Aurora Medicine Announces Completion of Patient Enrollment in Phase III Clinical Trial of APL-1202 in China

VCBeat (WeChat ID: vcbeat) has learned that on September 23, 2019, Asieris Pharmaceuticals, a global innovative drug R&D company focused on anti-tumor and related diseases of the genitourinary system, announced that patient enrollment for its Phase III clinical trial of APL-1202 in China had been completed.

This novel drug, the first oral, reversible methionine aminopeptidase 2 (MetAP2) inhibitor to enter clinical trials globally, is indicated for the treatment of non-muscle-invasive bladder cancer. MetAP2 inhibitors suppress both tumor cell proliferation and tumor angiogenesis. APL-1202 has also entered clinical development in the United States.

The primary objective of this Phase III clinical trial was to evaluate the efficacy and safety of APL-1202 combined with intravesical chemotherapy versus placebo combined with intravesical chemotherapy in patients with intermediate- and high-risk non-muscle-invasive bladder cancer (NMIBC) who experienced recurrence after prior intravesical chemotherapy. A total of 357 patients were enrolled across 40 clinical centers in China.

“We are pleased to have participated in the clinical trials of APL-1202. Over the past two decades, there has been no therapeutic progress for superficial bladder cancer worldwide. This trial holds significant potential to improve treatment for patients with non-muscle-invasive bladder cancer. The availability of an oral medication represents a very exciting option for patients,” commented Professor Ye Dingwei, Vice President of Fudan University Shanghai Cancer Center and principal investigator of this clinical study. “APL-1202 brings hope to patients, and I eagerly anticipate its entry into clinical practice.”

“APL-1202 demonstrated encouraging efficacy and safety as a monotherapy for non-muscle-invasive bladder cancer in its Phase II clinical trial in China. The successful completion of enrollment in the Phase III clinical trial evaluating APL-1202 in combination with intravesical chemotherapy marks another significant milestone in the clinical development of APL-1202. We hope to provide patients with better treatment options as soon as possible,” said Dr. Pan Ke, Co-founder, Chairman, and CEO of Asieris Pharmaceuticals.

Bladder cancer is highly prevalent worldwide. According to Globalcan, there were 549,343 new cases and 199,922 deaths from bladder cancer globally in 2018. Of these, China accounted for 82,270 new cases. The current standard treatment is transurethral resection of bladder tumor (TURBT). Due to the high rate of postoperative recurrence, intravesical instillation of Bacillus Calmette-Guérin (BCG) immunotherapy or intravesical chemotherapy is required. Currently, second-line treatment options for patients with recurrence are very limited, and the standard therapy for high-risk patients who fail intravesical instillation is radical cystectomy. No oral medications have been approved for market launch to date.

Asieris Pharmaceuticals was established in March 2010 at China Medical City in Taizhou, Jiangsu Province, and has set up a research and development center in Shanghai. It is a domestic global innovative drug R&D company focused on anti-tumor and related diseases of the urogenital system. Asieris Pharmaceuticals is committed to becoming the most innovative, influential, respected, and trusted pharmaceutical enterprise in its specialized field.

The company focuses on the urogenital field, rapidly establishing a leading position and implementing in-depth strategic layouts. Asieris Pharmaceuticals fully leverages the global value of its independently developed, first-in-class novel drugs with breakthrough therapeutic potential, while also introducing new drugs that are in late-stage development or already marketed overseas into the Chinese market. This enhances the diversity and synergy of its product pipeline, enabling the rapid establishment of a leading position in the domestic market.