STOCKHOLM, June 13, 2019 /PRNewswire/ -- Medivir AB
(Nasdaq: MVIR) (Stockholm: MVIR) today announces the
results of an analysis of data from the first six patients with
advanced cancer in the liver treated with increasing MIV-818 doses.
The primary objective of the study is to evaluate the tolerability,
safety and pharmacokinetics of MIV-818. Evaluated doses have been
shown to be well-tolerated by patients. An effect signal, measured
as DNA damage, has been observed in liver biopsies from tumor
tissue in MIV-818 treated patients. In contrast to the tumor,
normal liver tissue does not appear to have been affected by the
treatment. This tumor selective effect was observed at low measured
levels of MIV-818 in plasma and is an early indication that MIV-818
works as expected, i.e. the substance has the intended
liver-directed effect. Based on the positive results from the first
six patients, Medivir has decided to initiate the phase Ib part of
the MIV-818 study.
"It is very promising to already at this early stage of clinical
development see clear indications that MIV-818 has a liver-directed
effect. It is therefore with great expectations that we will
proceed with the clinical program for MIV-818," says Medivir's CEO,
Dr. Uli Hacksell. "The development
of MIV-818 is a central part of our vision – creating shareholder
value and improving the lives of cancer patients through
transformative drugs."
Today, Thursday June 13 at 10.00 CET,
Medivir will host a telephone conference for investors, analysts
and the media where the study results and the next step will be
presented.
Phone numbers for participants from:
Sweden +46-8-566-426-93
Europe +44-33-3300-9270
US +1-833-526-8398
The conference call will also be streamed via a link on the
website: www.medivir.com
The presentation will be available on Medivir's website after
completion of the conference.
For further information, please contact:
Uli Hacksell, CEO, Medivir AB, phone: +46(0)73-125-0615.
Medivir AB is obliged to make this information public pursuant
to the EU Market Abuse Regulation. The information was
submitted for publication, through the agency of the contact person
set out above, at 08.00 CET on 13 June,
2019.
About MIV-818
MIV-818 is a pro-drug designed to selectively treat liver cancers
and to minimize side effects. It has the potential to become the
first liver-targeted, orally administered drug to benefit patients
with HCC and other forms of liver cancer.
About the study
The phase I/II study of MIV-818
consists of three parts: a phase Ia study in which individual
patients receive escalating doses of MIV-818. This will be followed
by a phase Ib study in which the dose is escalated in cohorts of
three patients in a 3+3 design in order to identify the recommended
phase II dose, which will be determined by the trial's independent
safety review committee. In the phase II part of the study two
cohorts of patients with liver cancer, will receive the recommended
dose of MIV-818. More information about the study is available at
www.clinicaltrials.gov, reference number NCT03781934.
About liver cancer
Liver cancer is the third leading cause of cancer-related deaths
worldwide and hepatocellular carcinoma (HCC) is the most common
cancer that arises in the liver. Although existing therapies for
advanced HCC are capable of extending the lives of patients,
treatment benefits are low while death rates remain high. HCC is a
very diverse disease with multiple cancer cell types and without
specific mutations seen in other tumor types. This has contributed
to the lack of success of molecularly targeted agents in HCC. The
limited overall benefit, taken together with the poor overall
prognosis for patients with intermediate and advanced HCC, results
in a large unmet medical need.
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/selective-effect-signal-on-liver-cancer-tissue-in-phase-ia-study-with-miv-818,c2839491
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