Progress in the clinical development of OTS167
First written in FY2016. 12 of 23 entries say "Restated". Latest entry: 2026-06-23.
No other company in this theme has enough history to compare yet.
- 2026-06-23AdvancedManagement Planning
「OTS167: Aim to complete the clinical trial early through expedited development」
For OTS167, a specific 2026 target was stated: in addition to continuing the clinical trial in the United States, the Company aims to complete the trial early. - FY2026-H1RestatedAnnual report
「For OTS167, we are conducting a Phase 1 clinical trial for breast cancer in the United States.」
The Phase 1 OTS167 breast cancer trial remains ongoing in the United States. The end of patient enrollment and safety confirmation for the acute myeloid leukemia trial are also reiterated. - FY2025ReframedAnnual report
「For OTS167, we had been conducting a Phase 1 clinical trial for breast cancer in the United States and Japan, but to streamline development activities, the plan is to end patient enrollment in Japan and continue the trial in the United States.」
For the Phase 1 OTS167 breast cancer trial, the development structure changed to a plan under which patient enrollment in Japan will end and the trial will continue in the United States. - FY2024-Q3ReframedAnnual report
「For OTS167, the aim is to out-license it to a pharmaceutical company at its current stage of development, rather than complete the previously planned in-house Phase 1 clinical trial. For the ongoing clinical trials, the company is working to reduce costs, including through outsourcing, and expects to reduce research and development expenses, particularly formulation costs.」
The development policy for OTS167 changed from a plan to complete an in-house Phase 1 clinical trial to one emphasizing out-licensing at its current stage and reducing the costs of ongoing trials. - FY2023-Q3RestatedAnnual report
「For OTS167, we are conducting a Phase 1 clinical trial for breast cancer in the United States and Japan. Patient enrollment in the Phase 1/2 clinical trial for acute myeloid leukemia conducted in the United States has ended, and the safety of repeated intravenous administration of OTS167 has been confirmed.」
The company reiterates that the Phase 1 OTS167 breast cancer trial remains ongoing in the United States and Japan, and that enrollment in the Phase 1/2 acute myeloid leukemia trial has ended and safety has been confirmed. - FY2023-Q1AdvancedAnnual report
「Patient enrollment in the Phase 1/2 clinical trial for acute myeloid leukemia conducted in the United States has ended, and the safety of repeated intravenous administration of OTS167 has been confirmed.」
For the Phase 1/2 OTS167 acute myeloid leukemia trial, the company reports that the safety of repeated intravenous administration was confirmed after patient enrollment ended. The Phase 1 breast cancer trial remains ongoing in the United States and Japan. - FY2022-Q3AdvancedAnnual report
「For OTS167, we had been conducting a Phase 1/2 clinical trial for acute myeloid leukemia at the University of Chicago and Cornell University in the United States, but patient enrollment ended in November 2021.」
For the Phase 1/2 OTS167 acute myeloid leukemia trial, the company reports the specific progress of completing patient enrollment in November 2021. The Phase 1 breast cancer trial remains ongoing in the United States and Japan. - FY2022-Q1RestatedAnnual report
「We are conducting a Phase 1 clinical trial of OTS167 for breast cancer at the University of Texas MD Anderson Cancer Center, Norwalk Hospital, and Memorial Sloan Kettering Cancer Center in the United States, and have additionally begun enrolling patients in the trial in Japan.」
For OTS167, the company continues to report the Phase 1 breast cancer trial in the United States and the start of patient enrollment in Japan. - FY2021-Q3AdvancedAnnual report
「We are also conducting a Phase 1 clinical trial of OTS167 for breast cancer at the University of Texas MD Anderson Cancer Center, Norwalk Hospital, and Memorial Sloan Kettering Cancer Center in the United States, and have additionally begun the trial in Japan.」
The company reports the specific progress of beginning the Phase 1 OTS167 breast cancer trial in Japan as well. - FY2021-Q2RestatedAnnual report
「For OTS167, we are conducting a Phase 1/2 clinical trial for acute myeloid leukemia at the University of Chicago and Cornell University in the United States. We are also conducting a Phase 1 clinical trial of OTS167 for breast cancer at Cornell University, the University of Texas MD Anderson Cancer Center, Norwalk Hospital, and Memorial Sloan Kettering Cancer Center in the United States.」
Clinical trials of OTS167 for acute myeloid leukemia and breast cancer remain ongoing in the United States. - FY2021-Q1RestatedAnnual report
「OTS167 targets MELK (Maternal Embryonic Leucine zipper Kinase), a molecule important for maintaining cancer stem cells. We are conducting a Phase 1/2 clinical trial for acute myeloid leukemia at the University of Chicago and Cornell University in the United States.」
The Phase 1/2 trial of OTS167 for acute myeloid leukemia and the Phase 1 trial for breast cancer remain ongoing in the United States. - FY2020-Q3RestatedAnnual report
「For OTS167, we are conducting a Phase 1/2 clinical trial for acute myeloid leukemia at the University of Chicago and Cornell University in the United States. We are also conducting a Phase 1 clinical trial of OTS167 for breast cancer at Cornell University, the University of Texas MD Anderson Cancer Center, Norwalk Hospital, and Memorial Sloan Kettering Cancer Center in the United States.」
Clinical trials of OTS167 for acute myeloid leukemia and breast cancer remain ongoing in the United States. - FY2020-Q2RestatedAnnual report
「For OTS167, we are conducting a Phase 1/2 clinical trial for acute myeloid leukemia at the University of Chicago and Cornell University in the United States.」
Clinical trials of OTS167 for acute myeloid leukemia and breast cancer remain ongoing in the United States. - FY2020-Q1AdvancedAnnual report
「We are also conducting a Phase 1 clinical trial of OTS167 for breast cancer at Cornell University, the University of Texas MD Anderson Cancer Center, Norwalk Hospital, and Memorial Sloan Kettering Cancer Center in the United States.」
Memorial Sloan Kettering Cancer Center has been added as a site for the Phase 1 OTS167 breast cancer trial in the United States. - FY2019-Q3AdvancedAnnual report
「We are also conducting a Phase 1 clinical trial of OTS167 for breast cancer at Cornell University, the University of Texas MD Anderson Cancer Center, and Norwalk Hospital in the United States.」
Norwalk Hospital has been added as a site for the Phase 1 OTS167 breast cancer trial in the United States. - FY2018RestatedAnnual report
「We are conducting a Phase 1/2 clinical trial of OTS167 for acute myeloid leukemia at the University of Chicago and Cornell University in the United States. We are also conducting a Phase 1 clinical trial of OTS167 for breast cancer at Cornell University and the University of Texas MD Anderson Cancer Center in the United States.」
Clinical trials of OTS167 for acute myeloid leukemia and breast cancer remain ongoing in the United States. - FY2018-Q3RestatedAnnual report
「OTS167 targets MELK (Maternal Embryonic Leucine zipper Kinase), a molecule important for maintaining cancer stem cells. We are conducting a Phase 1/2 clinical trial for acute myeloid leukemia at the University of Chicago and Cornell University in the United States.」
Clinical trials of OTS167 for acute myeloid leukemia and breast cancer remain ongoing in the United States. - FY2018-Q2RestatedAnnual report
「We are conducting a Phase 1/2 clinical trial of OTS167 for acute myeloid leukemia at the University of Chicago and Cornell University in the United States. We are also conducting a Phase 1 clinical trial of OTS167 for breast cancer at Cornell University and the University of Texas MD Anderson Cancer Center in the United States.」
Clinical trials for OTS167 targeting acute myeloid leukemia and breast cancer remain ongoing. - FY2017RestatedAnnual report
「We are conducting a Phase 1/2 clinical trial of OTS167 for acute myeloid leukemia in the United States. We have also begun a Phase 1 clinical trial of OTS167 for breast cancer at Weill Cornell Medicine in the United States.」
For OTS167, the company reports that the acute myeloid leukemia trial is being conducted and the breast cancer trial has begun. Both are annual reports of the development policy and progress presented through the immediately preceding quarter. - FY2017-Q3RestatedAnnual report
「This clinical trial targets patients with acute myeloid leukemia and will assess the safety and recommended dose of repeated intravenous administration of OTS167. Following confirmation, its objective is to obtain proof of concept (POC), including validation of the mechanism of action and clinical efficacy and safety, in various leukemias with a poor prognosis, including acute myeloid leukemia. Enrollment of the first patient was completed in July this year.」
For the Phase 1/2 trial for acute myeloid leukemia, the company reiterates the previously reported progress of completing enrollment of the first patient. - FY2017-Q2AdvancedAnnual report
「In addition, we have decided to begin a Phase 1 clinical trial of OTS167 for breast cancer. The trial will enroll patients with breast cancer, including triple-negative breast cancer, and will primarily assess the safety and recommended dose of oral administration of OTS167 in capsule form, with clinical efficacy against triple-negative breast cancer assessed as a secondary objective.」
For OTS167, plans to begin a Phase 1 clinical trial for breast cancer in addition to acute myeloid leukemia have taken concrete shape. - FY2017-Q1AdvancedAnnual report
「Following confirmation, the objective is to obtain proof of concept (POC), including validation of the mechanism of action and clinical efficacy and safety, in various leukemias with a poor prognosis, including acute myeloid leukemia. Enrollment of the first patient was completed in July this year.」
For OTS167, the company reports the specific progress of completing enrollment of the first patient in the Phase 1/2 acute myeloid leukemia trial. - FY2016First statedAnnual report
「The data obtained from this trial are highly significant for subsequent clinical trial planning and formulation development for OTS167, and we have begun a Phase 1/2 clinical trial of OTS167 for acute myeloid leukemia in the United States.」
In the Phase 1 solid-tumor trial, patient enrollment ended after safety and pharmacokinetics were confirmed, and a Phase 1/2 trial for acute myeloid leukemia was launched. The company states that good oral absorption was confirmed in the Australian trial.