M.T.3

Malignant Tumor Treatment Technologies, Inc. (Headquarters: Tokyo; President and CEO: Toshiyasu Miyazaki; “M.T.3”) announced today that the Japanese pharmaceutical regulatory agency, the Ministry of Agriculture, Forestry, and Fisheries, has granted approval for LAVURCHIN® as a radiation sensitizing agent for dogs with stage III or stage IV nasal cavity tumors.

Radiation therapy, a crucial treatment for malignant tumors that cannot be completely removed through surgery, has seen significant advancements in recent years in both human and veterinary medicine. However, challenges such as limitations on the number of radiation sessions and decreased effectiveness as tumors progress have highlighted the need for a radiation sensitizing agent to enhance treatment outcomes. Despite several candidate substances being studied, none have obtained pharmaceutical approval due to concerns about side effects.

After a long and challenging endeavor lasting over two and a half decades, "LAVURCHIN®" has emerged as a groundbreaking solution as the world’s first radiation sensitizing agent in the veterinary field approved by the Japanese Ministry of Agriculture, Forestry, and Fisheries (MAFF), the U.S. Food and Drug Administration (FDA), and the European Medicines Agency (EMA). Derived from marine organisms, including sea urchins from Hokkaido, a northern region of Japan, and deep-sea seaweed, this innovative agent not only enhances the effects of radiation therapy but also minimizes damage to normal tissues, ensuring high safety standards.

"We are delighted to announce the approval of LAVURCHIN® as the world's first radiation sensitizing agent for dogs," said Toshiyasu Miyazaki, President and CEO of M.T.3. "This significant milestone is a testament to our commitment to advancing cancer treatment and improving the lives of both animals and humans. We will continue our endeavors to make LAVURCHIN® available to those in need around the world."

In parallel with the Japanese approval, M.T.3 is conducting clinical research on "LAVURCHIN®" in the United States, demonstrating a global perspective. The company envisions bringing this revolutionary product to markets worldwide, including the United States, Europe, and Asia. Furthermore, future expansion into human medicine is also being considered.

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