STOCKHOLM, Oct. 10, 2019 /PRNewswire/ -- Medivir AB
(Nasdaq Stockholm: MVIR) today announces that the first
patient has been enrolled in a phase I study to investigate the
safety and tolerability of a combination treatment of birinapant
and radiation therapy in patients with recurrent Head and Neck
Squamous Cell Carcinoma (HNSCC). The initiative for the study came
from researchers at the US National Cancer Institute (NCI). The
study is sponsored and financed as part of NCI's Cancer Therapy
Evaluation Program (CTEP). Medivir provides birinapant and will be
afforded full access to all reports from the study under its
Cooperative Research and Development Agreement with NCI for
birinapant. The primary goals of which are to evaluate the safety
of the combination treatment and to establish a maximum tolerated
dose for further studies. The potential signs of a treatment
response in the patients are also investigated. Medivir's decision
to support this study was based on preclinical data from NCI
showing good effects from birinapant in combination with
radiotherapy in models of various types of cancer of the head and
neck region [1]). Further information on the study can be found at
clinicaltrials.gov with the reference number NCT03803774.
"We believe that birinapant has the potential to form part of
several different combination treatments for various types of
cancer," says Uli Hacksell, PhD., CEO of Medivir. "The
birinapant-radiation therapy combination treatment yielded
impressive results in the preclinical cancer models, and we are
eagerly awaiting the results of the phase I study, which will be a
good complement to the ongoing phase II combination study of
birinapant and Keytruda®.
For further information, please contact:
Uli Hacksell, CEO, Medivir AB, mobile: +46(0)8-5468-3100
About Head and Neck Squamous Cell Carcinoma (HNSCC)
HNSCC is diagnosed in about 550,000 individuals worldwide annually.
Of these around 63,000 cases occur in the
United States, where around 13,000 patients die from the
disease each year. Locoregionally advanced recurrent disease in
patients who have had prior chemoradiation therapy has a poor
prognosis, with a two year survival rate of less than 50%.
About birinapant
Birinapant is being developed to enhance responses, and extend
survival, of patients with solid tumors where existing treatments
do not provide sufficient survival benefit, or where patients no
longer have treatment options. Based on its unique design and
mechanism, birinapant has the potential to enhance patients'
responses in combination with other treatments. Medivir's initial
focus is on developing birinapant in combination with an
immuno-oncology agent.
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.
DF Eytan et al., SMAC Mimetic Birinapant plus Radiation
Eradicates Human Head and Neck Cancers with Genomic Amplifications
of Cell Death Genes FADD and BIRC2. Cancer Research (2016) 76,
5442-5454.
This information was brought to you by Cision
http://news.cision.com
https://news.cision.com/medivir/r/us-national-cancer-institute-initiates-phase-i-study-of-treatment-of-head-and-neck-cancer-patients-w,c2929519
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