Hong Kong-based Hutchinson China MediTech, or Chi-Med, has moved into an open-label Phase II clinical trial in thyroid cancer with candidate HMPL-012, sulfatinib, in China, building on other oncology efforts that include a U.S. Phase I clinical trial to treat neuroendocrine tumors.
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| Chi-Med CEO Christian Hogg |
The company said in a release that it dosed the first patient on March 1, with the study to evaluate the efficacy and safety focused on patients with locally advanced or metastatic radioactive iodine-refractory differentiated thyroid cancer, or medullary thyroid cancer.
The full trial to evaluate efficacy and safety will enroll around a total of 50 patients in both categories split evenly, the release said in a two-stage design that will see 15 patients apiece with each tumor type in a first stage.
The remaining 10 patients for each tumor type will be enrolled after efficacy assessment in the second stage.
The company said it "believes that sulfatinib's VEGFR/FGFR1 inhibition profile has strong potential in second-line thyroid cancer patients, particularly in China where there are few safe and effective treatment options for this patient population."
Now listed in London, Chi-Med, part of Li Ka-shing-controlled CK Hutchison Holdings, announced its intention in October to list on the Nasdaq and in In February filed an amended F-1 form with the U.S. Securities and Exchange Commission for the planned $100 million IPO in which it plans to sell American depositary shares (ADSs) under the symbol HCM.
On March 1, the company again filed an F-1 to include the audited consolidated financial results of Chi-Med for the year ended Dec. 31, 2015.
The company is focused on oncology and immunological diseases with 7 clinical-stage drug candidates in its pipeline, 5 of which already having "achieved proof-of-concept" that could see them become "eligible for accelerated approval by the U.S. Food and Drug Administration. It owns four of the candidates and has partnerships on the others with AstraZeneca ($AZN), Eli Lilly ($LLY) and Nestle Health Science.
- here's the release
- and the outline of the trial from Clinicaltrials.gov