Stem Cell Therapeutics Corp.
TSX VENTURE : SSS

Stem Cell Therapeutics Corp.

May 16, 2013 07:00 ET

Stem Cell Therapeutics Announces Completion of Dosing in Phase I Study of TTI-1612 in Patients With Interstitial Cystitis/Bladder Pain Syndrome

TORONTO, ONTARIO--(Marketwired - May 16, 2013) - Stem Cell Therapeutics Corp. (TSX VENTURE:SSS), a biopharmaceutical company developing cancer stem cell-related technologies, today announced that its wholly owned subsidiary Trillium Therapeutics has completed dosing in its Phase I study of TTI-1612 in patients with interstitial cystitis/bladder pain syndrome (IC/BPS). The study was designed to assess the safety and tolerability of single ascending doses of TTI-1612 in IC/BPS patients. Pharmacokinetics and changes in disease symptoms were also evaluated. A total of 28 patients were enrolled at four urology clinics in Southern Ontario. Preliminary data indicate that the drug is well tolerated and exhibits a favourable pharmacokinetic profile. Full results are expected to be published at a later date.

IC/BPS, also known as Painful Bladder Syndrome, is a chronic, debilitating and poorly treated bladder disease affecting millions of people. The disease is believed to develop as a result of dysfunction in the protective epithelial layer lining the bladder. TTI-1612, a locally-delivered recombinant growth factor, is being developed to correct the dysfunction and restore the bladder epithelium to a normal, healthy state.

This urology program, acquired by Stem Cell Therapeutics through its recent merger with Trillium Therapeutics, targets an indication of high unmet need and represents a substantial market opportunity. However, with its current focus on oncology and cancer stem cells, the Company will now actively seek a development partner to conduct the next phase of the clinical development program.

"Completing dosing in this clinical study in a timely manner is a significant early milestone in the development of TTI-1612," commented Dr. Bob Uger, the Company's Chief Scientific Officer. "We are encouraged by our clinical experience to date with this drug, and believe we are setting the groundwork for a partner to move this program forward into Phase II testing."

About Interstitial Cystitis/Bladder Pain Syndrome (IC/BPS):

Interstitial cystitis/bladder pain syndrome (IC/BPS) is a chronic bladder disease characterized by increased urinary urgency and/or frequency, nocturia (waking from sleep to urinate) and pelvic pain. These symptoms are often severe, and can impact both the physical and emotional health of patients. For many IC/BPS sufferers the disease adversely affects all major aspects of their lives, including social relationships, travel, leisure activities and employment. Once considered a rare disease, IC/BPS is now recognized as an increasingly common medical problem. Recently, a large epidemiological study found that 3.3 to 7.9 million women and 2 million men in the US alone suffer from IC symptoms. Current therapies often provide inadequate relief, and many IC/BPS patients report dissatisfaction with available treatment options. Since the current pipeline of new IC/BPS drugs is largely focused on analgesics and is unlikely to significantly alter the IC treatment landscape, novel and innovative approaches to treatment are needed.

About Stem Cell Therapeutics:

Stem Cell Therapeutics Corp. (SCT), 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 centers that represent one of the world's most acclaimed cancer research hubs. SCT's lead clinical program, which targets a metabolic pathway in leukemia blasts and leukemic stem cells, is currently being evaluated in a multi-centre Phase I study in patients with relapsed or refractory Acute Myeloid Leukemia (AML). 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.

Contact Information