Steba Biotech Announces Positive Top-Line Results from its Latin American Phase 3 Clinical Trial of TOOKAD® in Patients with Localized Prostate Cancer and Obtains First Marketing Authorization in Mexico

Feb 01, 2016, 07:30 ET from Steba Biotech

MEXICO CITY, Feb. 1, 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 positive top-line results from PCM304, its Latin American Phase 3 clinical trial of TOOKAD® (padeliporfin di-potassium), a novel investigational treatment for localized prostate cancer and other solid tumors. Analyses of the results showed that the primary endpoint has been met, demonstrating that TOOKAD® increased the rate of cancer-free patients at 12 months. Quality of life parameters (urinary and erectile functions) and safety are consistent with previous TOOKAD® clinical studies.

Based on these positive results, Steba Biotech has submitted marketing authorization application for TOOKAD® to the Comisión Federal para la Protección contra Riesgos Sanitarios (COFEPRIS), the Mexican health authority. After review, the COFEPRIS has granted the first marketing authorization for TOOKAD® for the treatment of low-risk localized prostate cancer patients on November 12, 2015.

"We are excited to bring a unique and innovative solution to physicians and patients for the management of low-risk prostate cancer in Mexico today and subsequently to other Latin American countries," said Raphael Harari, Chief Executive Officer of Steba Biotech. "This approval is recognition of the tremendous effort deployed over the years by the scientists of Steba Biotech and the Weizmann Institute to develop a therapy that can control effectively low-risk prostate cancer while preserving patients' quality of life."

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 PCM304 study design

The PCM304 study is a Latin American, prospective, multicenter, open label, single arm study enrolled 81 low- and intermediate-risk prostate cancer patients (clinical stage up to cT2a, PSA<20ng/ml, Gleason 3+3 or Gleason 3+4 provided it is not present in more than 2 cores with no more than 50% cancer in any core) in 3 centers across 3 Latin American countries.  Patients received TOOKAD® (4mg/kg infusion and 200J/cm light activation) and were then followed-up during a 12-month period with measure of PSA level, urinary, and erectile functions at months 3, 6, and 12, plus biopsies at 6 and 12 months. The primary endpoint measured the rate of absence of definite cancer based on biopsy at 12 months.

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 of prostate cancer among newly diagnosed patients. In Latin America, it is currently commonly managed through 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

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SOURCE Steba Biotech



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