Positive Outcomes from Global Phase III Clinical Trial

As a leading global biopharmaceutical company, Asieris Pharmaceuticals has announced promising results from a recent Phase III clinical study on their non-surgical treatment for cervical HSIL. The study showed significant efficacy and a good safety profile for their product APL-1702, which is a pioneering cold light photodynamic drug-device combination. This non-surgical therapy aims to treat cervical HSIL, a condition that can lead to cervical cancer if left untreated.

The study, led by Dr. Jinghe Lang from Peking Union Medical College Hospital, enrolled 402 eligible patients from various countries and demonstrated an 89.4% improvement in response rate compared to the placebo control group. Additionally, the APL-1702 treatment group showed a 103.9% increase in clearance rate of high-risk HPV16 and/or HPV18. The incidence of adverse events was low, with the majority being mild and self-healing without intervention.

Cervical cancer is a significant health concern globally, with China ranking second among malignant tumors in women. Current treatment options for high-grade cervical lesions involve invasive surgical procedures that come with potential risks and complications. The emergence of APL-1702 provides a non-surgical alternative that preserves the intact cervix and avoids or delays cervical trauma, offering a promising solution for patients with cervical precancerous lesions.

Leading experts in the field of cervical cancer, including Professor Chen Fei and Professor Qiao Youlin, have expressed their excitement about the study results and the potential impact of APL-1702 on women’s health. Professor Qiao emphasized the importance of non-surgical therapies in addressing the treatment gap for cervical precancerous lesions and contributing to the global efforts to eliminate cervical cancer by 2030.

Dr. Linda Wu, Chief Development Officer of Asieris Pharmaceuticals, highlighted the significance of the study findings and the company’s plans to submit a new drug application for APL-1702 in the second quarter of 2024. Asieris Pharmaceuticals aims to bring this innovative treatment to more patients worldwide, addressing the unmet clinical needs for non-surgical options in the management of cervical precancerous lesions.

In conclusion, the Phase III clinical study results for APL-1702 represent a significant advancement in the treatment of cervical HSIL. With its proven efficacy, low incidence of adverse events, and potential to address the unmet clinical needs for non-surgical therapies, APL-1702 offers hope for patients with cervical precancerous lesions. Asieris Pharmaceuticals continues to pave the way for innovative solutions in the field of genitourinary tumors and related diseases, striving to improve human health and patient outcomes globally.

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