TORONTO, ONTARIO--(Marketwired - July 25, 2013) - Stem Cell Therapeutics Corp. (TSX VENTURE:SSS)(SCTPF), a biopharmaceutical company developing cancer stem cell-related therapeutics, today provided the following corporate update:
- Safety and pharmacokinetic data from studies in rodents and non-human primates, using several variants of the company's high-affinity CD47 antagonist, are expected to become available in the third quarter. Stem Cell Therapeutics (SCT) has chosen to target the CD47 protein using a modified version of its natural ligand, SIRPa, fused to an immunoglobulin Fc region. The fusion protein has similar pharmacological properties to a traditional monoclonal antibody and other Fc fusion proteins on the market and in development. However, the SIRPaFc protein appears to have distinct binding properties compared to those of many anti-CD47 monoclonal antibodies. The safety data expected in the third quarter, combined with a large body of existing efficacy data, will direct the company's selection of a definitive clinical development candidate. A formal IND-enabling program is expected to commence shortly thereafter.
- Dosing in a Phase I multicenter dose-escalation study (50mg-350mg) with tigecycline in patients with relapsed or refractory acute myeloid leukemia (AML) is also expected to be completed in the third quarter. The program is based on Dr. Aaron Schimmer's discovery that tigecycline, an FDA-approved antibiotic, selectively targets leukemia cells and leukemic stem cells by inhibiting mitochondrial protein synthesis and thus shutting down the cells energy supply. The upcoming data will guide the design of a Phase II trial projected to commence in 2014. In parallel, the company and its collaborators are actively investigating improved formulations and novel analogues of tigecycline, efforts which are central to the commercialization of this technology.
- The company is continuing its ongoing dialogues with third parties regarding partnerships and collaborations on several of its internal programs, as well as its discussions related to the in-licensing of additional cancer stem cell assets. SCT anticipates being in a position to provide more details on these efforts by year end.
- The company is in the process of ceasing all activities associated with its pre-merger historic regenerative neurology programs and anticipates completing this in the third quarter. Moving forward all resources will be focused on the company's promising cancer stem cell programs. While SCT will attempt to monetize its intellectual property underpinning the legacy programs, the company has determined that doing so through the joint venture previously contemplated is not a viable option.
- SCT has initiated several efforts to amplify and broaden its visibility in a cost-effective way. These range from strengthening its Board of Directors and developing relationships with additional key opinion leaders in the cancer stem cell field, to working with investor relation firms and capital markets advisors, such as the recently announced appointment of ProActive Capital Group to assist in increasing awareness of the company among investors.
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. 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-stem cell asset being tested in a 28-patient Phase I trial in interstitial cystitis ("IC") patients, which is near completion. The Company also 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. For more information, visit www.stemcellthera.com.
Caution Regarding Forward-Looking Information:
This press release may contain forward-looking statements, which reflect SCT's current expectation regarding future events. These forward-looking statements involve risks and uncertainties that may cause actual results, events or developments to be materially different from any future results, events or developments expressed or implied by such forward-looking statements. Such factors include changing market conditions; the successful and timely completion of pre-clinical and clinical studies; the establishment of corporate alliances; the impact of competitive products and pricing; new product development risks; uncertainties related to the regulatory approval process or the ability to obtain drug product in sufficient quantity or at standards acceptable to health regulatory authorities to complete clinical trials or to meet commercial demand; and other risks detailed from time to time in SCT's ongoing quarterly and annual reporting. Except as required by applicable securities laws, SCT undertakes no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.
Neither TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in the policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this release.