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Dosing of CLK Inhibitor CTX-712 Starts in Patients with Relapsed or Refractory AML or MDS in the U.S.

Chordia announces first patient dosed in the Phase 1/2 study with Relapsed or Refractory acute myeloid leukemia or myelodysplastic syndrome in the U.S.

FUJISAWA, KANAGAWA, JAPAN, June 1, 2023/EINPresswire.com/ -- Chordia Therapeutics Inc. (“Chordia”), a biotech company engaged in the research and development of novel therapies for cancers, today announces first patient dosed in the Phase 1/2 study of CTX-712, a selective pan-CDC2-like kinase (“CLK”) inhibitor, in patients with relapsed or refractory acute myeloid leukemia (“AML”) or myelodysplastic syndrome (“MDS”) in the U.S.

This study is a multicenter, open label, Phase 1/2 study to evaluate safety and efficacy of CTX-712 in patients with relapsed or refractory AML or higher risk MDS. For more information, please visit the following website: clinicaltrials.gov/ (NCT05732103).

<About AML and MDS>
AML and MDS are diseases in which abnormal stem cells (abnormal clones) grow tumorigenically in the bone marrow and suppress normal hematopoiesis. The number of patients with relapsed or refractory AML or MDS in US is estimated to be approximately 14,000 and 11,000, respectively . Both diseases have not definitely effective second-line therapies, have poor prognoses, and have a high unmet medical need.

<About CTX-712>
CTX-712 is a first-in-class, orally available and selective small molecule inhibitor of CDC2-like kinase (CLK), a key regulator of the RNA splicing process that plays an important role in cell growth. CTX-712 inhibits the growth of various human tumor cell lines in vitro, and in addition, exhibits antitumor activity in multiple xenograft mouse models in vivo.

<Details of Phase 1 Clinical Trial in Japan>
The Phase 1 clinical trial in Japan is investigating the tolerability, safety, and pharmacokinetics (PK) of CTX-712 in patients with advanced, relapsed, or refractory malignancies. For details of the study, please refer to JapicCTI-184188.

<Important Notice>
In this press release, the definition of “press release” covers any oral presentation, question, and answer session, and written and/or oral materials discussed or distributed by Chordia Therapeutics in connection with this press release. This press release (including the oral description and related questions and answers) is not intended to constitute, represent, or form part of any offer, invitation, or solicitation to purchase and/or acquire anything, including securities.

<Disclaimer>
Any announcements by Chordia Therapeutics, including this press release, may contain information on products derived from pharmaceutical developments, but are intended to inform the latest information related to Chordia’s business, and not intended as promotions, solicitations, advertisements, or to provide medical advice.

<Forward-Looking Statements >
This press release and materials distributed in connection with this press release may contain forward-looking statements, information, beliefs, and opinions concerning our future operations, future positioning, and performance, including estimates, projections, goals, and plans. Forward-looking statements may include, but are not limited to, expressions such as "goals," "plans," "beliefs," "hopes," "continues," "expects," "intends," "assures," "will," "may," "should," "would," "could," "estimates," "projects," and/or other similar expressions, or the negative thereof. These forward-looking statements are based on assumptions concerning a number of important factors, including the following, which could cause actual results to differ materially from those expressed or implied by the forward-looking statements; highly influential factors that include economic conditions surrounding our global business, which include general economic conditions in Japan and the United States, competitive pressures and developments including changes in applicable laws and regulations, which include global healthcare reform, uncertainty as to our clinical success, and challenges inherent in new product development (which include regulatory decisions and their timing,) uncertainty as to the commercial success of new and existing products manufacturing difficulties, delays fluctuations in interest rates and exchange rates claims or concerns regarding the safety or efficacy of commercial products or product candidates the impact of a health crisis, such as the COVID-19 pandemic, on Chordia and its customers and suppliers (including foreign governments in countries in which the Company conducts business) or other aspects of its business. We undertake no obligation to update any forward-looking statements contained in this press release or any other forward-looking statements we may make, except as required by law or stock exchange rules. Past performance is not indicative of future operating results, and any of our operating results or statements in this press release are not estimates, forecasts, warranties, or projections of our future operating results.

<About Chordia Therapeutics>
Chordia was established in November 2017 at Shonan Health Innovation Park (“Shonan iPark”) in Fujisawa, Kanagawa Prefecture, as a biotech company engaged in the research and development of novel therapies for cancers, with the goal of researching and developing first-in-class anti-cancer drugs and creating innovative new drugs.
In addition to its leading program for CTX-712, Chordia is engaged in the research of several developments in our pipeline, including CTX-439, a CDK12 inhibitor, which is expected to be effective in cancers with specific abnormalities, as well as GCN2 inhibitors.

Established: November 2017
Address: 26-1, Muraoka-Higashi 2-chome, Fujisawa, Kanagawa 251-0012, Japan
Representative: Hiroshi Miyake, Representative Director

Invester Relations Team
Chordia Therapeutics Inc
ir@chordiatherapeutics.com

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