- Pivotal Phase 3 trial recruiting 100 patients, and examining complete response of tumors as the primary endpoint.
- Consists of induction and maintenance phases, with follow up 12 months post treatment
- The activation of ENLIGHTED marks a significant milestone for Steba’s ambitious development program
LUXEMBOURG, April 20, 2021 (News) — Steba Biotech, the pioneering Immune Photo Activate Cancer Treatment (ImPACT) specialist, today announces the treatment of the first patient in ENLIGHTED, its pivotal Phase 3 trial of Padeliporfin ImPACT for the treatment of Low Grade Upper Tract Urothelial Cancer (UTUC).
David Perry, Head of Research and Development, said, “The successful initiation of the pivotal trial for padeliporfin ImPACT is an important milestone in our ambitious new development program. Our aim is to unlock the potential of our novel oncology platform, Padeliporfin ImPACT, on solid tumors with high unmet medical need. Targeting diseases such as UTUC, where surgery is either impossible or clinically undesirable could be very beneficial for patients living with these conditions. The ENLIGHTED trial is one of two clinical and five pre-clinical programs that we are advancing this year.”
The International, multi-center ENLIGHTED study aims to recruit 100 patients with low-grade UTUC in either the kidney or the ureter. The patients will be treated with Padeliporfin ImPACT in two phases, induction treatment and maintenance treatment, and will be followed up for 1-5 years post treatment. The primary efficacy endpoint is the absence of UTUC tumors in the entire ipsilateral calyces’ renal pelvis and ureter which will be evaluated endoscopically and determined as either failure or success in achieving complete response. Primary endpoint data is expected in 2022 and submission is expected in 2023.
Jonathan Coleman, MD, Principal Investigator of ENLIGHTED and urologic surgeon at Memorial Sloan Kettering Cancer Center, said, “The treatment of UTUC remains a clinical challenge with limited options available to effectively help our patients while avoiding the risk of significant morbidity. This study will work closely with investigators in the U.S., Europe and Israel with the goal of confirming the safety and efficacy of Padeliporfin ImPACT as a promising new therapy for treating patients with urothelial cancers involving the upper urinary tract.”
Steba is focusing on the development of Padeliporfin ImPACT as an innovative oncology platform with the potential to offer surgery-like efficacy, combined with organ preservation in UTUC and other solid tumors for high-risk surgical patients with unmet needs – either because surgery is not the preferred clinical option (e.g. to delay the loss of a kidney) or the risk of surgery is too high. The U.S. Food and Drug Administration has granted Orphan Drug Designation (ODD) and Fast Track designation to Padeliporfin ImPACT for the treatment of adult patients with low-grade UTUC.
About Padeliporfin ImPACTPadeliporfin ImPACT (Immune Photo Activated Cancer Therapy) offers surgery-like efficacy combined with organ preservation. ImPACT is Steba’s oncology platform comprising the intravenous delivery of an inactive drug, Padeliporfin activated by non-thermal laser light. Upon activation, the drug rapidly triggers the constriction of the blood supply in the illuminated area only, resulting in targeted tumor necrosis that activates anti-tumor immunity which enhances cancer cell eradication.
About UTUCUpper tract urothelial carcinoma (UTUC) is a type of cancer that grows from the urothelium, a thin, continuous, protective layer of cells which line the urine collecting system from kidney to bladder . UTUC obstructs the flow of urine from the kidney causing severe flank pain and blood to appear in urine, which may not be visible with the naked eye and delays diagnosis . It currently accounts for 5-10 percent of urinary tract cancers , with the prognosis worse than bladder cancer and worsening over time, increasing the strain on healthcare services.
About Steba BiotechSteba Biotech is a Luxembourg based biotech company founded in 1996. It is focused on developing a novel potential cancer therapy, Padeliporfin ImPACT, considered a potential new chemical entity by FDA/EMA. Padeliporfin ImPACT offers surgery-like efficacy combined with organ preservation. The activation of Padeliporfin in the tumor has been shown in patients to lead to immediate occlusion of the tumor blood supply followed by self-propagating necrosis of the entire tumor with minimal collateral damage to surrounding normal tissue. We are focusing our new Padeliporfin ImPACT development on de-risked indications where surgery is most needed but overly debilitating or ineligible. Thus far, Padeliporfin ImPACT has proven to be safe and efficacious in Phase 3 localized prostate cancer and is approved in Europe in that indication. U.S. ODAC recommended against TOOKAD VTP (brand name for Padeliporfin ImPACT in prostate cancer) approval in early prostate cancer, citing concerns that it might be used too broadly, i.e. in patients that might not need it, where a wait and see approach might be better. Our U.S. development strategy now focused on indications where surgery would be required but comes with overly debilitating consequences or cannot be conducted in patients.
Disclaimer This press release contains certain forward-looking statements concerning Steba Biotech and its business. Such forward looking statements are based on assumptions that Steba considers to be reasonable. However, there can be no assurance that such forward-looking statements will be verified, which statements are subject to numerous risks and to the development of economic conditions, financial markets and the markets in which Steba operates. The forward-looking statements contained in this press release are also subject to risks not yet known to Steba or not currently considered material by Steba. The occurrence of all or part of such risks could cause actual results, financial conditions, performance, or achievements of Steba to be materially different from such forward-looking statements.
This press release and the information that it contains do not constitute an offer to sell or subscribe for, or a solicitation of an offer to purchase or subscribe for, Steba shares in any country. The communication of this press release in certain countries may constitute a violation of local laws and regulations. Any recipient of this press release must inform oneself of any such local restrictions and comply therewith.
1. Upper Tract Urothelial Carcinoma. (n.d.). Accessed January 8, 2021; https://www.urotoday.com/library-resources/upper-tract-urothelial-carcinoma/109835-upper-tract-urothelial-carcinoma.html.2. Taylor, W. S. (2019). Delays to Diagnosis and Management of Upper Tract Urothelial Carcinoma. Journal of Endoluminal Endourology, 2(3), e5–e11. https://doi.org/10.22374/jeleu.v2i3.45.3. Soria, F., Shariat, S. F., Lerner, S. P., Fritsche, H.-M., Rink, M., Kassouf, W., Thalmann, G. N. (2016). Epidemiology, diagnosis, preoperative evaluation and prognostic assessment of upper-tract urothelial carcinoma (UTUC). World Journal of Urology, 35(3), 379–387. doi: 10.1007/s00345-016-1928-x.4. Eylert, M., Hounsome, L., Verne, J., Bahl, A., Jefferies, E., & Persad, R. (2013). Prognosis is deteriorating for upper tract urothelial cancer: data for England 1985-2010. BJU International, 112(2), E107-E113. doi: 10.1111/bju.12025.
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