April 7, 2023
KinoPharma, Inc.

Phase 2 clinical trial initiated for the treatment of cutaneouswarts, a human papillomavirus infection.
- Development of a novel antiviral drug against human papillomavirus KinoPharma, Inc. (KinoPharma) and IWAKI SEIYAKU CO., LTD. (IWAKI SEIYAKU) havejointly commenced a Phase 2 clinical trial to confirm the efficacy of a drug candidate for thetreatment of cutaneous warts ('the Drug') in humans.
Development background
KinoPharma and IWAKI SEIYAKU have been jointly developing an ointment since January
2021 based on KinoPharma's novel antiviral agent against human papillomavirus (HPV). This
collaboration was further developed and a co-development and commercialization agreement
was signed in August 2022 to advance clinical development for the indication of cutaneous
warts. After confirming the safety of the Drug in animals and humans, the decision was madejointly to commence a Phase 2 clinical trial to confirm the efficacy of the Drug against cutaneous
warts, and a notification of clinical trial (CTN) was submitted to the Pharmaceuticals andMedical Devices Agency (PMDA) today.
About the Drug
Based on KinoPharma's novel concept of human papillomavirus (HPV) antiviral drugs
targeting human host factors, KinoPharma and IWAKI SEIYAKU have collaborated to develop
an ointment formulation that is the optimal delivery method for HPV infection on the skin andmucous membranes, and have filed a patent application.
What is human papillomavirus (HPV)?
It is so named because it forms a raised papilla-like tumor when it infects the skin or otherparts of the body. There are more than 100 different types of HPV, some of which may lead tocancer and others to benign neoplasms. HPV infection is known to cause a number of diseases
such as skin (cutaneous warts), anogenital (condyloma acuminatum, anal cancer), reproductiveorgan (cervical cancer) and upper aerodigestive tract (oropharyngeal cancer, etc.) infections.
What are cutaneous warts?
Cutaneous warts are small proliferative lesions (benign tumors) of the skin caused by infection
with the human papillomavirus (HPV). HPV enters the skin through small wounds and infects
cells in the basal layer of the epidermis. Infected cells actively divide and form warts.
Treatment generally involves cryotherapy using liquid nitrogen, but there are problems suchas the need for repeated procedures and pain associated with the treatment. There are noapproved antiviral drugs for HPV. Cutaneous warts are relatively common in children, but can

occur in all age groups, with an estimated prevalence of 3.4% (based on data from the 2021
Japan Social Insurance Medical Practice Survey).
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About IWAKI SEIYAKU CO., LTD.
IWAKI SEIYAKU is a pharmaceutical company focused on the manufacture and distribution of theethical, OTC medicines, and Aesthetic products. The company is especially active in the dermatology
market. IWAKI SEIYAKU is expanding its brand and product portfolio in the future and will makeevery effort to supply this product stably.
About KinoPharma, Inc.
KinoPharma is a biotech engaged in research and development of novel antivirals in collaboration
with Kyoto University and other top universities in Japan. It is involved in the development of newconcept antiviral drugs that suppress viral replication by targeting host factors.
In addition to HPV-related diseases, KinoPharma is also working on the development of drugs fordeadly viral infections and next-generation pandemic viral infections.
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Contact
Business Administration Dept., KinoPharma, Inc.
E-mail：info@kinopharma.com
HP：https://www.kinopharma.com/