Stockholm, Sweden — Medivir AB (Nasdaq Stockholm: MVIR) today informs that additional data from the phase II study of remetinostat in patients with early stage cutaneous T-cell lymphoma (CTCL) will be presented during the International Investigative Dermatology (IID) meeting, which will take place from 16-19 May 2018 in Orlando, FL, USA. The focus of the presentation is the effect of remetinostat on reducing pruritis (itching), as seen in the phase II study.
Remetinostat (previously called SHAPE) is Medivir’s proprietary topical HDAC inhibitor that is being developed for the treatment of mycosis fungoides-type CTCL.
The data will be presented both as a poster and at an oral session by one of the study’s investigators, Dr Madeleine Duvic, Professor of Internal Medicine and Dermatology at the MD Anderson Cancer Center in Houston, Texas.
Oral session; Friday May 18, 12:30 pm – 1:30 pm (EST). Poster session; Saturday, May 19, 11:45 am – 1:45 pm (EST).
Anti-pruritic properties of remetinostat (SHAPE), a topical histone deacetylase inhibitor (HDACi); data from a randomized phase 2 study in patients with stage IA- IIA mycosis fungoides.
Authors: M. Duvic, J. Guitart, A. Huen, P. Porcu, NR. LeBoeuf, J. Skolnik, K. Owen, J. Ohd and YH. Kim.
The abstract is available at: https://www.jidonline.org/article/S0022-202X(18)30841-8/abstract
Details of all presentations for IID 2018 are available at the meeting website: http://iid2018.org/
For further information, please contact:
Erik Björk, CFO, Medivir AB, mobile: +46 (0)72 228 2831
John Öhd CMO, Medivir AB, mobile: +46 (0)72 529 62 00
About mycosis fungoides (MF) and cutaneous T-cell lymphoma (CTCL)
Cutaneous T-cell lymphoma (CTCL) is an orphan hematologic cancer. According to the National Cancer Institute, mycosis fungoides (MF) is the most common variant of CTCL. MF affects an estimated 15,000 to 20,000 people in the United States, with an estimated 1,500 new cases annually. Around 75% of affected patients are in early-stages (stages IA-IIA) where the disease is confined to the skin. Patients remain at these stages for extended periods and require long-term, skin-directed treatments for their disease. A small proportion of patients go on to develop cutaneous tumors or systemic disease, and these patients then require systemic anti-cancer therapy, which may include systemic histone deacetylase (HDAC) inhibitors. Pruritus, or itching, is a major symptom that adversely affects quality of life in many CTCL patients. Available topical drugs for early-stage CTCL are not always effective and tolerable, and sometimes worsen pruritus. Medivir estimates that the addressable market for an efficacious and tolerable treatment for early-stage CTCL in the US alone is approximately USD 900m annually.
Remetinostat is a unique topical histone deacetylase (HDAC) inhibitor that Medivir is developing for the treatment of early-stage mycosis fungoides (MF) type CTCL. Remetinostat has been designed to be effective in the skin but degraded rapidly in the bloodstream to avoid the adverse effects associated with systemically administered HDAC inhibitors. In the phase II study, remetinostat also demonstrated a dose-dependent efficacy on skin lesions, as measured by the primary end-point CAILs. Based on this, Medivir has initiated discussions with the US FDA and is preparing for a phase III study in CTCL.
Medivir is a research-based pharmaceutical company with a focus on oncology. We have a leading competence within protease inhibitor design and nucleotide/nucleoside science and we are dedicated to develop innovative pharmaceuticals that meet great unmet medical need. Medivir is listed on the Nasdaq Stockholm Mid Cap List (ticker: MVIR). www.medivir.com.