Steba Biotech Completes its European Phase 3 Clinical Trial of TOOKAD® in Patients with Low-Risk Prostate Cancer and Submits Marketing Authorization Application to the European Medicine Agency

Jan 25, 2016, 07:30 ET from Steba Biotech

LUXEMBOURG, Jan. 25, 2016 /PRNewswire/ -- Steba Biotech, a privately owned biotechnology company focused on the development of innovative and minimally invasive photodynamic therapies and systems to treat cancers, today announced completion of PCM301, its European Phase 3 clinical trial of TOOKAD® (padeliporfin di-potassium), a novel investigational treatment for localized prostate cancer and other solid tumors. PCM301 is the first prospective randomized controlled trial evaluating the efficacy and safety of a focal therapy in prostate cancer. The data will be presented at the upcoming European Association of Urology scientific meeting in March.

Based on these results, Steba Biotech has submitted on January 7, 2016 a Marketing Authorization Application (MAA) to the European Medicine Agency (EMA) for TOOKAD®. The MAA requests EMA approval of TOOKAD® for the treatment of localized prostate cancer.

"With the completion of the PCM301 trial, our clinical experience with TOOKAD® now includes nearly 450 patients. We look forward to having the lead study investigator, Mark Emberton, M.D., share the full data at the upcoming European Association of Urology meeting," said Raphael Harari, Chief Executive Officer of Steba Biotech. "The submission of the MAA for TOOKAD® is a major milestone for Steba Biotech and we look forward to working closely with the EMA during the review period. If approved, TOOKAD® would provide physicians and patients with a unique innovative solution to manage low-risk prostate cancer."

About TOOKAD® (padeliporfin di-potassium)

TOOKAD® is a first-in-class photosensitizer derived from palladium-substituted bacteriochlorophyll and developed in collaboration with the Weizmann Institute. It was designed to address limitations of previous attempts in photodynamic therapies. Through its high solubility and activation with low energy, near-infrared light, TOOKAD® enables highly localized vascular occlusion that triggers targeted necrosis of tumor lesions, while sparing surrounding healthy tissue.

About PCM301 study design

The PCM301 study is a European, prospective, multicenter, open label, randomized, controlled study that compared TOOKAD® versus active surveillance. The study enrolled 413 low-risk prostate cancer patients (clinical stage up to cT2a, PSA<10 ng/ml, absence of Gleason pattern 4 or 5, at least one positive cancer core with 3 to 5mm cancer involvement or 2-3 positive cancer cores with no more than 5mm cancer involvement) in 47 centers across 10 European countries. 206 patients were included in the TOOKAD® arm (4mg/kg infusion and 200J/cm light activation) and 207 in the active surveillance arm. Patients were then followed-up during a 2-year period with measure of PSA level, urinary, and erectile functions every 3 months, plus biopsies at 12 and 24 months. The first co-primary endpoint compared the rates of absence of definite cancer based on biopsy at 24 months between TOOKAD® and active surveillance. The second co-primary endpoint compared the rates of treatment failure associated with observed progression of disease between TOOKAD® and active surveillance. Progression of disease to moderate- or high-risk was defined as the observation of 4 or more positive cores over the entire period, or at least one positive core longer than 5mm, or Gleason pattern 4 or 5, or PSA>10ng/mL in 3 consecutive measures, or any T3 stage prostate cancer, or any metastasis, or any prostate cancer-related death.

About low-risk prostate cancer

Low-risk prostate cancer (typically defined by clinical stage T1c-T2a, PSA<10 ng/ml, Gleason score ≤6) is one of the most common stages among newly diagnosed prostate cancer patients. It is currently managed through active surveillance, radical prostatectomy or radiotherapy. A key challenge in the management of the disease is to avoid progression to higher grade, which is associated with higher risk of metastasis and mortality, while preserving the patients' quality of life (in particular urinary and erectile functions).

About Steba Biotech

Steba Biotech is a privately-owned, biotechnology company headquartered in Luxembourg with offices in France, Israel, Switzerland, and the US. Steba Biotech is focused on the development of TOOKAD® (padeliporfin di-potassium), an innovative and minimally invasive photodynamic therapy evaluated in late-stage clinical trials to demonstrate its ability to safely and effectively treat low-risk prostate cancer. Steba Biotech is also pursuing early stage studies of TOOKAD® in esophageal cancer, urothelial carcinoma, advanced prostate cancer, renal carcinoma, and triple negative breast cancer in collaboration with Memorial Sloan Kettering Cancer Center, the Weizmann Institute, and Oxford University.

Contact

Bertrand Gaillac, Steba Biotech, +33-1-40-72-34-03, info@stebabiotech.com

Logo - http://photos.prnewswire.com/prnh/20160120/324446LOGO

SOURCE Steba Biotech