Date: 2016-08-30
Type of
information: Treatment of the first patient
phase: 1
Announcement: treatment of the first patient
Company: Oncternal Therapeutics (USA - CA)
Product: TK216 - small molecule Ewing Sarcoma breakpoint region 1/Friend leukemia virus integration 1 fusion protein inhibitor
Action
mechanism:
- TK216 is a first-in-class small molecule that inhibits the biological activity of ets-family transcription factor oncoproteins in a variety of tumor types, stopping cancer cell growth and tumor formation. In Ewing sarcoma, it is designed to target a single and well-characterized genetic mutation that causes the disease. TK216 is being developed collaboratively by Georgetown University and Oncternal.
- TK216 has received Orphan Drug Designation from the FDA and Fast Track Designation for treating Ewing patients who are relapsed or refractory to standard therapies.
- Oncternal and Georgetown are also planning clinical studies in glioblastoma, prostate cancer and lymphoma in the next year.
Disease: Ewing sarcoma
Therapeutic
area: Cancer - Oncology - Rare diseases
Country: USA
Trial
details:
- Ewing sarcoma is characterized by genomic rearrangements resulting in over-expression of ets family transcription factors driving tumor progression. TK216 is designed to inhibit this effect by inhibiting downstream effects of the EWS-FLI1 transcription factor. This study is a first in human study of TK216 in subjects with Ewing sarcoma. The study is designed to establish initial safety and efficacy data to assess the potential of TK216 for further development. (NCT02657005)
Latest
news: • On August 30, 2016, Oncternal Therapeutics announced that the first patient has been dosed in a Phase 1 clinical trial of TK216 in Ewing sarcoma. The trial will evaluate safety and efficacy of TK216 in patients with relapsed or refractory Ewing sarcoma.
Is
general: Yes
