept was first postulated in the 1960s, it wasn't until 1994 that proof of their existence was demonstrated, when Dr. John Dick and colleagues in Toronto isolated CSCs (known as leukemic stem cells, or LSCs) from bulk acute myeloid leukemia cells. More recently, CSCs have been identified in many other human malignancies, including solid tumors such as bladder, brain, breast, colon, ovarian and prostate cancers. There is accumulating evidence that CSCs are resistant to conventional chemotherapies and radiation. Thus, CSCs are thought to be responsible for a phenomenon well known to oncologists: most patients will experience an initial response to conventional chemotherapies but will ultimately relapse. To cure cancer CSCs need to be destroyed, but the current armament of therapies is poorly equipped to do so.

About Stem Cell Therapeutics:

Stem Cell Therapeutics Corp. (SCT) is a biopharmaceutical company dedicated to advancing cancer stem cell discoveries into novel and innovative cancer therapies. Building on over half a century of leading and groundbreaking Canadian stem cell research, the company is supported by established links to a group of Toronto academic research institutes and cancer treatment centers, representing one of the world's most acclaimed cancer research hubs. The Company has two premier preclinical programs, SIRPaFc and a CD200 monoclonal antibody (mAb), which target two key immunoregulatory pathways that tumor cells exploit to evade the host immune system. SIRPaFc is an antibody-like fusion protein that blocks the activity of CD47, a molecule that is upregulated on cancer stem cells in AML and several other tumors. The CD200 mAb is a fully human monoclonal antibody that blocks the activity of CD200, an immunosuppressive molecule that is overexpressed by many hematopoietic and solid tumors. SCT's clinical stage programs include the recently in-licensed program focused on the structure of tigecycline, which is currently being evaluated in a multi-centre Phase I study in patients with acute myeloid leukemia (AML), as well as TTI-1612, a non-cancer stem cell asset that recently completed a 28-patient Phase I trial in interstitial cystitis ("IC") patients. For more information, visit: www.stemcellthera.com.

SOURCE: Stem Cell Therapeutics

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