Jiangsu Yahong Pharmaceutical Technology Co., Ltd. "apl-1202 interim clinical analysis results of phase II in China" made on-site report at Eau 2016 Munich annual meeting
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Last Update: 2016-03-23
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Source: Internet
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Author: User
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(on behalf of Ye Dingwei, vice president of Fudan cancer hospital in Shanghai, Professor Dai Bo made a field report on the results of mid-term analysis of apl-1202 phase II clinical trial in China) On March 12, at the 2016 academic annual meeting of European Association of Urology (EAU) held in Munich, Germany, Jiangsu Yahong Pharmaceutical Technology Co., Ltd presented the preliminary research results of a phase II clinical trial of apl-1202, an oral me TAP2 inhibitor At the invitation of the Organizing Committee of the conference, Professor Dai Bo, urology department of Fudan tumor hospital in Shanghai, on behalf of Professor Ye Dingwei, the main researcher of this clinical experiment and vice president of Fudan tumor hospital in Shanghai, made "oral me" at the scene of the conference The mid-term analysis results of phase II clinical trial of apl-1202, an inhibitor of TAP2, in the treatment of high-risk non myometrial invasive bladder cancer (NMIBC) patients with recurrent bladder perfusion in China were reported on the spot and praised by experts from various countries The Organizing Committee of the conference congratulated Professor Dai and looked forward to seeing the phase III clinical research results of apl-1202 as soon as possible This single group, open, multicenter concept validation phase II clinical trial in China was conducted to evaluate the efficacy, safety and steady-state pharmacokinetic (PK) of apl-1202 in the treatment of high-risk non myometrial invasive bladder cancer (NMIBC) patients with recurrent bladder perfusion The main therapeutic efficacy index was 12-month recurrence free rate The preliminary results from 36 patients with relapse of chemotherapy perfusion and 2 patients with relapse of BCG perfusion showed that apl-1202 was safe and tolerable at a dose of 750 mg / day for 12 weeks, and then maintained alternately for 15 months every 3 months The preliminary results also suggest that the efficacy of apl-1202 in these patients with perfusion failure is similar to that of the patients receiving perfusion chemotherapy for the first time "The preliminary results of apl-1202 in the treatment of patients with recurrent high-risk non myometrial invasive bladder cancer (NMIBC) by bladder perfusion are encouraging and lay a foundation for further clinical research," said Professor Ye Dingwei, vice president of Cancer Hospital Affiliated to Fudan University and the main researcher of phase II clinical trial "The choice of high-risk non myometrial invasive bladder cancer (NMIBC) patients after failure of bladder perfusion is very limited The standard treatment is radical cystectomy These patients are in urgent need of new therapeutic drugs "We are pleased to report the preliminary results of apl-1202 in high-risk patients who have failed perfusion therapy, which indicates that apl-1202 has a good development prospect," said Dr Pan Ke, chairman and CEO of Jiangsu Yahong Pharmaceutical Technology Co., Ltd "Apl-1202 showed significant antitumor activity in a number of mouse orthotopic bladder cancer models The current clinical efficacy is consistent with our preclinical efficacy study results We are very grateful to our patients for their participation in phase II clinical trials Based on these results, we will make some adjustments to the original clinical development plan to speed up the provision of a new treatment plan for such patients "
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