STOCKHOLM, May 13, 2019 /PRNewswire/ -- Medivir AB
(Nasdaq Stockholm: MVIR) today announces that positive
data from the investigator-initiated study evaluating the effects
of remetinostat in basal cell carcinoma (BCC) patients has been
presented at the 2019 Society for Investigative Dermatology (SID)
annual meeting in Chicago,
USA. This clinical study is
conducted at the Stanford University
School of Medicine in California,
USA under the leadership of the principal investigator, Dr
Kavita Sarin. Initial results
suggest that remetinostat gel offers a potentially effective and
well-tolerated, non-surgical intervention for treatment of
localized BCCs.
Interim results of an open-label clinical trial of the topical
HDAC inhibitor, remetinostat, as neoadjuvant treatment for BCC were
presented. The patients enrolled had at least one BCC of any
subtype between 5 and 25 mm in size. Participants applied
remetinostat gel 1% 3 times daily under bandage occlusion to BCC(s)
for 6 weeks prior to undergoing surgical excision. The primary
outcome was overall response rate (ORR) and secondary objectives
include safety and tolerability.
Interim results from the study:
- The ORR, at least a 30% decrease in longest diameter, was 64%
(9/14).
- The average decrease in tumor area is 70% (n=14), while the
average decrease in longest diameter is 62% (n=14). 43% (6/14) of
tumors were fully cleared.
- No systemic toxicities have been observed.
- Grade 2 eczematous local site reactions occurred in 71% (10/14)
tumors treated with topical remetinostat under bandage
occlusion.
- 2 of 14 subjects had their study drug temporarily discontinued
(for 1-3 days) due to adverse events. The reaction improves within
2-4 weeks of discontinuing medication.
"We are pleased about what appears to be a very positive outcome
of treating BCC patients with topical remetinostat," said Dr
Uli Hacksell, Medivir's Chief
Executive Officer. "Remetinostat has already demonstrated efficacy
in treating MF-CTCL and we are excited about the potential
opportunity to develop remetinostat for multiple indications."
The presentations are available on the Medivir website:
www.medivir.com.
For further information, please contact:
Uli Hacksell, CEO, Medivir AB, phone: +46(0)73-125-0615.
About remetinostat and the investigator sponsored
study
Remetinostat is a histone deacetylase (HDAC) inhibitor. The unique
design of remetinostat enables topical application, making it
active only in the skin. As soon as it reaches the blood stream, it
is degraded, avoiding the side effects associated with other HDAC
inhibitors.
The primary objective of the investigator-initiated study is to
assess the effects of topical remetinostat in BCC patients and
could establish that remetinostat has the potential for use in
other skin-associated cancers in addition to MF-CTCL. Medivir is
providing remetinostat drug for this study, and will have full
access to, and the rights to use, all clinical data after the study
is complete. Further details of the study can be found at
www.clinicaltrials.gov with the reference NCT03180528.
About Medivir
Medivir develops innovative drugs with a focus on cancer where the
unmet medical needs are high. The company is investing in
indication areas where available therapies are limited or missing
and there are great opportunities to offer significant improvements
to patients. Collaborations and partnerships are important parts of
Medivir's business model and the drug development as well as the
commercialization is conducted either by Medivir or in partnership.
Medivir's share (ticker: MVIR) is listed on Nasdaq Stockholm's
Small Cap list. www.medivir.com.
This information was brought to you by Cision
http://news.cision.com
https://news.cision.com/medivir/r/positive-data-from-the-remetinostat-phase-ii-study-in-basal-cell-carcinoma-presented-at-sid-annual-m,c2812175
The following files are available for download:
|
https://mb.cision.com/Main/652/2812175/1044032.pdf
|
Press release
(PDF)
|
View original
content:http://www.prnewswire.com/news-releases/positive-data-from-the-remetinostat-phase-ii-study-in-basal-cell-carcinoma-presented-at-sid-annual-meeting-300848672.html
SOURCE Medivir
