APL-1702 (Cevira®) is a photodynamic drug-device combination product. It is developed for the treatment of cervical high grade squamous intraepithelial lesion (HSIL) caused by infection with all HPV subtypes.
The treatment with APL-1702 is simple and easy to operate. The ointment is applied into the device, which is placed on the patient’s cervix by a gynecologist. The drug is absorbed by diseased cells and metabolized into molecules to be used for photodynamic therapy within a preset period of time. After that, the built-in light source will automatically turn on to activate and enable molecules to kill tumor cells, leading to a therapeutic effect. The light source will automatically stop photoactivation of the drug after the preset period. Patients can move freely during the entire treatment period, and remove the device by themselves after the treatment.
APL-1702 received the prestigious Fierce Innovation Award (FIA) in the Medical Device Innovation category for its novel design in 2019. Asieris Pharmaceuticals has obtained the exclusive global rights for the development and commercialization of APL-1702.
Unmet Market Demand
Cervical cancer is one of the most common gynecological malignancies. Its incidence ranks 2nd among female malignancies in China, with approximately 130,000 new cases each year. The 3-5 years survival rate of patients with cervical cancer is below 50%, and the annual death toll is about 53,000, which accounts for about 18.4% of all malignant tumor-related deaths in women. Long-lasting infection with HPVs causes precancerous cervical lesions. If treated, it may develop into cervical cancer. HSIL is a high-grade precancerous cervical lesion. If it is accompanied by high-risk HPV infection, it is more likely to develop into cervical cancer. In 2019, the number of women with precancerous cervical lesions in China was approximately 3.5 million, and the compound annual growth rate from 2015 to 2019 was 1.3%. With the wider use of cervical cytology screening, more patients with precancerous cervical lesions are detected in precancerous stage, and the number of detected patients is expected to rise in the future.
Currently, no non-surgical treatment is available for the treatment of precancerous cervical lesions globally. APL-1702 is expected to provide a new non-surgical treatment option to help patients avoid pain and side effects of surgical treatment, especially the impact on reproductive functions of patients of childbearing age.
Significant Clinical Value
APL-1702 has completed a randomized, double-blind, placebo-controlled multicenter Phase IIb clinical trial in Europe and the United States. The results showed that it had significant efficacy and safety profile in patients with precancerous cervical lesions, with the following advantages:
Significant therapeutic effect on HSIL
APL-1702 has completed a randomized, double-blind, placebo-controlled, multi-center Phase IIb clinical trial and the results showed that it has a good therapeutic effect on precancerous cervical lesions and has an effective efficacy to eliminate HPVs.
Obvious advantages in safety profile
Conventional surgical treatment may cause adverse reactions like bleeding, infection, and organic injury of the cervix, which may cause a series of reproductive dysfunctions such as premature delivery and miscarriage. The results of the clinical trial showed that APL-1702 has a good safety profile. As a local non-surgical treatment option, APL-1702 has obvious advantages in safety profile over surgical treatment, with only local and self-limiting adverse reactions, which helps patients, especially women of childbearing age, avoid surgical treatment and related risks.
Easy and convenient procedure
During the treatment with APL-1702, ointment is applied into the device, which is placed on the patient’s cervix by a gynecologist. After that, patients can leave the hospital, and during the treatment, patients can move freely and remove the device themselves after the treatment. It is easy to operate and is not restricted by medical facilities and environment.
Asieris Pharmaceuticals is conducting a global multi-center Phase III clinical trial for APL-1702.