Alteogen Biologics, a subsidiary of Korean biotech firm Alteogen, has signed a deal to license Papilocare, an intravaginal medical device for managing human papillomavirus (HPV) infection and related cervical lesions, from Spanish women's health company Procare Health, the company said on Wednesday.
Papilocare is a gel-form device intended to support recovery and normalization of HPV-associated cervical lesions by promoting re-epithelialization of the cervical and vaginal mucosa.
Persistent high-risk HPV infection can progress through lesions such as cervical dysplasia to cervical cancer. There is no approved drug that directly eliminates the infection, so HPV-positive cases and low-grade cervical lesions are often managed through repeat testing and observation.
The device drew its clinical evidence from PALOMA 1 and PALOMA 2, two randomized controlled trials run in Europe. In a pooled analysis, the high-risk HPV clearance rate at six months was 85.4 percent in the Papilocare group versus 43.4 percent in the control group, the company said. In PALOMA 2, the normalization rate for high-risk HPV-positive low-grade cervical lesions was 84.6 percent in the treatment group versus 46.4 p...