Tosk, Inc. reported today the completion of Phase 1 safety trials and the initiation of POC studies in human cancer patients for the prevention of mucositis side effects using its drug TK-90. Mucositis is the inflammation and ulceration of the mucosal membranes lining the digestive tract.

Tosk scientists have worked for more than a decade to develop an innovative, cost-effective drug discovery technology that uses the common fruit fly as a model for human diseases. The objective of the technology is the development of a family of drugs that relieves the painful, debilitating, and potentially fatal side effects from front line cancer therapies such as methotrexate, doxorubicin, cisplatin, EGFR inhibitors, and radiation.

The physicians dosing the trial’s first patients have reported favorable results for both preliminary safety and efficacy of TK-90, according to Tosk’s CEO, drug industry veteran Brian Frenzel. The study involves increasing the dose of TK-90 while maintaining a high dose of the anti-cancer drug methotrexate.

Frenzel, who has led multiple medical product companies, says that “we’ve focused most of our efforts on reducing the side effects of cancer drugs in order to improve both the quality of life and outcomes for patients. Toxic side effects not only cause suffering, but can be potentially fatal, thereby often forcing physicians to reduce the optimal dosage of widely used cancer therapies. They also raise costs because it can cost more to treat the side effects than the cancer itself.” Frenzel calls Tosk’s drugs “companion” drugs because they are administered alongside “parent” drugs that are front line cancer therapies.

Tosk recently received a $2 million grant from the National Cancer Institute (NCI) to continue its highly promising oncologic kRAS research program to develop a drug to make EGFR-inhibiting drugs effective in the 40 percent of patients who do not currently benefit from treatment. In addition to the TK-90 and kRAS projects, Tosk has two other side-effect-reducing product development programs underway designed to alleviate chemotherapeutic toxic effects on the heart and other vital organs.