Cosmo Pharmaceuticals “Eleview” shows successful results in clinical trial

On May 8, 2017

Cosmo Pharmaceuticals announced that clinical trial of Eleview in comparison to a standard saline solution in subjects undergoing Endoscopic Mucosal Resection (EMR) of colonic lesions ≥20 mm show successful result.The principal investigators, among the world’s top endoscopists, were D. Rex, Indiana University, Indianapolis; M. Wallace, Mayo Clinic Jacksonville; P. Sharma, University of Kansas City, Kansas City; A. Repici, Istituto Clinico Humanitas, Milano; P. Bandari, Solent Center for Digestive Diseases, Portsmouth (UK).

226 patients were enrolled, the per protocol population used in the primary analysis set was 211. Most patients were referred to the investigators for the potential complexity of their case. For this reason, the lesions’ size and location varied greatly. The mean lesion size in the Eleview arm was 31.64 mm but ranged from 20 mm to 100 mm. In the comparator arm, the mean lesion size was 32.31 mm with ranges from 20 mm to 70 mm. The location varied from the caecum to the rectum, with the majority in the right section of the colon.

The primary endpoints were divided into:

Efficacy Endpoints
- Total injected volume needed to complete the EMR procedure
- Total injected volume per lesion size
- Time to resect the lesion completely
Safety Endpoints
- Procedural complications assessed by:
  - Intra-procedural bleeding
  - Early (<24h) and delayed (≥24h post EMR) post-procedural bleeding
  - Perforation
  - Post-Polypectomy Syndrome
  - Hospital admissions for any post-procedural clinically relevant complication

The secondary endpoints were:

Sydney Resection Quotient: calculated by dividing the lesion size (in mm) by the number of resections required to remove the lesion
Injected volume needed to provide an initial lift
Number of re-injections
Number of resection pieces
Ease of use, rated on a 5-point visual analog scale for: very easy, easy, neutral, difficult and very difficult
Proportion of subjects with en bloc resection
Number of single session complete removal of lesions
Need for additional treatment modality for coagulation, avulsions or ablation

Cosmo Pharmaceuticals CEO, Alessandro Della Chà said that the results of this trial clearly prove that Eleview is a substantial improvement over the saline solution. They are very pleased that they can now start marketing this unique product in the US market through their subsidiary Aries and provide endoscopists in the USA with a unique medical device that will make it possible for them to work faster and more efficiently than before with the only commercially available FDA cleared device.