Nuvilex contracts with Austrianova for cGMP-compliant Cell-in-a-Box encapsulation of cells for clinical trials

A manufacturing agreement that covers all aspects of the production of the encapsulated live cells has been signed by Nuvilex and Austrianova.

An initial payment has been made by Nuvilex to Austrianova as part of a set-up fee to encapsulate the live cells required by Nuvilex for use in its clinical trials. Austrianova was contracted to perform the encapsulation because it developed and matured the entire Cell-in-a-Box cellulose-based live-cell encapsulation process.

Austrianova is considered the world’s foremost expert in this unique and proprietary technology.

The Cell-in-a-Box encapsulation of live cells capable of converting the anticancer prodrug ifosfamide into its cancer-killing form will be performed at Austrianova’s manufacturing facilities being established in Thailand.

The cells that will be encapsulated are those that result from the cell cloning currently underway by Nuvilex at Inno Biologics’ facilities in Malaysia. The capsules containing the live cancer prodrug-activating cells will be implanted in patients with advanced, inoperable pancreatic cancer and, together with ifosfamide, will form Nuvilex’s novel treatment for this deadly disease.

In addition, the encapsulated cells will be used in connection with Nuvilex’s planned clinical trials that are related to pancreatic and other forms of cancer. All steps of the encapsulation process will strictly adhere to cGMP-standards.

Nuvilex CEO and president Kenneth L. Waggoner noted the signing of the manufacturing agreement with Austrianova for the cGMP-compliant encapsulation of the live cells that will be used in the company’s late-phase clinical trials in patients with advanced, inoperable pancreatic cancer and for other newly planned clinical trials represents an indispensable step as Nuvilex continues to prepare for conducting these essential trials.

"Austrianova is the only company in the world with the ‘in-house’ knowledge to perform the cellulose-based live-cell encapsulation process known as ‘Cell-in-a-Box®’. We are very pleased that Professor Dr. Walter H. Günzburg and Dr. Brian Salmons, who developed the Cell-in-a-Box® technology, have agreed to work closely with us in our endeavors," Waggoner added.