Shanghai, China-March 30, 2017
Asieris Pharmaceuticals, a clinical stage bio pharmaceutical company, today announced that the first patient with NMIBC relapsed from previous intravesical chemotherapies has been treated in its ACCRUE-1 pivotal trial at Shanghai Fudan University Cancer Center.
“Dosing the first patient in our ACCRUE-1 pivotal trial marks an important milestone in our efforts to drive innovation in the field of NMIBC treatment”, commented Kevin Pan, Ph.D., Founder and Chief Executive Officer of Asieris. “We are working hard to accumulate the clinical evidence of APL-1202 and look forward to partnering with regulators in China and other countries to meet the urgent needs of these patients.”
“Given the poor prognosis for most NMIBC patients relapsed from prior intravesical therapies and the lack of new drugs for the past 20 years, APL-1202 holds great potential as a disruptive player based on the efficacy and safety results from a PoC Phase II study, which are much better than expected”, commented Professor Dingwei Ye,M.D., the ACCURE-1 trial’s Co-Principal Investigator, who serves as the Chair-elect of the Genito-Urinary oncology Committee, Chinese Society of Clinical Oncology, and the Vice President of Shanghai Fudan University Cancer Center.” We are optimistic about the potential of APL-1202 to continue demonstrating favorable efficacy and safety in the pivotal trial and look forward to having this new treatment available for our patients as soon as possible.”
The ACCRUE-1 (APL-1202 and Chemotherapyvs. Chemotherapy alone in Patients with Relapsed Non-Muscle Invasive Urothelial Bladder Cancer) clinical trial is a multicenter, double-blind, place bo-controlled trial in China (CTR20170169) evaluating APL-1202 in combination with intravesical epirubicin for the treatment of patients with intermediate- or high-risk NMIBC relapsed from chemotherapies. The primary endpoint of the ACCRUE-1 trial is median event-free survival, and key secondary endpoints are non-recurrence rates at 12-, 18-, and 24-month as well as safety. The design of this pivotal trial has been accepted by the Center for Drug evaluation (CDE) of CFDA. For more information about this trial, please visit (http://www.chinadrugtrials.org.cn).
APL-1202 is a first-in-class, reversible and orally available methionine aminopeptidase II (metaP2) inhibitor. metaP2 is known for its role in cancer angiogenesis and proliferation. APL-1202’s mechanism of action was initially discovered by researchers at the Johns Hopkins University (JHU), and Asieris has in-licensed the global intellectual properties from JHU. In preclinical models, Asieris discovered that APL-1202 enhanced the tumor-suppressing effects of chemo- and immuno-therapies.
APL-1202 is the first oral drug in the world that enters a pivotal clinical trial forth treatment of NMIBC. The interim analysis results from a proof-of-concept Phase II trial where relapsed high-risk NMIBC was treated by APL-1202 as a single agent were presented at the 31st European Association of Urology (EAU) Congress in Munich, 2016.
Bladder cancer (BC) is a common disease worldwide. With 360,000 new cases and 145,000deaths each year, the prevalence of BC is near 2.7 million, with the majority in males and the highest incident rates in developed countries.
Approximately75% of patients with BC present with a disease confined to the mucosa (stageTa, CIS) or the submucosa (stage T1), grouped as non-muscle invasive BC (NMIBC). The standard of care is Trans-Urethral Resection of the Bladder Tumor (TURBT), followed by intravesical bacillus Calmette-Guérin (BCG) immunotherapy or a chemotherapy due to high recurrence rates of BC. While intravesical BCG is the first-line inwestern countries, intravesical chemotherapies are more commonly used in China. The choice of a second-line is very limited, and radical cystectomy is the standard of care for high-risk patients. Currently there is no oral therapies approved or in clinical development for this disease.
About Asieris Pharmaceuticals
Asieris Pharmaceuticals is a China-based biopharmaceutical company focusing on developing innovative oncology drugs for the global market. Asieris takes a unique R&D approach by capitalizing on the vast existing knowledge of drugs with human experiences. APL-1202 is Asieris’ leading drug candidate.Asieris is also investigating small-molecular compounds with novel immune-oncology mechanisms. To learn more about Asieris’ drug candidates and technologies, please visit Asieris’ website at www.asieris.com.