TORONTO, ONTARIO--(Marketwired - Jan. 13, 2014) - Stem Cell Therapeutics Corp. (TSX VENTURE:SSS)(SCTPF), an immuno-oncology company developing cancer stem cell-related therapeutics, today provided the following six-month corporate update:
- Pilot non-human primate tolerability studies have been completed using SIRPaFc, Stem Cell Therapeutics' proprietary CD47 antagonist. Three separate human SIRPaFc proteins, possessing different Fc regions with varying levels of effector function, were evaluated in a repeat-dose regimen in cynomolgus macaques. Safe dosing levels, substantially above the anticipated human therapeutic dose, were established for each drug candidate. Greater tolerability was observed to correlate with decreasing effector function. Anemia and thrombocytopenia were the primary adverse events observed, which in most cases were asymptomatic and reversible. These studies, while preliminary in nature, provided firm support for moving the SIRPaFc program forward into the next development phase. In parallel with conducting the manufacturing activities and toxicology studies typically associated with the IND-enabling phase of drug development, the company will significantly amplify its preclinical efficacy studies. This will be critical in order to uncover the full potential of this promising immune checkpoint inhibitor and to expand its use in the treatment of both solid and liquid tumors.
- Preclinical SIRPaFc efficacy data in an acute myeloid leukemia xenograft model was recently reported at the 55th Annual Meeting of the American Society of Hematology (ASH). SIRPaFc was shown to promote potent anti-leukemic responses at low doses. When combined with the non-human primate tolerability data, this indicates a wide therapeutic window. For details on the ASH presentation please consult our website at www.stemcellthera.com.
- On December 13, 2013, the company completed a $33 million private placement, principally with participation from experienced U.S. healthcare institutional investors.Importantly, this substantial financing, one of the largest by a Canadianbiopharmaceutical company last year, was primarily driven by the strength and promise of the SIRPaFc technology. Its proceeds will allow the company to execute an optimal development program over the next three years, which will include manufacturing, formal toxicology testing, as well as clinical studies in cancer patients.
- Dosing in the investigator-driven Phase I multicenter dose-escalation study (50mg- 350mg) with tigecycline in patients with relapsed or refractory acute myeloid leukemia (AML) is nearing completion. Dosing has advanced to the 350mg cohort, a dose level that greatly exceeds the 100mg dose approved for anti-infective use and is well within the range of doses that have demonstrated anti-cancer activity in published preclinical studies. Patient recruitment has been slowed by the submission of a protocol amendment. The cost of this study has been covered by the academic sponsor. As the exclusive licensee of this technology, the company continues to monitor the progress of the trial and anticipates its completion in 2014. Following a thorough evaluation of the clinical data and the program's commercial potential the company will decide on an appropriate path forward.
About Stem Cell Therapeutics:
Stem Cell Therapeutics Corp. (SCT) is an immuno-oncology company 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 prominent 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
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.
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