Shuttle Pharmaceuticals and POLA Pharma Agree to License U.S. Rights to Doranidazole

8/15/17

Shuttle Pharmaceuticals, Inc. (USA) and POLA Pharma Inc. (Japan), today announced agreement to license the U.S. rights for doranidazole, a hypoxic cell radiation sensitizer, for clinical development in treating cancers in combination with stereotactic body radiation therapy (SBRT). SBRT is used to deliver large doses of radiation in a few treatments with precise targeting of cancers. Current radiation dose limitations, due to sensitive normal tissues that may surround a tumor, support a role for radiation sensitizers to enhance the effectiveness of radiation. Clinical trials to determination safety and efficacy of the combination of doranidazole and SBRT are proposed for treating patients with pancreatic, lung and liver cancers.

"We believe there is need for improvement in the treatment of pancreatic cancers with radiation. Doranidazole in combination with SBRT offers a clinical and commercial opportunity," said Anatoly Dritschilo, MD and CEO of Shuttle Pharmaceuticals. "Tumors have regions of hypoxia that are considered a source of resistance to radiation therapy, leading to treatment failure and cancer recurrence. We are excited by this opportunity to advance SBRT with a hypoxic cell radiation sensitizer in the setting of personalized treatment of patients with cancers."

About Doranidazole

Radiation sensitizers are drugs used in combination with radiation therapy for treatment of solid tumors not amenable to surgery. Currently, chemotherapeutic drugs and biologic agents are used "off-label" as radiation sensitizers, demonstrating an unmet need for developing new sensitizing agents.

Doranidazole is a 2-nitro imidazole derivative that sensitizes hypoxic cancer cells to radiation therapy. POLA Pharma Inc. has completed clinical trials of doranidazole and radiation therapy in Japan, phase IIa in non-small cell lung cancer (NSCLC) and phase III in pancreatic cancer, combined with intra-operative radiation therapy. Doranidazole has also been licensed to Shenzhen Main Luck Pharmaceuticals (China) for the territory of China.

About the Companies

Shuttle Pharmaceuticals, Inc., based in Rockville, MD, is a drug discovery and development company with the founding objective to develop and commercialize radiation modifying agents for cancer treatment, including sensitizers, protectors and mitigators of radiation effects or damage. Further information about Shuttle Pharmaceuticals can be found at www.shuttlepharma.com.

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