APL-1202
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APL-1202
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Summary of Phase II Study

The China Phase II clinical trial of APL-1202 was to investigate the effect of APL-1202 for the treatment of high risk non-muscle-invasive bladder cancer (NMIBC) patients who have failed intravesical chemotherapy or BCG therapy. This clinical trial was approved by the Center for Drug evaluation of the China Food and Drug Administration, and was the only trial globally in using an oral medication to treat non-muscle-invasive bladder cancer. It was a single arm, multi-centered trial led by Fudan University Shanghai Cancer Center, and the Principal Investigator was Professor Dingwei Ye, who is the elected Chairman of Chinese Anti-Cancer Association Genitourinary Tumor Committee, and the Vice President of Fudan University Shanghai Cancer Center and the Chair of the Urology Department. Preliminary results from this Phase II study have shown good efficacy for APL-1202 and were well recognized by participating doctors and patients. For more details please refer to the attached video report. 

 
 
Key Findings from the Phase II Clinical Trial

Efficacy:
Superior to the current intravesical chemotherapy, with efficacy comparable or superior to first time chemotherapy treatment. In high-risk NMIBC patients (EORTC risk score≥ 10) who have failed intravesical chemotherapy, there was a signficant reduction in 1-year recurrence rate after APL-1202 treatment.

     
Safety:
The clinical use of APL-1202 indicates that the drug is superior in safety with the main side effect is only gastrointestinal irritation, and the incidence is less than 10%, the safety of APL-1202 is significantly superior than intravesical chemotherapy drugs (such as MMC) and immunotherapy drugs (such as BCG) currently used in clinical treatment.


Route of Administration:
Comparing to intravesical therapy, oral administration is more convenient and safer for use, and has been well accepted by patients. In addition, it can avoid injury, pain, and potential urethral infections associated with intravesical drug administration.



Overview of Pivotal Trial
Principle investigators and participating clinical centers:
Shanghai Fudan Cancer Center and Peking Union Medical College Hospital are leading this trial, with approximately 50 participating hospitals nationwide. The co-Principal Investigators are Professor Dingwei Ye of Shanghai Fudan Cancer Center and Professor Hanzhong Li of Peking Union Medical College Hospital.

 
Other participating clinical centers include such famous hospitals as Peking University First Hospital, Sun Yat-sen Cancer Center, First Affiliated Hospital of Xi'an Jiaotong University, Tongji Hospital Affiliated with Tongji Medical College of Central China University of Science and Technology, First Affiliated Hospital of Nanchang University, Shanghai 10th People's Hospital, Jiangsu Cancer Hospital, Second Affiliated Hospital of Third Military Medical University, Beijing Cancer Hospital, Xinhua Hospital affiliated with Shanghai Jiaotong University School of Medicine

This clinical trial is currently recruiting patients. 

Recruitment criteria
Population: Relapsed non-muscular invasive bladder cancer patients after chemotherapy treatment
Inclusion criteria: moderate to severe non-muscular invasive bladder cancer patients, with no prior BCG or other immunotherapy treatment
(For specific inclusion criteria, please refer to the detailed admission criteria provided by the participating hospital)
 
Contact us
If you (your relatives) are NMIBC patient(s) and want to know more information about the drug APL-1202 or interested in clinical trial, please call Asieris Pharmaceuticals at 021-68585280-608.

If you are a clinical urologist and want to know more about APL-1202, and interested in participating in this clinical trial, please call Jiangsu Asieris Pharmaceuticals at 021-68585280-608 or visit the China Food and Drug Administration Drug evaluation Center Clinical Drug Trials Registration and Public Notification Portal (
http://www.chinadrugtrials.org.cn), search with query words: APL-1202.




Results from a phase II trial of APL-1202 in chemo-relapsed high-risk NMIBC patients indicated that:

Unexpected efficacy likely due to a new MoA
    As a new generation of reversible metaP2 inhibitor, APL-1202 can
    inhibit tumor cell proliferation and tumor angiogenesis;

    APL-1202's efficacy in reducing recurrence rates and extending
    recurrence-free survival appears to be greater than those from
    first-line chemotherapies, helping some patients avoid radical
    cystectomy.
 
 
 
Superior human safety
    No drug-related serious adverse events, with major side effects limited to gastrointestinal irritation at an incidence <10%. 

Oral Administration

    Dosing APL-1202 is convenient and safe, without causing pain or injury to urethra.




The standard of care for non-muscle invasive bladder cancer is Trans-Urethral Resection of Bladder Tumor (TURBT). Because of high tumor recurrence after TURBT, intravesical chemo- or immuno therapies are required, however, these therapies have significant limitations.

  Radical Cystectomy
Radical Cystectomy is the standard treatment for high-risk NMIBC patients who have failed intravesical therapies, and will cause significant deterioration of patients' quality of life.

Intravesical Therapies
Intravesical instillation is an invasive procedure, causing pain, bleeding and inflammation in patient's urinary tract. Due to a short treatment time (1-2 hours each time, once a week), the efficacy is poor. 30-50% of patients experience dysuria, urinary frequency and hematuria.

No new drug has been approved over the past two decades worldwide, and currently no new drug under clinical development in China.