Non-Melanoma Skin Cancers Therapy

Enzymatic Topical Agent

  • Indication:Treatment of non-melanoma skin cancers
  • Classification:Biological drug
  • Target audience:Outpatient setting
  • Development status:U.S. Phase I/II study is underway

MW005, a topical biological drug for the treatment of non-melanoma skin cancers, is a clinical-stage product candidate under development.  MW005 is based on a proprietary formulation, designed to ease self-administration by the patients, and is based on the same active substance of NexoBrid and EscharEx, a concentrate of proteolytic enzymes enriched in bromelain.

Cancers of the skin are by far the most common of all types of cancers with about approximately 5.4 million basal and squamous cell skin cancers are diagnosed each year in the US. The number of these cancers has been increasing for many years due to combination of better skin cancer detection, people getting more sun exposure, and people living longer. We have recently launched a new clinical program to evaluate its drug product candidate MW005 in patients with non-melanoma skin cancers.

Scientific Evidence

The clinical development plan of MW005 is supported by the results from several toxicological and other preclinical studies, as well as vast clinical experience from NexoBrid and EscharEx, which share the same active substance. In addition, a recent publication that details case series experience using MW005 (a concentrate of proteolytic enzymes enriched in bromelain) for the destruction of basal cell carcinoma, provides a preliminary proof-of-concept that MW005 may be a safe and effective destructive treatment for basal cell carcinomas.

In was an ongoing open-label Phase I/II study of MW005 for the treatment of low-risk Basal Cell Carcinoma (BCC) that received positive initial data from eleven patients. The initial data showed MW005 to be safe and well-tolerated, with a majority of the patients who completed the study achieving complete histological clearance of their target lesions following treatment with MW005.

In the first cohort, eleven patients with either superficial or nodular BCC were treated. Patients enrolled into the study received seven topical applications of MW005, once every other day. At the end of eight weeks post treatment period, all patients undergo complete excision, and the specimen is subject to an independent histological clearance examination. Based on the data generated to date, MW005 is safe, well-tolerated and an effective treatment for BCC with a majority of patients who completed the study demonstrating a complete histological clearance of target lesions.