Clinical Trials

Date: 2016-02-16

Type of information: Completion of the trial

phase: 1

Announcement: completion of the trial

Company: Cellceutix (USA - MA)

Product: Kevetrin® (thioureidobutyronitrile)

Action mechanism:

In the laboratory, Kevetrin® activates p53, a tumor suppressor protein that has an important role in protecting the body. p53 functions by activating proteins that repair DNA and kill cells that have genetic mutations such as in cancers. Research experiments showed that when cancer cells were treated with Kevetrin, it activated p53 which induced p21, a protein that inhibits cancer cell growth. p53 also induced PUMA (p53 up-regulated modulator of apoptosis), a protein that causes tumor cell death. Because of these activities, slowing cancer cell growth and causing cancer cell death, Kevetrin may help to treat tumors.

Disease: solid tumors

Therapeutic area: Cancer - Oncology

Country: USA

Trial details:

This phase 1, open-label, dose-escalation, safety, pharmacokinetic and pharmacodynamic study is evaluating Kevetrin® (thioureidobutyronitrile) administered intravenously, in patients with advanced solid tumors (NCT01664000 )

Latest news:

• On February 16, 2016, Cellceutix announced the successful completion of its Phase 1 trial of Kevetrin® in patients with advanced solid tumors conducted at Dana-Farber Cancer Institute and Beth Israel Deaconess Medical Center. The open-label, dose escalation study met Cellceutix’s objectives by demonstrating the safety and tolerability of Kevetrin®, while providing key information on the pharmacokinetics of Kevetrin®. These data are being utilized in designing a Phase 2 study, which will evaluate Kevetrin® as a component of combination therapy in the treatment of ovarian cancer. As disclosed on February 10, 2016, the FDA informed Cellceutix that increasing the frequency of Kevetrin® dosing from once weekly to three times weekly would be acceptable based upon the data from the Phase 1 study. Cellceutix is developing Kevetrin® under an Orphan Drug designation for ovarian cancer from the FDA.