Vancouver, BC - Sustained Therapeutics (the “Company”) announced today regulatory clearance for a pivotal Phase II/III human trial of its second product, a novel medication for the treatment of a rare form of cancer. Upper Tract Urethral Carcinoma (“UTUC”) is an orphan disease, a malignancy of the cells lining the renal pelvis. It affects about 6,000 patients each year in North America.
The Company’s product (“ST-02”) is delivered directly to the site of the carcinoma in the renal pelvis through a ureteric catheter, rather than via infusion or systemic delivery, and then releases slowly. Sustained Therapeutics believes that this delivery mechanism of its new product may provide benefits over current standard of care treatment for UTUC. ST-02 is based on Sustained Therapeutics’ proprietary sustained release platform technology.
This is an investigator sponsored trial (“IST”) being carried out by the Vancouver Prostate Centre (“VPC”) and supported by funding from the Canadian Institutes for Health Research. VPC has received a No Objection Letter (“NOL”) from Health Canada to conduct this study for ablation of urothelial carcinomas in the upper urinary tract. An initial 25 patients will take part in the study through the VPC and other sites across Canada, and if successful and subject to regulatory approval will be expanded to enroll an additional 50 patients across North America. The study will be led by Dr. Peter Black of the VPC.
“ST-02 has significant potential to treat this rare cancer, and the NOL from Health Canada is a very positive first step to evaluate this approach in this cancer, where surgical removal of the kidney is often the only effective treatment option,” says Dr. Martin Gleave, Sustained Therapeutics’ Chief Medical Officer and Distinguished Professor in the UBC Department of Urologic Sciences and Director of the VPC. “We are enabling rapid advancement of this therapy by running an Investigator Sponsored Trial (IST) and collaborating with talented colleagues like Dr. Peter Black at the VPC and others elsewhere.”
“ST-02 is designed for extended exposure in the renal pelvis, where the cancer is located, by coating the tissue and delivering chemotherapy for longer, right where it is needed. This is potentially a very important new development for patients suffering from UTUC,” confirms Mr. William Annett, Sustained Therapeutics’ Chief Executive Officer. “If successful, it demonstrates that our platform technology can be used for multiple different extended-release products.”
About Sustained Therapeutics:
Sustained Therapeutics is a clinical-stage company utilizing its advanced clinical and research expertise to develop locally injected sustained-release therapeutics for the treatment of a broad range of conditions, including cancer, inflammatory diseases and pain. A spin-off from the University of British Columbia its novel sustained-release drug delivery platform is also the basis for ST-01, the Company’s medication for managing both acute and chronic pain. Sustained Therapeutics has completed a successful Phase I trial of ST-01 and currently has two Phase II trials underway, one in acute post-operative pain and the other in chronic pain.
William Annett, Chief Executive Officer
wannettsustainedtherapeutics [dot] com
Notice Regarding Forward-Looking Statements:
This news release contains forward-looking statements within the meaning of the U.S. Private Securities Litigation Reform Act of 1995 and forward-looking information within the meaning of applicable Canadian securities laws (collectively, "forward-looking statements"), including statements regarding the planned initial and expanded Phase II/III trials, beliefs that the delivery mechanism of our new product may provide benefits over current standard of care treatment for UTUC, and the potential benefits of ST-02 and the Company’s platform technology including the significant potential to treat a rare form of cancer and the potential success of demonstrating that our platform technology can be used for multiple different extended-release products. Statements in this document regarding future expectations, beliefs, or plans constitute forward-looking statements that involve risks and uncertainties, which may cause actual results to differ materially from the statements made. Without limiting the foregoing, the words "may”, “will”, “potential”, "believes" and “if” are intended to identify forward-looking statements. You are cautioned that such statements are subject to a multitude of risks and uncertainties that could cause actual results, future circumstances, or events to differ materially from those projected in the forward-looking statements. These risks include, but are not limited to: those associated with the success of research and development programs, the ability to raise additional funding, and the need to obtain regulatory approval. Forward-looking statements are developed based on assumptions about such risks, uncertainties and other factors, including, but not limited to: research and development plans proceeding substantially as envisioned, safety of product, and availability of financing on reasonable terms. Forward-looking statements are made as of the date hereof, and the Company disclaims any intention and has no obligation or responsibility, except as required by law, to update or revise any forward-looking statements, whether as a result of new information, future events, or otherwise.