Zhejiang Medicine Terminates Phase III Oncology Trial

Zhejiang Medicine Co. Ltd. has terminated its Phase III oncology trial for oral forms of prochloridine mesylate to treat acute myeloid leukemia due to a lack of efficacy.

In a statement issued by the Chinese company, Zhejiang indicated the trial of its in-house-developed prochloridine mesylate was terminated due to a lack of efficacy. In its announcement, Zhejiang said the prochloridine mesylate tablets (XC302) did not demonstrate the desired efficacy in the clinical trial. Additionally, the company noted a lack of biomarkers that would allow the drug to be more efficient in targeting the disease. The company said the drug would be unable to compete in the market and announced its decision to terminate the trial despite having passed Phase I and Phase II regulatory hurdles in that country.

The prochloridine mesylate tablets were being developed in three doses, 12.5 mg, 25 mg and 50 mg. Prochloridine mesylate has been previously approved in China and in other countries, the company said. The company said it will continue to invest in the drug as a potential for other indications, but did not specify what those may be.

Acute myeloid leukemia is characterized by uncontrolled proliferation and accumulation of leukemic blasts in the bone marrow, peripheral blood and occasionally in other tissues. These cells disrupt normal hematopoiesis and rapidly cause bone marrow failure and death. In the United States alone, there are an estimated 19,950 new AML cases per year and 10,430 estimated deaths per year. In China, cancer has become a leading cause of death, with lung cancer being the most commonly diagnosed. According to the American Cancer Society, there were approximately 4.3 million new diagnoses of cancer in China in 2015, along with about 2.8 million cancer-related deaths. The five leading causes of cancer death among both men and women in China are cancers of the lung and bronchus, stomach, liver, esophagus, and colorectum, accounting for about three-quarters of all cancer deaths, the American Cancer Society said.

In the announcement of the trial termination, which was issued Thursday, Zhejiang said it does not anticipate the news to negatively impact its finances.  Zhejiang said R&D expenses for the failed trial have been "included in the corresponding profit or loss for the current earning period."

Shares of Zhejiang Medicine Co. are sold on the Shanghai Stock Exchange. Company shares are up more than 3.2 percent as of 3 p.m. GMT.