On March 21, 2024 Oxcia reported that it has obtained approval from the South African Health Products Regulatory Authority, (SAHPRA) for the start of the phase 1 / 2 study of OXC-101 in solid cancers, more specifically gynecological cancers, prostate cancer and head and neck cancer (Press release, Oxcia, MAR 21, 2024, View Source;utm_medium=rss&utm_campaign=key-milestone-for-oxc-101-study-approval-in-south-africa [SID1234641346]). The study will take place at two clinical sites in South Africa. Oxcia is now applying for ethical approval and sending in a protocol amendment. The study is estimated to start early to mid-summer.

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"I am thrilled for this opportunity to build further clinical experience with OXC-101 and demonstrate safety and efficacy in less heavily pretreated patients than those treated so far" says Ulrika Warpman Berglund, CEO at Oxcia.

The clinical phase 1 / 2 study with OXC-101 in advanced solid cancers has already been extended in Sweden. Recruitment of patients with prostate and gynecological cancer is ongoing. The goal is to gather more clinical data with OXC-101 and align with regulatory agencies on the optimal effective dose and move into phase 2 development once capital has been secured.

For further information, please contact:

Ulrika Warpman Berglund, CEO

Phone: +46 (0) 73 270 96 05

Email: [email protected]

Briefly about OXC-101

OXC-101 is a "mitotic MTH1 inhibitor" and belongs to a completely new class of cancer drugs. It has potential for broad anticancer effect and suitability for large patient populations. It is given as a tablet. OXC-101 has demonstrated clinical benefits which supports further development in the phase 1 MASTIFF study.

OXC-101 makes intelligent use of the cancer cell’s inherent high levels of oxidative DNA damage and oxidative stress. OXC-101 stops cancer cell division by preventing microtubules from functioning. This generates additional oxidative stress (ie, ROS) and increased levels of oxidatively damaged DNA building blocks. By inhibiting MTH1, more damaged DNA building blocks remain and build into the DNA, causing even more DNA damage. The cancer cell can no longer handle the high levels of oxidative stress and DNA damage, resulting in the death of the cancer cell.