TORONTO, ONTARIO -- (Marketwired) -- 04/17/13 -- Stem Cell Therapeutics Corp. (TSX VENTURE: SSS), a biopharmaceutical company developing cancer stem cell-related technologies, today announced the execution of a definitive license agreement with University Health Network ("UHN"), Toronto, Canada. The agreement, developed in collaboration with MaRS Innovation, provides Stem Cell Therapeutics ("SCT") with exclusive worldwide rights to an innovative clinical cancer stem cell program.
As announced on November 6, 2012, the technology licensed by SCT is based on Dr. Aaron Schimmer's discovery that an FDA-approved antibiotic, tigecycline, selectively targets leukemia cells and leukemic stem cells by inhibiting mitochondrial protein synthesis and thus shutting down the cells energy supply. A Phase I multicenter dose- escalation clinical trial in patients with relapsed or refractory acute myeloid leukemia (AML) is nearing completion and data are expected this summer. Dr. Schimmer will join Dr. John Dick as a scientific advisor to SCT. Furthermore, a clinical advisory board, chaired by Dr. Schimmer, will be assembled in the near term to guide and assist in the future development of the program.
"Using tigecycline to eradicate cancer stem cells, which are resistant to conventional chemotherapy and believed to be responsible for disease relapse, is an innovative and potentially curative approach to the treatment of AML," commented Dr. Bob Uger, SCT's Chief Scientific Officer. "This program will provide the foundation for further research into mitochondrion-targeting therapies, an area that is of substantial interest to the scientific community."
The newly acquired tigecycline program complements SCT's other cancer stem cell program, SIRPaFc. The latter is an antibody-like Fc fusion protein that targets the CD47 protein with high affinity, facilitating the elimination of cancer cells and cancer stem cells by the patient's own immune system. This program is at a preclinical stage and IND-enabling studies are expected to start pending the conclusion of an ongoing pharmacokinetic and safety study.
"We use two distinctly different approaches to target cancer stem cell in these programs. Tigecycline is a repurposed small molecule aimed at an intracellular metabolic target, while SIRPaFc is a novel biologic targeting an extracellular immunoregulatory pathway," remarked SCT's Chief Executive Officer, Dr. Niclas Stiernholm. "In our quest to become a Canadian cancer stem cell powerhouse with a diverse arsenal of product candidates, we are now assessing other opportunities and expect to add new collaborations and projects in due course."
"The conclusion of our recent financing, followed by the acquisition of Trillium and the licensing of the tigecycline technology completes my task of refocusing and reinvigorating the company," added David Allan. "The appointment of Dr. Stiernholm as CEO of SCT now permits me to become non-executive chairman, a role in which I look forward to supporting the new management team, particularly assisting with the company's activities and visibility in the capital markets."
The initial consideration of $1.6 million for the UHN License is to be satisfied by the issuance of 5,028,571 SCT common shares and 1,600,000 SCT common share purchase warrants to UHN and MaRS Innovation, each warrant allowing its holder to acquire one additional common share at an exercise price of $0.40 until March 15, 2018. Additional consideration under the UHN License includes an annual license maintenance fee and development milestones. The securities issued by the Corporation will be subject to a statutory four-month hold period from the date of their issuance.
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 Acute Myeloid Leukemia (AML):
AML is the most common type of acute leukemia in adults, with approximately 13,000 new cases diagnosed each year in the United States. The majority of AML patients receive induction chemotherapy. In patients less than 60 years of age, remission rates of up to 75% can be achieved, and patients with good-risk or standard-risk cytogenetics will typically receive post-remission therapy with high dose cytarabine. However, relapses are common, and the majority of patients will die from their disease. AML in elderly patients (greater than 60 years of age) is notoriously difficult to treat, with five-year survival rates of less than 10%. There is ample evidence that AML is sustained by CSCs (known as leukemic stem cells), and the failure to eradicate these CSCs using conventional chemotherapy is thought to be responsible for disease relapse.
About Stem Cell Therapeutics:
Stem Cell Therapeutics Corp. (TSX VENTURE: SSS), a Toronto-based biopharmaceutical company, is Canada's only public 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 multiple Toronto academic institutes and oncology treatment centres that represent one of the world's most acclaimed cancer research hubs. In addition to the recently in-licensed clinical tigecycline program, SCT currently has two premier preclinical programs, SIRPaFc and a CD200 mAb, which target two key immunoregulatory pathways that tumour cells exploit to evade the host immune system. SIRPaFc is a fusion protein that blocks the activity of CD47, a molecule that is upregulated on cancer stem cells in AML and several other tumours. 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 tumours. 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.
Stem Cell Therapeutics Corp.
Dr. Niclas Stiernholm
Chief Executive Officer
+1 416 595 0627
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